Prothena Partners Present Data Supporting Next Generation Treatments for Parkinson’s and Alzheimer’s Disease at AD/PD™ 2026




Prothena Partners Present Data Supporting Next Generation Treatments for Parkinson’s and Alzheimer’s Disease at AD/PD™ 2026

DUBLIN–(BUSINESS WIRE)–$PRTA #Prothena–Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, today announced partner presentations on clinical updates from prasinezumab for the treatment of Parkinson’s disease and BMS-986446 for the treatment of Alzheimer’s disease at the International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD™ 2026) in Copenhagen, Denmark, and online.

Roche Presentations on Prasinezumab for the Potential Treatment of Parkinson’s Disease

Industry Symposium – Pathways to Progress: Exploring Innovations in AD and PD for Future Practice

• Chair: Malú G. Tansey, Ph.D., Indiana University School of Medicine Stark Neuroscience Institute
• Date: Tuesday March 17, 2026

This symposium reviewed the evolving understanding of the molecular pathophysiology and disease heterogeneity across Alzheimer’s disease (AD) and Parkinson’s disease (PD). Explored current and emerging treatment pathways, e.g. alpha-synuclein, amyloid-beta and neuroinflammation; including diagnostics, biomarkers and therapeutics. Considered how the advancing understanding of AD and PD informs innovative clinical development approaches and clinical practice.

Oral Presentation – Modeling Parkinson’s Disease Progression to Quantify Long-Term Treatment Effects via the Concept of ‘Time Saved’

• Presenter: Benjamin Ribba, Roche
• Date: Thursday March 19, 2026

The comparison of PASADENA open-label extension (OLE) data with PPMI-based model predictions supports potential disease-modifying efficacy with an estimated two years of ‘time saved’ providing an intuitive measure of long-term benefit. The observed PASADENA OLE outcomes consistently deviated from the model-predicted progression, suggesting a sustained treatment effect. On average, participants were approximately two years less advanced in disease severity five years after the start of the trial compared to the virtual comparator.

Oral Presentation – Prasinezumab in Early-Stage Parkinson’s Disease: Additional Data from the PADOVA Study

• Presenter: Tania Nikolcheva, M.D., Ph.D., Roche
• Date: Saturday March 21, 2026

Longer term data from the PADOVA OLE study in early-stage PD showed a sustained effect of prasinezumab in slowing Parkinson’s progression on top of effective symptomatic therapies. The totality of the evidence suggests a possible clinical benefit of prasinezumab and informed the initiation of the Phase III PARAISO study.

Poster Presentation – Prasinezumab’s Impact on Neuromelanin- and Iron-Sensitive MRI Biomarkers in Parkinson’s Disease: Findings from the PADOVA Phase IIb Study

Exploratory biomarker analysis of PADOVA suggests that prasinezumab is biologically active. This is supported by imaging biomarkers crucial to PD pathology, showing a slowing in the progressive loss of neuromelanin signal in substania nigra pars compacta and reduced iron accumulation in the putamen.

Poster Presentation – Sustained Effect on Prasinezumab on Parkinson’s Disease Motor Progression in the Open-Label Extension of the PASADENA Trial, 5-Year Update

At Year 5, the combined PASADENA arm (delayed- and early-start groups) showed less disease progression compared to the PPMI cohort. This lower progression was observed across multiple measures.

Poster Presentation – Digital Health Technology Detects Group Differences in Practically-Defined OFF L-DOPA State: Results of PADOVA Phase IIb Study of Prasinezumab

Post-hoc Digital Health Technology analyses showed consistent trends favoring prasinezumab in digital data collected in the practically-defined OFF L-DOPA state, in line with the PASADENA Phase 2a Simple Sum digital finding and clinical PADOVA readout.

Bristol Myers Squibb Presentation on BMS-986446 for the Potential Treatment of Alzheimer’s Disease

Oral Presentation – Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BMS-986446 in Healthy Participants, Including Those of Japanese Ethnicity

• Presenter: Ilena George, M.D., Bristol Myers Squibb
• Date: Saturday March 21, 2026

Single-dose BMS-986446 was safe and well tolerated in all participants, including those of Japanese ethnicity. Plasma exposure of BMS-986446 increased dose proportionally. No anti-drug antibodies were detected. These results support BMS-986446 dosing in ongoing clinical studies without adjustments for Japanese ethnicity.

About Prasinezumab

Prasinezumab is an investigational monoclonal antibody designed to bind aggregated alpha-synuclein and thereby reduce neuronal toxicity. By reducing the build-up of alpha-synuclein protein in the brain, prasinezumab can potentially prevent further accumulation and spreading between cells, which may slow progression of the disease.

About Parkinson’s Disease

Parkinson’s disease is a chronic, progressive and debilitating neurodegenerative disease characterized by the gradual loss of neurons that make dopamine and other nerve cells. Today, Parkinson’s disease affects over 10 million people worldwide. The prevalence of Parkinson’s disease is increasing, and it has become one of the fastest-growing neurological disorders. Currently, symptomatic treatments that effectively alleviate motor symptoms are available. However, no therapies slow down or stop the clinical progression of Parkinson’s disease.

About BMS-986446

BMS-986446 is a humanized monoclonal antibody that targets multiple domains of the microtubule binding region of tau, a highly pathogenic tau fragment associated with neurofibrillary tangle formation and cognitive decline in Alzheimer’s disease. BMS-986446 binds to specific regions of the tau protein (R1–R3 within the microtubule-binding domain) to stop cell-to-cell spread of tau and tau uptake into cells. It also activates microglia—the brain’s immune cells—through its Fc receptor function, promoting the clearance of tau via phagocytosis.

About Alzheimer’s Disease

Alzheimer’s disease is a progressive, multifaceted and devastating neurodegenerative disease and the most common type of dementia in adults. Changes in the brain disrupt communication between neurons, impacting memory, cognition and behavior. As a result, Alzheimer’s disease has a significant impact on the day-to-day lives of those it directly affects, as well as on their families, caregivers and friends, resulting in considerable shifts in interpersonal relationships. There remains a critical need for disease-modifying therapies that can slow or delay the progression of Alzheimer’s disease as well as therapies that manage and ease neurobehavioral symptoms.

About Prothena

Prothena Corporation plc is a late-stage clinical biotechnology company with expertise in protein dysregulation with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including Parkinson’s disease, ATTR amyloidosis with cardiomyopathy, Alzheimer’s disease, Amyotrophic lateral sclerosis (ALS) and a number of other neurodegenerative diseases. Prothena is developing and applying CYTOPE^®, a novel technology that incorporates a cell-internalizing domain to drive efficient cytosolic delivery with highly specific macromolecular effectors. For more information, please visit the Company’s website at www.prothena.com and follow the Company on X (formerly Twitter) @ProthenaCorp.

Forward-Looking Statements

This press release contains forward-looking statements. These statements relate to, among other things, the treatment potential, designs, proposed mechanisms of action, and potential administration of prasinezumab and BMS-986446; and the continued advancement of our preclinical and clinical pipeline, including the potential and advancement of CYTOPE. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, as well as those described in the “Risk Factors” sections of our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 27, 2026, and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. We undertake no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events, or changes in our expectations.

Contacts

Mark Johnson, CFA

Senior Vice President, Head of Investor Relations and Corporate Communications

650-837-8550

IR@prothena.com
Media@prothena.com

Omeros Announces Upcoming Presentation at EBMT 2026 Highlighting Advances in TA-TMA Treatment




Omeros Announces Upcoming Presentation at EBMT 2026 Highlighting Advances in TA-TMA Treatment

SEATTLE–(BUSINESS WIRE)–Omeros Corporation (NASDAQ: OMER) today announced that it will host an industry session at the 52^nd Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) on March 22, 2026, from 2:30pm – 4pm CET in Madrid, Spain. The session, titled “Advances in TA-TMA Treatment: Evaluating the Role of a Novel Targeted Therapy,” will be co-chaired by Rafael Duarte, MD, PhD, Hospital Universitario Puerta de Hierro Majadahonda, and Mohamad Mohty, MD, PhD, Hôpital Saint-Antoine, AP-HP, and will feature speakers Miguel-Angel Perales, MD, Memorial Sloan Kettering Cancer Center, and Michelle L. Schoettler, MD, MS, Children’s Healthcare of Atlanta.

The EBMT Annual Meeting is a key event for professionals in transplantation and cellular therapy, bringing together stakeholders from around the world.

About Omeros Corporation

Omeros is an innovative, commercial-stage biotechnology company that discovers and develops first-in-class protein and small-molecule therapeutics for large-market and orphan indications, with particular emphasis on complement-mediated diseases, cancers, and addictive or compulsive disorders. Omeros’ lead lectin pathway inhibitor YARTEMLEA^® (narsoplimab-wuug), which inhibits the pathway’s effector enzyme MASP-2, is FDA-approved and commercially available in the U.S. for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients aged two years and older. A marketing authorization application for YARTEMLEA in TA-TMA is currently under review at the European Medicines Agency. OMS1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials.

Under a recently announced asset purchase and licensing agreement, Novo Nordisk acquired global rights to zaltenibart (formerly OMS906), a MASP-3 inhibitor in clinical development for PNH and other alternative pathway indications, along with associated intellectual property and related assets. Omeros’ pipeline also includes OMS527, a phosphodiesterase 7 inhibitor in clinical development for cocaine use disorder that is fully funded by the National Institute on Drug Abuse, as well as a growing portfolio of novel molecular and cellular oncology programs. For more information about Omeros and its programs, visit www.omeros.com.

Contacts

Jennifer Cook Williams

Cook Williams Communications, Inc.

Investor and Media Relations

IR@omeros.com

Curi Bio and Battelle Announce Strategic Partnership to Accelerate the Adoption of New Approach Methods in Neuromuscular Pharmacology




Curi Bio and Battelle Announce Strategic Partnership to Accelerate the Adoption of New Approach Methods in Neuromuscular Pharmacology

SEATTLE & COLUMBUS, Ohio–(BUSINESS WIRE)–#BioTech–Curi Bio, a world leader in human-relevant 3D tissue technology, and Battelle, the world’s largest independent nonprofit research and development organization, today announced a strategic partnership to commercialize next-generation Neuromuscular Junction (NMJ) assay technology. This collaboration combines Curi Bio’s innovative microphysiological systems with Battelle’s extensive GLP-ready infrastructure to offer a transformative, human-relevant alternative to traditional pharmacology methodologies.

Advancing the 3Rs: At the core of this partnership is a commitment to the 3Rs (Replacement, Reduction, and Refinement). By providing functional, 3D human-tissue models that replicate complex neuromuscular physiology, the Curi Bio-Battelle partnership enables researchers to replace long-standing animal-based bioassays with highly reproducible new approach methods.

Innovation Meets Infrastructure: The partnership leverages Curi Bio’s proven Mantarray™ ecosystem which provides real-time functional readouts of human heart, muscle, and neuromuscular junction contractility. By offering a ready-to-use commercial solution for BoNT potency, Curi Bio enables customers to generate data with their specific drug products, accelerating the adoption of human-relevant, cell-based NMJ assays. Battelle serves as the scale and integration partner, offering the regulatory expertise and specialized laboratory facilities necessary to implement these technologies across global drug substance and medical countermeasure (MCM) development pipelines.

“We are excited to partner with Battelle to scale our technology for applications with significant commercial and governmental utility,” said Elliot Fisher, Chief Business Officer and Co-Founder of Curi Bio. “With the FDA’s new Non-Animal Models (NAMs) guidance and the NIH’s $150M commitment to human-relevant alternatives, the regulatory landscape is clearly shifting toward the scalable platforms we’ve built. This partnership is a high priority as we set the new gold standard for potency testing with our human-relevant NMJ assay and position Curi Bio at the forefront of animal-free drug development.”

“The partnership shows how technology innovators and technology integrators can combine strengths to accelerate real-world adoption of new approach methods,” said Bob Moyer, Research Leader at Battelle. “Battelle brings R&D scale, regulatory expertise, and world-class laboratory capabilities, while Curi Bio contributes cutting-edge technology and transformative human relevant models—together enabling innovation to translate into practical impact.”

About Curi Bio: Curi Bio provides a suite of human-relevant 3D tissue models and instrumentation to accelerate drug discovery and development. By integrating human iPSCs, tissue engineering, and automated data analysis, Curi Bio helps researchers build more predictive models of human disease. For more information, visit www.curibio.com or contact Marketing Director Jacqueline De Rose at jacqueline@curibio.com.

About Battelle: Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. For more information, visit www.battelle.org or contact Media Relations Director Katy Delaney at (614) 424-7208 or at delaneyk@battelle.org.

Contacts

Curi Bio

Jacqueline De Rose

Marketing Director

jacqueline@curibio.com
www.curibio.com

Battelle

Katy Delaney

Media Relations Director

(614) 424-7208

delaneyk@battelle.org
www.battelle.org

Bristol Myers Squibb Transforms the Classical Hodgkin Lymphoma Treatment Paradigm with Expanded U.S. and EMA Approvals for Opdivo® (nivolumab)




Bristol Myers Squibb Transforms the Classical Hodgkin Lymphoma Treatment Paradigm with Expanded U.S. and EMA Approvals for Opdivo® (nivolumab)

In the U.S., FDA approval establishes Opdivo in combination with doxorubicin, vinblastine and dacarbazine (AVD) as the first immunotherapy combination approved for adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin Lymphoma (cHL)

With approval in the EU, Opdivo in combination with brentuximab vedotin is now the first immunotherapy combination approved to treat certain pediatric and adult patients with relapsed or refractory cHL

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #CheckMate—Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo^® (nivolumab) has received approval for two new classical Hodgkin Lymphoma (cHL) indications in the U.S. and the European Union (EU). The U.S. Food and Drug Administration (FDA) granted approval of Opdivo in combination with doxorubicin, vinblastine and dacarbazine (AVD) for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV cHL.¹ In the EU, the European Commission (EC) approved Opdivo in combination with brentuximab vedotin for the treatment of children 5 years of age and older, adolescents, and adults up to 30 years of age with relapsed or refractory cHL after one prior line of therapy.²

“These approvals represent a defining moment for people living with classical Hodgkin Lymphoma,” said Monica Shaw, MD, Senior Vice President of Oncology Commercialization. “In the U.S., we are particularly proud that Opdivo in combination with AVD now stands as an immunotherapy combination available for adults and pediatric patients, ages 12 and older, with previously untreated advanced disease.¹ Concurrently, in the EU, Opdivo in combination with brentuximab vedotin has also achieved a milestone as the first immunotherapy combination for certain relapsed or refractory patients.² These milestones reflect our continued commitment to advancing science that meaningfully improves the lives of patients and families worldwide.”

The U.S. approval is based on the Phase 3 SWOG 1826 (CA2098UT) study, evaluating Opdivo in combination with AVD for adult and pediatric (12 years and older) patients with previously untreated Stage III or IV cHL.³ A submission based on SWOG 1826 study is also currently under evaluation by the European Medicines Agency (EMA).

Opdivo and Yervoy are associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions, other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials. Please see the Important Safety Information section below.

The EU approval is based on the Phase 2 CheckMate -744 (CA209744) study, evaluating Opdivo in combination with brentuximab vedotin for the treatment of children 5 years of age and older, adolescents and adults up to 30 years of age with relapsed or refractory cHL after one prior line of therapy.⁴

“For decades, treatment approaches in classical Hodgkin Lymphoma have presented significant challenges, both for newly diagnosed patients and those facing relapse,”^5,6 said Alex Herrera, M.D., Chief of Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, City of Hope National Medical Center. “In the U.S., the nivolumab-based combination for patients with previously untreated Stage III or IV cHL demonstrated improved progression-free survival compared with standard of care, BV-AVD. The SWOG 1826 study provides data for frontline use of this immunotherapy-based regimen.”⁵

“The availability of another treatment option for people living with certain types of Hodgkin lymphoma can make a real difference,” says Gwen Nichols, M.D., Chief Medical Officer of Blood Cancer United. “Each new FDA-approved therapy brings renewed hope for patients and their families, and advances like this one signal meaningful progress in improving outcomes for people facing this disease.”⁵

SWOG 1826 (Study CA209-8UT) demonstrated a 58% reduction in the risk of disease progression or death as determined per investigator (Hazard Ratio [HR] 0.42; 95% Confidence Interval [CI] 0.27–0.67; P=<0.0001). The trial demonstrated a statistically significant improvement in the primary endpoint of progression-free survival (PFS) for patients who received Opdivo in combination with AVD, which reflect a median follow-up of 13.7 months in the intention to treat population. After a median follow-up of 36.7 months, the median overall survival (OS) had not been reached in either treatment arm with a total of 26 deaths: 9 (1.8%) deaths in the Opdivo in combination with AVD arm and 17 (3.4%) deaths in the BV plus AVD arm.⁷

Select Safety Profile from SWOG 1826 (CA2098UT)

Serious adverse reactions occurred in 39% of patients receiving Opdivo in combination with doxorubicin, vinblastine, and dacarbazine (AVD) (n=490). The most frequent serious adverse reactions reported in ≥5% patients who received Opdivo in combination with AVD were peripheral neuropathy (41%), neutropenia (7%), pyrexia (7%), febrile neutropenia (6%), and nausea (6%). Fatal adverse reactions occurred in 3 patients (0.6%), all from sepsis. The most common adverse reactions were nausea (70%), neutropenia (61%), fatigue (59%), anemia (51%), constipation (49%), leukopenia (44%), musculoskeletal pain (42%), transaminases increase (41%), vomiting (33%), and stomatitis (30%).

About SWOG 1826 (CA2098UT)

SWOG 1826, also known as CA2098UT, is a randomized, multicenter, Phase 3 study evaluating Opdivo^® (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for adult and pediatric (12 years and older) patients with previously untreated Stage III or IV classical Hodgkin Lymphoma (cHL).³ The study is designed to assess progression-free survival as the primary endpoint, with key secondary endpoints that include overall survival and other measures of efficacy and safety.³ The SWOG 1826 study is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) under a Cooperative Research and Development Agreement with Bristol Myers Squibb and conducted in the NCI National Clinical Trials Network (NCTN) led by the SWOG Cancer Research Network in collaboration with the Children’s Oncology Group (COG).³ It is the largest cHL study conducted in the NCTN.³ Bristol Myers Squibb co-sponsored the study and supplied Opdivo to the NCI through a Cooperative Research and Development agreement.³

About CheckMate -744 (CA209744)

CheckMate -744, also known as CA209744, is a risk-based, response-adapted, open-label, Phase 2 study investigating Opdivo^® (nivolumab) in combination with brentuximab vedotin for children, adolescents, and young adults (between 5 and 30 years old) with CD30+ classical Hodgkin lymphoma (cHL) that has relapsed or is refractory after first-line treatment.⁴ The study aimed to determine the safety and efficacy of nivolumab plus brentuximab vedotin, with a subsequent treatment arm of brentuximab vedotin plus bendamustine for patients with a suboptimal response.⁴ The trial evaluated the overall effectiveness and tolerability of these regimens in this younger, relapsed/refractory patient population.⁴

Data from the Phase 2 CheckMate -744 study were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2023 and demonstrated that Opdivo in combination with brentuximab vedotin achieved high complete metabolic response rates in children, adolescents, and young adults with relapsed or refractory cHL after one prior line of therapy.⁶ The response-adapted regimen enabled the majority of patients to proceed to consolidation while maintaining a manageable safety profile.⁶ Responses were durable at follow-up, supporting the potential of Opdivo-based, chemotherapy-sparing approaches in this population.⁶

About Classical Hodgkin Lymphoma

Hodgkin lymphoma (HL), also known as Hodgkin disease, is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system.⁸ HL is the most common cancer diagnosed in adolescents (ages 15-19).⁹ It is most often diagnosed in early adulthood (ages 20-39) and late adulthood (older than 55 years of age).¹⁰ Classical Hodgkin lymphoma is the most common type of HL, accounting for 95% of cases.¹¹ Despite progress in frontline therapy, advanced-stage HL still carries a substantial risk of relapse, highlighting the need for innovative approaches.¹⁰

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients.

The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

INDICATIONS

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.

OPDIVO® is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.

OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

OPDIVO® (nivolumab) in combination with platinum-doublet chemotherapy, is indicated for neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent OPDIVO® as adjuvant treatment after surgery.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-authorized test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT.

OPDIVO® (nivolumab), in combination with doxorubicin, vinblastine, and dacarbazine (AVD), is indicated for the treatment of adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma (cHL).

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.

OPDIVO® (nivolumab), in combination with cisplatin and gemcitabine, is indicated for the first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (CRC).

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1).

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (≥1).

IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

Immune-Mediated Pneumonitis

OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis.

Immune-Mediated Colitis

OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%).

Immune-Mediated Hepatitis and Hepatotoxicity

OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%).

OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% (35/320) of patients.

Immune-Mediated Endocrinopathies

OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.

In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456) of patients, including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%).In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, adrenal insufficiency occurred in 7% (48/666) of patients, including Grade 4 (0.

Contacts

Bristol Myers Squibb
Media Inquiries:
media@bms.com

Investors:
investor.relations@bms.com

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Pfizer Recommends Shareholders Reject the Mini-Tender Offer by Tutanota LLC




Pfizer Recommends Shareholders Reject the Mini-Tender Offer by Tutanota LLC

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced that it has received notice of an unsolicited mini-tender offer by Tutanota LLC (“Tutanota”) to purchase up to 1 million shares of Pfizer common stock at a price of $32.00 per share in cash. The offer price of $32.00 per share is conditioned on, among other things, the closing price per share of Pfizer common stock exceeding $32.00 per share on the last trading day before the offer expires. This means that unless this condition is waived by Tutanota, Pfizer shareholders who tender their shares in the offer will receive a below-market price. The offer states that as of the date of the offer, Tutanota expects to extend the offer until the market price of Pfizer’s common stock exceeds the offer price. The offer is for approximately 0.02% of the shares of Pfizer common stock outstanding as of the March 9, 2026 offer date.

Pfizer recommends that shareholders do not tender their shares in response to Tutanota’s offer because the offer requires that the closing stock price for Pfizer’s common stock exceed the offer price, and it is subject to numerous additional conditions, including Tutanota obtaining financing for the offer, which Tutanota states it does not currently have. There is no guarantee the conditions of the offer will be satisfied. Under the terms of the offer, Tutanota can extend the offer and delay payment beyond the expiration date of the offer, currently scheduled for 5:00 p.m., New York City time, on Monday, April 13, 2026. The offer states that Tutanota intends to extend the offer until Pfizer’s stock price exceeds $32.00 per share. Per the terms of the offer, any shareholders who tender (or have already tendered) their shares can withdraw them prior to the expiration of the offer, currently scheduled for April 13, 2026, in accordance with the offering documents.

Pfizer does not endorse Tutanota’s unsolicited mini-tender offer and is not affiliated or associated in any way with Tutanota, its mini-tender offer or its offer documentation.

Tutanota has made many similar mini-tender offers for shares of other companies. Mini-tender offers seek to acquire less than 5 percent of a company’s shares outstanding, thereby avoiding many disclosure and procedural requirements of the U.S. Securities and Exchange Commission (“SEC”) that apply to offers for more than 5 percent of a company’s shares outstanding. As a result, mini-tender offers do not provide investors with the same level of protections as provided for larger tender offers under U.S. securities laws.

The SEC has cautioned investors that some bidders making mini-tender offers at below-market prices are “hoping that they will catch investors off guard if the investors do not compare the offer price to the current market price.” More on the SEC’s guidance to investors on mini-tender offers is available at SEC.gov | Mini-Tender Offers: Tips for Investors.

Pfizer urges investors to obtain current market quotations for their shares, to consult with their broker or financial advisor and to exercise caution with respect to Tutanota’s offer. Pfizer recommends that stockholders who have not responded to Tutanota’s offer take no action. Stockholders who have already tendered their shares may withdraw them at any time prior to the expiration of the offer, in accordance with Tutanota’s offer documentation. The offer is currently scheduled to expire at 5:00 p.m., New York City time, on April 13, 2026. Tutanota may extend the offering period at its discretion.

Pfizer encourages brokers and dealers, as well as other market participants, to review the SEC’s letter regarding broker-dealer mini-tender offer dissemination and disclosure at Letter to SIA re: Broker-Dealer Mini-Tender Offer Dissemination and Disclosures and the NASD Notice to Members 99-53 issued in July 1999 regarding guidance to members forwarding mini-tender offers to their customers, which can be found at https://www.finra.org/sites/default/files/NoticeDocument/p004221.pdf.

Pfizer requests that a copy of this news release be included with all distributions of materials relating to Tutanota’s mini-tender offer related to shares of Pfizer common stock.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Category: Financial

Contacts

Media Contact:
PfizerMediaRelations@Pfizer.com

Investor Contact:
IR@Pfizer.com

Imaginostics Receives Siemens Healthineers Letter of Support as Companies Advance Quantitative MRI Dialogue




Imaginostics Receives Siemens Healthineers Letter of Support as Companies Advance Quantitative MRI Dialogue

ORLANDO, Fla.–(BUSINESS WIRE)–#Alzheimers–Imaginostics, Inc. today announced that it has received a Letter of Support from Siemens Healthineers in connection with ongoing exploratory discussions regarding potential collaboration in quantitative MRI and imaging biomarkers.

As part of these discussions, Imaginostics and Siemens Healthineers intend to continue dialogue concerning potential technical and commercial pathways for Imaginostics’ envisioned ImagiView™ and ImagiSight™ offerings and their potential applications for Siemens Healthineers MAGNETOM MRI systems.

“Quantitative MRI and imaging biomarkers have the potential to make imaging more objective, reproducible, and clinically actionable,” said Dr. Codi Gharagouzloo, Scientific Founder & CSO. “This Letter of Support marks an important milestone for Imaginostics, and we look forward to continuing the technical and commercial dialogue with Siemens Healthineers,” added Valerie Gharagouzloo, Co-Founder and CEO.

The companies plan to continue evaluating potential opportunities within their respective technical, development, regulatory, and commercial frameworks. Any future collaboration or commercial activity would remain subject to further discussions, internal approvals, and definitive agreements.

About Imaginostics

Imaginostics is building vascular intelligence from the ground up through precision diagnostic and prognostic imaging. The company is developing a first-of-its-kind quantitative MRI technology designed to enable AI-powered, data-driven digital twin insights aimed at detecting complex diseases earlier and enabling more personalized care. By transforming imaging into quantitative biological insights, Imaginostics seeks to support a shift from reactive to preventative healthcare and contribute to improved outcomes across a lifetime. Vascular Health for Life™.

The company is currently in a pre-FDA stage and is not yet providing clinical services.

Contacts

Valerie Gharagouzloo, CEO, media@imaginostics.com

ImmunityBio Announces Approval in Macau SAR, China for ANKTIVA® in BCG-Unresponsive NMIBC with CIS ± Papillary Tumors




ImmunityBio Announces Approval in Macau SAR, China for ANKTIVA® in BCG-Unresponsive NMIBC with CIS ± Papillary Tumors

• Macau SAR, China regulator grants approval for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in patients with BCG-unresponsive NMIBC with CIS ± papillary tumors
• Authorization follows a reliance-based review referencing prior FDA and EMA decisions
• First ANKTIVA authorization in Asia, supporting ongoing global expansion across 34 countries and territories

CULVER CITY, Calif.–(BUSINESS WIRE)–ImmunityBio, Inc. (NASDAQ: IBRX), today announced that the Pharmaceutical Administration Bureau (ISAF) of the Macau Special Administrative Region of the People’s Republic of China has granted regulatory approval for ANKTIVA® (nogapendekin alfa inbakicept-pmln).

The approval establishes ANKTIVA’s initial presence in Asia and reflects the Company’s strategy to expand global access through reliance-based regulatory pathways. In Macau, ANKTIVA is approved in combination with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) ± papillary tumors, consistent with its approved use in the United States.

The authorization was granted following a review that considered prior regulatory decisions by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), in accordance with applicable local requirements.

“This approval in Macau reflects the strength of the clinical and regulatory foundation supporting ANKTIVA in BCG-unresponsive NMIBC CIS, with or without papillary tumors,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “The data from QUILT 3.032, published in NEJM Evidence and The Journal of Urology, demonstrate durable responses in this disease setting. As we continue to work with regulatory authorities, our focus remains on enabling global access to an immunotherapy designed to activate NK and T-cell function and address the underlying immune deficit in bladder cancer.”

This approval in Macau represents the first authorization for ANKTIVA in Asia. The Company continues to engage with additional health authorities across the region as part of its international regulatory strategy.

“This authorization marks an important step in establishing ANKTIVA in Asia and advancing our broader international expansion strategy,” said Richard Adcock, President and CEO of ImmunityBio. “We are engaging with additional health authorities across the Asia-Pacific region and, in parallel, beginning to prepare for potential commercial distribution, recognizing there is still meaningful work ahead as we pursue further regulatory authorizations. Our focus is on executing this expansion in a disciplined manner, building on our existing approvals to support long-term global access for patients.”

About ANKTIVA®

ANKTIVA® (nogapendekin alfa inbakicept-pmln) is a first-in-class interleukin-15 (IL-15) receptor agonist designed to activate and proliferate natural killer (NK) cells and CD8+ T cells. In the QUILT-3.032 study in patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors, ANKTIVA in combination with BCG demonstrated a complete response rate of 71%, with a median duration of response of 26.6 months.

About ImmunityBio

ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield^™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist, ANKTIVA^® (nogapendekin alfa inbakicept). Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by a portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding ImmunityBio’s regulatory activities in Macau and other jurisdictions; the potential pursuit, timing, and outcome of additional regulatory submissions and authorizations; the Company’s plans for potential commercial distribution; and its broader international expansion strategy for ANKTIVA.

These forward-looking statements are based on the Company’s current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those described herein. Such risks and uncertainties include, among others, the determinations of regulatory authorities, including ISAF, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global health authorities; the possibility that additional data, analyses, or clinical studies may be required; risks related to manufacturing, supply, and distribution; and other factors affecting the Company’s business.

Additional information regarding these and other risks can be found under the heading “Risk Factors” in ImmunityBio’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission, as well as in subsequent filings with the SEC, which are available at www.sec.gov. ImmunityBio cautions you not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release, and the Company undertakes no obligation to update any forward-looking statements except as required by law.

Contacts

ImmunityBio Contacts:

Investors

Hemanth Ramaprakash, PhD, MBA

ImmunityBio, Inc.
+1 858-746-9289

Hemanth.Ramaprakash@ImmunityBio.com

Media

Sarah Singleton

ImmunityBio, Inc.
+1 415-290-8045

Sarah.Singleton@ImmunityBio.com

Incyte to Highlight Late-Breaking Hidradenitis Suppurativa Data at the 2026 American Academy of Dermatology (AAD) Annual Meeting




Incyte to Highlight Late-Breaking Hidradenitis Suppurativa Data at the 2026 American Academy of Dermatology (AAD) Annual Meeting

– New, late-breaking 54-week data for povorcitinib in hidradenitis suppurativa (STOP-HS1 & STOP-HS2) to be highlighted

– Featured abstracts for ruxolitinib cream (Opzelura^®) and povorcitinib include multiple ePosters in atopic dermatitis, hidradenitis suppurativa and vitiligo

WILMINGTON, Del.–(BUSINESS WIRE)–$INCY #AAD2026–Incyte (Nasdaq:INCY) today announced that data from key programs in its Inflammation and Autoimmunity (IAI) franchise will be presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting, to be held March 27 – 31, 2026, in Denver.

“At AAD 2026, we are presenting late‑breaking 54-week results from the Phase 3 STOP‑HS program evaluating povorcitinib in hidradenitis suppurativa (HS),” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation and Autoimmunity, Incyte. “These data provide longer term evidence of the safety and efficacy of povorcitinib in HS patients and further strengthen the significant growth potential of our Inflammation and Autoimmunity franchise.”

Details on key data presentations at AAD include:

Late-Breaking Oral Presentations

Hidradenitis Suppurativa

Povorcitinib in Patients With Moderate to Severe Hidradenitis Suppurativa: 54-Week Efficacy and Safety Results From the STOP-HS1 & STOP-HS2 Phase 3 Studies

(Session: S034 – Late-Breaking Research: Session 2. Saturday, March 28, 2026, 1:00 p.m. MT)

ePoster Exhibits

Atopic Dermatitis

Ruxolitinib Cream Improves Patient-Reported Outcomes in Adults With Moderate Atopic Dermatitis (TRuE-AD4)

​(Abstract #: 75312)

Ruxolitinib Cream Is Efficacious in Adults With Moderate Atopic Dermatitis Regardless of Baseline Disease Severity and Previous Medication History

​(Abstract #: 70667)

Hidradenitis Suppurativa

Povorcitinib for Moderate-to-Severe Hidradenitis Suppurativa: Week 24 Interim Phase 3 Results in Anti-TNF-Experienced Patients

(Abstract #: 75195)

Physician Perspectives on Diagnosis and Treatment of Hidradenitis Suppurativa: Results From the Global HERALD (Hidradenitis Suppurativa Experiences in the Real World) Survey

​(Abstract #: 75265)

Disease Burden and Treatment History of Hidradenitis Suppurativa: Patient Perspectives From the Global HERALD (Hidradenitis Suppurativa Experiences in the Real World) Survey

​(Abstract #: 75268)

Vitiligo

Association Between Repigmentation and Quality of Life Among Patients With Vitiligo Treated With Ruxolitinib Cream in the TRuE-V Studies

​(Abstract #: 75247)

Real-World Factors Influencing Vitiligo Care: Insights From a Patient Survey Assessing the Use of Ruxolitinib Cream

​(Abstract #: 75258)

More information regarding the 2026 AAD Annual Meeting can be found at: https://www.aad.org/member/meetings-education/am26/education.

About Povorcitinib

Povorcitinib (INCB54707) is an oral small-molecule JAK1 selective inhibitor currently in Phase 3 clinical trials for HS, vitiligo and prurigo nodularis (PN), as well as a Phase 2 trial for asthma.

About Opzelura^® (ruxolitinib) Cream

Opzelura^® (ruxolitinib) cream, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. FDA for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended.

In Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

Incyte has worldwide rights for the development and commercialization of Opzelura.

Opzelura is a registered trademark of Incyte.

About Incyte^®

Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation and Autoimmunity.

To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.

Incyte Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from Incyte’s clinical development pipeline and the potential for povorcitinib to provide a safe and effective treatment option for HS and further strengthen the significant growth potential of Incyte’s Inflammation and Autoimmunity franchise, contain predictions, estimates and other forward-looking statements.

These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA, EMA, and other regulatory authorities; the efficacy or safety of Incyte’s products; the acceptance of Incyte’s products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on form 10-K for the year ended December 31, 2025. Incyte disclaims any intent or obligation to update these forward-looking statements.

Contacts

Media
media@incyte.com

Investors
ir@incyte.com

LEO Pharma to Present 17 Scientific Abstracts at AAD 2026 Highlighting Real‑World Evidence, Long‑Term Outcomes and Patient Experience Across Multiple Dermatological Conditions




LEO Pharma to Present 17 Scientific Abstracts at AAD 2026 Highlighting Real‑World Evidence, Long‑Term Outcomes and Patient Experience Across Multiple Dermatological Conditions

MADISON, N.J.–(BUSINESS WIRE)–LEO Pharma A/S, a global leader in medical dermatology, today announced it will present 17 scientific posters at the 2026 American Academy of Dermatology (AAD) Annual Meeting (March 27-31, Denver, Colorado), highlighting new real-world and clinical data across its medical dermatology portfolio and pipeline for inflammatory skin diseases.

Key data to be presented by LEO Pharma at AAD 2026 include:

• ADBRY^® (tralokinumab) 12‑month real‑world data from the TRACE study evaluating the safety and effectiveness of ADBRY among patients with atopic dermatitis (AD), including analyses in patients with hand and foot involvement and patients with skin of color.^1-3
• ANZUPGO^® (delgocitinib) data evaluating outcomes with ANZUPGO cream 20 mg/g in adults with moderate-to-severe chronic hand eczema (CHE), including results across patients with and without prior systemic therapy exposure, further characterizing treatment response in this difficult-to-treat population.⁴
• SPEVIGO^® (spesolimab) long-term data from the EFFISAYIL program evaluating intravenous and subcutaneous SPEVIGO for treatment of GPP flares and characterizing baseline non‑flaring disease phenotype.^5-7

“We’re proud to present LEO Pharma’s largest body of research to date at the AAD Annual Meeting, highlighting new real-world and clinical insights across Atopic Dermatitis, Generalized Pustular Psoriasis and Chronic Hand Eczema,” said Sophie Lamle, EVP, Development at LEO Pharma. “Together, these findings reflect continued advancements in the understanding and management of chronic dermatologic diseases and underscore our ambition to help address critical treatment gaps for patients.”

The company’s full roster of presentations at the 2026 AAD Annual Meeting is listed below.^1-17

About Atopic Dermatitis

Atopic Dermatitis (AD) is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.¹⁸ AD is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.¹⁹ Type 2 cytokines, including IL-13, play an important role in the key aspects of AD pathophysiology.^18-19 Excessive IL-22 production is also known to contribute to the pathogenesis of AD.²⁰

About Generalized Pustular Psoriasis

Generalized Pustular Psoriasis (GPP) is a chronic, heterogeneous, neutrophilic inflammatory disease associated with skin and systemic symptoms that is distinct from plaque psoriasis. GPP is recognized as a separate clinical entity from other forms of psoriasis, with the IL-36 pathway being a key driver of GPP and triggering response to treatment.^21,22 GPP can become life-threatening (mortality rates ranging from 2% to 16%) due to severe complications, such as multisystem organ failure and sepsis requiring urgent hospital care; many GPP patients also suffer from various comorbidities, which contribute to the ongoing burden for the patient and healthcare systems.^23,24 GPP symptoms appear unpredictably and present on a continuum, which greatly impacts a patient’s quality of life, and may cause fear and anxiety over the disease course, as well as long-term impacts on quality of life related to work/school, emotional health, social activities and finances.^24,25

About Chronic Hand Eczema

Chronic Hand Eczema (CHE) is defined as Hand Eczema (HE) that lasts for more than three months or relapses twice or more within a year.²⁶ HE is one of the most common skin disorders of the hands, and in a substantial number of patients it can develop into a chronic condition.²⁷ CHE affects approximately one in ten adults in the U.S.²⁸ It is a fluctuating disease characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on the hands and wrists.²⁶ The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.²⁹

CHE has been shown to cause psychological and functional burdens that impact patient quality of life.^30,31 Individuals living with CHE experience substantial impairment in daily activities, with an average activity impairment of more than 40%.³² Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.³³

About ADBRY^® (tralokinumab)/ADTRALZA^® (tralokinumab)

ADBRY^® (tralokinumab), which is marketed outside of the U.S. under the tradename ADTRALZA^® (tralokinumab), is a high-affinity fully human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms.^34,35 Tralokinumab specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).³⁶

Tralokinumab is approved for the treatment of moderate-to-severe AD in adult and adolescent patients 12 years and older in the European Union, Canada, Great Britain, the United Arab Emirates, South Korea, the U.S., and Saudi Arabia. Tralokinumab is approved for use in adults with moderate- to-severe AD in Switzerland and Japan.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR ADBRY^® (TRALOKINUMAB)

What is ADBRY?

• ADBRY^® (tralokinumab) injection is a prescription medicine used to treat people 12 years of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. ADBRY can be used with or without topical corticosteroids.
• It is not known if ADBRY is safe and effective in children under 12 years of age.

Do not use ADBRY if you are allergic to tralokinumab or to any of its ingredients.

What should I discuss with my healthcare provider before starting ADBRY?

Tell your healthcare provider about all your medical conditions, including if you:

• have eye problems.
• have a parasitic (helminth) infection.
• are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with ADBRY.
• are pregnant or plan to become pregnant. It is not known whether ADBRY will harm your unborn baby. There is a pregnancy exposure registry for women who use ADBRY during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. You or your healthcare provider can get information and enroll you in this registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/.
• are breastfeeding or plan to breastfeed. It is not known whether ADBRY passes into your breast milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use ADBRY?

• See the detailed “Instructions for Use” that comes with ADBRY for information on how to prepare and inject ADBRY and how to properly store and throw away (dispose of) used ADBRY prefilled syringes and autoinjectors.
• Use ADBRY exactly as prescribed by your healthcare provider.
• Your healthcare provider will tell you how much ADBRY to inject and when to inject it.
• ADBRY comes as a single-dose prefilled syringe with needle guard or as an autoinjector.
• ADBRY is given as an injection under the skin (subcutaneous injection).
• If your healthcare provider decides that you or a caregiver can give the injections of ADBRY, you or your caregiver should receive training on the right way to prepare and inject ADBRY. Do not try to inject ADBRY until you have been shown the right way by your healthcare provider. In children 12 years of age and older, it is recommended that ADBRY be given by or under supervision of an adult.
• If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time.
• If you inject too much ADBRY than prescribed, call your healthcare provider or call Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
• Your healthcare provider may prescribe other medicines to use with ADBRY. Use the other prescribed medicines exactly as your healthcare provider tells you to.

What are the possible side effects of ADBRY?

ADBRY can cause serious side effects including:

• Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using ADBRY and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:
  • breathing problems
  • itching
  • skin rash
  • swelling of the face, mouth, and tongue
  • fainting, dizziness, feeling lightheaded (low blood pressure)
  • hives
• Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision.

The most common side effects of ADBRY include:

• upper respiratory tract infections
• Eye and eyelid inflammation, including redness, swelling, and itching
• Injection site reactions
• High count of a certain white blood cell (eosinophilia)

These are not all the possible side effects of ADBRY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please click here for full U.S. Prescribing Information, including Patient Information and Instructions for Use.

About SPEVIGO^® (spesolimab)

SPEVIGO^® (spesolimab) is a humanized, selective antibody that specifically blocks the activation of the IL-36R, a signaling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP.³⁷ It is the first targeted therapy for the treatment of GPP and has been evaluated in the largest clinical program specifically for the treatment of patients with GPP.^38-40

INDICATION AND IMPORTANT SAFETY INFORMATION FOR SPEVIGO^® (SPESOLIMAB)

INDICATION

SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age or older and weighing at least 40 kg.

CONTRAINDICATIONS

SPEVIGO is contraindicated in patients with severe or life-threatening hypersensitivity to spesolimab or to any of the excipients in SPEVIGO. Reported hypersensitivity reactions have included drug reaction with eosinophilia and systemic symptoms (DRESS).

WARNINGS AND PRECAUTIONS

Infections: SPEVIGO may increase the risk of infections. In patients with a chronic infection or a history of recurrent infection, consider the potential risks and expected clinical benefits of treatment prior to prescribing SPEVIGO. Treatment with SPEVIGO is not recommended in patients with any clinically important active infection until the infection resolves or is adequately treated. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur during or after treatment with SPEVIGO. If a patient develops a clinically important active infection, discontinue SPEVIGO therapy until the infection resolves or is adequately treated.

Risk of Tuberculosis: Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SPEVIGO. Avoid use of SPEVIGO in patients with active TB infection. Consider initiating anti-TB therapy prior to initiating SPEVIGO in patients with latent TB or a history of TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SPEVIGO treatment.

Hypersensitivity and Infusion-Related Reactions:

• SPEVIGO-associated hypersensitivity reactions may include immediate reactions, such as anaphylaxis, and delayed reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS).
• Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported in clinical trials with spesolimab in subjects with GPP.
• If a patient develops signs of anaphylaxis or other serious hypersensitivity, discontinue SPEVIGO immediately and initiate appropriate treatment.
• If a patient develops mild or moderate hypersensitivity during an intravenous infusion or other infusion-related reactions, stop SPEVIGO infusion and consider appropriate medical therapy (e.g., systemic antihistamines and/or corticosteroids). Upon resolution of the reaction, the infusion may be restarted at a slower infusion rate with gradual increase to complete the infusion.

Vaccinations: Prior to initiating SPEVIGO for treatment of GPP, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid use of live vaccines in patients during and for at least 16 weeks after treatment with SPEVIGO. No specific studies have been conducted in SPEVIGO-treated patients who have recently received live viral or live bacterial vaccines.

ADVERSE REACTIONS

Intravenous SPEVIGO for Treatment of GPP Flare (Study Effisayil-1): Most common adverse reactions reported in ≥5% of patients treated with SPEVIGO in the clinical trial were asthenia and fatigue, nausea and vomiting, headache, pruritus and prurigo, infusion site hematoma and bruising, and urinary tract infection (UTI).

Specific Adverse Reactions

• Infections: The most frequent adverse reactions that occurred in subjects treated with intravenous SPEVIGO were infections. During the 1-week placebo-controlled period in Study Effisayil-1, infections were reported in 14% of subjects treated with SPEVIGO compared with 6% of subjects treated with placebo. Serious infection (UTI) was reported in 1 subject (3%) in the SPEVIGO group and no subjects in the placebo group. Infections observed through Week 1 in Study Effisayil-1 in subjects treated with SPEVIGO were mild (29%) to moderate (71%).
• Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS): Two cases of DRESS were reported in Study Effisayil-1 in subjects with GPP who were treated with intravenous SPEVIGO. RegiSCAR DRESS validation scoring (with the following categories: “no,” “possible,” “probable,” or “definite” DRESS) was applied to the reported cases. Reported cases were assessed as “no DRESS” and “possible DRESS.”

Subcutaneous SPEVIGO for Treatment of GPP When Not Experiencing a Flare (Study Effisayil-2): Regarding the exposure-adjusted incidence rates for subjects on randomized treatment prior to receiving rescue treatment for flare or completing trial without a flare, the rate per 100-patient years for injection site reaction (including erythema, pain, swelling, induration, urticaria, and warmth at the injection site) was 31.6 for the subcutaneous SPEVIGO cohort (600 mg loading dose followed by 300 mg every 4 weeks) vs 12.7 for the placebo cohort. The rate per 100-patient years for UTI was 18 for SPEVIGO vs 0 for placebo. The rate per 100-patient years for pruritus was 8.8 for SPEVIGO vs 0 for placebo. The rate per 100-patient years for arthralgia was 13.3 for SPEVIGO vs 6 for the placebo cohort. There were 3 subjects who discontinued subcutaneous SPEVIGO due to treatment-emergent adverse events of psoriasis compared to no subjects in the placebo cohort who discontinued placebo for any treatment-emergent adverse event.

Safety in Study Effisayil-2 After Flare: In Effisayil-2, subjects who experienced a GPP flare and received at least one dose of an open-label single intravenous 900 mg dose of SPEVIGO were treated with open-label subcutaneous SPEVIGO 300 mg. These subjects (n=19) received subcutaneous dosing at every 12 weeks, which could have been increased to every 4 weeks based on GPPPGA total score or pustulation subscore increased by ≥1 from any previous open-label maintenance visit. The reported safety profile of open-label subcutaneous SPEVIGO use after treatment of GPP flare with open-label intravenous SPEVIGO use was consistent with the safety profiles of use of SPEVIGO from Trial Effisayil-1 and randomized controlled data from Trial Effisayil-2.

Clinical Development of Spesolimab

• Guillain-Barre Syndrome (GBS): Among approximately 835 subjects exposed to spesolimab during clinical development, GBS was reported in 3 subjects who received various doses of spesolimab via various methods of administration in clinical trials for unapproved indications.

SPECIFIC POPULATIONS

Pediatric Use: The safety and effectiveness of SPEVIGO for the treatment of GPP have been established in pediatric patients 12 years of age and older and weighing at least 40 kg. Use of SPEVIGO for this indication is supported by data from a randomized, placebo-controlled study, which included 6 pediatric subjects 14 to 17 years of age with a history of GPP treated with subcutaneous SPEVIGO (Study Effisayil-2), and evidence from an adequate and well-controlled study of intravenous SPEVIGO in adults with GPP (Study Effisayil-1), with additional pharmacokinetic analyses showing similar drug exposure levels in adults and pediatric subjects 12 years of age and older and weighing 40 kg or more. The safety and effectiveness of SPEVIGO in pediatric patients younger than 12 years of age or in pediatric patients weighing less than 40 kg have not been established.

Please see SPEVIGO Prescribing Information, including Medication Guide.

About ANZUPGO® (delgocitinib) Cream

ANZUPGO® (delgocitinib) cream is currently FDA-approved in the U.S. as the first and only topical pan-JAK treatment for chronic hand eczema (CHE). Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended.⁴¹ ANZUPGO cream is also approved in the European Union, United Kingdom, Switzerland, United Arab Emirates and Canada under the brand name ANZUPGO for the treatment of moderate to severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or not advisable. ANZUPGO cream is also under investigation in other markets.

ANZUPGO cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate-to-severe CHE in adults. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.^41,42

In 2014, LEO Pharma obtained the exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where Shionogi & Co., Ltd. owns the rights.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR ANZUPGO^® (DELGOCITINIB) CREAM

What is ANZUPGO?

ANZUPGO is a prescription medicine used on the skin (topical) to treat moderate-to-severe chronic hand eczema (CHE) in adults who are not well-controlled with or cannot use topical corticosteroids.

The use of ANZUPGO along with other JAK inhibitors or strong immunosuppressants is not recommended.

IMPORTANT SAFETY INFORMATION

ANZUPGO is for use on the skin (topical use) only. Do not use ANZUPGO in or on your eyes, mouth or vagina.

What is the most important information I should know about ANZUPGO?

ANZUPGO may cause serious side effects, including:

Serious Infections: ANZUPGO may increase your risk of infections. ANZUPGO contains delgocitinib. Delgocitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth or applying on the skin, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body.

Contacts

Samantha Cranko

U.S. & Canada Communications

Email: media@leo-pharma.com

Jes Broe Frederiksen

Global Communications

Email: jebfe@leo-pharma.com

Read full story here

HealthWarehouse.com Reports Full Year 2025 Results




HealthWarehouse.com Reports Full Year 2025 Results

46% increase in revenues and positive cash flow for the year

Record year for prescriptions processed and cash generated from operations

CINCINNATI–(BUSINESS WIRE)–HealthWarehouse.com, Inc. (OTCQB:HEWA) announced today its results of operations for the year ended December 31, 2025. The Company reported net sales for the year of $49.0 million, a 46% increase over the year ended December 31, 2024, resulting from 87% growth in our partner services prescription revenues, offset in part by a decline in direct-to-consumer sales.

The Company reported net income of $265,000 for the year and positive cash flow of $1.6 million, as reflected by the non-GAAP measure of Adjusted EBITDA defined below. The Company reported net loss of $69,000 and Adjusted EBITDA of $189,000 for the fourth quarter.

HealthWarehouse.com, a technology company with a focus on healthcare e-commerce, sells and delivers prescription and over-the-counter medications to all 50 states as an Approved Digital Pharmacy through the National Association of Boards of Pharmacy (NABP). HealthWarehouse.com provides a platform focused on increasing access to and reducing costs of healthcare products for consumers and business partners nationwide.

Joseph Peters, President and CEO, commented, “2025 was a record year for the Company for total sales and prescriptions processed, while generating record cash from operations. We were able to report net income and positive cash flow by leveraging our prior investments in infrastructure. Our financial results for the past two years, during which our sales have increased $28.7 million and our Adjusted EBITDA $1.5 million, are further proof that our business model can scale profitably.”

“As we said in our third-quarter release in November, our sales of compounded versions of certain GLP-1 prescription medications were declining. Despite slower growth, we generated positive cash flow during the fourth quarter. Additionally, we are optimistic about new product launches that will allow us to continue to serve longstanding partners, and we are focused on adding partners via our new-business pipeline,” Peters said.

HealthWarehouse.com continues to invest in proprietary technology to remain at the forefront of new developments and offerings in the world of healthcare, focusing on patient experience, operational efficiency, and scalability.

Peters added, “Our success would not be achievable without our dedicated employees, who are committed to our mission of providing world-class service to our customers. I truly appreciate their dedication.”

The Company also announced that it will hold its Annual Meeting of Shareholders virtually on May 12, 2026. Shareholders of record as of March 13, 2026, will receive notice of the meeting and instructions for participating in proxy materials to be distributed soon.

2025 Annual Overview

Net Sales: Net sales increased from $33.6 million for the year ended December 31, 2024, to $49.0 million for the year ended December 31, 2025, an increase of $15.4 million, or 45.8%. Prescription sales were $46.2 million for the year ended December 31, 2025, an increase of $15.3 million, or 49.3%, compared with $30.9 million for the year ended December 31, 2024. These increases were primarily due to growth in our partner services (B2B) business related to fulfillment of brand and compounded GLP-1 medications. Sales for the direct-to-consumer (B2C) prescription business were down 24.3% in 2025 due to a reduction in sales of higher-cost branded medications and increased competition. Over-the-counter net sales increased by 15.9% from $2.2 million in the year ended December 31, 2024, to $2.5 million in the year ended December 31, 2025. The increase in B2C over-the-counter sales was primarily due to higher marketplace sales.

Our authority to dispense high-dollar compounded GLP-1 medications has ended this year. That will have a significant impact on our sales in 2026, and beyond until that volume can be replaced with new partners and expansion of the catalogs of our existing partners. The Company currently expects positive cash from operations during 2026.

Gross Profit: Cost of sales was $31.9 million for the year ended December 31, 2025, compared with $19.5 million for the year ended December 31, 2024. That increase of $12.4 million, or 63.4%, was primarily the result of growth in sales of high-cost GLP-1 medications in our B2B prescription businesses. Gross profit for the year ended December 31, 2025, was $17.1 million, a $3.0 million or 21.4% increase compared with the same period in 2024, due to the increase in sales volume, offset in part by lower gross margins. Gross margin percentage decreased year-over-year from 42.0% for the year ended December 31, 2024, to 35.0% for the year ended December 31, 2025. In the B2B prescription business, branded and compounded drugs have lower gross margins, due to higher costs and price competition.

Operating Expenses: Selling, general and administrative (SG&A) expenses totaled $16.7 million for the year ended December 31, 2025, compared with $14.2 million for the year ended December 31, 2024, an increase of $2.5 million, or 17.7%. Despite the increase, SG&A expenses were significantly lower relative to sales, decreasing 8.2 percentage points to 34.1% of sales for the year ended 2025. The growth in sales of high cost GLP-1 medications in our B2B prescription businesses did not result in a comparable increase in operating expenses. For the year ended December 31, 2025, increased expenses were primarily related to the growth in order volume in the B2B segment, which included increases in shipping expense, salaries and related expenses, shipping supplies expense; legal expense, advertising and marketing expense, rent expense, software and engineering expenses, corporate taxes, maintenance and repairs expenses and accounting services expense. Those increases were partially offset by decreases in credit card fees, health and other benefits expense, and stock-based compensation.

Net Income and Adjusted EBITDA: Net income of $265,000 for the year ended December 31, 2025, improved by $598,000 from the net loss of $333,000 for the year ended December 31, 2024, primarily as a result of increased sales and gross profit and continued controls on expenses. Earnings before interest, taxes, depreciation and amortization including amortization of a right-of-use lease asset (“EBITDA”), as adjusted for stock-based compensation and certain non-recurring charges (“Adjusted EBITDA”), were $1.6 million for 2025, up from $1.1 million for 2024. EBITDA and Adjusted EBITDA are non-GAAP financial measures. Definitions of these non-GAAP terms and a reconciliation to GAAP measures are provided below.

2025 Fourth Quarter Overview

Net Sales: Total net sales were $9.9 million for the fourth quarter ended December 31, 2025, a decrease of $3.9 million, or 28.1%, compared with the fourth quarter of 2024. Prescription sales were $9.0 million for the fourth quarter, a decrease of $4.1 million, or 31.0%. That was due to lower sales in the B2B and B2C prescription business, primarily related to lower sales of compounded GLP1 medications. Over-the-counter sales increased by 40.2% to $776,000 due to an increase in marketplace sales.

Gross Profit: Gross profit for the fourth quarter of 2025 was $3.8 million, a $575,000 or 13.0% decrease compared with the fourth quarter of 2024. Lower revenues in the B2B and B2C prescription businesses were partly offset by higher gross margins. Gross margin was 39.0% in the fourth quarter of 2025 versus 32.2% in the same period in 2024, due primarily to improved margins in the prescription business.

Operating Expenses: Operating expenses were $4.0 million for the fourth quarter of 2025, a decrease of $250,000 or 6.0% compared with the same quarter in 2024. The decrease in 2025 was related to decreases in shipping and shipping-supplies expenses, salaries and related expenses, and credit card fees. The decreases were offset by increases in marketing and advertising expenses.

Net Income and (non-GAAP) Adjusted EBITDA: The Company reported a net loss of $69,000 for the fourth quarter of 2025, compared with net income of $189,000 during the same period in 2024. Adjusted EBITDA for the fourth quarter of 2025 was $189,000, compared with $523,000 in the fourth quarter of 2024.

Use of Non-GAAP Financial Measures

HealthWarehouse.com, Inc. (the “Company”) prepares its consolidated financial statements in accordance with the United States generally accepted accounting principles (“GAAP”). In addition to disclosing financial results prepared in accordance with GAAP, the Company discloses information regarding EBITDA and Adjusted EBITDA, which are commonly used. In addition to adjusting net income or net loss to exclude interest, taxes, depreciation and amortization, including amortization of right of use lease asset, (“EBITDA”), Adjusted EBITDA also excludes stock-based compensation, and certain nonrecurring charges. EBITDA and Adjusted EBITDA are not measures of performance defined in accordance with GAAP. However, Adjusted EBITDA is used internally in planning and evaluating the Company`s performance. Accordingly, management believes that disclosure of this metric offers lenders and other shareholders an additional view of the Company`s operations that, when coupled with GAAP results, provides a more complete understanding of the Company’s financial results.

Adjusted EBITDA should not be considered as an alternative to net income, net loss, or to net cash provided by or used in operating activities, as a measure of operating results or of liquidity. It may not be comparable to similarly titled measures used by other companies, and it excludes financial information that some may consider important in evaluating the Company`s performance.

Reconciliation of Net Loss (GAAP) to Adjusted EBITDA (Non-GAAP)

About HealthWarehouse.com

HealthWarehouse.com, Inc. (OTCQB: HEWA), a technology company with a focus on healthcare e-commerce, sells and delivers prescription and over-the-counter medications to all 50 states as an Approved Digital Pharmacy through the National Association of Boards of Pharmacy (“NABP”). HealthWarehouse.com provides a platform focused on increasing access and reducing costs of healthcare products for consumers and business partners nationwide. Based in Florence, Kentucky, the Company operates America’s Leading Online Pharmacy and is a pioneer in affordable healthcare. As one of the first Approved Digital Pharmacies by the National Association of Boards of Pharmacy, HealthWarehouse.com services the mission of providing affordable healthcare and incredible patient services to help Americans. Learn more at www.HealthWarehouse.com

Forward-Looking Statements

This announcement and the information incorporated by reference herein contain “forward-looking statements” as defined in federal securities laws, including but not limited to Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, which statements are based on our current expectations, estimates, forecasts and projections. Statements that are not historical facts, including statements about the beliefs, expectations and future plans and strategies of the Company, are forward-looking statements. Actual results may differ materially from those expressed in forward looking statements or in management’s expectations. Important factors which could cause or contribute to actual results being materially and adversely different from those described or implied by forward looking statements include, among others, risks related to competition, management of growth, access to sufficient capital to fund our business and our growth, new products, services and technologies, potential fluctuations in operating results, international expansion, outcomes of legal proceedings and claims, fulfillment center optimization, seasonality, commercial agreements, acquisitions and strategic transactions, foreign exchange rates, system interruption, cyber-attacks, access to sufficient inventory, government regulation and taxation and fraud. More information about factors that potentially could affect HealthWarehouse.com’s financial results is included in HealthWarehouse.com’s audited Annual Reports and Quarterly Reports available at otcmarkets.com and prior filings with the Securities and Exchange Commission.

Contacts

Dan Seliga, Chief Financial Officer, (800) 748-7001