Hercules Pharmaceuticals Appoints Elie Bahou as Executive Vice President, Chief Pharmacy Strategy Officer




Hercules Pharmaceuticals Appoints Elie Bahou as Executive Vice President, Chief Pharmacy Strategy Officer

Veteran pharmacy leader to advance Hercules’ strategy with operational excellence and AI-driven innovation

PORT WASHINGTON, N.Y.–(BUSINESS WIRE)–Hercules Pharmaceuticals, a national leader in pharmaceutical distribution and provider-aligned GPO services, today announced the appointment of Elie Bahou, PharmD, MBA, as Executive Vice President, Chief Pharmacy Strategy Officer.

Bahou brings decades of executive leadership across pharmacy services, distribution, and PBM strategy. Most recently, as Senior Vice President and System Chief Pharmacy Officer at Providence St. Joseph Health, he directed one of the nation’s largest integrated pharmacy enterprises, advancing payer-provider collaborations, strengthening supply chain resiliency, and designing innovative models to expand patient access. Earlier in his career, Bahou held leadership roles with Cardinal Health, where he developed deep expertise in pharmaceutical distribution, and with OptumRx, where he helped shape payer and PBM strategies that informed his provider-focused approach to pharmacy services.

In his new role, Bahou will oversee enterprise-wide pharmacy strategy, uniting clinical insight with operational execution to enhance provider partnerships, accelerate manufacturer collaboration, and scale Hercules’ leadership position through operational excellence and AI-driven innovation. His efforts will support the creation of a smarter, more reliable healthcare supply chain for providers and partners nationwide.

“Elie is one of the most respected pharmacy leaders in the country, with a proven ability to lead large-scale pharmacy enterprises while keeping patients at the center,” said Sara Amani, CEO of Hercules Pharmaceuticals. “He brings the strategic perspective and operational expertise to help drive Hercules’ next phase of growth and impact.”

“Hercules is uniquely positioned to redefine how pharmacy services connect patients, providers, and manufacturers,” said Elie Bahou. “I am honored to join a team committed to delivering innovative solutions that ensure affordable, reliable access to high-value medicines nationwide.”

Hercules is addressing one of the most urgent challenges in U.S. healthcare: drug shortages and systemic supply chain vulnerabilities. By diversifying sourcing channels and expanding manufacturer partnerships, the company helps providers reduce concentration risk, secure consistent access to essential therapies, and safeguard patient care against disruption. In parallel, Hercules delivers financial strength to health systems, specialty pharmacies, community practices, and retail by improving cash flow and reducing dependence on a limited number of large distributors. Through this model, Hercules strengthens provider resilience while ensuring patients receive the medicines they need, when they need them.

Contacts

Media Contact:

press@herculesrx.com
1-800-815-5800

FORE Biotherapeutics Presents Phase 1/2a Plixorafenib Data Demonstrating Prolonged Duration of Effect in BRAF Altered Thyroid Cancers at American Thyroid Association® 2025 Annual Meeting




FORE Biotherapeutics Presents Phase 1/2a Plixorafenib Data Demonstrating Prolonged Duration of Effect in BRAF Altered Thyroid Cancers at American Thyroid Association® 2025 Annual Meeting

Plixorafenib demonstrated mPFS of 64 months and a clinical benefit rate of 85.7% in patients with MAPKi-naïve BRAF V600-mutated papillary thyroid cancer, a potential future development indication for plixorafenib

Global registrational FORTE Phase 2 study is evaluating BRAF alterations, including in thyroid cancers

PHILADELPHIA–(BUSINESS WIRE)–FORE Biotherapeutics, a registration stage biotherapeutics company dedicated to developing targeted therapies to treat patients with cancer, today presented new plixorafenib results from the previously completed Phase 1/2a clinical trial that demonstrate treatment with plixorafenib in patients with BRAF-altered papillary thyroid cancer (PTC) and anaplastic thyroid cancer (ATC) resulted in durable disease control that appears very favorable compared with historical data with standard treatment options. The data also demonstrate an encouraging safety profile consistent with previously reported results following treatment with plixorafenib. The data are being presented at the American Thyroid Association^® (ATA) 2025 Annual Meeting, taking place September 10-14, 2025 in Scottsdale.

“These results presented at ATA 2025 demonstrate durable clinical benefit in both V600 mutated and BRAF fusion thyroid tumors, and durable disease control in patients with stable disease. These new findings continue to support the strong clinical profile of plixorafenib as well as the potential to benefit patients with BRAF-altered thyroid cancers,” said Eric J. Sherman, M.D., Head and Neck Cancer Medical Oncologist at the Memorial Sloan Kettering Cancer Center, and Principal Investigator for the ongoing FORTE Phase 2 plixorafenib study. “Patients with differentiated thyroid cancer, including papillary thyroid cancers which account for about 80% of all thyroid cancers, are in dire need of new treatment options. BRAF V600E alterations occur in approximately 60% of papillary thyroid cancers, underscoring the need for development of a targeted therapy such as plixorafenib that addresses the mechanistic drivers of these tumors along with the compelling clinical efficacy and safety profile demonstrated by treatment with plixorafenib.”

“We are excited to share these data that show additional evidence of strong and durable clinical activity of plixorafenib, in both BRAF V600 mutant and BRAF fusion thyroid cancers,” said Stacie Peacock Shepherd, M.D., Ph.D., Chief Medical Officer of Fore. “The data also demonstrate a high duration of response in MAPKi-naïve patients, highlighting the unique mechanism of action of plixorafenib that avoids paradoxical MAPK pathway activation and delivers differentiated results as a single therapeutic agent in BRAF altered cancers. We continue to advance our ongoing registrational FORTE basket study, which includes BRAF V600 altered thyroid cancers, as we aim to generate further data to inform treatment and help patients with BRAF driven tumors.”

The results presented at ATA 2025 are from 21 patients with thyroid cancer, 16 with PTC and 5 with ATC, treated with plixorafenib in a previously completed Phase 1/2a study that treated a total of 113 patients with advanced, unresectable solid tumors that were intolerant to standard therapy or had no standard therapy available. All 21 patients with thyroid cancer received prior radiation therapy, nearly all underwent prior surgery, and the majority had received prior systemic anticancer therapies. The safety profile of treatment with plixorafenib in patients with ATC or PTC was consistent with previously reported results from the Phase 1/2a study.

Treatment with plixorafenib with and without cobicistat in MAPK-inhibitor naïve patients with a BRAF V600 mutation demonstrated an encouraging clinical benefit with a differentiated duration of response and support plixorafenib’s paradox breaker mechanism of action in BRAF-altered tumors, including a median progression free survival (mPFS) of 63.9 months and a clinical benefit rate (CBR: response or stable disease ≥ 24 weeks) of 85.7% (6 of 7 patients). Four MAPK-inhibitor naïve PTC patients remained on treatment for over 5 years, including one partial response (PR) of 59.2 months (treatment duration=7.6 years) and a second PR of 30.9 months (treatment duration=8.3 years). In four ATC patients with a BRAF V600 mutation, all of whom were MAPK-inhibitor naïve, the mPFS was 16.1 months, with one confirmed PR lasting 17.8 months and two patients reaching stable disease. In the three PTC patients that received prior MAPK inhibition therapy as well as at least one prior BRAF inhibition therapy, all three patients reached stable disease, with a CBR of 33.3%. Clinical benefit was also observed in patients with BRAF fusion PTC, with one of three patients achieving a PR lasting 12.9 months (treatment duration=25 months, continued post-study completion), and one patient with ATC having stable disease.

The results presented at ATA 2025 demonstrate a differentiated and durable clinical benefit in BRAF altered anaplastic and papillary thyroid cancers, compared to historical results of approved and investigational therapies, including BRAF, MEK, and pan-RAF inhibitors. Plixorafenib’s novel mechanism of action does not induce paradoxical activation of the MAPK pathway, thereby not requiring combination with a MEK inhibitor and potentially improving upon safety, efficacy, and durability compared with treatments containing prior generation RAF inhibitors.

FORE is advancing the registration-intended FORTE Master Protocol, a global Phase 2 clinical trial which includes four sub-protocol baskets evaluating plixorafenib in distinct patient populations. The three monotherapy indications currently under evaluation are BRAF V600 progressive or recurrent primary CNS tumors, rare BRAF V600 mutated advanced solid tumors, including ATC, and solid tumors with BRAF fusions, including PTC and ATC. BRAF v600E alterations occur in 45% of ATC and approximately 60% of PTC, representing a differentiated potential future development opportunity for plixorafenib.

Poster Presentation Details:

Title: Clinical Activity and Safety of Novel BRAF Inhibitor (BRAFi) Plixorafenib (FORE8394; PLX8394) in Advanced Thyroid Cancers (TC) Harboring BRAF Alterations

Lead Author & Presenter: Eric J. Sherman, M.D., Memorial Sloan Kettering Cancer Center

Poster Session: Clinical Thyroid Diseases & Cancer

Date and Time: Friday, September 12, 2025, 3:00 – 4:00 p.m. MT

Poster Number: 300

About FORE Biotherapeutics

Fore is a registration stage targeted oncology company dedicated to developing innovative treatments that provide better outcomes for patients with the hardest-to-treat cancers. The Company’s lead asset plixorafenib (FORE8394; formerly PLX8394) is a V600 and non-V600 BRAF inhibitor rationally designed with a first-in-class mechanism to address treatment gaps from 1^st and 2^nd generation BRAF inhibitors. Plixorafenib has demonstrated single-agent efficacy signals across a variety of tumor types with a favorable safety profile in a Phase 1/2a clinical trial of over 100 patients and is currently enrolling patients in FORTE, a global registrational basket trial to support three distinct indications. For more information, please visit www.fore.bio or follow us on X and LinkedIn.

Contacts

Investors and Media:
Argot Partners

212.600.1902 | ForeBio@argotpartners.com

Mandos Health to Present New Analyses in Niemann-Pick Disease Type C at the 2025 American Neurological Association Annual Meeting




Mandos Health to Present New Analyses in Niemann-Pick Disease Type C at the 2025 American Neurological Association Annual Meeting

THOUSAND OAKS, Calif.–(BUSINESS WIRE)–Mandos Health^® by Beren Therapeutics Public Benefit Corporation (P.B.C.) announced today that new analyses detailing the clinical and biological effects of its investigational drug, adrabetadex, in Niemann-Pick Disease Type C (NPC) will be presented at the 150^th annual meeting of the American Neurological Association (ANA) September 13–16 in Baltimore, Maryland.

The first abstract, recognized by ANA as an “Abstract of Distinction,” reports improved overall survival in adrabetadex-treated participants with neurological onset before 6 years of age compared to matched external controls. The second abstract provides biomarker data supporting the potential of adrabetadex as a disease-modifying therapy if approved. NPC is a rare and progressive neurodegenerative disorder characterized by impaired cholesterol trafficking, severe neurological deficits, and ultimately, premature mortality.

“This is one of the most rigorously conducted investigations comparing treated participants to matched external controls in Niemann-Pick Disease Type C (NPC),” said Dr. Elizabeth Berry-Kravis, Professor of Pediatrics, Director of RUSH Pediatric Neurosciences F.A.S.T. Center for Translational Research at Rush University Medical Center and lead study author. “For those of us who have witnessed the relentless and heart-breaking progression of this condition, we are encouraged by the potential for adrabetadex to meaningfully alter the disease course, extend survival and improve outcomes for patients with NPC and their families.”

Both analyses will be featured in poster presentations during the ANA meeting:

About Niemann-Pick Disease Type C (NPC)

NPC is a rare, autosomal-recessive, severe, neurodegenerative disorder caused by pathologic variants in the NPC1 (~95% of cases) or NPC2 genes, leading to impaired cholesterol trafficking resulting in progressive neurological decline and premature death. Earlier neurological onset is associated with more rapid progression and poorer prognosis, with mean survival of ~5.6 years for early infantile onset (age of neurological onset <2 years) and ~13.4 years for late infantile onset (2 to <6 years). Individuals with early and late infantile-onset NPC typically present with manifestations affecting multiple organs, but the most severe and debilitating effects occur in the brain.

About Adrabetadex (VTS-270)

Adrabetadex (VTS-270) is a proprietary mixture of 2-hydroxypropyl-β-cyclodextrin isomers under investigation as a treatment for NPC. By reestablishing intracellular cholesterol trafficking, adrabetadex directly addresses the core pathology of NPC.

Adrabetadex has not been approved by the FDA or any other health authority at this time.

About Mandos LLC

Mandos LLC is a wholly-owned subsidiary of Beren Therapeutics Public Benefit Corporation (P.B.C.), a biotechnology company creating the potential for possibilities for individuals living with Niemann-Pick Disease Type C (NPC), a condition characterized by defects in cholesterol trafficking. The company’s experienced team of scientists are focused on evaluating adrabetadex, a derivatized cyclodextrin, as a potential treatment that can target the underlying pathology of NPC. Since 2021, Mandos Health has supported the NPC community by providing access to adrabetadex* through its Expanded Access Program (EAP). The company will continue working closely with patients, families, researchers, regulators, and others on a path to bring forth this potentially transformative therapy for NPC and other cholesterol-trafficking diseases. For more information, please visit https://mandoshealth.com/about-us.

About Rush University Medical Center

Rush University System for Health (RUSH) is an academic health system whose mission is to improve the health of the individuals and diverse communities it serves through the integration of outstanding patient care, education, research and community partnerships. RUSH comprises Rush University Medical Center, Rush University, Rush Copley Medical Center, and Rush Oak Park Hospital, as well as numerous outpatient care facilities. Rush University, with more than 2,500 students, is a health sciences university that comprises Rush Medical College, the College of Nursing, the College of Health Sciences, and the Graduate College.

*Adrabetadex is an investigational drug that has not been approved by the U.S. Food and Drug Administration and has not been found safe and effective to treat NPC or any other condition.

Contacts

Amanda Eckel

BGB Group

Aeckel@bgbgroup.com

Orano Med Achieves Key Milestone in French ATEF Facility Construction, an Essential Asset for Large-Scale Production of Innovative Lead-212-based Therapies




Orano Med Achieves Key Milestone in French ATEF Facility Construction, an Essential Asset for Large-Scale Production of Innovative Lead-212-based Therapies

BESSINES-SUR-GARTEMPE, France–(BUSINESS WIRE)–Orano Med:

• ATEF (Advanced Thorium Extraction Facility) plant is now watertight, marking a major step toward the completion of civil engineering work.
• Construction is progressing according to schedule, with start-up planned for 2027.
• A site visit brought together institutional partners, local authorities, and economic stakeholders to celebrate this achievement.
• ATEF will be the world’s first industrial facility dedicated to the production of thorium-228, the precursor of lead-212 used in innovative targeted alpha therapies against cancer.

Orano Med, a subsidiary of the Orano group specializing in the development of targeted alpha therapies in oncology, announced today that the Advanced Thorium Extraction Facility (ATEF) in Bessines-sur-Gartempe, near Limoges, France, has now reached the dry-in phase, with sealing works completed. This marks a major milestone since the groundbreaking in November 2024.

To celebrate this milestone, a site visit was organized, bringing together numerous institutional and local partners who have supported the project since its inception. Among those present were Andréa Brouille, mayor of Bessines-sur-Gartempe and first vice-president of the Nouvelle-Aquitaine region, and Alain Auzemery, president of the ELAN community of municipalities and vice-president of the Haute-Vienne departmental council. Representatives from these authorities, the Nouvelle-Aquitaine Development and Innovation Agency (ADI NA), the Limoges and Haute-Vienne Chamber of Commerce and Industry, and the Limousin Union of Metallurgy Industries and Trades also took part in the visit.

Both Orano Med and Orano Projets¹ teams were present to share the progress of the work and discuss the next steps. “Construction is progressing according to schedule. We have the full commitment of our partners and all the companies and stakeholders involved to bring this exciting ATEF plant to fruition,” underscored Bruno Pagnard, ATEF project manager.

Eric Pluche, director of Orano’s Bessines-sur-Gartempe site, also emphasized the significance of the new ATEF facility, both for the development embarked upon by the Bessines-sur-Gartempe industrial site and, more broadly, for the local economy, which is gaining an innovative platform that will create skilled jobs. “With the hiring of 70 new employees, Orano is demonstrating its commitment to investing in the region over the long term and helping to boost its attractiveness,” he commented.

Orano Med is developing a new generation of targeted cancer therapies, known as Targeted Alpha Therapy (TAT), using the unique properties of lead-212. The development of these promising drugs has long been hampered by the difficulty of producing them on an industrial scale. With a floor area of nearly 7,000 m² and a production capacity ten times greater than that of the Maurice Tubiana laboratory, ATEF will be the world’s first industrial-scale facility dedicated to the production of thorium-228, a key precursor for the production of lead-212.

The coming months will be devoted to completion of civil engineering work, followed by the installation and qualification of the plant equipment. The facility is scheduled to begin operations in 2027. The total investment is estimated at €250 million, including €22 million of French government funding through the France 2030 scheme under the “Industrialization and Health Capacities 2030” call for projects.

“The ATEF plant is a key component in Orano Med’s fully integrated industrial platform. This platform will cover the entire value chain of targeted alpha therapies, from precursor production to lead-212–based therapies. It will enable the large-scale production of these treatments to meet the needs of patients worldwide,” said Fabrice Darvey, Director of Industrial Operations at Orano Med.

The combined production capacities of ATEF and the Maurice Tubiana laboratory will in the short term provide the necessary supplies for clinical trials and commercial launches of the first treatments developed by Orano Med. Within ten years, this industrial platform will be able to treat up to 25,000 patients per year.

About Orano Med

Orano Med, a subsidiary of the Orano Group, is a clinical-stage biotechnology company which develops a new generation of targeted therapies against cancer using the unique properties of lead-212 (²¹²Pb), an alpha-emitting radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha-Emitter Therapy (TAT). AlphaMedix, its most advanced asset in clinical development for GEP-NETs tumors, received Breakthrough Designation from the FDA in 2024. The company is advancing several potential treatments using ²¹²Pb combined with various targeting agents through clinical and preclinical studies. Orano Med has ²¹²Pb manufacturing facilities, laboratories, and R&D centers in France and in the US. It is expanding its GMP-manufacturing capacities for ²¹²Pb radiolabeled pharmaceuticals in North America and Europe and building a unique, independent, and fully integrated industrial platform to serve the needs of patients globally. For more information, please visit: http://www.oranomed.com

About Orano

As a recognized international leading operator in the field of nuclear materials, Orano delivers solutions to address present and future global energy and health challenges. Its expertise and mastery of cutting-edge technologies enable Orano to offer its customers high value-added products and services throughout the entire fuel cycle. Every day, the Orano group’s 17,500 employees draw on their skills, unwavering dedication to safety and constant quest for innovation, with the commitment to develop know-how in the transformation and control of nuclear materials, for the climate and for a healthy and resource-efficient world, now and tomorrow.

Orano, giving nuclear energy its full value.

Contacts

Halsin Partners

Mike Sinclair

msinclair@halsin.com

Apimeds Welcomes FDA Draft Guidance as Catalyst for Advancing Apitox Non-Opioid Pain Program




Apimeds Welcomes FDA Draft Guidance as Catalyst for Advancing Apitox Non-Opioid Pain Program

MATAWAN, N.J.–(BUSINESS WIRE)–Apimeds Pharmaceuticals US, Inc. (NYSE: APUS) today welcomed the U.S. Food and Drug Administration’s (FDA) newly released draft guidance on the development of non-opioid pain therapies, highlighting its potential to accelerate the company’s lead program, Apitox, for chronic osteoarthritis pain. The draft guidance, entitled “Development of Non-Opioid Analgesics for Chronic Pain, Draft Guidance for Industry”, can be found here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-non-opioid-analgesics-chronic-pain.

Erik Emerson, Chief Executive Officer of Apimeds, issued the following statement:

“The FDA’s draft guidance represents a landmark moment for companies like Apimeds that are committed to developing safe, non-opioid treatments for chronic pain. The agency’s call for flexibility in the number of required trials, openness to biomarkers, and willingness to accept strong scientific justification is more than regulatory encouragement; it’s an affirmation of the value of platforms like Apitox.

The guidance opens the door to more efficient development timelines, including the possibility of a single, well-controlled chronic pain trial supported by confirmatory evidence, along with potential fast track or breakthrough designations. For Apitox, this could translate into accelerating our path to regulatory submission, and ultimately, faster relief to patients suffering from osteoarthritis pain.

The FDA’s leadership in advancing non-opioid pain therapies is an important step toward reshaping how we approach one of the world’s most urgent healthcare challenges. For Apimeds, this guidance reinforces our belief that innovative biologic treatments like Apitox can redefine the standard of care in osteoarthritis and beyond. We are committed to working closely with regulators to bring safer, more effective solutions for pain management to patients as quickly as possible.”

About Apimeds Pharmaceuticals

Apimeds Pharmaceuticals (NYSE American: APUS) is a clinical-stage biopharmaceutical company focused on developing non-opioid, biologic-based therapies for pain management. The company’s lead product candidate, Apitox, is in late-stage clinical development for osteoarthritis of the knee. For more information visit www.apimedsus.com. Information on the Apimeds’ website does not constitute a part of and is not incorporated by reference into this press release.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “anticipate”, “believe”, “expect”, “plan” and “will” are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and the information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Apimeds undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Apimeds will be realized or, even if substantially realized, that they will have the expected consequences to or effects on the company or its business or operations. Readers are cautioned that certain important factors may affect Apimeds’ actual results and could cause such results to differ materially from any forward-looking statements that may be made in this press release. Factors that may affect Apimeds’ results include, but are not limited to, the ability of Apimeds to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to Apimeds’ ability to advance its product candidate and successfully complete clinical trials; risks relating to its ability to hire and retain qualified personnel; and the additional risk factors described in Apimeds’ filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC on April 15, 2025 (as amended on May 2, 2025).

Contacts

Media Contact:
Erik Emerson, CEO

erik@apimedsus.com

Corstasis Therapeutics Strenghtens Leadership Team with the Appointment of Dr. Amin Medjamia as VP of Medical Affairs




Corstasis Therapeutics Strenghtens Leadership Team with the Appointment of Dr. Amin Medjamia as VP of Medical Affairs

HENDERSON, Nev.–(BUSINESS WIRE)–#Biotech–Corstasis Therapeutics Inc. (www.corstasis.com), a late clinical-stage innovator of outpatient therapies for the treatment of fluid overload in patients with cardiorenal and hepatic diseases, announced today the appointment of Amin M. Medjamia M.D. as Vice President of Medical Affairs.

Dr. Medjamia is an accomplished physician and medical affairs leader with more than 20 years of experience spanning biotechnology and medical devices. At Corstasis, he will oversee clinical strategy, scientific communications, and clinical algorithm development via medical engagement as the company advances its lead program Enbumyst™ (bumetanide nasal spray).

Prior to joining Corstasis, Dr. Medjamia held senior leadership roles at Abiomed, a Johnson & Johnson MedTech company, where he directed global evidence generation for the company’s portfolio of mechanical circulatory support devices. His leadership contributed to PMA approvals, global reimbursement milestones in France and Japan, and large-scale international randomized controlled trials.

“We are honored to welcome Dr. Medjamia to Corstasis at this critical time,” said Ben Esque, CEO of Corstasis. “His passion and expertise in cardiovascular medicine and evidence strategy will strengthen our ability to develop and deliver new pathways to improve patient outcomes and reduce cost of care.”

“I am excited to join Corstasis and help advance its mission of improving outpatient options for patients suffering from fluid overload,” said Dr. Medjamia.

About Corstasis Therapeutics

Corstasis Therapeutics is a late clinical-stage biopharmaceutical company whose mission is to develop and commercialize enhanced outpatient treatment options for patients with cardiorenal and hepatic diseases, with the intent of improving outcomes and reducing overall healthcare costs. Our lead product, *Enbumyst™ bumetanide nasal spray, has been developed for the short-term treatment of edema associated with congestive heart failure, liver and kidney disease, with an anticipated PDUFA action date of September 14, 2025.

*Enbumyst™ (Bumetanide Nasal spray) is an investigational therapy that has not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority.

For more information, please visit www.corstasis.com.

Contacts

Corstasis Therapeutics Inc.

Ben Esque, CEO

Phone: 702-541-9222

Email: Info@corstasis.com

ENHERTU® Type II Variation Application Validated in the EU for Previously Treated Patients with HER2 Positive Metastatic Solid Tumors




ENHERTU® Type II Variation Application Validated in the EU for Previously Treated Patients with HER2 Positive Metastatic Solid Tumors

• Submission based on three phase 2 trials where Daiichi Sankyo and AstraZeneca’s ENHERTU showed clinically meaningful responses across a broad range of tumors
• If approved, ENHERTU would become the first HER2 directed medicine and antibody drug conjugate to receive a tumor agnostic indication in the EU

TOKYO & MUNICH–(BUSINESS WIRE)–The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU^® (trastuzumab deruxtecan) for the treatment of adult patients with HER2 positive (immunohistochemistry [IHC] 3+) unresectable or metastatic solid tumors who have received prior treatment and have no satisfactory alternative treatment options.

ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

The validation confirms the completion of the application and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use. The application is based on data from three phase 2 trials including DESTINY-PanTumor02, DESTINY-CRC02 and DESTINY-Lung01 where ENHERTU demonstrated clinically meaningful responses across a broad range of tumors.

“ENHERTU has shown a clinically meaningful benefit across several studies in HER2 positive metastatic solid cancers and this validation by the EMA is an important first step toward bringing this medicine to these patients in the EU,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “We look forward to working with the EMA to potentially secure a tumor agnostic indication for ENHERTU in the EU, similar to several other regions of the world where this approval has been received.”

About DESTINY-PanTumor02

DESTINY-PanTumor02 is a global, multicenter, multi-cohort, open-label phase 2 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) for the treatment of previously treated HER2 expressing tumors, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic cancer or other tumors.

The primary efficacy endpoint of DESTINY-PanTumor02 is confirmed objective response rate (ORR) as assessed by investigator. Secondary endpoints include duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), safety, tolerability and pharmacokinetics. Results from DESTINY-PanTumor02 were published in the Journal of Clinical Oncology.

DESTINY-PanTumor02 enrolled 267 patients, including 111 HER2 positive (IHC 3+) adult patients, at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

About DESTINY-Lung01

DESTINY-Lung01 is a global phase 2, open-label, two-cohort trial evaluating the efficacy and safety of ENHERTU (6.4 mg/kg and 5.4 mg/kg) in patients with HER2 mutant (cohort 2, n=91) or HER2 overexpressing (defined as IHC 3+ or IHC 2+) (cohort 1 and 1a, n=90) unresectable or metastatic non-small cell lung cancer (NSCLC) who had progressed after one or more systemic therapies.

The primary endpoint is confirmed ORR by independent central review. Key secondary endpoints include DOR, DCR, PFS, OS and safety. Results from the HER2 mutant cohort were published in The New England Journal of Medicine and results from the HER2 overexpressing cohort were published in The Lancet Oncology.

DESTINY-Lung01 enrolled 181 patients, including 17 HER2 positive (IHC 3+) adult patients, at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

About DESTINY-CRC02

DESTINY-CRC02 is a global, randomized, two arm, parallel, multicenter phase 2 trial evaluating the efficacy and safety of two doses (5.4 mg/kg or 6.4 mg/kg) of ENHERTU in patients with locally advanced, unresectable or metastatic HER2 positive (IHC 3+ or IHC 2+/ in situ hybridization (ISH)+) colorectal cancer of BRAF wild-type, RAS wild-type or RAS mutant tumor types previously treated with standard therapy. The trial was conducted in two stages. In the first stage, patients (n=80) were randomized 1:1 to receive either 5.4 mg/kg or 6.4 mg/kg of ENHERTU. In the second stage, additional patients (n=42) were enrolled in the 5.4 mg/kg arm.

The primary endpoint is confirmed ORR as assessed by blinded independent central review. Secondary endpoints include DOR, DCR, investigator-assessed confirmed ORR, clinical benefit ratio, PFS, OS and safety. Results from DESTINY-CRC02 were published in The Lancet Oncology.

DESTINY-CRC02 enrolled 122 patients, including 64 HER2 positive (IHC 3+) adult patients, at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

About HER2 Expression in Solid Tumors

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of various tissue cells throughout the body and is involved in normal cell growth.¹ In some cancers, the HER2 gene is amplified or the cells have activating mutations.² HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis.³

In the EU, HER2 directed therapies have been used to treat breast, gastric and lung cancers. Although HER2 is expressed in solid tumor types including biliary tract, bladder, cervical, endometrial, ovarian and pancreatic cancers, testing is not routinely performed in these additional tumor types and as a result, available literature is limited.² In these solid tumors, HER2 overexpression, classified as IHC 3+, has been observed at rates from 1% up to 31%.^4,5,6 Approximately 1% to 5% of patients with NSCLC have tumors with HER2 overexpression (IHC 3+).^4,7 In metastatic colorectal cancer, an estimated 2% to 4% of patients have tumors that are HER2 overexpressing (IHC 3+).^8,9 HER2 positive expression (IHC 3+) has been reported in approximately 4% to 28% of endometrial cancers and 1% to 5% of ovarian cancers.^{5,10,11,12,13}

About ENHERTU

ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

ENHERTU (5.4 mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

ENHERTU (5.4 mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

ENHERTU (5.4 mg/kg) is approved in more than 40 countries/regions for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

ENHERTU (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (6.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (5.4 mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the ENHERTU Clinical Development Program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers.

About the Daiichi Sankyo and AstraZeneca Collaboration

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and DATROWAY^® in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY.

About the ADC Portfolio of Daiichi Sankyo

The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo.

The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo.

The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform.

Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

About Daiichi Sankyo

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com.

References

¹ Iqbal N, et al. Mol Biol Int. 2014;852748.

² Omar N, et al. Pathogenesis. 2015;2(3):1-9.

³ Pillai R, et al. Cancer. 2017;1;123(21): 4099-4105.

⁴ Yan M, et al. Cancer Metastasis Rev. 2015;34(1):157–164.

⁵ Buza N, et al. Modern Pathology. 2013;26(12):1605-12.

⁶ Gårdmark T, et al. BJU Int. 2005;95(7):982-6.

⁷ Zinner RG, et al. Lung Cancer. 2004;44(1):99-110.

⁸ Cecchi F, et al. J Clin Oncol. 2023;41(4).

⁹ Valtora E, et al. Mod Pathol. 2015;28(11):1481-91.

¹⁰ Semiz HS, et al. Turk Patologi Derg. 2023;39(1):55-63;

¹¹ Halle MK, et al. Br J Cancer. 2017;118(3):378-387

¹² Uzunparmak B, et al. Ann Oncol. 2023;34(11):1035-1046

¹³ Ersoy E, et al. Int J Gynecol Pathol. 2022;41(4):313-319

Contacts

Global/US:
Jennifer Brennan

Daiichi Sankyo

jennifer.brennan@daiichisankyo.com
+1 908 900 3183 (mobile)

EU:
Simone Jendsch-Dowé

Daiichi Sankyo

simone.jendsch-dowe@daiichisankyo.com
+49 (89) 78080 (office)

Japan:
Daiichi Sankyo Co., Ltd.

DS-PR_jp@daiichisankyo.com

Investor Relations Contact:
DaiichiSankyoIR_jp@daiichisankyo.com

EADV 2025: Galderma Reinforces Leadership in Dermatology With Latest Advances in Sensitive Skin and Itch




EADV 2025: Galderma Reinforces Leadership in Dermatology With Latest Advances in Sensitive Skin and Itch

• Galderma will present a wealth of data including new findings showing the impact of modern living on sensitive skin and insights from the largest global survey conducted on the condition
• Late-breaking data on Nemluvio’s^® (nemolizumab) mode of action in atopic dermatitis (AD) and long-term safety and efficacy data in prurigo nodularis (PN) and moderate-to-severe AD up to two years will also be presented, supporting its potential as a frontline treatment that addresses key disease symptoms^1-5
• The company will also host a symposium on itch, industry hubs on sensitive skin and acne, and multiple Meet the Expert sessions, demonstrating its ongoing commitment to healthcare professional education and clinical excellence

ZUG, Switzerland–(BUSINESS WIRE)–Galderma (SIX: GALD), the dermatology category leader, today announced it will unveil updates from its portfolio at the 34^th European Academy of Dermatology and Venereology (EADV) congress, taking place in Paris, September 17-20, 2025. Highlighting its commitment to addressing skin conditions across the dermatology spectrum, Galderma will present 12 abstracts, including data on sensitive skin, prurigo nodularis, and atopic dermatitis, and host a variety of events – from industry hubs on sensitive skin and acne, to a symposium on itch.

Unveiling the global landscape of sensitive skin

Galderma will present data from its robust research into sensitive skin, a growing global issue which now affects up to 70% of people worldwide – a 68% increase over the last 20 years.^6,7 Data from a first-of-its-kind real-world clinical study conducted in China by Galderma’s Global Sensitive Skin Faculty (GSSF) – a global network of dermatology experts dedicated to advancing sensitive skin research and education – will be presented, revealing the biological impact of modern living and associated environmental factors on individuals with sensitive skin.⁸ Full results from the study will be presented by GSSF members Prof. Adam Friedman, GSSF Co-Chair and Chair of Dermatology at The George Washington University, United States (U.S.); Dr. Aaron Farberg, Dermatologist and Mohs Surgeon, Baylor University Medical Center, U.S.; and Prof. Martina Kerscher, Head of Division of Cosmetic Sciences, University of Hamburg, Germany, at an industry hub, titled ‘Sensitive skin syndrome: A rising phenomenon linked to modern lifestyles and environmental changes’. The hub will take place on Friday, September 19 from 11:15 AM – 12:00 PM CET, Hub 2.12.

Findings from the largest global survey on the impact and prevalence of sensitive skin as reported by almost 17,000 participants will also be presented.⁷ This multi-continent investigation highlights the impact of sensitive skin and the need for targeted, region-specific interventions to optimize the care of individuals affected by the condition worldwide.⁷ Other data to be presented include the efficacy and tolerability of a gentle exfoliating hydroxy acid lotion in managing sensitive skin, as well as an evaluation of the key differences between sensitive skin and rosacea.

Galderma’s efforts to support people with sensitive skin spans from research and education to products, as evidenced by its flagship skincare brand, Cetaphil^®, which offers a range of solutions for people with sensitive skin.

Presenting data on Nemluvio’s mode of action and long-term benefit as a potential front-line therapy in prurigo nodularis and atopic dermatitis

Galderma will also be presenting seven abstracts on its first-in-class monoclonal antibody, Nemluvio, including late-breaking data from a skin and blood proteomic analysis of patients with moderate-to-severe atopic dermatitis.¹ These results will be presented on Friday September 19 at 3:15 – 3:30 PM CET in the Paris Nord room. Interim analysis data in prurigo nodularis showing continued improvements in itch intensity and skin lesions up to 100 weeks will also be shared on Wednesday September 17, 6:10 – 6:17 PM CET, Room E01 – E03.² Additional data will be presented on Nemluvio’s long-term safety and efficacy in moderate-to-severe atopic dermatitis, including in adolescents up to 56 weeks, and adolescents and adults up to 104 weeks also showing continued improvements in itch intensity and skin lesions.^3,9 These data reinforce Nemluvio’s safety and efficacy profile, following its approval in the United States, Europe and several other countries around the world for the treatment of prurigo nodularis and moderate-to-severe atopic dermatitis.^2-5

Galderma will also host a symposium titled ‘Ditching the itch: Exploring the latest advances in atopic dermatitis and prurigo nodularis, targeting freedom from itch and long-term skin lesion control’ on Friday, September 19 from 1:00 – 2:00 PM CET, Room S03. Experts will discuss advancing treatment strategies in atopic dermatitis and prurigo nodularis, and the importance of understanding itch as the most urgent symptom to target as it severely affects patients’ quality of life in these diseases.^10,11

Showcasing dermatology leadership through expert engagements

Expert dermatologists will discuss approaches and advancements in the treatment of acne during an industry hub titled, ‘A holistic approach to acne and acne sequelae: Combining retinoids, CTMP™ and cosmetic corrective procedures’ on Thursday September 18 from 2:15 – 3:00 PM CET, Hub 2.07.

Galderma will also host a series of Meet the Expert sessions on atopic dermatitis at its booth (#EO1), including dedicated sessions titled ‘What would you do? A case-based discussion on atopic dermatitis treatment strategies’ on Thursday September 18; 12:00 – 12:30 PM CET and ‘Rethinking atopic dermatitis relief: Science-driven skincare solutions across the flare cycle’ on Thursday September 18 from 11:45 AM – 12:00 PM CET and Friday, September 19 from 2:00 – 2:15 PM CET.

More details on Galderma’s scientific presentations at EADV can be found here.

About Nemluvio

Nemluvio was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. In Japan, nemolizumab is marketed as Mitchga^® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.^12,13 Nemluvio is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including the U.S. Food and Drug Administration and European Commission.^4,5 Additional reviews and submissions are ongoing.

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References

1. Liu D, et al. Nemolizumab suppressed multiaxial inflammatory pathways and improved barrier protein signatures in skin and blood proteomic analysis of patients with moderate-to-severe AD. Late-breaking oral presented at the European Academy of Dermatology and Venereology (EADV) Congress; September 17-20, 2025; Paris, France
2. Metz M, et al. Clinically meaningful and sustained itch and skin responses in the OLYMPIA open-label extension nemolizumab study in patients with prurigo nodularis: An interim analysis up to 100 weeks. Poster presented at the EADV Congress; September 17-20, 2025; Paris, France
3. Nemluvio AD data. Silverberg J, et al. Nemolizumab long-term safety and efficacy up to 104 weeks in ARCADIA open-label extension study in adolescents and adults with moderate-to-severe atopic dermatitis. Poster presented at the EADV Congress; September 17-20, 2025; Paris, France
4. Nemluvio^® U.S. Prescribing Information. Available online. Accessed September 2025
5. Nemluvio^® European Medicines Agency. Summary of Product Characteristics. Available online. Accessed September 2025
6. Richters R, et al. What Is Sensitive Skin? A Systematic Literature Review of Objective Measurements. Skin Pharmacol Physiol. 2015;28(2),75-83. doi:10.1159/000363149
7. Vidal S, et al. Defining the Prevalence, Clinical Characteristics, and Demographic Influences on Patients with Sensitive Skin Syndrome: Insights from the Largest Global Survey of Sensitive Skin. Poster presented at the EADV Congress; September 17-20, 2025; Paris, France
8. Friedman A. Sensitive skin syndrome: A rising phenomenon linked to modern lifestyles and environmental changes. Presented during an industry hub at the EADV Congress; September 17-20, 2025; Paris, France
9. Reich A, et al. Long-term efficacy and safety of nemolizumab in adolescents with moderate-to-severe atopic dermatitis: Post hoc analyses from ARCADIA LTE 1-year cut-off. Poster presented at the EADV Congress; September 17-20, 2025; Paris, France
10. Aggarwal P, et al. Clinical characteristics and disease burden in prurigo nodularis. Clin Exp Dermatol. 2021;46(7):1277-1284. doi: 10.1111/ced.14722
11. Silverberg JI, et al. Patient burden and quality of life in atopic dermatitis in US adults: a population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018;121(3):340-347. doi: 10.1016/j.anai.2018.07.006
12. Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Accessed September 2025
13. Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Accessed September 2025

Contacts

For further information:

Christian Marcoux, M.Sc.

Chief Communications Officer

christian.marcoux@galderma.com
+41 76 315 26 50

Richard Harbinson

Corporate Communications Director

richard.harbinson@galderma.com
+41 76 210 60 62

Céline Buguet

Franchises and R&D Communications Director

celine.buguet@galderma.com
+41 76 249 90 87

Emil Ivanov

Head of Strategy, Investor Relations, and ESG

emil.ivanov@galderma.com
+41 21 642 78 12

Jessica Cohen

Investor Relations and Strategy Director

jessica.cohen@galderma.com
+41 21 642 76 43

Tubulis Strengthens Leadership Team with Appointment of Halley Gilbert as Chief Legal and Operating Officer




Tubulis Strengthens Leadership Team with Appointment of Halley Gilbert as Chief Legal and Operating Officer

MUNICH–(BUSINESS WIRE)–Tubulis today announced the appointment of Halley Gilbert, JD, as Chief Legal Officer and Chief Operating Officer (CLO/COO). Bringing over 20 years of transaction and operations experience in the biopharmaceutical industry, Ms. Gilbert will further expand Tubulis’ leadership capabilities at a pivotal stage of clinical and corporate development. In this newly created role, she will leverage her combined expertise as an attorney and seasoned biotech executive to shape Tubulis’ strategy and support the continued growth of the company’s U.S. presence. Ms. Gilbert will be responsible for legal and administrative functions and play a key role in executing strategic transactions for the company.

“Halley’s extensive legal and operational experience and deep commitment to supporting rapidly growing biotech companies make her an ideal addition to our team as we further expand our clinical and business operations,” said Dr. Dominik Schumacher, CEO and Co-founder of Tubulis. “Her industry know-how and strategic leadership will be instrumental as we advance our lead ADC candidates through clinical development and continue to expand our pipeline with new modalities.”

“ADCs are transforming the oncology landscape, and Tubulis is leading the way with its differentiated approach to ADC design,” said Halley Gilbert, JD, CLO and COO of Tubulis. “Their innovative platforms and exciting research ethos allow them to unlock the full therapeutic potential of this powerful drug class. I am thrilled to be joining such a motivated team and look forward to helping shape the path toward commercialization and delivering a meaningful clinical impact to patients.”

Ms. Gilbert brings extensive legal and operational experience within the life sciences industry, having served as CLO and COO at both public and private biotech companies. Most recently, she served as Chief Legal Officer of Cargo Therapeutics and played a key leadership role in the company’s initial public offering and subsequent sale. Prior to Cargo, Ms. Gilbert was the first employee of Invyvid, Inc. (formerly Adagio), where she enabled the company’s rapid growth from launch to IPO, and accelerated its transition from early R&D to late-stage clinical development. In addition, for the past five years, Ms. Gilbert has been a member of the Board of Directors at Vaxcyte, Inc., Arcutis Biotherapeutics, and CytomyX Therapeutics, Inc.

About Tubulis

Tubulis generates uniquely matched antibody-drug conjugates with superior biophysical properties that have demonstrated durable on-tumor delivery and long-lasting anti-tumor activity in preclinical models. The two lead programs from our growing pipeline, TUB-040, targeting NaPi2b, and TUB-030, directed against 5T4, are being evaluated in the clinic in high-need solid tumor indications. We will solidify our leadership position by continuing to innovate on all aspects of ADC design leveraging our proprietary platform technologies. Our goal is to expand the therapeutic potential of this drug class for our pipeline, our partners and for patients. Visit www.tubulis.com or follow us on LinkedIn.

Contacts

For Tubulis
Dominik Schumacher, CEO & Co-founder

Phone: +49 (0) 175 800 5594

Email: contact@tubulis.com

Media Requests for Tubulis
Trophic Communications

Stephanie May, PhD

Phone: +49 (0) 171 185 56 82

Email: tubulis@trophic.eu

Abselion Launches AAVX and AAV9 Total Capsid Quantification Kits




Abselion Launches AAVX and AAV9 Total Capsid Quantification Kits

• Ready-to-use solution for Amperia benchtop platform supports rapid, reliable quantification across a range of serotypes
• Kits incorporate Thermo Fisher Scientific’s CaptureSelect affinity reagents for enhanced specificity and consistency

CAMBRIDGE, United Kingdom–(BUSINESS WIRE)–#AAV–Abselion, a pioneering life sciences technology company focused on simplifying biomolecule quantification, has expanded its product offering, with the launch of the AAVX Total Capsid Quantification Kit and the AAV9 Total Capsid Quantification Kit. Both kits are designed for use with its Amperia™ benchtop quantification platform and include Thermo Fisher Scientific’s CaptureSelect™ affinity reagents. Combining these trusted reagents with Abselion’s consistent assay format reduces the need for in-house optimisation. These kits offer researchers working in adeno-associated virus (AAV) development and characterisation a more streamlined and accessible workflow to generate reproducible titre measurements across a broad range of serotypes and process conditions.

Abselion’s Amperia benchtop platform is a simple-to-use solution for rapid and accurate automated quantification of a range of biomolecules, without optics, fluidics, or specialist training. Each kit is supplied in a ready-to-use format, including sensor strips, assay plates, matched detection reagents, and assay buffers for the binding and detection steps. The expanded kit range enhances the utility of Amperia for scientists working across gene therapy development and process workflows, offering a practical, dependable approach to total capsid quantification from purified or complex samples.

Abselion has entered into a licensing agreement with Thermo Fisher Scientific to incorporate CaptureSelect affinity reagents into its AAV quantification kits. CaptureSelect technology is based on recombinant single-domain antibodies designed for high target specificity, low cross-reactivity, and consistent batch performance to ensure robust titre quantification. With the integration of these reagents, the new kits advance Abselion’s AAV assay format, bringing improved performance and broader serotype applicability.

Both kits use a sandwich-style immunoassay format, in which biotin- and HRP-conjugated CaptureSelect antibodies are sequentially applied to bind AAV capsids. The resulting signal is detected electrochemically using Amperia sensor strips, enabling accurate quantitative detection across a range of AAV sample types and concentrations.

The AAVX Total Capsid Quantification Kit includes CaptureSelect Anti-AAVX Biotin and HRP Conjugates, enabling broad serotype coverage including AAV1–8 and AAVrh10. The AAV9 Total Capsid Quantification Kit incorporates CaptureSelect Anti-AAV9 Biotin and HRP Conjugates for focused quantification of AAV9 particles.

Dr Ruizhi Wang, CEO and Founder, Abselion, said: “Reliable quantification of total AAV capsid concentration is key to maintaining consistency and supporting informed decision-making. The integration of Thermo Fisher Scientific’s CaptureSelect reagents strengthens the performance of Abselion’s AAV kits and reflects our focus on making high-quality titre measurement simpler and more accessible. With these additions, Amperia offers researchers a ready-to-use solution that combines trusted reagent technologies with a streamlined assay format, enabling reliable quantification across a wider range of serotypes and development workflows.”

Dr Kelly Flook, Sr. Manager, Product Management, Pharma Analytics, Thermo Fisher Scientific, said: “CaptureSelect affinity reagents are designed to deliver high specificity and lot-to-lot consistency, making them well suited for applications such as AAV capsid quantification. We’re pleased that Abselion has incorporated these reagents under licence to support their assay kits for the Amperia platform.”

For further information about Abselion’s AAVX and AAV9 Total Capsid Quantification Kits, please visit: https://www.abselion.com/assay-kits/ or download the application note “Empowering AAV Quantification for Gene Therapy Research”. The Abselion team will also be attending Festival of Biologics (30 Sep–02 Oct in Basel, Switzerland). Meet the team at booth 240 to learn more.

Please contact Codon Communications for high-resolution images.

Contacts

Codon Communications
Dr Michelle Ricketts

Tel: +44 7789 053885

Email: michelle.ricketts@codoncommunications.com