Pacira Reports Preliminary Unaudited Fourth Quarter and Full-Year 2025 Revenues




Pacira Reports Preliminary Unaudited Fourth Quarter and Full-Year 2025 Revenues

— Record-high EXPAREL sales driven by volume growth of 7 percent, marking strongest fourth quarter performance in three years–

BRISBANE, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) — Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today reported preliminary, unaudited total revenue of $726.4 million for the year ended December 31, 2025, compared with $701.0 million for the year ended December 31, 2024. The company also repurchased 2.0 million shares of its common stock during the fourth quarter.

“We closed 2025 having achieved another year of solid execution and meaningful progress advancing our 5×30 strategic priorities, leaving us well-positioned for sustainable, long-term success,” said Frank D. Lee, chief executive officer of Pacira BioSciences. “Strong EXPAREL volume growth in the second half of the year underscores the value of our commercial investments and positions us for significant and sustainable revenues moving forward. We enter 2026 with momentum that provides us with a strong foundation and clear line of sight to further operational progress and an exciting chapter of growth ahead.”

Preliminary Unaudited Fourth Quarter Revenue Highlights

• Fourth quarter EXPAREL net product sales of $155.8 million in 2025, compared with $147.7 million in 2024. Fourth quarter volume growth of 7 percent was partially offset by a shift in vial mix and discounting associated with the launch of a new group purchasing organization (GPO) partnership.
• Fourth quarter ZILRETTA net product sales of $33.0 million in 2025, compared with $33.1 million in 2024.
• Fourth quarter iovera° net product sales of $7.0 million in 2025, compared with $6.5 million in 2024.
• Other revenue, comprised of sales of bupivacaine liposome injectable suspension, was $1.1 million in the fourth quarter of 2025, compared with zero in the fourth quarter of 2024.

Preliminary Unaudited Full-Year Revenue Highlights

• Full-year EXPAREL net product sales of $575.1 million in 2025, compared with $549.0 million in 2024. Full-year volume growth of 6 percent was partially offset by a shift in vial mix and discounting associated with the company’s new GPO partnerships.
• Full-year ZILRETTA net product sales of $116.6 million in 2025, compared with $118.1 million in 2024.
• Full-year iovera° net product sales of $24.2 million in 2025, compared with $22.8 million in 2024.
• Other revenue, comprised of sales of bupivacaine liposome injectable suspension and royalties, was $10.5 million in 2025, compared with $11.1 million in 2024.

The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the fourth quarter or full year 2025. Pacira expects to report its complete financial results for the fourth quarter and full-year 2025, along with the company’s financial guidance, later in the first quarter of 2026.

Share Repurchase Program

During the fourth quarter of 2025, the company repurchased 2.0 million shares of its common stock through open market transactions for $50.0 million (exclusive of broker fees and excise tax incurred). At December 31, 2025, the company had 41.1 million shares of common stock outstanding and $150.0 million remaining on its current share repurchase authorization, which expires December 31, 2026.

Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Pacira today announced the granting of inducement awards on January 5, 2026 to ten new employees under Pacira’s Amended and Restated 2014 Inducement Plan (the “Inducement Plan”) as a material inducement to each employee’s entry into employment with the company. In accordance with Nasdaq Listing Rule 5635(c)(4), the awards were approved by the People & Compensation Committee of the Board of Directors (the “Committee”) without stockholder approval.

Six employees received stock options to purchase an aggregate of 14,000 shares of Pacira common stock and ten employees received restricted stock units for an aggregate of 22,300 shares of Pacira common stock. The stock options have a 10-year term and a four-year vesting schedule with 25 percent of the underlying shares vesting on the first anniversary of the recipient’s first day of employment and in successive equal quarterly installments over the 36 months thereafter.

The stock options have an exercise price of $25.10 per share, the closing trading price of Pacira common stock on the Nasdaq Global Select Market on the date of grant. Each restricted stock unit represents the contingent right to receive one share of Pacira common stock and the restricted stock unit awards vest annually in four equal installments beginning on January 2, 2027.

Vesting of the equity awards is subject to the employee’s continued employment with Pacira. Each equity award is also subject to the terms and conditions of an award agreement.

About Pacira

Pacira delivers innovative, non-opioid pain therapies to transform the lives of patients. Pacira has three commercial-stage non-opioid treatments: EXPAREL^® (bupivacaine liposome injectable suspension), a long-acting local analgesic currently approved for infiltration, fascial plane block, and as an interscalene brachial plexus nerve block, an adductor canal nerve block, and a sciatic nerve block in the popliteal fossa for postsurgical pain management; ZILRETTA^® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection indicated for the management of osteoarthritis knee pain; and iovera_®º, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. The company is also advancing a pipeline of clinical-stage assets for musculoskeletal pain and adjacencies, its most advanced product candidate, PCRX-201 (enekinragene inzadenovec), a novel locally administered gene therapy, is in Phase 2 clinical development for osteoarthritis of the knee. To learn more about Pacira, visit www.pacira.com.

About EXPAREL^® (bupivacaine liposome injectable suspension)

EXPAREL is indicated to produce postsurgical local analgesia via infiltration in patients aged 6 years and older, and postsurgical regional analgesia via an interscalene brachial plexus block in adults, a sciatic nerve block in the popliteal fossa in adults, and an adductor canal block in adults. The safety and effectiveness of EXPAREL have not been established to produce postsurgical regional analgesia via other nerve blocks besides an interscalene brachial plexus nerve block, a sciatic nerve block in the popliteal fossa, or an adductor canal block. The product combines bupivacaine with multivesicular liposomes, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the multivesicular liposome platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

Important Safety Information about EXPAREL for Patients

EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting. In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. In the study where EXPAREL was given to children, the most common side effects were nausea, vomiting, constipation, low blood pressure, low number of red blood cells, muscle twitching, blurred vision, itching, and rapid heartbeat. EXPAREL can cause a temporary loss of feeling and/or loss of muscle movement. How much and how long the loss of feeling and/or muscle movement depends on where and how much of EXPAREL was injected and may last for up to 5 days. EXPAREL is not recommended to be used in patients younger than 6 years old for injection into the wound, for patients younger than 18 years old, for injection near a nerve, and/or in pregnant women. Tell your health care provider if you or your child has liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from the body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL can affect the nervous system and the cardiovascular system; may cause an allergic reaction; may cause damage if injected into the joints; and can cause a rare blood disorder.

About ZILRETTA^® (triamcinolone acetonide extended-release injectable suspension)

On October 6, 2017, ZILRETTA was approved by the U.S. Food and Drug Administration as the first and only extended-release intra-articular therapy for patients confronting osteoarthritis (OA)- related knee pain. ZILRETTA employs proprietary microsphere technology combining triamcinolone acetonide—a commonly administered, short-acting corticosteroid—with a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief. The pivotal Phase 3 trial on which the approval of ZILRETTA was based showed that ZILRETTA significantly reduced OA knee pain for 12 weeks, with some people experiencing pain relief through Week 16. Learn more at www.zilretta.com.

Indication and Select Important Safety Information for ZILRETTA

Indication: ZILRETTA is indicated as an intra-articular injection for the management of OA pain of the knee. Limitation of Use: The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated.

Contraindication: ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids or any components of the product.

Warnings and Precautions:

• Intra-articular Use Only: ZILRETTA has not been evaluated and should not be administered by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous routes. ZILRETTA should not be considered safe for epidural or intrathecal administration.
• Serious Neurologic Adverse Reactions with Epidural and Intrathecal Administration: Serious neurologic events have been reported following epidural or intrathecal corticosteroid administration. Corticosteroids are not approved for this use.
• Hypersensitivity reactions: Serious reactions have been reported with triamcinolone acetonide injection. Institute appropriate care if an anaphylactic reaction occurs.
• Joint infection and damage: A marked increase in joint pain, joint swelling, restricted motion, fever and malaise may suggest septic arthritis. If this occurs, conduct appropriate evaluation and if confirmed, institute appropriate antimicrobial treatment.

Adverse Reactions: The most commonly reported adverse reactions (incidence ≥1%) in clinical studies included sinusitis, cough, and contusions.

Please see ZILRETTALabel.com for full Prescribing Information.

About iovera_®°

The iovera° system uses the body’s natural response to cold to treat peripheral nerves and immediately reduce pain without the use of drugs. Treated nerves are temporarily stopped from sending pain signals for a period of time, followed by a restoration of function. Treatment with iovera° works by applying targeted cold to a peripheral nerve. A precise cold zone is formed under the skin that is cold enough to immediately prevent the nerve from sending pain signals without causing damage to surrounding structures. The effect on the nerve is temporary, providing pain relief until the nerve regenerates and function is restored. Treatment with iovera° does not include injection of any substance, opioid, or any other drug. The effect is immediate and can last up to 90 days. The iovera° system is not indicated for treatment of central nervous system tissue. Additional information is available at www.iovera.com.

Indication and Select Important Safety Information for iovera°

Indication: iovera° applies freezing cold to peripheral nerve tissue to block and/or relieve pain for up to 90 days. It should not be used to treat central nervous system tissue.

Important Safety Information

• Do not receive treatment with iovera° if you experience hypersensitivity to cold or have open and/or infected wounds near the treatment site. 
• You may experience bruising, swelling, inflammation and/or redness, local pain and/or tenderness, and altered feeling at the site of application.
• In treatment area(s), you may experience damage to the skin, skin darkening or lightening, and dimples in the skin.
• You may experience a temporary loss of your ability to use your muscles normally outside of the treatment area.
• Talk to your doctor before receiving treatment with iovera°.

About PCRX-201 (enekinragene inzadenovec)

PCRX-201 (enekinragene inzadenovec) features an innovative design based on the company’s proprietary high-capacity adenovirus vector platform. It is currently being studied in the fundamental, underlying chronic inflammatory processes that contribute to “wear and tear” over time in osteoarthritis of the knee, a condition that affects more than 14 million individuals in the U.S. today.

In November 2024, Pacira reported promising data from a large Phase 1 study in which PCRX-201 provided sustained improvements in knee pain, stiffness, and function through two years following local administration, with a well-tolerated safety profile. PCRX-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and Advanced Therapy Medicinal Products (ATMP) designation from the European Medicines Agency. PCRX-201 is the first gene therapy to achieve these clinical results and earn these regulatory designations in osteoarthritis of the knee—a testament to its promise and potential.

Given the promising Phase 1 results, dosing is underway in a Phase 2 study of PCRX-201 (the ASCEND study) for the treatment of knee osteoarthritis. To learn more about PCRX-201 and the company’s clinical development program, please visit the investor events section of the company’s investor website.

About the High-capacity Adenovirus Vector Platform

In February 2025, in support of the company’s ‘5×30’ growth strategy, Pacira acquired GQ Bio Therapeutics GmbH (GQ Bio) and its novel high-capacity adenovirus (HCAd) vector gene therapy vector platform. This platform solves many of the challenges in the field of gene therapy that have prevented its utilization in treating common diseases, such as osteoarthritis.

Key features include:

• The HCAd vector is much more efficient at delivering genes into cells compared to many other gene therapies that rely on adenovirus associated virus, or AAV, vectors. As a result, the desired effect can be achieved with much smaller doses.
• The vector used in the HCAd platform can carry up to 30,000 base pairs of DNA, which enables gene therapy with multiple or larger genes compared to AAV vectors.
• Genetic medicines based on the HCAd platform can be administered locally and have the potential for redosing at therapeutically appropriate intervals.
• Lower dose levels and efficient delivery of genes into cells means that thousands of doses can be produced in a single batch. As a result, therapies built on the HCAd platform are expected to have a commercially attractive and viable cost of goods profile.

Beyond PCRX-201 and other product candidates in preclinical development, the company has identified numerous well-validated cytokines that could also be the basis for locally administered genetic therapies using the HCAd platform.

Forward-Looking Statements

Any statements in this press release about Pacira’s future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “should,” “will,” “would,” and similar expressions, constitute forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Private Securities Litigation Reform Act of 1995, including, without limitation, statements related to: ‘5×30’, our growth and business strategy, our future outlook, the strength and efficacy of our intellectual property protection and patent terms, our future growth potential and future financial and operating results and trends, our plans, objectives, expectations (financial or otherwise) and intentions, including our plans with respect to the repayment of our indebtedness, anticipated product portfolio and product development programs, strategic alliances, plans with respect to the Non-Opioids Prevent Addiction in the Nation (“NOPAIN”) Act, the expected cost savings and benefits of a July 2025 reduction in force and any other statements that are not historical facts. For this purpose, any statement that is not a statement of historical fact should be considered a forward-looking statement. We cannot assure you that our estimates, assumptions and expectations will prove to have been correct. Actual results may differ materially from these indicated by such forward-looking statements as a result of various important factors, including risks relating to, among others: the failure to realize the anticipated benefits and synergies from the acquisition of GQ Bio Therapeutics GmbH; risks associated with acquisitions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; our manufacturing and supply chain, global and United States economic conditions (including tariffs, inflation and rising interest rates), and our business, including our revenues, financial condition, cash flows and results of operations; the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL, ZILRETTA and iovera°; the rate and degree of market acceptance of EXPAREL, ZILRETTA and iovera°; the size and growth of the potential markets for EXPAREL, ZILRETTA and iovera° and our ability to serve those markets; our plans to expand the use of EXPAREL, ZILRETTA and iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL, ZILRETTA, iovera° and any of our other product candidates, including PCRX-201; the commercial success of EXPAREL, ZILRETTA and iovera°; the related timing and success of United States Food and Drug Administration supplemental New Drug Applications and premarket notification 510(k)s; the related timing and success of European Medicines Agency Marketing Authorization Applications; our plans to evaluate, develop and pursue additional product candidates utilizing our proprietary multivesicular liposome (“pMVL”) drug delivery technology; the approval of the commercialization of our products in other jurisdictions; clinical trials in support of an existing or potential pMVL-based product; our commercialization and marketing capabilities; our ability to successfully complete capital projects; the outcome of any litigation; the recoverability of our deferred tax assets; assumptions associated with contingent consideration payments; assumptions used for estimated future cash flows associated with determining the fair value of the Company and the anticipated funding or benefits of our share repurchase program. and factors discussed in the “Risk Factors” of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. Except as required by applicable law, we undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, and readers should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these statements. These factors include the matters discussed and referenced in the “Risk Factors” of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the SEC.

CONTACT: Investor Contact:
Susan Mesco, (973) 451-4030
susan.mesco@pacira.com

Media Contact:
Sara Marino, (973) 370-5430
sara.marino@pacira.com

Krystal Biotech Announces Positive Interim Clinical Update from KB407 Phase 1 CORAL-1 Study with Confirmation of Wild-Type CFTR Delivery to the Lungs of Patients with Cystic Fibrosis




Krystal Biotech Announces Positive Interim Clinical Update from KB407 Phase 1 CORAL-1 Study with Confirmation of Wild-Type CFTR Delivery to the Lungs of Patients with Cystic Fibrosis

Confirmed wild-type CFTR delivery and expression in conducting airway cells of patients with class I mutations

KB407 transduction confirmed in all six patients with successful bronchoscopies irrespective of modulator-status; percentage of conducting airway cells transduced in each patient ranged from 29.4% to 42.1%

Registrational repeat dosing CORAL-3 study design submitted to FDA in late December; anticipating enrollment in study to start in 1H 2026 following alignment with the FDA

Investor call to be held January 8 at 4:30 pm ET to discuss data update and timelines for KB407 repeat dosing study start

PITTSBURGH, Jan. 08, 2026 (GLOBE NEWSWIRE) — Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced a positive interim clinical update from the highest dose cohort of CORAL-1, the Company’s multi-center, dose escalation Phase 1 study evaluating KB407 in patients with cystic fibrosis (CF), confirming the successful lung delivery and expression of wild-type cystic fibrosis transmembrane conductance regulator (CFTR) protein following inhaled administration of KB407.

“Molecular confirmation of delivery and expression of unmodified, wild-type CFTR protein in clinically relevant ciliated and secretory cells of the lungs of patients with CF is a tremendous breakthrough and a first for our field,” said Jorge Lascano, MD, Professor of Medicine, Associate Director of the Adult Cystic Fibrosis Program, and Director of the Cystic Fibrosis Therapeutics Development Center at the University of Florida. “High rates of KB407 transduction and broad distribution across patient airways irrespective of underlying lung disease, genetic background, or modulator status – combined with the redosability of KB407 and demonstrated functionality of its full-length CFTR payload – underscore the transformative potential of KB407 as a mutation-agnostic therapy for the many patients either ineligible for or underserved by currently availably modulators.”

The Company will host an investor conference call and webcast today, Thursday, January 8, 2026, at 4:30 pm ET, to discuss the clinical data updates. Investors and the general public can access the live webcast at: https://www.webcaster5.com/Webcast/Page/3018/53466. For those unable to listen to the live webcast, an archived version will also be available on the Investors section of the Company’s website for at least 30 days.

CORAL-1 Highest Dose Cohort Interim Results

KB407 is being evaluated in the Company’s CORAL-1 study, an open label, multi-center Phase 1 study in patients with CF that includes three dose escalation cohorts evaluating either one, two, or four daily administrations of 10⁹ PFU of KB407 via inhalation. Additional details of the CORAL-1 study can be found at www.clinicaltrials.gov under NCT identifier NCT05504837.

Positive interim safety results from the first two dose escalation cohorts, referred to as Cohorts 1 and 2, were reported in 4Q 2024. Today’s update is focused on safety and molecular findings from patients dosed in the highest dose cohort of CORAL-1, Cohort 3.

As of the January 6, 2026 data cut-off, a total of seven (7) patients have been dosed with KB407 in the highest dose Cohort 3 of CORAL-1. Four of the seven patients were ineligible for modulator therapy. All patients received four daily administrations of 10⁹ PFU of KB407 via inhalation, followed by a bronchoscopy 24-96 hours after receiving their last dose of KB407. Bronchoscopies for six of the seven patients were successful and yielded biopsies suitable for molecular analysis. At least 28 days of safety follow up data was available for all seven patients dosed with KB407 as of data cut-off.

KB407 transduction was confirmed in all Cohort 3 patients with successful bronchoscopies irrespective of modulator-status and genetic background, with broad airway distribution and transduction as assessed by CFTR or viral marker immunofluorescence, ranging from 29.4% to 42.1% across these six patients. Key molecular findings are summarized below:

Modulator Ineligible Patients (n = 4)

* Positive cell counts for patients 3 and 4 based on viral marker expression given potential for background endogenous CFTR
** Overall values are based on the combined cell counts across all analyzable biopsies from a given patient while range values reflect cell counts from individual biopsies; conducting airway cells defined as airway-exposed epithelial cells lining the bronchi of the lung

All biopsies suitable for analysis from the four modulator ineligible patients (combined n = 23 biopsies) were positive for CFTR or viral marker expression, indicative of widespread dissemination of KB407 throughout the conducting airways of the lung.

Modulator Eligible Patients (n = 2)

* Overall values are based on the combined cell counts across all analyzable biopsies from a given patient while range values reflect cell counts from individual biopsies; conducting airway cells defined as airway-exposed epithelial cells lining the bronchi of the lung

All biopsies suitable for analysis from the two modulator eligible patients (combined n = 8 biopsies) were positive for viral marker expression.

Consistent with the safety profile previously reported from Cohorts 1 and 2, inhaled KB407 continued to be well tolerated by patients treated with the highest dose in Cohort 3. All but one KB407-related adverse event were mild to moderate in severity and transient in nature. One serious adverse event (SAE) of asthma exacerbation was reported 24 hours after completion of the bronchoscopy. The SAE was deemed procedure related, and not related to KB407, by the independent data monitoring committee. The SAE resolved in 5 days.

“Today’s update has profound implications for Krystal and for the many CF patients unable to benefit from modulator therapy ,” said Suma Krishnan, President, Research & Development, Krystal Biotech, Inc. “With clear evidence of CFTR protein expression in patients with class I mutations and reproducible KB407 transduction across a diverse CF population, we are moving forward with conviction into our repeat dosing study with registrational intent, CORAL-3. We are excited to be working with the Cystic Fibrosis Foundation to accelerate clinical development and potential registrational timelines.”  

The Company submitted the CORAL-3 study design to the United States Food and Drug Administration (FDA) in late December. CORAL-3 is designed to evaluate the safety and efficacy of repeat KB407 administration, including regular assessments of lung function by spirometry, and support potential registration. The Company expects to align on the CORAL-3 study design with the FDA in 1Q 2026 and start enrollment in CORAL-3 in 2Q 2026. Additional details on the study design will be provided by the time of study initiation.

About CF

CF is an inherited disease caused by genetic mutations that result in dysfunctional or absent CFTR protein. Lack of functional CFTR causes dehydrated mucus buildup in the lungs, pancreas, and other organs. This mucus buildup in the lungs leads to loss of lung function, and eventually, respiratory failure. According to the US Cystic Fibrosis Foundation, close to 40,000 children and adults are living with CF in the United States, and an estimated 105,000 are diagnosed with CF across 94 countries. Although CFTR modulators are effective in patients with certain CFTR mutations, patients may still experience pulmonary symptoms requiring treatment. Further, a meaningful proportion of CF patients harbor genetic mutations that are not expected to be responsive to modulators and currently have no available disease-modifying treatment options, representing a significant unmet need.

About KB407

KB407 is a redosable gene therapy designed to deliver two copies of the full-length CFTR transgene to the lung via inhalation for the treatment of CF. By enabling expression of full-length, wild-type CFTR protein in the lung, treatment with KB407 has potential to restore CFTR-mediated ion transport, mucus clearance, and lung function in patients with CF regardless of their underlying genetic mutation. KB407 has been shown to successfully transduce patient-derived epithelial cells and deliver functional CFTR in 2D and 3D in vitro organotypic systems and, as demonstrated in the CORAL-1 Phase 1 study, is amendable to inhaled administration via nebulization, with successful lung delivery and broad airway distribution confirmed in multiple patients with cystic fibrosis.

About Krystal Biotech, Inc.

Krystal Biotech, Inc. (NASDAQ: KRYS) is a fully integrated, commercial-stage, global biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs. VYJUVEK®, the Company’s first commercial product, is the first-ever redosable gene therapy and the first genetic medicine approved in the United States, Europe, and Japan for the treatment of dystrophic epidermolysis bullosa. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines in respiratory, oncology, dermatology, ophthalmology, and aesthetics. Krystal Biotech is headquartered in Pittsburgh, Pennsylvania. For more information, please visit http://www.krystalbio.com, and follow @KrystalBiotech on LinkedIn and X (formerly Twitter).

Forward-Looking Statements

This press release contains “forward looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995 based on the Company’s current expectations and beliefs regarding its product candidate, KB407 for the treatment of patients with cystic fibrosis. These forward-looking statements include, without limitation, statements relating to the potentially transformative potential of KB407 as a mutation-agnostic therapy; and the Company’s planned study, CORAL-3, that is designed to evaluate the safety and efficacy of repeat KB407 administration, including expected alignment on the CORAL-3 study design with the FDA in 1Q 2026 and initiation of enrollment in CORAL-3 in 2Q 2026. All statements other than historical facts are or may be deemed to be forward‑looking statements and involve known and unknown risks, uncertainties, and assumptions that could cause actual results to differ materially from those indicated by such forward-looking statements as a result of various important factors, including uncertainties inherent in the initiation and conduct of clinical trials, regulatory review of clinical trials, and applications for marketing approvals; whether results of early clinical trials will be indicative of the results of later-stage studies; and such other important factors as are set forth under the caption “Risk Factors” in the Company’s annual and quarterly reports on file with the U.S. Securities and Exchange Commission. The Company provides this information as of the date of this press release and assumes no obligation to update any forward-looking statements.

CONTACT
Investors and Media:                                                                                        
Stéphane Paquette
Krystal Biotech
spaquette@krystalbio.com                                                                                   

MiNK Therapeutics and University of Wisconsin–Madison Announce Phase 1 Clinical Trial of Allo-iNKT Cell Therapy (AgenT-797) to Evaluate Prevention of Graft-Versus-Host Disease




MiNK Therapeutics and University of Wisconsin–Madison Announce Phase 1 Clinical Trial of Allo-iNKT Cell Therapy (AgenT-797) to Evaluate Prevention of Graft-Versus-Host Disease

• Non-dilutive public-private funded trial with NIAID STTR & Mary Gooze Clinical Trial and Translation Award
• Expands iNKT platform into transplantation with an off-the-shelf, HLA-independent, lymphodepletion-free experimental therapy in patients at risk for GvHD

NEW YORK, Jan. 08, 2026 (GLOBE NEWSWIRE) — MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering off-the-shelf allogeneic invariant natural killer T (allo-iNKT) cell therapies, today announced the upcoming initiation of a Phase 1, investigator-sponsored clinical trial evaluating its lead therapy, agenT-797, in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).

The trial, led by Hongtao Liu, MD, PhD, Associate Professor of Medicine, University of Wisconsin School of Medicine and Public Health, with co-investigator Kalyan V. G. Nadiminti, MD, Assistant Professor of Medicine at the University of Wisconsin School of Medicine and Public Health, will evaluate the safety, tolerability, and preliminary efficacy of agenT-797 in reducing graft-versus-host disease (GvHD), relapse, and other post-transplant complications in patients with high-risk leukemias and other blood cancers.

Two complementary public-private funding awards support the advancement of agenT-797 development in HSCT and GvHD. First, an NIH STTR grant from the National Institute of Allergy and Infectious Diseases (NIAID) supports MiNK and the University of Wisconsin–Madison team to develop and evaluate agenT-797 in preclinical models. Second, a philanthropic clinical grant, the Mary Gooze Clinical Trial Award to the University of Wisconsin–Madison directly funds enrollment, immune monitoring, and operations for the Phase 1. Together, these awards enable the simultaneous execution of translational and clinical studies of iNKTs in GvHD prevention.

“This trial marks an important step in expanding our iNKT platform into GvHD, targeting one of the most serious and persistent complications of stem cell transplantation, where effective options remain limited,” said Jennifer Buell, PhD, President and Chief Executive Officer of MiNK Therapeutics. “Our objective is to reduce GvHD and relapse while supporting immune reconstitution, with the potential to improve survival and quality of life for transplant patients—without the cytotoxic burden of lymphodepleting conditioning regimens.”

GvHD is a leading cause of morbidity and mortality following HSCT, affecting up to half of recipients. iNKT cells are uniquely suited to this setting, as they can suppress inflammatory allo-immune responses while preserving anti-leukemia activity and immune competence. agenT-797, an off-the-shelf, donor-derived iNKT cell therapy, has demonstrated favorable safety and immune-modulating activity in solid tumors and ARDS—without the need for lymphodepletion or human leukocyte antigen (HLA) matching.

The University of Wisconsin Carbone Cancer Center’s More for Stage IV philanthropic fund is providing support for the trial through the Mary Gooze Clinical Trial and Translation Award to the collaborative team also including Jenny Gumperz, PhD, Professor of Medical Microbiology & Immunology at the University of Wisconsin School of Medicine and Public Health. Beyond clinical testing, the award supports mechanistic research in the Gumperz laboratory to define how iNKT cells control leukemia. The work complements an ongoing collaboration between UW–Madison and MiNK under an NIAID-funded STTR grant, aimed at developing a universal, donor-independent iNKT platform for hematologic malignancies.

Dr. Hongtao Liu, MD, PhD, the study Principal Investigator, said, “As a transplant physician, I see firsthand the toll GvHD takes on patients and families. This study is designed not only to reduce this life-threatening complication but also to enhance immune reconstitution and reduce relapse risk, with the potential to change post-transplant outcomes.”

Professor Jenny Gumperz, leading researcher of iNKT biology, said, “Our research has shown that iNKT cells can restore immune balance and promote healthy engraftment. This trial brings years of translational work full circle by enabling clinical evaluation of an innovative immune-regulating therapy for patients in need.”

About MiNK Therapeutics

MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering allogeneic invariant natural killer T (iNKT) cell therapies and precision-targeted immune technologies. MiNK’s proprietary platform is designed to restore immune balance and drive cytotoxic responses across cancer, immune-mediated diseases, and pulmonary immune failure. MiNK’s lead candidate, agenT-797, is an off-the-shelf iNKT cell therapy currently in clinical development for GvHD, solid tumors, and severe pulmonary inflammation. With a scalable cryopreserved manufacturing process and differentiated biology bridging innate and adaptive immunity, MiNK is committed to developing next-generation immune reconstitution therapies. For more information, visit www.minktherapeutics.com or follow us on X @MiNK_iNKT.

About AgenT-797

AgenT-797 is an allogeneic invariant natural killer T (iNKT) cell therapy that harnesses the dual power of innate and adaptive immunity. iNKTs function as “master regulators,” combining the cytotoxic capabilities of NK cells with T-cell–like antigen recognition and memory. This unique biology enables a robust, pathogen-agnostic immune response that can be directed against hard-to-treat tumors. Manufactured by MiNK Therapeutics in Lexington, MA, agenT-797 is a scalable, off-the-shelf product designed to provide accessible, transformative treatment options. In clinical trials, agenT-797 can bolster peripheral memory T-cell activation, enhance tumor infiltration, and potentially improve outcomes for patients with solid cancers (Cytryn et al. AACR IO 2024, Oncogene. 2024) and to combat inflammation in critically ill patients with severe respiratory pathology (Nature Communications. 2024).

About the University of Wisconsin School of Medicine and Public Health

The University of Wisconsin School of Medicine and Public Health is recognized as one of the nation’s leading institutions in health sciences education, research, and service. Founded in 1907 as the medical school of the University of Wisconsin-Madison, in 2005 it became the nation’s first school to integrate the disciplines of medicine and public health. With a deep commitment to a vision of healthy people and healthy communities, we translate discovery into application and interconnect clinical care, education and research. The school employs more than 5,600 faculty and staff and provides educational opportunities for nearly 3,000 students and postgraduate trainees. For federal fiscal year 2024, the school ranked #9 in the nation among public medical schools for NIH funding according to the Blue Ridge Institute for Medical Research. Some of the nation’s leading researchers, educators, and clinicians are among the faculty, including several National Medal of Science recipients and National Academy of Science honorees.

About Mary Gooze Clinical Trial and Translation Award

Established by the University of Wisconsin Carbone Cancer Center in honor of advocate and philanthropist Mary Gooze, the Mary Gooze Clinical Trial and Translation Award supports early-stage clinical and translational research aimed at addressing critical unmet needs in advanced and life-threatening diseases. The award provides seed funding to accelerate the development of innovative therapies with the potential to transform patient care, particularly in areas where treatment options remain limited.

Forward-Looking Statements

This press release contains forward-looking statements made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic potential, safety, and anticipated benefits of agenT-797; clinical trial design, timing, and enrollment; and MiNK’s broader development plans. These statements are subject to risks and uncertainties detailed in MiNK’s most recent filings with the Securities and Exchange Commission. MiNK cautions investors not to place undue reliance on these statements, which speak only as of the date of this release.

Contacts:

Investor Contact: 917-362-1370 | investor@minktherapeutics.com
Media Contact: 781-674-4428 | communications@minktherapeutics.com

Source: MiNK Therapeutics

Easy Environmental Solutions Enters 2026 With Accelerated Global Momentum and a Clear Path to Scale




Easy Environmental Solutions Enters 2026 With Accelerated Global Momentum and a Clear Path to Scale

Company surpasses 2025 international development targets and advances toward multi-continent deployment of disruptive integrated soil and water technologies

MANKATO, Minn., Jan. 08, 2026 (GLOBE NEWSWIRE) — Easy Environmental Solutions, Inc. (OTC: EZES) enters 2026 with strong global traction and a rapidly expanding commercial footprint, following a year in which the company exceeded internal targets across Africa, the Middle East, Europe, and Asia. With multiple first-of-kind deployments scheduled and trials progressing across four continents, EZES is shifting decisively from technology validation to large-scale infrastructure rollout—positioning itself as a next-generation provider of sustainable agriculture and water systems on a global scale.

“2025 was about proving performance in real-world conditions across dramatically different environments,” said Bakry Osman, Director for Africa and the Middle East. “2026 is where scale, integration, and long-term value creation begin to converge.”

Africa: From First Deployment to Continental Expansion

EZES will deploy Africa’s first EasyFEN™ unit in Kenya, establishing a flagship model for localized, climate-resilient agricultural infrastructure from the plant juice derived from local green biomass. With each fully automatic modular unit capable of producing locally up to 1 million acres of Liquid Microbial Fertilizer per year, the EasyFEN™ enables on-site production of Terreplenish®, the company’s microbial soil solution, using local organic waste streams—reducing production costs while improving soil fertility, water retention, and crop resilience.

The Kenyan deployment is expected to serve as a regional reference point for governments, agribusinesses, and development partners seeking scalable solutions to food security and climate stress

Later in 2026, EZES will introduce its Easy NanoVoid™ “tiny oxygen bubble” technology alongside Terreplenish®, creating an integrated soil regeneration and water purification platform. Leadership describes the convergence of these technologies as a structural leap forward.

Later in 2026, EZES will introduce its Easy NanoVoid5:49 PM™ “tiny oxygen bubble” technology alongside Terreplenish®, creating an integrated soil regeneration and water purification platform. Leadership describes the convergence of these technologies as a structural leap forward.

“Localized biological production paired with advanced super oxygen saturated NanoVoid™ water treatment creates compounding impact,” said Mark Gaalswyk, Founder & Chief Executive Officer. “This combination dramatically changes the economics of sustainability.”

Additional momentum includes:

• Ghana: Ongoing trials with a follow-on EasyFEN™ deployment planned
• South Africa: Trials supporting reforestation and ecosystem restoration in the Western Cape
• Egypt: Trials beginning March 2026, opening a new North African expansion corridor
• Saudi Arabia – Trials beginning on February 26 via a large existing customer relationship

Middle East: Infrastructure-Level Solutions Aligned With National Priorities

EZES is advancing trials across the Middle East in alignment with national food security, water efficiency, and sustainability agendas.

In Saudi Arabia, trials beginning in late February aim to support multi-unit Easy FEN deployment across diverse regions. EZES’s ability to localize production, reduce water intensity, and regenerate soils aligns directly with the Kingdom’s agricultural transformation priorities.

“What resonates with partners in the region is performance and economics,” said Nathan Carpenter, Vice President, Eastern Hemisphere Sales. “Cost versus value versus impact is where EZES consistently differentiates itself.”

In Oman, high-level meetings in January will explore establishing EasyFEN™ systems as government-owned agricultural infrastructure to strengthen national food resilience.

Completed EasyFEN™ (patents pending) shipping to Kenya

Europe: France as a Strategic Anchor Market

In France, EZES is preparing to finalize an agreement with investors to deploy EasyFEN™ units in Bordeaux, followed by the introduction of the NanoVoid™ Bubble technology. France’s combination of advanced agriculture, stringent environmental standards, and openness to high-performance sustainable solutions makes it a strategic European anchor market.

The Bordeaux deployment will showcase how EZES’s integrated platform—localized production, microbial soil regeneration, and advanced water treatment—can operate within one of the world’s most demanding regulatory environments.

Looking Ahead: From Validation to Value Creation

At the core of EZES’s strategy is a unified platform—Terreplenish, localized production through modular Easy FEN™, and NanoVoid™ Bubble technology—delivered as a comprehensive, scalable system.

“The world has not seen this level of integration at this cost, with this breadth of application,” said Osman. “We are building systems designed for the next decade—not just the next season.”

As 2026 begins, Easy Environmental Solutions is positioning itself not simply as a technology provider, but as a builder of globally relevant infrastructure designed to address food security, clean water scarcity, and climate resilience at scale.

About Easy Environmental Solutions

Easy Environmental Solutions, Inc. (OTC: EZES), is an innovative company developing modular technologies to solve major world problems. With a strong goal for sustainability and efficiency, EZES aims to provide solutions for various industries through its unique approach to manufacturing and technology development.

Forward-Looking Statements

This press release contains discussions that may constitute ‘forward-looking’ statements. Often these statements contain the words “believe,” “estimate,” “project,” “expect” or similar expressions. These statements are made in reliance on the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements.

Factors that would cause or contribute to such differences include, but are not limited to, acceptance of the Company’s current and future products and services in the marketplace, the ability of the Company to develop effective new products and receive regulatory approvals of such products, competitive factors, dependence upon third-party vendors, and other risks detailed in the Company’s periodic reports filed with OTC Markets. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release.

Contact:

Mark K. Gaalswyk, CEO – Mark@easyenviro.com
Nick Vincent, Sales Operations Manager – nickvincent@easyenviro.com
Bill Bliler – Director, Business Development – billbliler@easyenviro..com

www.easyenviro.com
www.easyenergysystems.com
www.easyenergyfinance.com
Phone: 952-400-6045
Email: info@easyenviro.com

Photos accompanying this announcement are available at 

https://www.globenewswire.com/NewsRoom/AttachmentNg/c5b0da45-fe85-4327-87b1-57910a27976f

https://www.globenewswire.com/NewsRoom/AttachmentNg/5eabd5dd-442e-49b9-8ccc-eb69588a31e2

Vystar Corp. Submits Binding Letter of Intent to Acquire Stake in GoPaid.com LLC and Form Strategic Partnership with Capital R3alm to Launch R3alm Oracle and R3alm Collectibles




Vystar Corp. Submits Binding Letter of Intent to Acquire Stake in GoPaid.com LLC and Form Strategic Partnership with Capital R3alm to Launch R3alm Oracle and R3alm Collectibles

Worcester, Massachusetts, Jan. 08, 2026 (GLOBE NEWSWIRE) — Vystar Corporation (OTCQB: VYST), a diversified innovation company with operations spanning eco-friendly products and collectibles monetization, today announced that it has submitted a binding Letter of Intent (LOI) to acquire an equity stake in GoPaid.com LLC, a company specializing in the sourcing, archiving, and monetization of high-value memorabilia.

Under the terms of the LOI, the acquisition will also includes a percentage of GoPaid’s proprietary cryptocurrency, or the lesser of a $10 million valuation. In addition, the LOI grants Vystar the option to acquire up to an additional 10% equity stake and 3% of the cryptocurrency over a two-year period, exercisable on a semi-annual basis.

The purchase price for the initial stake consists of 1,000 shares of Vystar’s Series C preferred common stock. Vystar will provide strategic support for GoPaid. Upon closing, Vystar will hold a minority, non-controlling interest, focused on strategic planning, technology integration, and collaboration.

Strategic Purpose of the Transaction

The proposed acquisition and partnership serve a dual strategic objective:

1. Investment in GoPaid’s memorabilia tokenization initiatives, leveraging its established physical asset sourcing and archiving capabilities; and
2. The launch and underwriting of R3alm Oracle, a sector-specific decentralized oracle network dedicated to collectibles and memorabilia markets.

In parallel, Vystar has committed to assisting in raising $250,000, to support the convergence of private-market collectibles with Web3 technologies as part of a broader joint venture with Capital R3alm to develop R3alm Collectables, a tokenized collectibles and NFT marketplace.

Transaction Timeline and Key Terms

• LOI Date: December 4, 2025
• Signatories:
  • Gregory Rotman, President & CEO, GoPaid.com LLC
  • Jamie Rotman, President & CEO, Vystar Corporation
• Target Closing: On or before January 30, 2026
• Binding Provisions: Access to information, expense allocation, exclusivity, and mutual cooperation
• Next Steps: Completion of due diligence and execution of definitive agreements

Partnership Vision and Platform Development

Through the collaboration between Vystar, GoPaid, and Capital R3alm, the parties aim to redefine community finance by merging institutional-grade physical memorabilia with advanced Web3 infrastructure.

• GoPaid, led by the Rotman family, contributes more than a decade of experience in merchandise creation, VIP ticketing, and curated fan experiences for over 100 global music acts, supplying premium collectibles across music, sports, and non-sports categories.
• Vystar Corp. brings its diversified operating portfolio, including RxAir^™ air purification systems and Vytex^® natural rubber latex, along with public-company governance and capital markets experience.
• Capital R3alm, an Ohio-based C-Corporation operating as a regulated private investment company, provides a unified Web3 ecosystem for tokenization, trading, governance, analytics, and alerts.

Capital R3alm operates as a decentralized “digital kingdom,” integrating multiple subsidiaries and platforms to empower investors with ownership over their data, assets, and wealth in the Web3 era.

Platform Initiatives

The partnership will focus on three core initiatives:

Tokenization of Memorabilia

Iconic collectibles—such as Sports and Non-Sport Collectables, Music Memorabilia, Movie Posters and other collectables—are expected to be converted into fractional digital tokens, expanding global access and liquidity. Tokenization has the potential to unlock trillions in previously illiquid assets by transforming ownership and market access.

R3alm Collectibles Marketplace

A white-label marketplace targeted for launch in Q2 2026, integrating secure storage, asset protection, yield-bearing token structures, metaverse galleries, and DAO-based governance.

R3alm Oracle Network

A decentralized oracle network delivering real-time valuations, provenance verification, and market analytics for collectibles. The platform combines AI-driven analytics, zero-knowledge privacy frameworks, and cross-chain architecture, with governance supported by a dedicated utility token.

The initiative also extends to R3alm Music History Holdings (RMH), a vehicle designed to tokenize artist assets and integrate fan loyalty programs.

Market Opportunity and Financial Outlook

The global collectibles market—including fine art, sports memorabilia, NFTs, luxury items, and music merchandise—is projected to grow from approximately $464 billion in 2025 to over $900 billion by 2035. Management believes tokenization and blockchain verification will play an increasingly central role in liquidity, transparency, and global participation.

Internal projections for the combined initiatives indicate scalable revenue opportunities, expanding assets under management, and long-term valuation potential across collectibles, oracle services, and music-focused holdings.

Strategic Benefits for Vystar Shareholders

Vystar believes this transaction:

• Diversifies its portfolio into high-growth Web3 and real-world asset markets
• Creates multiple revenue participation paths through equity, token economics, and platform fees
• Enhances long-term shareholder value through early participation in tokenized collectibles infrastructure

The Company intends to provide ongoing updates as definitive agreements are finalized and milestones are achieved.

To Read Related Documents Please Click Here

About Vystar Corporation

Vystar Corporation (OTCQB: VYST) has four main areas of focus; Vytex, RXAIR, Fluid Energy Conversion (FEC), GOPAID.com. Vystar is confident it can succeed in spaces where it can make outstanding products that are protected by patents and copyrights. This precludes potential competitors from seeking to duplicate Vystar’s products.

GOPAID.com – products and strategic ventures in tokenization of collectibles and digital assets.

Vytex Allergy Free Natural Rubber Latex – The Company owns the formulations and intellectual property that creates what Vystar believes to be the highest quality products as against any competitor’s products. By way of example, Vystar can manufacture allergy and ammonia free natural latex products ranging from: (i) foam utilized in pillows, mattresses and toppers; (ii) gloves; (iii) condoms; and (iv) and other latex products. The Company believes its FDA approved products are unrivaled in the industry and maintains a substantial inventory warehoused in the United States. To view our products go to www.vytex.com.

RXAIR Residential and Medical Air Purification – Vystar has built a line of products for the home and medical facilities. The product lines range from a personal $500 unit to an industrial $6,000 unit for hospitals or similarly situated medical services. Vystar owns the patents and has achieved FDA approval, as well as EPA, CARB and other air purification certifications. Vystar has sold more than 20,000 residential and 400 hospital units RXAIR Video’s. In addition, Vystar has invested in manufacturing and high-speed tooling for the units. These units are built to eliminate germs, viruses and bacteria. Vystar maintains a stockpile of more than a thousand units and replacement cartridges. Also important, Vystar is under a medical device exemption from the recent tariffs. RXAIR AIR PURIFIER ONLINE STORE.

FEC – The Hughes Reactor changes flow of liquid or gas into sound waves. The sound can be brought to powerful levels using a mechanism that has no moving parts. This allows the reactor the ability to harness the energy into various uses. The uses for this patented technology include: Flow Meter, hard water abatement, air purification, multiple dialysis applications and combustion enhancements for natural gas, biofuels, gasoline. This energy is powerful, clean, and controllable. It can be used to measure flow, to push forward chemical reactions such as combustion, or to mix chemicals together thoroughly and instantly. All of this technology is protected by Vystar’s intellectual property.

Investor Relations & Media Contact
Vystar Corporation
https://vystarcorp.com/investor-relations
https://gopaid.com
https://r3alm.com/

Follow us on social media:
Twitter: @VystarCompany @RxAir
Facebook: @RxAir
Instagram: @rxair_air_purification

Contacts:
Vystar
Media & Investors: Jamie Rotman, jrotman@vytex.com

Distributor Opportunities: info@rxair.com

Media, Investors or To Partner with Vystar, Company Phone Number: (508) 791-9114 For information on FEC partnerships, contact info@Rxair.com or 508-791-9114

Forward-Looking Statements

Forward-looking Statements: Investors are cautioned that certain statements contained in this document as well as some statements in periodic press releases and some oral statements of VYST officials are “Forward-Looking Statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Act”). Forward-looking statements include statements which are predictive in nature, which depend upon or refer to future events or conditions, which include words such as “believes,” “anticipates,” “intends,” “plans,” “expects,” and similar expressions. In addition, any statements concerning future financial performance (including future revenues, earnings or growth rates), ongoing business strategies or prospects, and possible future VYST actions, product development and delivery, which may be provided by management, are also forward-looking statements as defined by the Act. Forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements and to vary significantly from reporting period to reporting period. Although management believes that the assumptions made and expectations reflected in the forward-looking statements are reasonable, there is no assurance that the underlying assumptions will, in fact, prove to be correct or that actual future results will not be different from the expectations expressed in this report. These statements are not guarantees of future performance and VYST has no specific intention to update these statements.

ALK to present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco




ALK to present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco

ALK (ALKB:DC / OMX: ALK B) today announced that the company’s president & CEO, Peter Halling, is scheduled to give a company presentation at the 44^th Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, 15 January 2026, at 9.45 AM PST / 12.45 PM EST / 6.45 PM CET.

Representatives of the company will be available for meetings at the conference.

ALK-Abelló A/S

For further information, please contact:

Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525

Media: Maiken Riise Andersen, tel. +45 5054 1434

Business Development: Rasmus Just, tel. +45 4171 8431

About ALK
ALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. ALK manufactures and markets allergy immunotherapy (‘AIT’) treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,800 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net.

Attachment

• InvestorNews_08January26_JP Morgan Global Healthcare Conference

ALX Oncology to Present at the 44th Annual J.P. Morgan Healthcare Conference




ALX Oncology to Present at the 44th Annual J.P. Morgan Healthcare Conference

SOUTH SAN FRANCISCO, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) — ALX Oncology Holdings Inc. (“ALX Oncology”; Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today announced its participation in the 44th Annual J.P. Morgan Healthcare Conference in San Francisco. Chief Executive Officer Jason Lettmann and Chief Medical Officer Barbara Klencke will deliver a corporate presentation on Thursday, January 15, 2026, at 12:00 p.m. Pacific Time.

The live webcast of the J.P. Morgan fireside chat can be accessed by visiting the Investors section of ALX Oncology’s website at www.alxoncology.com under the Events section of the Events and Presentations tab. A replay of the webcast will be archived for up to 90 days following the fireside chat date.

About ALX Oncology
ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action. A Phase 1, dose-escalation trial of ALX2004 is ongoing in patients with EGFR-expressing solid tumors. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology.

Investor Relations Contact:
Elhan Webb, CFA, IR Consultant
ewebb@alxoncology.com

Media Contact:
Michele Parisi, SparkPoint Healthcare Communications
mparisi@sparkpointpr.com
(925) 864-5028

Illumina and PREMIA partner to expand clinical access to CGP in Asia




Illumina and PREMIA partner to expand clinical access to CGP in Asia

TAIPEI, Taiwan, Jan. 08, 2026 (GLOBE NEWSWIRE) — Illumina Taiwan Biotechnology Co., Ltd., and Precision Medicine Asia, Limited (PREMIA), a leading Asian cancer clinical-genomic screening network, today announced the formation of a strategic partnership that will expand access to comprehensive genomic profiling (CGP) for all eligible oncology patients across the Chang Gung Memorial Hospital (CGMH) system. This partnership also aims to support the creation of an Asia-wide clinical-genomic oncology database to advance precision oncology.

“We are committed to ensuring that all cancer patients benefit from the most advanced medical science available,” stated Dr. Chang-Fu Kuo, Director of the Center for Artificial Intelligence in Medicine at CGMH. “Integrating CGP will streamline our testing workflows and help clinicians gain a better understanding of each patient’s tumor biology, enabling them to routinely consider key genomic insights alongside clinical judgement and established guidelines to provide patients with more informed and personalized treatment plans.”

Chang Gung Memorial Hospital, one of Taiwan’s leading healthcare systems and medical centers serving approximately 2.7 million patients each year, with over 300 industry-sponsored clinical trials currently ongoing throughout the system, has long been dedicated to translating cutting-edge technologies into clinical practice.

Jerry Cheng, General Manager for Taiwan, Hong Kong and Macao at Illumina, added, “Illumina remains at the forefront of advanced oncology profiling solutions, empowering clinicians to gain clinically and scientifically meaningful insights faster. This partnership will accelerate personalized care decisions at CGMH, and through the depth and scale of data generated over time, together with clinicians and industry partners, we look forward to supporting translational research and drug development across Asia.”

In May 2024, CGP was incorporated into Taiwan’s National Health Insurance (NHI) program.

About Illumina 

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit illumina.com and connect with us on X, Facebook, LinkedIn, Instagram, TikTok, and YouTube.  

About Precision Medicine Asia (Taiwan) Limited (PREMIA) 

Established in 2018, PREMIA is the first company in Asia to collaborate with hospitals in the region by providing a clinical-genomic data management platform that helps accelerate development of innovative therapeutics and diagnostics. Along with these activities, PREMIA is dedicated to forming partnerships with biopharmaceutical and healthcare technology companies, worldwide, to improve efficiencies and expand access to novel medicines and health-tech solutions for patients. For more information, please visit www.premia-inc.com. 

Contacts: 

Illumina 

Sam Shen, Illumina Public Relations 

PR@illumina.com  

PREMIA 

Sydnie Reed 

Vice President, Head of Business Development and Partnering 

sreed@premia-inc.com

CorMedix Therapeutics Announces Leadership and Board Updates




CorMedix Therapeutics Announces Leadership and Board Updates

BERKELEY HEIGHTS, N.J., Jan. 08, 2026 (GLOBE NEWSWIRE) — CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced an addition to its executive leadership team and updates to its Board of Directors. CorMedix CEO Joseph Todisco has signed an extended employment contract, reaffirming his long-term commitment to the organization. In addition to his role as CEO, Mr. Todisco will also assume the role of Chairman of the Board of Directors, succeeding Myron Kaplan. Mr. Kaplan will transition into a newly created board position of Lead Independent Director.

“Under the leadership of Mr. Todisco, CorMedix has evolved from a single product, development stage company into a multi-product, diversified commercial operation with positive cashflow and a strong pipeline,” says former Chairman and new Lead Independent Director, Myron Kaplan. “His succession to Chairman strengthens CorMedix Therapeutics and best positions the company for future success.”

CorMedix is also pleased to announce the appointment of Mr. Mike Seckler to the role of EVP & Chief Commercial Officer. Mr. Seckler joins CorMedix with a wealth of experience across multiple therapeutic areas including hematology and oncology, and most recently served as CEO of Evome Medical Technologies Inc. Mr. Seckler’s previous experience includes roles as COO of FerGene Inc., a Blackstone Life Sciences and Ferring Pharmaceuticals joint partnership gene therapy company, as well as head of Global Marketing and Corporate Communications for Ferring International.

Joseph Todisco, CEO of CorMedix, commented, “I’m excited to announce the addition of Mike Seckler to our leadership team as Chief Commercial Officer. As CorMedix Therapeutics now has commercial and pipeline products spanning multiple therapeutic areas, his deep experience as a commercial leader will provide critical expertise as we look to increase our base business as well as prepare for new launches. I’m also honored to assume the role of Chairman of the Board of Directors from Myron Kaplan, and I am sincerely grateful for his mentorship and guidance over these past few years. With a strong leadership team in place, I am excited about the future for CorMedix Therapeutics.”

About CorMedix

CorMedix Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. CorMedix is commercializing DefenCath^® (taurolidine and heparin) for the prevention of catheter-related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products, including MINOCIN^® (minocycline) for Injection, REZZAYO^® (rezafungin), VABOMERE^® (meropenem and vaborbactam), ORBACTIV™ (oritavancin), BAXDELA^® (delafloxacin), and KIMYRSA^® (oritavancin), as well as TOPROL-XL^® (metoprolol succinate).

CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition (TPN) and Pediatric Hemodialysis populations and also intends to develop DefenCath as a catheter lock solution for use in other patient populations. REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of IFD in adult patients undergoing allogeneic BMT. Topline results of the Phase III study for REZZAYO are expected in Q2 2026. For more information visit: www.cormedix.com or www.melinta.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Exchange, as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements including, but not limited to statements regarding financial guidance, sales estimates, synergy estimates and timing, expectations and timing regarding clinical studies and development and expectations of CorMedix’s product pipeline, results of the real-world study, expectations regarding implementation and perceived benefits of CorMedix’s products. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576

MannKind Provides Business Updates and 2026 Growth Drivers




MannKind Provides Business Updates and 2026 Growth Drivers

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) — MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions for cardiometabolic and orphan lung diseases, today provided business updates and outlined anticipated growth drivers for 2026, including progress across its commercial programs and clinical development initiatives.

“MannKind closed 2025 on a high note, marked by milestones that reinforce our growth trajectory—including the acquisition of scPharmaceuticals and a record-setting fourth quarter surpassing $100 million in net revenue,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “With two high-potential launches on the horizon, 2026 is shaping up to be a catalyst-rich year that positions MannKind for long-term value creation.”

Major Catalysts Driving 2026:

Afrezza^® (insulin human) Inhalation Powder

• FDA decision on Afrezza label update (dose conversion) anticipated with a PDUFA target action date of January 23, 2026
  • Would update the initial dose for mealtime insulin when switching from subcutaneous rapid-acting insulin
• FDA accepted for review the supplemental Biologics License Application (sBLA) for Afrezza^® Inhalation Powder in children and adolescents living with type 1 or type 2 diabetes with a PDUFA target action date of May 29, 2026
  • If approved, it would be the first needle-free insulin option for pediatric patients in 100+ years of insulin therapy

FUROSCIX^® (furosemide injection) for Subcutaneous Use

• Supplemental New Drug Application (sNDA) for FUROSCIX ReadyFlow^™ Autoinjector accepted for review by U.S. Food and Drug Administration (FDA) with a PDUFA target action date of July 26, 2026
  • If approved, it would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/ml) in under 10 seconds

Pipeline

• Nintedanib DPI (MNKD-201) saw its first patient enrolled in December for the INFLO-1 Phase 1b study (U.S.) and anticipates first patient in for INFLO-2 Phase 2 (global) in Q2 2026
• Advancing Bumetanide DPI (MNKD-701) pre-clinical development

United Therapeutics Collaborations

• Tyvaso DPI bridging study anticipated following 1H 2026 readout of TETON-1 study
• Formulating a second dry powder investigational molecule under the expanded collaboration with United Therapeutics using MannKind’s proprietary Technosphere^® platform

About MannKind
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease.

With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life.

Learn more at mannkindcorp.com.

Forward-Looking Statements
Statements in this press release that are not statements of historical fact are forward-looking statements that involve risks and uncertainties. These statements include, without limitation, statements regarding potential product launches, ongoing clinical trials and preclinical studies, expected initiation and patient enrollment timelines, and the expected timing for trial results; the development of a new dry powder inhalation therapy and investigational molecule under the expanded collaboration with United Therapeutics and the planned preclinical studies thereof; the expected timing for regulatory events related to Afrezza and the FUROSCIX ReadyFlow Autoinjector; and other statements about future events. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that unforeseen delays that may impact the timing of clinical trials and reporting data, the risk that issues develop in the review by the FDA that subject us to unanticipated delays or prevent us from obtaining the desired regulatory approval as well as other risks; detailed in MannKind’s filings with the Securities and Exchange Commission (“SEC”), including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

FUROSCIX is a registered trademark of scPharmaceuticals Inc, a subsidiary of MannKind Corporation.

AFREZZA and MANNKIND are registered trademarks of MannKind Corporation.

CONTACT: MannKind Contacts:

Media Relations:
Christie Iacangelo
(818) 292-3500
media@mnkd.com

Investor Relations:
Kate Miranda
(781) 301-6869
ir@mnkd.com