Aldeyra Therapeutics Announces PDUFA Extension of the New Drug Application of Reproxalap for the Treatment of Dry Eye Disease




Aldeyra Therapeutics Announces PDUFA Extension of the New Drug Application of Reproxalap for the Treatment of Dry Eye Disease

LEXINGTON, Mass.–(BUSINESS WIRE)–Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the reproxalap New Drug Application (NDA) for the treatment of dry eye disease. The extended PDUFA target action date is March 16, 2026.

Following submission on June 16, 2025, the NDA was accepted for review as a “complete class 2 response” by the FDA on July 16, 2025, with a target PDUFA action date of December 16, 2025. On December 12, 2025, the FDA met with Aldeyra to request submission to the NDA of the Clinical Study Report (CSR) for the dry eye disease field trial of reproxalap, for which top-line results were announced on May 5, 2025. The field trial, which was supportive of the activity of reproxalap relative to vehicle, did not meet the primary endpoint of improvement in dry eye symptoms relative to the vehicle control. Prior to submitting the NDA in June, the field trial was discussed with the FDA.

At the December 12 meeting, the FDA made no other requests and did not identify any other specific issues with the NDA review. The CSR, which had been previously submitted to the Investigational New Drug (IND) file for reproxalap, was submitted to the NDA the same day of the meeting and was considered a major amendment to the NDA by the FDA. Per the FDA’s earlier request during the NDA review, the safety data from the field trial was submitted to the NDA on August 21, 2025. The CSR has been reviewed by the FDA under the IND.

In early December, the FDA shared with Aldeyra a draft of the prospective label, and Aldeyra has submitted a response. The FDA notified Aldeyra that if no major deficiencies are identified during the extended review, the FDA plans to communicate proposed labeling requests and, if necessary, any anticipated postmarketing requirements by February 16, 2026.

Conference Call & Webcast Information

Aldeyra will host a conference call at 8:00 a.m. ET tomorrow, Tuesday December 16, 2025, to discuss the PDUFA extension. The dial-in numbers are (833) 470-1428 for domestic callers and (646) 844-6383 for international callers. The access code is 438712. A live webcast of the conference call will be available on the Investor Relations page of the company’s website at https://ir.aldeyra.com. After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

About Aldeyra

Aldeyra Therapeutics is a biotechnology company devoted to discovering innovative therapies designed to treat immune-mediated diseases. Our approach is to develop pharmaceuticals that modulate protein systems, instead of directly inhibiting or activating single protein targets, with the goal of optimizing multiple pathways at once while minimizing toxicity. Our product candidates include RASP (reactive aldehyde species) modulators ADX-248, ADX-246, and chemically related molecules for the potential treatment of systemic and retinal immune-mediated diseases. Our late-stage product candidates are reproxalap, a RASP modulator for the potential treatment of dry eye disease and allergic conjunctivitis, and ADX-2191, a novel formulation of intravitreal methotrexate for the potential treatment of primary vitreoretinal lymphoma and retinitis pigmentosa.

Safe Harbor Statement

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Aldeyra’s future expectations, plans, and prospects, including without limitation statements regarding: anticipated timing of regulatory action; the outcome of the New Drug Application of reproxalap for the treatment of dry eye disease, including, if approved, the label for reproxalap; and the goals, opportunity, and commercial potential for reproxalap. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “on track,” “scheduled,” “target,” “design,” “estimate,” “predict,” “contemplates,” “likely,” “potential,” “continue,” “ongoing,” “aim,” “plan,” or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. All of Aldeyra’s development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, funding, and other factors that could delay the initiation, enrollment, or completion of clinical trials. Important factors that could cause actual results to differ materially from those reflected in Aldeyra’s forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra’s clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; delay in or failure to obtain regulatory approval of Aldeyra’s product candidates, including as a result of the FDA not accepting Aldeyra’s regulatory filings, issuing a complete response letter, or requiring additional clinical trials or data prior to review or approval of such filings or in connection with resubmissions of such filings; the ability to maintain regulatory approval of Aldeyra’s product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity, or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Aldeyra’s product candidates in clinical trials focused on the same or different indications; the scope, progress, expansion, and costs of developing and commercializing Aldeyra’s product candidates; uncertainty as to Aldeyra’s ability to commercialize (alone or with others) and obtain reimbursement for Aldeyra’s product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyra’s product candidates and the ability to serve those markets; Aldeyra’s expectations regarding Aldeyra’s expenses and future revenue, the timing of future revenue, the sufficiency or use of Aldeyra’s cash resources and needs for additional financing; the rate and degree of market acceptance of any of Aldeyra’s product candidates; Aldeyra’s expectations regarding competition; Aldeyra’s anticipated growth strategies; Aldeyra’s ability to attract or retain key personnel; Aldeyra’s commercialization, marketing and manufacturing capabilities and strategy; Aldeyra’s ability to establish and maintain development partnerships; Aldeyra’s ability to successfully integrate acquisitions into its business; Aldeyra’s expectations regarding federal, state, and foreign regulatory requirements; political, economic, legal, social, and health risks, public health measures, and war or other military actions, that may affect Aldeyra’s business or the global economy; regulatory developments in the United States and foreign countries; Aldeyra’s ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra’s business and the market in which it operates; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Aldeyra’s Annual Report on Form 10-K for the year ended December 31, 2024, and Aldeyra’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC website at https://www.sec.gov/. In addition to the risks described above and in Aldeyra’s other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra’s results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

Contacts

Investor & Media
Laura Nichols

(781) 257-3060

investorrelations@aldeyra.com

Washington Launches New Tools to Help Medical Professionals Deliver Life-saving Medications for Opioid Use Disorder




Washington Launches New Tools to Help Medical Professionals Deliver Life-saving Medications for Opioid Use Disorder

The Health Care Authority (HCA) and Department of Health (DOH) are equipping health care providers and emergency medical services (EMS) personnel with practical, research-based resources to expand treatment access and reduce overdose deaths.

OLYMPIA, Wash.–(BUSINESS WIRE)–The Washington State Health Care Authority (HCA) and Department of Health (DOH) just released a new resource library to help health care providers and emergency medical services (EMS) personnel build knowledge and confidence to prescribe and administer medications for opioid use disorder (MOUD).

Powerful MOUD like buprenorphine and methadone can help manage opioid withdrawals and cravings and cut opioid-related deaths by half. Yet, these medications remain underused across the medical community.

The new MOUD resource library gives Washington providers practical, easy-to-follow guidance for discussing and providing MOUD to their patients, which helps break down common barriers to treatment like stigma and lack of information. HCA and DOH has also launched an awareness campaign to connect providers to training, clinical support, and patient education materials.

“Despite the proven effectiveness of MOUD, many providers still hesitate to raise the option with patients, often because of uncertainty about how to approach the conversation,” said HCA’s Jessica Blose, Washington State’s opioid treatment authority. “These resources are designed to give health care providers and EMS personnel the knowledge, tools, and expertise they need to make MOUD a routine, life-saving part of care.”

Provider hesitation around MOUD often stems from a lack of information and comfort with the medications, as well as past barriers to prescribing. Until 2023, providers needed special training and registration to prescribe MOUD. The requirement, known as the X-Waiver, was removed by the Mainstreaming Addiction Treatment (MAT) Act of 2023, making MOUD far more accessible.

The new resource library, hosted at ScalaNW.org/MOUD, includes:

• Brief guides, videos, and printable tools that dispel common myths about MOUD.
• Conversation prompts and quick reference sheets tailored for busy medical settings.
• Testimonials from clinicians and first responders across Washington who share their experiences discussing, prescribing, and managing MOUD.

“Every day, health care providers and first responders have the chance to change the course of someone’s life,” said Dr. Tao Sheng Kwan-Gett, State Health Officer at DOH. “These new tools help providers and first responders meet people with opioid use disorder (OUD) where they are with compassion and evidence-based treatment that will save lives and open doors to recovery. Expanding access to these treatments will improve health and bring hope to individuals, families, and communities across Washington.”

The new MOUD resource library is part of the state’s opioid response strategy and is funded by the state’s opioid settlement funds. It builds on the ScalaNW program, which launched in 2024 to equip emergency room clinicians with resources to prescribe and administer MOUD and connect patients to follow-up care.

“OUD is a treatable medical condition, and medical professionals have a powerful opportunity to give people options and access to medications that could save their lives,” said Liz Wolkin, a registered nurse and HCA’s ScalaNW program manager. “We heard directly from providers across the state and designed these tools to help them partner with patients who are ready to start treatment and ultimately save more lives.”

Media Contact

For media inquiries, contact Becky Thomas at bthomas@cplusc.com.

For more information, visit the:

• ScalaNW website
• HCA website
• DOH website

About HCA

Functioning as both the state’s largest health care purchaser and its behavioral health authority, HCA is a leader in ensuring Washington residents have the opportunity to be as healthy as possible.

There are three pillars of work: Apple Health (Medicaid); the Public Employees Benefits Board (PEBB) and School Employees Benefits Board (SEBB) programs; and behavioral health and recovery. Under these pillars, HCA purchases health care, including behavioral health treatment, for more than 2.7 million Washington residents and provides behavioral health prevention, crisis, and recovery supports to all Washington residents.

Contacts

Becky Thomas

bthomas@cplusc.com

Leading Independent Proxy Advisory Firm ISS Recommends STAAR Stockholders Vote “FOR” Alcon Merger




Leading Independent Proxy Advisory Firm ISS Recommends STAAR Stockholders Vote “FOR” Alcon Merger

STAAR Urges Stockholders to Vote “FOR” Alcon Merger on the WHITE Proxy Card TODAY

LAKE FOREST, Calif.–(BUSINESS WIRE)–STAAR Surgical Company (NASDAQ: STAA) (“STAAR”), the global leader in phakic IOLs with the EVO family of Implantable Collamer^® Lenses (EVO ICL™) for vision correction, today announced that leading independent proxy advisory firm Institutional Shareholder Services (“ISS”) has issued a new report and revised its recommendation with respect to STAAR’s merger with Alcon. ISS is now recommending that all STAAR stockholders vote “FOR” STAAR’s amended merger agreement with Alcon (SIX/NYSE: ALC) at STAAR’s Special Meeting of Stockholders on December 19, 2025 at 8:30 a.m. (Pacific Time).

STAAR issued the following statement:

The STAAR Board is committed to maximizing stockholder value and serving the best interests of all STAAR stockholders. In the ISS report issued today, ISS recommended a vote “FOR” the Alcon merger and noted that “uncertainties about valuation are now outweighed by the combination of more acute downside risks and improved terms”¹ with respect to the Alcon agreement.

STAAR clearly faces challenges as a standalone company. It is not hard to see from STAAR’s financial results that the Company is facing headwinds. STAAR’s net sales have been on a downward trajectory since 2023 as a result of the overweight exposure to China, increasing competition, a limited product offering and a historical inability to penetrate markets beyond high myopia patients.

STAAR previously indicated that it believed China procedure volumes were positive year over year in 1Q25, softened during 2Q25, and did not improve in 3Q25. Like others in the industry, STAAR has not seen a rebound in 4Q25.

These trends reinforce the significant, sustained challenges STAAR faces as a standalone company and the benefit to stockholders provided by the certain, premium value that would be realized in the Alcon merger.

After having completed a robust go-shop process, it is clear that there is not any buyer for STAAR who is willing to present a bid with a price at or above Alcon’s offered $30.75 per share.

STAAR urges stockholders to follow the ISS recommendation and vote “FOR” the Alcon transaction.

Time is short. STAAR will hold a virtual Special Meeting of Stockholders on December 19, 2025, at 8:30 a.m. (Pacific Time). Stockholders of record as of the close of business on October 24, 2025, are entitled to vote at the meeting.

The Alcon merger agreement, as revised on December 9, 2025, provides STAAR stockholders with $30.75 per share in cash, representing a 74% premium to STAAR’s 90-day Volume Weighted Average Price and a 66% premium to the closing price of STAAR common stock on August 4, 2025. The Company encourages stockholders to protect the value of their investment and vote “FOR” the Alcon merger on the WHITE proxy card TODAY.

Stockholders with questions about voting their shares should contact STAAR’s proxy solicitor, Innisfree M&A Incorporated:

• For stockholders: +1 877-750-8233 (toll-free from the U.S. and Canada) or +1 412-232-3651 (from other countries)
• For banks and brokerage firms: +1 212-750-5833

About STAAR Surgical

STAAR Surgical (NASDAQ: STAA) is the global leader in implantable phakic intraocular lenses, a vision correction solution that reduces or eliminates the need for glasses or contact lenses. Since 1982, STAAR has been dedicated solely to ophthalmic surgery, and for 30 years, STAAR has been designing, developing, manufacturing, and marketing advanced Implantable Collamer^® Lenses (ICLs), using its proprietary biocompatible Collamer material. STAAR ICLs are clinically-proven to deliver safe long-term vision correction without removing corneal tissue or the eye’s natural crystalline lens. Its EVO ICL™ product line provides visual freedom through a quick, minimally invasive procedure. STAAR has sold more than 3 million ICLs in over 75 countries. Headquartered in Lake Forest, California, the company operates research, development, manufacturing, and packaging facilities in California and Switzerland. For more information about ICL, visit www.EVOICL.com. To learn more about STAAR, visit www.staar.com.

Additional Information About the Merger and Where to Find It

This communication relates to the proposed transaction involving STAAR. In connection with the proposed transaction, STAAR has filed relevant materials with the U.S. Securities and Exchange Commission (the “SEC”), including STAAR’s definitive proxy statement on Schedule 14A (the “Proxy Statement”), on September 16, 2025. The Proxy Statement was first sent to STAAR stockholders on September 16, 2025, and was thereafter supplemented. This communication is not a substitute for the Proxy Statement or any other document that STAAR may file with the SEC or send to its stockholders in connection with the proposed transaction. BEFORE MAKING ANY VOTING DECISION, STOCKHOLDERS OF STAAR ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED OR TO BE FILED WITH THE SEC, INCLUDING THE PROXY STATEMENT, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS THERETO, IN CONNECTION WITH THE PROPOSED TRANSACTION WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain the documents (when available) free of charge at the SEC’s website, www.sec.gov, or by visiting STAAR’s investor relations website, https://investors.staar.com.

No Offer or Solicitation

This communication is for informational purposes only and is not intended to and does not constitute, or form part of, an offer, invitation or the solicitation of an offer or invitation to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of any securities, or the solicitation of any vote or approval in any jurisdiction, pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law.

Participants in the Solicitation

Under SEC rules, STAAR and certain of its directors, executive officers and other members of management and employees may be deemed to be participants in the solicitation of proxies from the holders of STAAR’s common stock in connection with the proposed transaction. Information about the directors and executive officers of STAAR and their ownership of STAAR’s common stock is set forth in the Proxy Statement, the definitive proxy statement for STAAR’s 2025 Annual Meeting of Stockholders (the “Annual Proxy Statement”), which was filed with the SEC on April 24, 2025 (and which is available at https://www.sec.gov/ix?doc=/Archives/edgar/data/0000718937/000095017025058174/staa-20250424.htm), including the sections captioned “Compensation of Directors,” “Information Regarding Executive Officers” and “Security Ownership of Principal Shareholders and Management,” or its Annual Report on Form 10-K for the year ended December 27, 2024, which was filed with the SEC on February 21, 2025 (and which is available at https://www.sec.gov/ix?doc=/Archives/edgar/data/0000718937/000095017025024813/staa-20241227.htm), and in other documents filed by STAAR with the SEC. To the extent holdings of such participants in STAAR’s securities have changed since the amounts described in the Proxy Statement, such changes have been reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Change in Ownership on Form 4 filed with the SEC by STAAR’s directors and executive officers. These documents can be obtained free of charge from the sources indicated above. Additional information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in other relevant materials to be filed with the SEC in respect of the proposed transaction when they become available.

Forward-Looking Statements

The information covered by this communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements often contain words such as “anticipate,” “believe,” “expect,” “plan,” “estimate,” “project,” “continue,” “will,” “should,” “may,” and similar terms. All statements in this communication that are not statements of historical fact are forward-looking statements. These forward-looking statements are neither promises nor guarantees and involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from what is expressed or implied by the forward-looking statements, including, but not limited to: (1) the occurrence of any event, change or other circumstances that could give rise to the termination of the Alcon merger agreement or could cause the consummation of the proposed transaction to be delayed or to fail to occur; (2) the failure to obtain approval of the proposed transaction from STAAR’s stockholders; (3) the failure to obtain certain required regulatory approvals or the failure to satisfy any of the other closing conditions to the completion of the proposed transaction within the expected timeframes or at all; (4) risks related to disruption of management’s attention from STAAR’s ongoing business operations due to the proposed transaction; (5) the effect of the announcement of the proposed transaction on the ability of STAAR to retain and hire key personnel and maintain relationships with its customers, suppliers and others with whom it does business, or on its operating results and business generally; (6) the ability of STAAR to meet expectations regarding the timing and completion of the transaction; (7) the outcome of any legal proceedings that may be instituted against STAAR related to the proposed transaction; (8) the possibility that STAAR’s stock price may decline significantly if the proposed transaction is not consummated; and (9) other important factors set forth in the Proxy Statement under the caption “Risk Factors” and STAAR’s Annual Report on Form 10-K for the year ended December 27, 2024 under the caption “Risk Factors,” as any such factors may be updated from time to time in STAAR’s other filings with the SEC.

Forward-looking statements speak only as of the date they are made and, except as may be required under applicable law, STAAR undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

STAAR Contacts:
Niko Liu, CFA

United States: +1 626-303-7902 (ext 3023)

Hong Kong: +852-6092-5076

nliu@staar.com
investorrelations@staar.com

Connie Johnson

+1 626-303-7902 (ext 2207)

cjohnson@staar.com

Lucas Pers / Alexandra Benedict

Joele Frank, Wilkinson Brimmer Katcher

+1 212-895-8692 / +1 212-895-8644

GenSci and RTW Investments Announce Strategic Partnership on Anti-TSHR Antibody GS-098 (YB-101) for Graves’ Disease and Thyroid Eye Disease, With Global Ex-China Development Being Led by Yarrow Bioscience




GenSci and RTW Investments Announce Strategic Partnership on Anti-TSHR Antibody GS-098 (YB-101) for Graves’ Disease and Thyroid Eye Disease, With Global Ex-China Development Being Led by Yarrow Bioscience

• Collaboration to focus on building a leading, US-based biotech dedicated to addressing underserved patients impacted by autoimmune and endocrinology disorders
• GenSci to receive $70 million non-refundable upfront payment, a $50M near-term development milestone and further development, regulatory and commercial milestone payments in a total deal value up to $1.365 billion with tiered double-digit royalties on future net sales in licensed territories; GenSci retains the rights for development and commercialization of GS-098 in China
• Agreement grants Yarrow Bioscience, Inc. exclusive global ex-China rights to develop and commercialize GS-098 (YB-101) for Graves’ disease (GD) and thyroid eye disease (TED)

SHANGHAI & NEW YORK–(BUSINESS WIRE)–Shanghai Scizeng Medical Technology Co., LTD, a subsidiary of Changchun GeneScience Pharmaceutical Co., Ltd. (“GenSci”), RTW Investments, LP (“RTW”), and Yarrow Bioscience, Inc. (“Yarrow”) today announced an exclusive global ex-China license agreement for GS-098, a clinical-stage, first-in-class, humanized monoclonal antibody targeting the thyroid-stimulating hormone receptor (TSHR) for the treatment of Graves’ disease (GD) and thyroid eye disease (TED). Founded in 1997, GenSci – a subsidiary of Changchun High‑Tech Industries Co., Ltd (“Changchun High-Tech”) – is a fully integrated, leading biopharmaceutical company based in China with a broad innovative pipeline across endocrinology, immune & pulmonary, oncology, and women’s health as well as commercial leadership in recombinant human growth hormone (rhGH) products. Yarrow was founded to develop transformative therapies for autoimmune thyroid diseases and backed by RTW, a preeminent global, full life-cycle life sciences investment firm based in New York.

GS-098, which will be continued as YB-101 outside of China, is designed to rapidly and efficiently block the pathogenic activity of thyroid-stimulating autoantibodies that drive disease progression in GD and TED. By selectively binding the TSHR and preventing autoantibody-induced receptor activation, YB-101 inhibits the biological pathway responsible for hyperthyroidism and orbitopathy. This targeted mechanism has the potential to provide meaningful clinical benefit while avoiding systemic immunosuppression.

Under the terms of the agreement, Yarrow receives exclusive global ex-China rights to develop, manufacture, and commercialize GS-098 (YB-101) for GD and TED. GenSci retains rights for development and commercialization in China. GenSci will receive a $70 million non-refundable upfront payment, a $50M near-term development milestone, and further development, regulatory and commercial milestone payments in a total deal value up to $1.365 billion with tiered double-digit royalties on future net sales in licensed territories.

“This landmark partnership with RTW Investments and Yarrow Bioscience, Inc is a strategic step in our vision of becoming a global pharma innovator. GS-098, originated from our Shanghai R&D center, is a first-in-class molecule and has demonstrated the best-in-class potential,” said Dr. Lei Jin, Founder, General Manager & Chief Scientist of GenSci and General Manager of Changchun High-Tech Industry Group. “Our partners RTW Investments and Yarrow Bioscience, Inc have demonstrated exceptional expertise and experience in developing innovative drugs in the field of immunology and shown great commitment and passion to develop GS-098 in the ex-China territory. We believe that our combined expertise and resources will bring this breakthrough medicine to the Graves’ Disease and Thyroid Eye Disease patients speedily and worldwide.”

“This collaboration represents a tremendous opportunity for Yarrow and GenSci to advance GS-098 (YB-101) toward meaningful clinical milestones in both Graves’ disease and thyroid eye disease,” said Rebecca Frey, Pharm.D., President and Chief Executive Officer of Yarrow Bioscience. “Patients suffering from these debilitating autoimmune conditions continue to face substantial unmet needs. YB-101’s highly targeted, TSHR-directed mechanism of action has the potential to transform the treatment landscape, and we look forward to working closely with GenSci to bring this promising therapy to patients worldwide.”

“Our partnership with GenSci reflects RTW’s commitment to advancing high-impact science through long-term, collaborative company creation,” said Peter Fong, Partner and President at RTW Investments, LP. “We are dedicated to building world-class biotechnology companies, and Yarrow represents a model example of this mission in action. Rebecca and the Yarrow leadership team bring exceptional scientific and operational expertise, and we look forward to working closely with them to advance GS-098 (YB-101) and realize its full potential for patients.”

About GS-098 (YB-101)

GS-098 (YB-101) is a clinical-stage, humanized monoclonal antibody targeting the thyroid-stimulating hormone receptor (TSHR). The antibody is designed to rapidly and efficiently block the pathogenic activity of thyroid-stimulating autoantibodies that drive disease progression in Graves’ disease (GD) and thyroid eye disease (TED). By binding selectively to the TSH receptor and blocking autoantibody-induced receptor activation, YB-101 directly inhibits the biological pathway responsible for hyperthyroidism and orbitopathy. This novel and targeted approach represents a potential breakthrough for patients who are inadequately controlled with first-line therapies and remain at high risk for complications of GD and TED. In 2025 Yarrow executed an exclusive license agreement with Changchun GeneScience Pharmaceutical Co., Ltd. to obtain global ex-China rights to develop GS-098 in GD and TED.

About Changchun GeneScience Pharmaceutical Co., Ltd. (“GenSci”)

GenSci is a leading biopharmaceutical company in China, specializing in pediatric and women’s health. Additionally, GenSci is active in four other therapeutic areas: Endocrinology, Metabolic, Immunology/Respiratory, and Oncology. The company has over 9,000 employees, and integrates research, development, production, and commercialization of innovative therapies for patients with unmet medical needs. Established in 1996, the company is a subsidiary of Changchun High‑Tech Industries Co., Ltd and is headquartered in Changchun, China.

For further information about GenSci, please visit http://www.genscigroup.com/

About RTW Investments, LP

RTW Investments, LP is a New York-based, global, full life-cycle investment firm that focuses on identifying transformational and disruptive innovations across the biopharmaceutical and medical technologies sectors. As a leading partner of industry and academia, RTW combines deep scientific expertise with a solution-oriented investment approach to advance emerging therapies by building and supporting the companies developing them.

For further information about RTW, please visit www.rtwfunds.com

About Yarrow Bioscience, Inc.

Yarrow Bioscience is a clinical-stage biotechnology company focused on developing transformative therapies for autoimmune thyroid diseases. The company’s lead candidate, YB-101, is a humanized monoclonal antibody targeting the thyroid-stimulating hormone receptor (TSHR) for the treatment of Graves’ disease and thyroid eye disease. Yarrow is headquartered in New York and is backed by leading healthcare investor RTW Investments, LP.

Contacts

PR contact: info@yarrowbioscience.com

Hercules Pharmaceuticals Appoints Ali Ahmed as Chief Commercial Officer




Hercules Pharmaceuticals Appoints Ali Ahmed as Chief Commercial Officer

PORT WASHINGTON, N.Y.–(BUSINESS WIRE)–Hercules Pharmaceuticals today announced the appointment of Ali Ahmed as Executive Vice President, Chief Commercial Officer. Ahmed will lead commercial strategy, enterprise growth, and strategic partnerships as Hercules scales its national platform and expands its role as a strategic partner within the U.S. pharmaceutical distribution ecosystem.

Ahmed brings deep experience across healthcare and enterprise technology, including leadership roles at Fresenius Kabi and Salesforce. He previously served on the executive team at Fresenius Kabi as Senior Vice President and General Manager of the BioPharma Business Unit, where he led commercialization of biosimilars to expand access to high-quality care. Ahmed also served as Global Head of Life Sciences Innovation at Salesforce, partnering with pharmaceutical companies to modernize commercial execution, launch strategy, and patient engagement through data, analytics, and digital platforms. His background combines pharmaceutical commercialization expertise with modern customer and data-platform fluency, positioning him to help Hercules scale responsibly while accelerating value creation for partners across the ecosystem.

Hercules has built a patient-centric, data-led distribution model designed to help partners operate more effectively in an increasingly consolidated and constrained market. The company has embedded artificial intelligence across its commercial, supply chain, and customer engagement workflows to generate insights that supports both upstream manufacturers and downstream providers. These capabilities enable more precise demand forecasting, smarter inventory placement, dynamic pricing insights, and earlier visibility into market shifts that affect access and continuity of supply.

From its inception, Hercules has operated with a clear ethical mandate. The company applies technology and data intelligence with intentional guardrails, ensuring that growth, automation, and optimization are aligned with transparency, fairness, and responsible market participation. Technology is applied not simply to drive efficiency, but to strengthen trust, protect access for patients and providers, and support long-term sustainability across the healthcare supply chain.

“As consolidation continues to place pressure on every participant in healthcare, value creation depends on intelligence, flexibility, and principled execution,” said Sara Amani, Founder and CEO of Hercules Pharmaceuticals. “Our AI-enabled platform is designed to help partners make better decisions while operating with integrity in a complex market. Ali brings the strategic leadership, legal fluency, and judgment required to expand that model responsibly and advance a more resilient standard for protecting patient access at scale.”

“Hercules has built an infrastructure that recognizes the responsibility that comes with scale,” said Ali Ahmed. “The company already uses AI to translate data into insights across the supply chain. My focus is to expand how those insights are applied and shared in ways that create value, protect access, and uphold the standards required for long-term trust in an unpredictable market environment.”

Hercules continues to gain momentum as health systems, specialty pharmacies, and manufacturers seek partners that offer more than transactional distribution. With a national footprint, global sourcing access, and an AI driven operating model grounded in disciplined governance, Hercules supports a more adaptive and resilient healthcare supply chain in a market shaped by consolidation.

About Hercules Pharmaceuticals

Hercules Pharmaceuticals is a national pharmaceutical distributor and steward of AriaGPO, providing manufacturers with a differentiated, provider-aligned route to market across the U.S. healthcare system. Purpose-built to address drug shortages and structural concentration in pharmaceutical distribution, Hercules enables manufacturers to diversify channel exposure, expand provider access, and deliver critical therapies with greater speed, transparency, and reliability.

Through a technology-enabled operating platform, AI-powered decision intelligence, and direct relationships with health systems, specialty pharmacies, and community-based providers nationwide, Hercules supports responsible competition, sustainable market access, and long-term supply continuity for manufacturers and their provider partners.

Contacts

Media Contact:

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Strategies to Succeed in the $5+ Billion Tourette Syndrome Drugs Market, 2026-2034 – ResearchAndMarkets.com




Strategies to Succeed in the $5+ Billion Tourette Syndrome Drugs Market, 2026-2034 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Tourette Syndrome Drugs Market Outlook 2026-2034: Market Share, and Growth Analysis” has been added to ResearchAndMarkets.com’s offering.

The Tourette Syndrome Drugs Market is projected to witness significant expansion in the coming years, escalating from a valuation of USD 2.76 billion in 2025 to approximately USD 5.03 billion by 2034, with a notable CAGR of 6.9%. The market predominantly caters to the pharmacological management of tic disorders, inclusive of vocal and motor tics associated with TS, and often addresses co-morbidities such as ADHD and OCD.

The market’s growth is driven by an enhanced rate of diagnosis, improved awareness among medical professionals and caregivers, and better access to specialized neurology and psychiatry care. Ongoing research and development efforts are directed towards creating safer, more effective, and targeted therapies.

Among major emerging trends is the introduction of novel drug classes such as VMAT-2 inhibitors. The treatment paradigm is evolving from severe case management to earlier intervention and broader therapy application, including pediatric and adult care segments. There is notable growth in outpatient and specialty clinic prescriptions, paralleling the expanding geographical access to neurology treatments.

The competitive landscape consists of leading pharmaceutical companies, biotech firms focusing on innovative tic treatment solutions, and generic manufacturers providing older, often less costly therapies. Challenges include the side-effect profile of older medications, regulatory hurdles, and regional healthcare disparities.

Market Insights:

• The diagnostics and awareness improvements are expected to expand patient volume, especially as TS is increasingly detected early in children transitioning to adult care.
• Older antipsychotic therapies, despite their dominance, face constraints due to adverse effects, spurring demand for more tolerable medications.
• The emergence of newer therapies like VMAT-2 inhibitors presents opportunities for differentiation in the treatment space.
• The pediatric segment, the largest for TS drugs, sees adults as a growing focus due to the persistence of TS symptoms and evolving care paradigms.
• Hospital and specialty clinic channels remain crucial for prescribing, heavily influencing market dynamics.
• While mature markets lead in treatment adoption, emerging markets present a significant growth opportunity as they enhance diagnostic access and infrastructure.

Regional Analysis

North America, with its robust neurology infrastructure, leads in market size and sophistication, while Europe presents mature but varied opportunities. Asia-Pacific and Latin America offer growth prospects influenced by expanding healthcare investments and rising awareness but face challenges like limited infrastructure.

Market Segmentation:

• By Product: Antipsychotics, Non-antipsychotics
• By Distribution Channel: Offline, Online

The report employs comprehensive analytical tools like Porter’s Five Forces and scenario-based modeling to evaluate market dynamics. It also considers macroeconomic indicators, policy influences, and consumer trends in forecasting, alongside recent deal flows and technology innovations.

Competitive Intelligence

The competitive landscape is examined through frameworks detailing business models, product offerings, financial performance, and strategic advancements of key players. Emerging innovators and startups are identified for their potential to disrupt the market.

The report provides a granular outlook on market trends, opportunities, and challenges through 2034, supported by detailed regional insights and strategic recommendations.

Key Attributes

Key Companies Featured in the Report:

• Otsuka Pharmaceutical
• Lundbeck
• Teva Pharmaceutical
• Neurocrine Biosciences
• Emalex Biosciences
• Supernus Pharmaceuticals
• Janssen (Johnson & Johnson)
• AbbVie (Allergan)
• Ipsen
• Roche
• Novartis
• Pfizer
• Sunovion Pharmaceuticals
• Medtronic (DBS therapy)
• UCB

For more information about this report visit https://www.researchandmarkets.com/r/pwewx2

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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The OpenFold Consortium Names Dr. Jan Domanski as Senior Science Lead to Drive the Next Generation of Open Source AI Models for Structural Biology and Drug Discovery




The OpenFold Consortium Names Dr. Jan Domanski as Senior Science Lead to Drive the Next Generation of Open Source AI Models for Structural Biology and Drug Discovery

DAVIS, Calif.–(BUSINESS WIRE)–The OpenFold Consortium, a leading open-science initiative developing AI foundation models for biomolecular structure prediction, today announced that Dr. Jan Domanski has joined the consortium as senior science lead. In this role, Dr. Domanski will spearhead scientific innovation, engineering excellence, and ecosystem growth as OpenFold advances its mission to democratize access to high-performance AI models for structural biology and drug discovery. He will work closely with Dr. Jennifer Wei, OpenFold’s senior technical lead, and a global network of academic and industry contributors to build an open, modular software stack that links state-of-the-art AI models with rich experimental and simulation data to improve model generalization and robustness for drug discovery.

“Dr. Domanski embodies the spirit of OpenFold: a deep scientific understanding of proteins coupled with professional engineering expertise and a builder’s mindset,” said Dr. Woody Sherman, Chair of the OpenFold Executive Committee. “His experience architecting AI-driven platforms to drive drug discovery programs from concept to clinic will be invaluable as we expand OpenFold’s reach beyond structure prediction toward accurate biomolecular interactions, dynamics, and generative design.”

As part of the Open Molecular Software Foundation (OMSF), OpenFold is committed to advancing open and reproducible science across molecular modeling. Following the preview release of OpenFold3, an open-source model capable of predicting protein, nucleic acid, and small-molecule interactions with near–AlphaFold 3 accuracy, the consortium is now focused on building the next generation of foundation models that integrate AI and physics-based approaches for biomolecular understanding and drug discovery.

“OpenFold has already proven that open collaboration can match or exceed the capabilities of proprietary AI models,” said Dr. Domanski. “The next phase is to make these models truly usable and extensible—to enable every scientist, from academia to biotech, to contribute, adapt, and apply them across new frontiers of biology and medicine.”

Dr. Domanski brings over a decade of experience at the intersection of machine learning, molecular simulation, and scientific software development. With a Ph.D. obtained through the NIH Oxford-Cambridge Scholars Program, a joint program between the University of Oxford and the NIH, he studied membrane protein folding under the supervision of Professors Mark Sansom and Philip Stansfeld at Oxford and Dr. Robert Best at the NIH. Dr. Domanski has dedicated his career to building tools that bridge cutting-edge computation with experimental science to accelerate drug discovery and innovation in the life sciences. Dr. Domanski also worked at D. E. Shaw Research where he applied the long timescale molecular dynamics simulations to small-molecule discovery, understanding the relationship between protein structure and function.

Prior to joining OpenFold, Dr. Domanski was Founder and CTO of Labstep, a pioneering digital lab automation platform acquired by STARLIMS. In 2022, Dr. Domanski joined Charm Therapeutics, where he was among the first five employees. There, he built and scaled the company’s machine learning and software engineering teams, collaborated closely with medicinal chemists and structural biologists, and led the development of DragonFold, a state-of-the-art co-folding model that powered Charm’s integrated small-molecule discovery platform. This technology contributed to the identification of CHM-029, Charm’s next-generation menin inhibitor expected to enter the clinic in 2026.

The OpenFold Consortium is supported by member organizations and philanthropic partners. By investing in OpenFold today, you have a unique opportunity to shape the future of open, trustworthy AI infrastructure in the life sciences, ensuring that state-of-the-art models remain freely accessible to scientists everywhere.

If you or your organization are excited to support open, community-driven AI for science, please contact Dr. Mallory Tollefson at mallory.tollefson@omsf.io. Your support helps accelerate discovery, empower the next generation of scientists, and sustain critical tools that the entire biomedical ecosystem relies on.

Contacts

Media Contact:

Mallory Tollefson, Ph. D.

OpenFold Consortium

mallory.tollefson@omsf.io

Atelerix Enters Agreement with Cherry Biotech to Integrate Non-cryogenic Transport Solutions With Advanced Organoid Models




Atelerix Enters Agreement with Cherry Biotech to Integrate Non-cryogenic Transport Solutions With Advanced Organoid Models

Partnership brings together proven non-cryogenic biosample preservation technology and advanced organoid models to support growth in preclinical research and biotech sectors

NEWCASTLE, England–(BUSINESS WIRE)–Atelerix, a biotech company revolutionising cell preservation and biological transport with its pioneering hydrogel encapsulation technology, today announced it has entered a partnership with Cherry Biotech, a French company specialising in organ-on-chip and organoid technologies for biomedical research.

The initial agreement will explore the integration of Atelerix’s patented hydrogel technology with Cherry Biotech’s advanced 3D organoid models to facilitate global extended-duration shipment. In collaboration, the companies aim to improve the reliability and consistency of transporting these temperature-sensitive materials without the complications of cold-chain logistics, enabling significant growth and expanded customer access to high-quality, human-relevant preclinical data worldwide. Through an initial 12-month trial period, both parties will validate their strategic and technical alignment, establishing the groundwork for a scalable, long-term commercial partnership.

Cherry Biotech’s in vitro product range combine AI analysis, high-resolution live imaging and precisely controlled organoid culture to better predict the efficacy and safety of drugs, generating real life-like preclinical data. As part of the partnership, Atelerix’s hydrogel technology will also be validated for the stable shipment of Cherry Biotech’s recently released organoidPlate – an advanced multiwell plate with ready to use organoids for adipose tissue, breast cancer, liver and lung, which is now available for worldwide shipping.

The MoU builds on a test period whereby Cherry Biotech demonstrated strong performance of Atelerix’s biosample preservation technology across multiple organ models, preserving membrane integrity and biological function at ambient or controlled temperatures.

Alastair Carrington, CEO, Atelerix, commented: “This latest partnership with Cherry Biotech is a key step in expanding our commercial traction, broadening market reach, and increasing visibility for Atelerix’s solutions. It is fantastic to work alongside such an innovative CRO, we are delighted that our preservation technology has already proven itself in delivering organoid models reliably and hassle-free to researchers worldwide. This partnership provides key validation, reinforcing the potential of ambient logistics to support the adoption of assay-ready animal model alternatives, advancing drug testing and better predicting human responses.”

Pierre Gaudriault, Chief Business Development Officer, Cherry Biotech, added: “Partnering with Atelerix strengthens our ability to deliver cutting-edge organoid models to researchers in pharma and academia worldwide. The hydrogel preservation technology maintains cell viability for days at room temperature, removing cold-chain constraints and reducing environmental footprint. This innovation brings unprecedented convenience and reliability to our customers. In short, Aterelix is making easy global shipping for our product possible.”

Contacts

Media
Jake Brown

jake.brown@zymecommunications.com

GENESIS Pharma announces a new partnership with Otsuka Pharmaceutical Europe Ltd. for the commercialization of donidalorsen for hereditary angioedema in Central and Eastern Europe




GENESIS Pharma announces a new partnership with Otsuka Pharmaceutical Europe Ltd. for the commercialization of donidalorsen for hereditary angioedema in Central and Eastern Europe

ATHENS, Greece–(BUSINESS WIRE)– 

ANNOUNCEMENT FOR EUROPEAN MEDICAL & PHARMACEUTICAL TRADE MEDIA AND EUROPEAN FINANCIAL MEDIA ONLY

GENESIS Pharma, a regional biopharma company focused on the commercialization of innovative medicines in Central and Eastern Europe, announces an exclusive agreement with Otsuka Pharmaceutical Europe Ltd. (OPEL), the European operation of global healthcare company Otsuka Pharmaceutical Co., Ltd., for donidalorsen. Under the terms of the agreement, GENESIS Pharma will exclusively distribute and commercialize donidalorsen in fourteen markets: Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovakia and Slovenia.

In November 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for donidalorsen in the routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older. The CHMP opinion is currently under review by the European Commission (EC), to determine donidalorsen’s authorisation in the European Union (EU). Donidalorsen is an investigational RNA-targeted medicine designed to reduce the production of prekallikrein (PKK), interrupting the pathway that leads to HAE attacks^1,2.

Mr. Constantinos Evripides, Managing Director of GENESIS Pharma stated: “We are excited to expand our international partnerships in the CEE region through this new collaboration with Otsuka Pharmaceutical Europe Ltd., a company focusing on some of the world’s unresolved health issues. The addition of donidalorsen to our robust rare disease medicines portfolio is another step forward in our mission to support patients with rare and serious conditions, ensuring access to innovative treatments in our region. Thus, we look forward to the forthcoming decision from the European Commission.”

Donidalorsen was discovered and developed by Ionis Pharmaceuticals, Inc. (Ionis). In December 2023, Otsuka acquired exclusive rights to commercialize donidalorsen in Europe through a licensing agreement with Ionis.

About Hereditary Angioedema (HAE)

HAE is a rare, chronic and potentially life-threatening genetic condition that involves recurrent, unpredictable attacks of swelling episodes that can affect the extremities, face, abdomen, genitals and even the larynx, posing serious risk for patients.³ Symptoms of HAE usually begin in childhood or early adulthood, with some individuals experiencing their first episodes as young as two years old.^4,5 HAE imposes a significant burden on patients and their families, with unpredictable and often debilitating attacks which can disrupt daily life, limit activities and reduce productivity at work or school. ^6-8 HAE is most commonly caused by an inherited deficiency or dysfunction of C1 esterase inhibitor, which leads to uncontrolled activation of the plasma kallikrein-kinin system and excessive production of bradykinin.^5,9,10 Approximately 15,000 individuals are living with HAE in Europe with a worldwide prevalence estimated to be 1 in 50,000.^3,5,11

About GENESIS Pharma

GENESIS Pharma is a regional biopharma company focused on the commercialization of innovative biopharmaceutical products targeting severe and rare diseases in Central and Eastern Europe. Established in 1997, GENESIS Pharma was among the first pharmaceutical companies in Europe to specialize in the marketing, sales and distribution of biopharmaceutical products. GENESIS Pharma maintains a strong portfolio in therapeutic areas with high unmet medical need through long standing strategic alliances with some of the leading global biopharma companies. For more information, please visit www.genesispharma.com and follow us on LinkedIn.

REFERENCES

1. Riedl MA, et al. N Engl J Med 2024;391(1):21–31.
2. Riedl MA, et al. J Allergy Clin Immunol Pract 2025;13(9):2381–2389.
3. Raasch J, et al. World Allergy Organ J 2023;16(6):100792.
4. Busse P, et al. J Allergy Clin Immunol Pract 2021;9(1):132–150.e3.
5. Maurer M, et al. Allergy 2022;77(7):1961–1990.
6. Aygoren-Pursun E, et al. Orphanet J Rare Dis 2014;9:99.
7. Chong-Neto HJ, World Allergy Organ J 2023;16(3):100758.
8. Mendivil J, et al. Orphanet J Rare Dis 2021;16:94.
9. Santacroce R, et al. Review J Clin Med 2021:10(9):2023.
10. Longhurst HJ, Bork K. Br J Hosp Med (Lond) 2019:2;80(7):391–398.
11. Lumry WR. Hereditary angioedema: the economics of treatment of an orphan disease. Front Med (Lausanne). 2018;5:22.

Contacts

For more information, please contact:
Natalia Karahaliou, Communications Manager

nkarahaliou@genesispharma.com
+30 210 87 71 605

LEO Pharma Submits Adolescent Label Expansion Application for Anzupgo® to EMA




LEO Pharma Submits Adolescent Label Expansion Application for Anzupgo® to EMA

• LEO Pharma has submitted a label expansion application to EMA to expand Anzupgo® (delgocitinib) cream to adolescent patients (12–17 years) with moderate to severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate – the application has been accepted for review.
• The application is supported by results from DELTA TEEN, a phase 3 trial investigating efficacy and safety of Anzupgo® in adolescents with moderate to severe chronic hand eczema (CHE).¹
• The label expansion submission for adolescent patients demonstrates LEO Pharma’s commitment to investigating use within relevant sub-populations where treatments can help make a fundamental difference for patients with skin diseases.

BALLERUP, Denmark–(BUSINESS WIRE)–NOT FOR UK USE – NOT INTENDED FOR UK MEDIA

LEO Pharma A/S, a global leader in medical dermatology, today announced submission of a label expansion application to the European Medicines Agency (EMA) to expand the use of Anzupgo^® (delgocitinib) cream to adolescents aged 12 to 17 years, living with moderate to severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate in the European Union. The label expansion application has been accepted for review by EMA.

“With the submission of our label expansion application for Anzupgo^®, LEO Pharma is reinforcing our commitment aiming at improving the lives of patients with skin diseases,” said Sophie Lamle, Executive Vice President, Development. “Adolescents living with this debilitating disease, in the EU, currently have no treatment options specifically approved for moderate to severe CHE, and we are proud to take this important step toward addressing that unmet need. Backed by our global expertise and dedication to innovation, we are excited about the potential to bring a treatment that can help make a meaningful difference in the everyday lives of adolescent patients.”

Research on adolescents with CHE shows that the disease can impact far beyond the skin. CHE can have considerable negative impact on quality of life, affecting psychosocial well-being, school performance and participation in leisure activities.²

The label expansion application is supported by results from DELTA Teen, a phase 3 trial with Anzupgo^® (delgocitinib) 20mg/g cream, that investigated the efficacy and safety of twice-daily applications of Anzupgo^® compared with cream vehicle in adolescents 12-17 years of age with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate .¹ The detailed results were presented as a late breaking presentation at European Academy of Dermatology and Venereology 2025 in Paris, France.

Anzupgo^® is currently approved in adult patients with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate in the European Union³, as well as several additional markets, including the US, Switzerland and the UK.

About Chronic Hand Eczema

Chronic Hand Eczema (CHE) is defined as hand eczema (HE) that lasts for more than three months or relapses twice or more within a year.^4,5 CHE is one of the most common skin diseases of the hands with a global prevalence rate of approximately 4.7%.^6,7 In a substantial number of patients, HE can develop into a chronic disease.⁶ CHE is a fluctuating disease characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists.⁸

CHE has been shown to cause psychological and functional burdens that impact patient quality of life,^9,10 with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities, and suffering disruption in their daily life due to the condition.¹¹ Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE.¹²

About Anzupgo^® (delgocitinib) Cream

Anzupgo^® cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE in adults. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.¹³

Anzupgo^® is approved in the European Union, United Kingdom, Switzerland, Canada, Australia, South Korea, and the United Arab Emirates for the treatment of moderate to severe Chronic Hand Eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate. Anzupgo^® cream is also under investigation in other markets.

Anzupgo^® (delgocitinib) cream is FDA approved in the U.S. for moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Use of Anzupgo^® in combination with other JAK inhibitors or potent immunosuppressants is not recommended by the U.S. FDA.¹⁴

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

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

About the DELTA TEEN Trial

DELTA TEEN was a 16-week, phase 3, randomized, double-blind, vehicle-controlled, parallel group, multi-site trial to evaluate the efficacy and safety of twice-daily applications of Anzupgo^® compared with cream vehicle in adolescents 12-17 years of age with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate.¹

The primary endpoint of DELTA TEEN was the Investigator’s Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) at Week 16. Treatment success was defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a two-step improvement from baseline.¹

About LEO Pharma

LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. Together, we reach far beyond the skin.

For more information, visit www.leo-pharma.com.

References

1. ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema (DELTA TEEN). Identifier: NCT05355818. https://clinicaltrials.gov/study/NCT05355818.
2. Haft MA, Park HH, Lee SS, Sprague JM, Eichenfield LF. Pediatric chronic hand eczema: Epidemiology, clinical presentation, and management. JAAD Int. 2023;11:165-173.
3. European Medicines Agency. Anzupgo 20 mg/g cream: summary of product characteristics. Amsterdam: EMA; 2024 [updated 2025 Jan 22; cited 2025 Dec 9]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/anzupgo
4. Lynde C, Guenther L, Diepgen TL, et al. Canadian hand dermatitis management guidelines. J Cutan Med Surg . 2010;14(6):267-284. Erratum in: J Cutan Med Surg. 2011 Nov-Dec;15(6):360.
5. Diepgen TL, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1–22.
6. Bissonnette R, et al. Redefining treatment options in chronic hand eczema (CHE). JEADV. 2010;24;1–20.
7. Apfelbacher C, Bewley A, Molin S, et al. Prevalence of chronic hand eczema in adults: a cross-sectional survey of over 60 000 respondents from the general population of Canada, France, Germany, Italy, Spain and the UK. Presented at the 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #3
8. Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.
9. Grant L, Seiding Larsen L, Burrows K, et al. Development of a Conceptual Model of Chronic Hand Eczema (CHE) Based on Qualitative Interviews with Patients and Expert Dermatologists. Adv Ther. 2020;37(2):692-706.
10. Dalgard FJ, Gieler U, Tomas-Aragones L, et al. The psychological burden of skin diseases: a cross-sectional multicenter study among dermatological out-patients in 13 European countries. J Invest Dermatol. 2015;135(4):984-991.
11. Cortesi PA, Scalone L, Belisari A, et al. Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids. Contact Dermatitis. 2014;70(3):158-168.
12. Voorberg AN, Loman L, Schuttelaar MLA. Prevalence and Severity of Hand Eczema in the Dutch General Population: A Cross-sectional, Questionnaire Study within the Lifelines Cohort Study. Acta Derm Venereol. 2022;102:adv00626.
13. Dubin C, Del Duca E, Guttman-Yassky E. Drugs for the Treatment of Chronic Hand Eczema: Successes and Key Challenges. Ther Clin Risk Manag. 2020;16:1319-1332. Erratum in: Ther Clin Risk Manag. 2021 Mar 18;17:233.
14. ANZUPGO^® (delgocitinib) cream. Prescribing Information. FDA. July 2025.

MAT-88642 December 2025

Contacts

Jes Broe Frederiksen

Global Corporate Communication

+45 53 60 59 48

jebfe@leo-pharma.com

Christian Bundgaard

Global Corporate Communication

+45 53 74 88 49

chbun@leo-pharma.com