Calluna Pharma Announces the Appointment of Gijs van den Brink, MD, PhD, as Independent Director




Calluna Pharma Announces the Appointment of Gijs van den Brink, MD, PhD, as Independent Director

OSLO, Norway & BOSTON–(BUSINESS WIRE)–Calluna Pharma AS, a clinical stage biotechnology company pioneering first-in-class antibodies to treat inflammatory and fibrotic diseases, today announced that Gijs van den Brink, MD, PhD, has been appointed as an independent director to the company’s Board of Directors. Dr. van den Brink is a highly accomplished researcher and drug developer, having led immunology research and clinical development at both Roche and GSK.

“Gijs brings an exceptional blend of scientific depth, clinical insight, and strategic leadership to our board of directors,” said Calluna CEO Mark Gaffney. “We are thrilled to welcome him and are confident his expertise will strengthen our mission as we advance our pipeline in fibrotic and other inflammatory disorders.”

Dr. van den Brink had a distinguished tenure at Roche, where he served on the Pharma Research and Early Development (pRED) leadership team and was SVP and Global Head of Immunology, CVM, Infectious Diseases, and Ophthalmology Discovery and Early Development. Prior to Roche he was SVP and Global Head of Immunology Discovery, Early- and Late-Stage Clinical Development at GSK. He is presently the chief scientific officer of Granite Bio and an Operating Partner at Forbion.

“I am delighted to join the Calluna board and support its talented management team and their innovative programs,” said Dr. van den Brink. “Calluna is pursuing highly promising innate immunity targets across its pipeline, and the company is deeply committed to advancing novel medicines that have the potential to transform care for patients. Their work has far-reaching implications for a broad spectrum of inflammatory and fibrotic disorders, an area that has been central to my research and industry career, and I look forward to contributing to its next stage of scientific and clinical progress.”

Dr. van den Brink earned his MD and PhD from the University of Amsterdam Medical Center and completed his training in internal medicine and gastroenterology in Amsterdam, Geneva, and Leiden. He later served as a board-certified gastroenterologist and Professor of Experimental Gastroenterology at the University of Amsterdam, where he spearheaded pioneering research in inflammatory bowel disease. He has authored more than 150 peer-reviewed publications.

About Calluna Pharma www.callunapharma.com

Calluna Pharma is a global clinical stage company pioneering a breakthrough approach to treating inflammatory and fibrotic diseases by leveraging the body’s innate immune system. The Company’s therapeutic approach targets upstream amplifiers of disease, offering potential applicability across a diverse array of medical conditions. Calluna Pharma has a pipeline of selective antibodies targeting immunological diseases with enhanced efficacy and tolerability.

Calluna Pharma is incorporated in Oslo, Norway and operates globally.

Contacts

Media Contact:
Jason Glashow

Glashow Strategic Communications

Email: Jason@glashowstrategic.com
Tel: +1 617-510-1800

Zoetis Announces Pricing of $1.75 Billion Convertible Senior Notes Offering




Zoetis Announces Pricing of $1.75 Billion Convertible Senior Notes Offering

Substantially All of Net Proceeds Expected to Be Used to Repurchase Approximately $1.6 Billion of Common Stock and for Capped Call Transactions

PARSIPPANY, N.J.–(BUSINESS WIRE)–$ZTS #animalhealth–Zoetis Inc. (NYSE: ZTS) (the “Company” or “Zoetis”) today announced that it has priced its previously announced offering of $1.75 billion aggregate principal amount of 0.25% convertible senior notes due 2029 (the “Notes”) in a private offering to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A of the Securities Act of 1933, as amended (the “Securities Act”). Zoetis has also granted the initial purchasers of the Notes an option to purchase, for settlement within a 13-day period beginning on, and including, the date on which the Notes are first issued, up to an additional $250 million aggregate principal amount of Notes. The offering is expected to close on December 18, 2025, subject to the satisfaction of customary closing conditions.

Use of Proceeds – Share Repurchases and Capped Call Transactions

Zoetis estimates that the net proceeds from the offering will be approximately $1,723.2 million (or approximately $1,969.6 million if the initial purchasers exercise their option to purchase additional Notes in full), after deducting the initial purchasers’ discounts and estimated expenses payable by Zoetis. Zoetis intends to use the net proceeds from the offering as follows, the net effect of which is expected to result in Zoetis repurchasing approximately $1.6 billion of common stock (or approximately $1.8 billion of common stock if the initial purchasers exercise their option to purchase additional Notes in full):

• Approximately $163.3 million to fund the cost of entering into the capped call transactions described below;
• Approximately $250.3 million to purchase approximately 2.1 million shares of Zoetis’ common stock, par value $0.01 per share, in privately negotiated transactions entered into concurrently with the pricing of the offering effected with or through one of the initial purchasers or its affiliate; and
• The remaining $1,309.6 million to repurchase additional shares of Zoetis’ common stock after the offering, which the Company expects to complete by no later than the first quarter of 2026.

If the initial purchasers exercise their option to purchase additional Notes, Zoetis expects to use a portion of the net proceeds from the sale of the additional Notes to enter into additional capped call transactions and to use the remainder of such net proceeds for additional repurchases of common stock following the date of the offering. All share repurchases will be conducted pursuant to the Company’s existing $6 billion share repurchase program and may be made on the open market or in privately negotiated transactions and may be made pursuant to a Rule 10b5-1 plan or otherwise.

Key Terms of the Notes

The Notes will be senior, unsecured obligations of Zoetis, and will accrue interest at a rate of 0.25% per annum, payable semi-annually in arrears on June 15 and December 15 of each year, beginning on June 15, 2026. The Notes will mature on June 15, 2029, unless earlier redeemed, repurchased or converted.

The initial conversion rate will be 6.7476 shares of Zoetis’ common stock per $1,000 principal amount of Notes (equivalent to an initial conversion price of approximately $148.20 per share of Zoetis’ common stock). The initial conversion price of the Notes represents a premium of approximately 22.50% over the last reported sale price of Zoetis’ common stock on the New York Stock Exchange (“NYSE”) on December 15, 2025. At any time prior to the close of business on the business day immediately preceding March 15, 2029, the Notes will be convertible at the option of the holders of the Notes only upon the satisfaction of specified conditions and during certain periods. On or after March 15, 2029, until the close of business on the second scheduled trading day immediately preceding the maturity date, the Notes will be convertible at the option of the holders of the Notes at any time regardless of these conditions.

Upon any conversion of the Notes, Zoetis will pay cash up to the aggregate principal amount of the Notes to be converted and pay or deliver, as the case may be, cash, shares of Zoetis’ common stock or a combination of cash and shares of Zoetis’ common stock, at Zoetis’ election, in respect of the remainder, if any, of Zoetis’ conversion obligation in excess of the aggregate principal amount of the Notes being converted, based on the then applicable conversion rate.

Zoetis may redeem for cash all or any portion (subject to certain limitations) of the Notes, at its option, on or after December 20, 2027 and prior to the 21st scheduled trading day immediately preceding the maturity date, if the last reported sale price of Zoetis’ common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which Zoetis provides notice of redemption at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. No sinking fund is provided for the Notes.

Subject to certain conditions, if Zoetis undergoes a “fundamental change” (as defined in the indenture that will govern the Notes), holders of the Notes may require Zoetis to repurchase for cash all or any portion of their Notes at a fundamental change repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus any accrued and unpaid interest to, but excluding, the fundamental change repurchase date. In addition, upon certain corporate events that occur prior to the maturity date or upon redemption, Zoetis will, under certain circumstances, increase the conversion rate for holders who elect to convert their Notes in connection with any such corporate event or convert their Notes called (or deemed called) for redemption during the related redemption period, as the case may be.

Capped Call Transactions – 75% Premium ($211.7150 Cap Price)

In connection with the pricing of the Notes, Zoetis entered into privately negotiated capped call transactions with certain of the initial purchasers or their respective affiliates and certain other financial institutions (the “option counterparties”). The capped call transactions will cover, subject to anti-dilution adjustments, the number of shares of Zoetis’ common stock initially underlying the Notes. The capped call transactions are expected generally to reduce potential dilution to Zoetis’ common stock upon any conversion of Notes and/or offset any cash payments Zoetis is required to make in excess of the principal amount of any converted Notes, as the case may be, with such reduction and/or offset subject to a cap based on a cap price initially equal to $211.7150 per share, which represents a premium of 75.0% over the last reported sale price of Zoetis’ common stock on NYSE on December 15, 2025.

Zoetis has been advised that the option counterparties or their respective affiliates, in connection with establishing their initial hedges of the capped call transactions, expect to purchase shares of Zoetis’ common stock and/or enter into various derivative transactions with respect to Zoetis’ common stock concurrently with or shortly after the pricing of the Notes. This activity could increase (or reduce the size of any decrease in) the market price of Zoetis’ common stock or the Notes at that time. In addition, the option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Zoetis’ common stock and/or purchasing or selling Zoetis’ common stock or other securities of Zoetis in secondary market transactions following the pricing of the Notes and prior to the maturity of the Notes (and are likely to do so (x) during any observation period related to a conversion of Notes or following any repurchase of Notes in connection with any “fundamental change” or “optional redemption” (each as defined in the indenture for the Notes) and (y) following any other repurchase of Notes if Zoetis elects to unwind a portion of the capped call transactions in connection with such repurchase). This activity could also cause or avoid an increase or decrease in the market price of Zoetis’ common stock or the Notes, which could affect the ability of noteholders to convert the Notes and, to the extent the activity occurs during any observation period related to a conversion of Notes, it could affect the amount and value of the consideration that noteholders will receive upon conversion of the Notes.

In addition, the concurrent repurchases of shares of Zoetis’ common stock described above may result in Zoetis’ common stock trading at prices that are higher than would be the case in the absence of these repurchases and may have affected the initial terms of the Notes, including the initial conversion price.

Neither the Notes nor the shares of Zoetis’ common stock potentially issuable upon conversion of the Notes, if any, have been, or will be, registered under the Securities Act, the securities laws of any other jurisdiction or any state securities laws and, unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state laws. The Notes will be offered and sold only to persons reasonably believed to be qualified institutional buyers in the United States pursuant to Rule 144A under the Securities Act. This news release is for informational purposes only and does not constitute an offer to sell, or a solicitation of an offer to buy, the Notes, nor shall there be any sale of the Notes in any state or jurisdiction in which such offer, solicitation or sale is unlawful.

About Zoetis

As the world’s leading animal health company, Zoetis is driven by a singular purpose: to nurture our world and humankind by advancing care for animals. After innovating ways to predict, prevent, detect, and treat animal illness for more than 70 years, Zoetis continues to stand by those raising and caring for animals worldwide – from veterinarians and pet owners to livestock producers. The company’s leading portfolio and pipeline of medicines, vaccines, diagnostics and technologies make a difference in over 100 countries.

DISCLOSURE NOTICES

Forward-Looking Statements:

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.

These forward-looking statements include, but are not limited to, statements regarding the anticipated completion of the offering and capped call transactions, the anticipated effects of entering into the capped call transactions, the intended use of the net proceeds from the offering, any repurchases of common stock, including any impact to the common stock’s trading prices, and other future events. These statements are not guarantees of future performance or actions and important factors (many of which are beyond the Company’s control) could cause actual results to differ materially from those set forth in the forward looking statements, including risks and uncertainties associated with market conditions, including market interest rates, the trading price and volatility of Zoetis’ common stock, and risks relating to the offering, the Company’s business and operations and results of financing efforts. Forward-looking statements are subject to risks and uncertainties. If one or more of these risks or uncertainties materialize, or if management’s underlying assumptions prove to be incorrect, actual results may differ materially from those contemplated by a forward-looking statement. Forward-looking statements speak only as of the date on which they are made. Zoetis expressly disclaims any obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. A further list and description of risks, uncertainties and other matters can be found in Zoetis’ most recent Annual Report on Form 10-K, including in the sections thereof captioned “Forward-Looking Statements and Factors That May Affect Future Results” and “Item 1A. Risk Factors,” in Zoetis’ Quarterly Reports on Form 10-Q, in Zoetis’ Current Reports on Form 8-K and in other documents on file with the U.S. Securities and Exchange Commission.

ZTS-COR

ZTS-IR

ZTS-FIN

Contacts

Media Contacts:

Jennifer Albano

1-862-399-0810 (o)

jennifer.albano@zoetis.com

Laura Panza

1-973-975-5176 (o)

laura.panza@zoetis.com

Investor Contacts:

Steve Frank

1-973-822-7141 (o)

steve.frank@zoetis.com

Nick Soonthornchai

1-973-443-2792 (o)

nick.soonthornchai@zoetis.com

Bicycle Therapeutics Establishes Multiple Strategic Partnerships to Create End-to-End Supply Chain to Support its Wholly Owned Radiopharmaceutical Pipeline




Bicycle Therapeutics Establishes Multiple Strategic Partnerships to Create End-to-End Supply Chain to Support its Wholly Owned Radiopharmaceutical Pipeline

Execution of a 15-year contract including an option to renew with UK Nuclear Decommissioning Authority for access to up to 400 tonnes of reprocessed uranium (RepU), with the potential to deliver tens of thousands of doses of ²¹²Pb every year

Partnership with the United Kingdom National Nuclear Laboratory (UKNNL) to scale up the extraction of ²²⁸Th from RepU for onward processing into a ²¹²Pb generator

Agreement with SpectronRx to develop a bespoke wholly owned ²¹²Pb generator, with initial quantities of ²¹²Pb successfully produced

CAMBRIDGE, England & BOSTON–(BUSINESS WIRE)–Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle^®) technology, today announced it has entered into a 15-year contract including an option to renew with the UK Nuclear Decommissioning Authority (NDA) for access to up to 400 tonnes of reprocessed uranium (RepU). RepU continually regenerates providing a potentially sustainable supply of ²¹²Pb. Bicycle intends to utilize the RepU provided by this agreement in its development of potential lifesaving therapies.

In addition, Bicycle announced a collaboration with United Kingdom National Nuclear Laboratory (UKNNL), pursuant to which it plans to extract ²²⁸Th from the RepU obtained from NDA. The extracted ²²⁸Th will then be further processed into ²²⁴Ra and loaded into a bespoke ²¹²Pb generator being developed exclusively for Bicycle by SpectronRx. ²¹²Pb is a radioisotope and one of the more potent therapeutic payloads against cancer cells known as Targeted Alpha Therapy (TAT).

Collectively, this bespoke set of arrangements is designed to support the potential discovery, development, and commercial supply of a portfolio of Bicycle^® Radioconjugates (BRC^®) containing ²¹²Pb.

“Cancer is a disease that affects millions worldwide, and tears too many families apart. Breakthroughs in medical science are giving more cancer patients and their loved ones hope, and this unique partnership could help take that work even further. Turning nuclear material into cutting-edge cancer treatments sounds like science fiction – but thanks to the brilliance of scientists, researchers and doctors, it could be a life-saving reality. Work like this shows exactly why we’re determined to support our life sciences innovators to make groundbreaking new treatments possible,” said Liz Kendall, Secretary of State.

“These new collaborations are testaments to the potential of Bicycle to advance a differentiated and exciting isotope agnostic radiopharmaceuticals portfolio. We believe we now have the resources and infrastructure we need to create the world’s first end-to-end ²¹²Pb radiopharmaceutical ecosystem from discovery through development to commercial supply. We believe the potential of BRCs and our ability to incorporate the appropriate isotopes for specific patient needs is unique and creates significant value-creating capabilities,” said Mike Hannay, D.Sc., FRPharmS, chief product and supply chain officer of Bicycle Therapeutics. “We are incredibly grateful to the UK government for their recognition of Bicycle’s potential to develop BRCs with a 15-year access agreement for reprocessed uranium, and to our partners SpectronRx with whom we are developing a bespoke ²¹²Pb generator. We look forward to advancing these dynamic collaborations and developing our pipeline of radiopharmaceuticals with the potential of improving lives for cancer patients around the globe.”

“I am delighted with the progress we are making in establishing ourselves as a potential leader in radiopharmaceutical R&D. Today’s announcement builds on our previous announcements concerning our agreement with Eckert & Ziegler to supply a range of radioisotopes for the manufacture of BRC products as well as the formation of our Research and Innovation Advisory Board (RAB) comprising some of the worlds most esteemed experts in radiopharmaceuticals,” said Bicycle Therapeutics CEO Kevin Lee, Ph.D. “As we continue to advance our emerging BRC pipeline, currently with novel targets EphA2 and MT1-MMP, we look forward to presenting initial EphA2 human imaging data in the first half of 2026 and initiating our own Bicycle study in 2026.”

About Bicycle Therapeutics

Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle^® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle^® Drug Conjugate (BDC^®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BDC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist^® (Bicycle TICA^®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle^® Radioconjugates (BRC^®) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle^® technology to develop therapies for diseases beyond oncology.

Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Mass. For more information, visit bicycletherapeutics.com.

Forward Looking Statements

This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: Bicycle’s expectations with respect to the benefits of its agreements and collaborations with NDA, UKNNL, and SpectronRx, respectively; Bicycle’s ability to advance a differentiated and exciting isotope agnostic radiopharmaceuticals portfolio; Bicycle’s ability to leverage its agreements with NDA and SpectronRx and collaboration with UKNNL to create the world’s first end-to-end ²¹²Pb radiopharmaceutical ecosystem; Bicycle’s ability to incorporate the appropriate isotopes for specific patient needs to support significant value-creating capabilities; the initiation of new clinical trials, the progress of Bicycle’s clinical trials, reporting data from Bicycle’s clinical trials and the timing of EphA2 human imaging data; the development of BRC molecules for radiopharmaceutical use; and the use of Bicycle Therapeutics’ technology through various partnerships to develop therapies for diseases beyond oncology. Bicycle Therapeutics may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in research and development and in the initiation, progress and completion of clinical trials and clinical development of Bicycle Therapeutics’ product candidates; the risk that Bicycle may not realize the intended benefits of its technology or partnerships; the risk that Bicycle may not achieve any of its clinical development strategies; timing of results from clinical trials; whether the outcomes of preclinical studies and prior clinical trials will be predictive of future clinical trial results; the risk that trials may have unsatisfactory outcomes; potential adverse effects arising from the testing or use of Bicycle’s product candidates; and other important factors, any of which could cause Bicycle Therapeutics’ actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled “Risk Factors” in Bicycle Therapeutics’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on October 30, 2025, as well as in other filings Bicycle Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle Therapeutics expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

Contacts

Investors:

Matthew DeYoung

Argot Partners

ir@bicycletx.com
212-600-1902

Media:

Deborah Elson

Argot Partners

media@bicycletx.com

Esco Aster Signs Exosome Clinical cGMP Manufacturing Contract With Shine-On Biomedical For A Novel First-In-Class HLA-G Targeting Exosome Drug Delivery Platform




Esco Aster Signs Exosome Clinical cGMP Manufacturing Contract With Shine-On Biomedical For A Novel First-In-Class HLA-G Targeting Exosome Drug Delivery Platform

SINGAPORE–(BUSINESS WIRE)–Esco Aster, a vertically integrated cell and derivatives CRDMO based at JTC LaunchPad Singapore, announced CMC manufacturing support for Shine-On Biomedical’s HLA-G targeted exosome program. Shine-On Biomedical sponsored Esco Aster in 2023 for cGMP services, starting with high-yield exosome development using Esco Aster’s cell line platform. The technical reports of process, analytical, and formulation development, exosome drug loading, GMP engineering runs, and stability studies supported Shine-On’s IND submission. The IND was cleared by the U.S. FDA in Q1 2025.

Furthermore, Esco Aster is providing technical services for exploratory exosome loading feasibility studies per Shine-On’s instruction. Shine-On Biomedical is an emerging innovator in exosome-based drug delivery.

ShineOn’s proprietary product, SOB100, a HLA-G targeted exosome drug delivery carrier, has passed the U.S. FDA IND review and ongoing Phase I study, making it as a first-in-class–potential HLA-G targeted exosome platform for drug development.

Statement From Hung-Che Chiang, General Manager of Shine-On Biomedical

“Preclinical studies have shown promising biodistribution characteristics supporting further exploration across small-molecule, nucleic acid, and protein-based payloads.”

In parallel, Esco Aster, providing Mitosis™ Enterprise Solutions to support potential future evaluation of single-use cGMP workflows at China Medical University Hospital.

This collaboration strengthens Esco Aster’s position as Singapore’s first fully homegrown CRDMO offering end-to-end engineered cancer exosome development—from cell line creation to GMP manufacturing using its patented 3D Tide Motion™ bioreactor. This technology lowers COGS by enabling multiple conditioned media harvests per run. Esco Aster also co-develops autologous cell therapy programs in ASEAN, including a T-cell reactivation platform targeting non-G12C KRAS mutation NSCLC.

Esco Aster supports Asia-Pacific innovators through biomanufacturing scale-up, market access, and commercialization across South Asia, ASEAN, and Oceania—a region valued at ~USD 10.5 trillion GDP with ~2.6 billion people. Supported by a network of medical centres and clinician-scientists, Esco Aster facilitates IIT and FIM studies, especially in Australia, where R&D incentives lower costs. The company advances its “One World BioSolutions for One Health” vision, enabling high yield at low GMP cost to strengthen Singapore’s and Asia’s bioeconomy.

© 2025 Esco Aster Pte. Ltd. and Shine-On Biomedical Co., Ltd. All rights reserved.

Contacts

Esco Aster Pte. Ltd.
mail@escoaster.com
Website: https://escoaster.com/

Shine-On Biomedical Co., Ltd.
service@shineon-bio.com
Website: https://en.shineon-bio.com/

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:

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

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

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