Galderma Expands Restylane® Portfolio in Japan With Launch of OBT™ Hyaluronic Acid Injectables Restylane Defyne™ and Refyne™




Galderma Expands Restylane® Portfolio in Japan With Launch of OBT™ Hyaluronic Acid Injectables Restylane Defyne™ and Refyne™

• Restylane^® Refyne™ and Restylane Defyne^™ are the first Optimal Balance Technology (OBT™) hyaluronic acid injectables ever approved and launched in Japan, bringing advanced flexibility and natural movement to the market^1,2
• This expands Galderma’s Restylane portfolio in Japan to four products, enabling treatment of a wider spectrum of patient and practitioner needs^3,4
• These two new launches underscore Galderma’s accelerating growth across the Japan & Asia Pacific (JPAC) region

ZUG, Switzerland–(BUSINESS WIRE)–Galderma (SIX: GALD), the pure-play dermatology category leader, has announced the launch of Restylane Defyne and Restylane Refyne: the first OBT‑based hyaluronic acid injectables ever authorized in Japan.^1,2 The products – designed for injection into the mid-to-deep dermis for the correction of moderate to severe facial wrinkles and folds – are now commercially available in the market.^1,2

Restylane Defyne and Refyne leverage the unique balance of softness, flexibility, and support delivered by Galderma’s proprietary OBT – designed to move in harmony with facial expressions while maintaining shape and lift – and are the first and only hyaluronic acid injectables clinically proven to restore youthful facial expressions.^1,2,5-11 Restylane Refyne offers a smooth, flexible gel, ideal for delicate, highly expressive areas, while Restylane Defyne provides support for areas such as the jawline and deeper facial folds.^1,2,5-11 These launches mark a major milestone for Galderma and represent an important chapter in its JPAC growth strategy, supporting the company’s continuing expansion in one of the region’s most dynamic aesthetics markets.

The Restylane portfolio in Japan now includes four products in total, with Refyne and Defyne joining NASHA-powered products, Restylane Classyc^™ and Restylane Lyft^™.^1-4 This versatile range enables clinicians to meet diverse patient needs, from soft, flexible formulations that smooth fine lines, to firmer gels that deliver contouring and support.^1-7,12,13

The approvals of Restylane Refyne and Defyne in Japan were based on two pivotal, double-blinded, randomized, active-controlled phase III studies investigating the products in 171 and 162 subjects, respectively. Restylane Refyne and Defyne met the studies’ endpoints, demonstrating a clinically meaningful improvement in wrinkle severity for up to 12 months, with most patients reporting at least a 1-grade improvement in self-assessment scores after six weeks.^1,2

With over 30 years of innovation and more than 77 million treatments administered worldwide, Restylane is highly relevant in addressing some of today’s most significant aesthetic trends and needs, from improving facial harmony following medication-driven weight loss to growing concerns around menopause-related skin health and aging.^5,14-17 The arrival of OBT technology in Japan now aligns the market more closely with global Restylane availability, reinforcing the brand’s position as the world’s most scientifically studied and diverse hyaluronic acid injectables range.

About the Restylane portfolio

Restylane hyaluronic acid treatments are designed differently to go beyond volumizing for natural-looking results.^4,5,18,19 Our hyaluronic acid is minimally modified and our innovative manufacturing process preserves its biocompatibility while creating individual products designed for a specific purpose.^20-22 Powered by NASHA, NASHA HD™, OBT and SB-NASHA™ technologies, Restylane offers gels with the highest firmness to the highest flexibility, enabling personalized treatments that deliver structural support, natural-looking results, and a healthy glow.^12,13,23,24 Trusted for almost three decades, our hyaluronic acid gels work in sync with your skin for 100% natural-looking results.^5-7

About Galderma

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

References

1. Restylane^® Defyne™. IFU. Japan. Available online. Accessed February 2026
2. Restylane^® Refyne™. IFU. Japan. Available online. Accessed February 2026
3. Restylane^® Lyft™. IFU. Japan. Available online. Accessed February 2026
4. Restylane^® Classyc™. IFU. Japan. Available online. Accessed February 2026
5. Di Gregorio C, et al. 25+ years of experience with the Restylane portfolio of injectable HA fillers for facial aesthetic treatment. E-poster presented at AMWC; March 27-29, 2024; Monaco
6. Solish N, et al. Dynamics of HA fillers formulated to maintain natural facial expression. J Cosmet Dermatol. 2019;18(3):738-746. doi: 10.1111/jocd.12961
7. Philipp‐Dormston WG, et al. Perceived naturalness of facial expression after HA filler injection in nasolabial folds and lower face. J Cosmet Dermatol. 2020;19(7):1600-1606. doi: 10.1111/jocd.13205
8. Philipp‐Dormston WG, et al. Evaluating perceived naturalness of facial expression after fillers to the nasolabial folds and lower face with standardized video and photography. Dermatol Surg. 2018;44(6):826-832. doi: 10.1097/DSS.0000000000001419.
9. Galderma. Data on file. MA-43049. xStrain and G’ Global HA filler rheology data. 2023
10. Galderma. Data on file. MA-42769. Restylane Defyne Clinical study report. 2020
11. Öhrlund Å. Evaluation of rheometry amplitude sweep cross-over point as an index of flexibility for HA fillers. JCDSA. 2018;8(2):47-54
12. Galderma Data on file. MA-56724. X-strain and G’ including Shaype
13. Öhrlund Å. Differentiation of NASHA and OBT hyaluronic acid gels according to strength, flexibility, and associated clinical significance. J Drugs Dermatol. 2014;23(1):1332-1336. doi: 10.36849/JDD.7648
14. Galderma. Data on file. MA-57232 [Updated]. 77 Million treated. 2025
15. Galderma. Data on file. MA-55607. Restylane^® 27 years data publications analysis. 2023
16. Fabi G, et al. The potential role of biostimulators/dermal fillers to address menopause-related skin conditions. Poster presented at IMCAS; January 29-31, 2026; Paris, France
17. Lorenc ZP, et al. Synergistic efficacy and safety of poly-L-lactic acid biostimulator and hyaluronic acid filler for facial fullness post weight loss due to glucagon-like peptide-1 receptor agonist medication. Presented at the ASDS 2025 Annual Meeting; November 13-16; Chicago, United States
18. Nikolis A, et al. The role of clinical examination in midface volume correction using hyaluronic acid fillers: should patients be stratified by skin thickness? Aesthet Surg J Open Forum. 2020;2(1):1–12. doi: 10.1093/asjof/ojaa005
19. Talarico S, et al. High patient satisfaction of a HA filler producing enduring full-facial volume restoration: an 18- month open multicenter study. Dermatol Surg. 2015;41:1361–1369. doi: 10.1097/DSS.0000000000000549
20. Edsman K, et al. Gel properties of hyaluronic acid dermal fillers. Dermatol Surg. 2012;38:1170–1179. doi: 10.1111/j.1524-4725.2012.02472.x.
21. Galderma. Data on file. MA-58650. Degree of modification of HA fillers.
22. Seo K. Facial volumization with fillers. Springer. 2021;29–83. doi: 10.1007/978-981-33-6212-3_2
23. Nikolis A, et al. Effectiveness and safety of a new hyaluronic acid injectable for augmentation and correction of chin retrusion. J Drugs Dermatol. 2024;23(4):255–261. doi: 10.36849/JDD.8145
24. Belmontesi M et al. Injectable non-animal stabilized hyaluronic acid as a skin quality booster: an expert panel consensus. J Drugs Dermatol. 2018;17(1):83–88.

Contacts

For further information:

Christian Marcoux, M.Sc.

Chief Communications Officer

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

Richard Harbinson

Corporate Communications Director

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

Céline Buguet

Franchises and R&D Communications Director

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

Emil Ivanov

Head of Strategy, Investor Relations, and ESG

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

Jessica Cohen

Investor Relations and Strategy Director

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

Bioscience Association Manitoba Announces 2026 Industry Celebration Winners




Bioscience Association Manitoba Announces 2026 Industry Celebration Winners

Industry Celebration: The DNA of Success takes place March 11, 2026

WINNIPEG, Manitoba–(BUSINESS WIRE)–The Bioscience Association Manitoba (BAM) is pleased to announce the award recipients who will be recognized at the Manitoba Bioscience Industry Celebration: The DNA of Success, in Winnipeg. This annual celebration brings together leaders from industry, academia, government, and the broader community to recognize excellence across Manitoba’s bioscience ecosystem.

The Industry Celebration highlights the people and organizations advancing bioscience, growing companies, and strengthening Manitoba’s position as a hub for bioscience innovation. As part of the evening’s program, BAM will present five awards recognizing achievement across education, leadership, emerging talent, and industry impact.

2026 Manitoba Bioscience Award Recipients

• Most Promising Bioscience Student of the Year | Leena Regi Saleth, University of Manitoba
  
  This award recognizes an outstanding student whose academic achievements and passion for bioscience signal strong potential for future leadership in the sector.

• Outstanding Leadership in Bioscience of the Year | Michelle Di Nella, Seven Oaks Chronic Disease Innovation Centre
  
  This award celebrates an individual who has demonstrated exceptional leadership and vision, contributing meaningfully to the growth and success of Manitoba’s bioscience community.

• Bioscience Educator of the Year | Dr. Samantha Pauls, College of Pharmacy, University of Manitoba
  
  This award honours an educator who has inspired and empowered youth to explore science, helping build curiosity, confidence, and pathways into bioscience careers.

• Emerging Bioscience Company of the Year | PolySense Solutions
  
  This award recognizes a company with extraordinary potential in the bioscience industry, demonstrating innovation, growth, and the ability to make meaningful impact.

• Bioscience Company of the Year | Bausch Health Canada
  
  This award highlights a company that exemplifies leadership, excellence, and long-term impact within the bioscience sector.

“The Industry Celebration is our opportunity to recognize the people and organizations shaping the future of bioscience in Manitoba,” said Andrea Ladouceur, President and CEO at BAM. “These award recipients reflect the depth of talent, innovation, and leadership that continues to strengthen our sector.”

The evening will feature award presentations, networking, and a celebration of achievements driving Manitoba’s bioscience community forward.

For more information about the Industry Celebration: The DNA of Success, visit https://biomb.ca/event/industry-celebration-2026/.

About Bioscience Association Manitoba (BAM)

Bioscience Association Manitoba (BAM) is a not-for-profit industry association that enables commercial success for Manitoba’s bioscience companies by acting as a catalyst for innovation, expanding the sector’s skills and workforce development, and leading with one unified voice to create local and global engagement.

Contacts

Chloe Gerrard

Communications, Marketing, and IT Manager

Bioscience Association Manitoba

chloe@biomb.ca

THX Pharma and Biocodex Announce a Strategic Licensing Agreement in Batten, Gaucher and Niemann-Pick Type C Diseases




THX Pharma and Biocodex Announce a Strategic Licensing Agreement in Batten, Gaucher and Niemann-Pick Type C Diseases

GENTILLY, France–(BUSINESS WIRE)–THX Pharma (Theranexus) and Biocodex, an independent international pharmaceutical group, today announced the execution of a strategic licensing agreement to advance the development of two drug candidates in three rare diseases with high unmet medical needs: Batten disease with Batten-1, and Gaucher disease and Niemann-Pick type C disease with TX01.

Under the agreement, Biocodex acquires from THX Pharma two licenses: an exclusive worldwide license for the development and commercialization of Batten-1, a drug candidate developed by THX Pharma in juvenile Batten disease (CLN3); and an exclusive license for the United States and Canada for the development and commercial exploitation of TX01, a new formulation of an already approved molecule intended for the treatment of Gaucher disease and Niemann-Pick type C disease.

These genetic diseases, frequently pediatric, cause severe and progressive visceral, hematological or neurological impairments, with a major impact on patients’ quality of life and life expectancy. For some of them, therapeutic options remain nonexistent or very limited, making each development program a considerable scientific and medical challenge. The shared ambition of Biocodex and THX Pharma is to advance therapeutic solutions where needs remain significant, relying on science, partnership and dialogue with all communities, including healthcare professionals and patient organizations.

THX Pharma will receive total payments that may reach €173 million, including an upfront payment of €12 million and up to €161 million in development and commercialization milestone payments, as well as double-digit tiered royalties on net sales. THX Pharma will lead the clinical development of the programs, with financial and scientific support from Biocodex, which will also carry out compassionate access, market access and commercialization activities in the territories covered by the licenses.

Batten-1 is currently in preparation for phase 3 (start planned in 2026). Juvenile Batten disease (CLN3) is an ultra-rare pediatric neurodegenerative disease leading to progressive loss of vision, cognitive and motor functions, followed by death in early adulthood. No treatment is approved to date. Batten-1 aims to become the first available treatment for this condition, with an international launch targeted for 2030. The Batten-1 program was initially developed by the Beyond Batten Disease Foundation.

TX01 is based on an adapted oral formulation of an already approved active substance and is intended for the treatment of two rare lysosomal diseases: Niemann-Pick type C disease and Gaucher disease type 1. This approach aims to improve treatment administration and its suitability for patients’ specific needs.

About Biocodex: Biocodex is an independent French pharmaceutical company present in over 100 countries. Building on decades of commitment in rare diseases, Biocodex works to advance therapies for patients facing high unmet medical needs, alongside its pioneering work in microbiota research and its innovative solutions in women’s health and established products addressing common health needs.

About THX Pharma: THX Pharma (Theranexus) is a biopharmaceutical company specializing in the development of innovative treatments for rare diseases, with a focus on neurological conditions. It is developing Batten-1, targeting the juvenile form of Batten disease, and TX01, a new formulation intended for the treatment of Gaucher disease and Niemann-Pick type C disease.

Contacts

Media:
BIOCODEX / Monet – Anne-Lise Le Vaillant or Florence Desremaux

rpbiocodex@monet-rp.com – +33 1 45 63 12 43

Calla Lily Clinical Care and Merck Announce Strategic Collaboration to Advance Intravaginal Drug Delivery Platform




Calla Lily Clinical Care and Merck Announce Strategic Collaboration to Advance Intravaginal Drug Delivery Platform

• Enhancing patient treatment experience and care with a new self-administered solution for vaginal therapeutics
• Versatile platform technology developed from a safe, award-winning, FDA-cleared medical device
• Strategic collaboration supporting the continued development of a novel intravaginal drug delivery approach to address unmet needs in women’s health

LONDON–(BUSINESS WIRE)–Calla Lily Clinical Care, a women’s health-focused medical technology company, and Merck, a leading science and technology company, have entered a strategic collaboration to support the continued development of Callavid^®, a novel platform for intravaginal drug delivery. The collaboration represents the first industry partnership for the Callavid technology.

Callavid is a transformational leak-resistant medical device designed to address challenges associated with the self-administration of vaginal therapeutics. Administration via the vaginal route can be associated with increased patient anxiety related to positioning, dosing accuracy, and concerns around leakage, particularly for certain therapeutics used in fertility treatments, oncology, and hormone therapies.

Developed by the team at Calla Lily Clinical Care, Callavid’s patented leak-free design delivers vaginal therapeutics using a small, tampon-shaped device combined with an integrated absorbent liner. Callavid is designed for hygienic insertion, remains in place during drug absorption, and can be easily and cleanly removed. By supporting more consistent drug delivery and reducing concerns around leakage and positioning, Callavid is uniquely designed to improve the overall patient experience when administering vaginal medications.

Thang Vo-Ta, Co-founder and CEO of Calla Lily Clinical Care, commented: “This collaboration with Merck marks an important milestone in the development of Callavid, our novel vaginal drug delivery platform. Merck’s scientific heritage and forward-looking approach to innovation make them an ideal partner as we work to address long-standing unmet needs in women’s health. By improving how vaginal therapeutics are delivered and experienced, Callavid has the potential to enhance both patient outcomes and quality of life. We see this collaboration as a meaningful step toward translating our technology into real-world clinical and patient impact.”

Dr Lara Zibners, Co-founder and Chairman of Calla Lily Clinical Care, said: “Our initial engagement with Merck through the Merck Innovation Challenge in October 2024 was an important moment of alignment around the need for more patient-centric innovation in women’s health. As both a clinician and a patient, I have seen how profoundly drug delivery can shape treatment experience. This collaboration builds on that early dialogue and reflects a shared interest in rigorously exploring new approaches that may improve how therapies are delivered and experienced by patients.”

About Calla Lily Clinical Care www.callali.ly/

Calla Lily Clinical Care is an ambitious women’s health focused company that has developed the proprietary Callavid^® platform for intravaginal drug delivery. Callavid is adaptable to a wide range of therapeutics, with initial target indications in fertility and pregnancy, where the Company seeks to offer the world’s first drug-device combination product to prevent threatened miscarriage and for IVF luteal phase support. The device is also capable of delivering therapeutics for oncology, menopause, infectious diseases, and live biotherapeutics to reduce repeated antibiotic use and antimicrobial resistance (AMR). For pharmaceutical partners, Callavid offers a differentiated drug delivery modality for pipeline drugs, and a means of extending the lifecycle of established assets, including off-patent therapeutics. The Company is a certified B-Corp.

Follow us on LinkedIn (@Calla Lily Clinical Care).

Contacts

Media
Lily Jeffery

lily.jeffery@zymecommunications.com

IEO and Laife Reply Join Forces to Digitalise the Biobank Through Artificial Intelligence




IEO and Laife Reply Join Forces to Digitalise the Biobank Through Artificial Intelligence

The two partners launch “Bianca”, the first large-scale digitalisation initiative in Italy focused on histopathological samples, aimed at training AI algorithms to support pathologists’ diagnostic activities.

TURIN, Italy–(BUSINESS WIRE)–The Pathology Division of the European Institute of Oncology (IEO) and Laife Reply, the Reply Group company specialised in AI and Big Data solutions for the healthcare sector, have entered into a collaboration to develop Bianca, the first project in Italy aimed at creating an AI-based digital biobank designed as an integral part of clinical diagnostic practice. The initiative is part of a broader technological innovation journey that structurally integrates research and development into routine diagnostic processes in pathology, transforming the traditional histopathological sample workflow into an end-to-end digital ecosystem. The complete digitalisation of histopathological and molecular diagnostic workflows aims to make analysis more efficient, scalable and reproducible, laying the foundations for the evolution of AI-supported oncological diagnostics.

Selected under the “Agreements for Innovation” programme promoted by the Italian Ministry of Enterprises and Made in Italy (MIMIT), and building on a well-established collaboration between IEO and Reply, the BIANCA project initially involves the digitalisation of histopathological slides using state-of-the-art scanners capable of generating ultra-high-resolution digital images of tissue samples. On this platform, Artificial Intelligence algorithms are developed and trained to analyse images and support pathologists in histological and molecular analysis, as well as in the formulation of clinical and diagnostic hypotheses.

Launched at the end of 2024 with a planned overall duration of 30 months, the project has now reached its midway point. The extensive archive of histopathological samples collected over the years by the IEO Biobank is currently at an advanced stage of digitalisation. At the same time, Laife Reply is working closely with the joint IEO Pathology and Information Systems team to train AI algorithms on different types of cancer. This includes the introduction of advanced algorithmic solutions based on self-annotation mechanisms, capable of automatically labelling pathological findings on images, reducing the manual workload for clinicians, accelerating model training, improving accuracy and enabling large-scale replicability.

The project is also exploring the use of multimodal algorithms capable of combining histopathological images with structured clinical data to identify and analyse new biomarkers. In particular, research activities are already underway on specific diseases, with the aim of predicting information that is currently obtainable only through complex tests, thereby reducing time, costs and the overall impact on patients.

“Bianca represents a turning point for oncological pathology,” said Professor Nicola Fusco, Director of the Pathology Division at IEO. “The integration of digitalisation and AI enables a significant improvement in the quality, standardisation and reproducibility of diagnosis—both histopathological and molecular—by optimising the entire workflow, reducing reporting times, rationalising costs and improving the overall efficiency of diagnostic services for our patients. At the same time, the project contributes to the training of a new generation of pathologists with highly specialised skills, capable of combining morphological and molecular expertise with advanced digital tools and AI algorithms, paving the way for a sustainable evolution of oncological diagnostics.”

“With Bianca, we are collaborating with IEO to support the evolution of pathology in the oncological field,” said Carlo Malgieri, Partner at Laife Reply. “This is not just about applying artificial intelligence to individual cases, but about building a scalable and industrialisable framework designed to be offered to hospitals and smaller healthcare organisations. The framework integrates sample digitalisation, advanced algorithms and high-performance analytics infrastructures. This approach makes it possible to support clinicians, enable new services for healthcare systems and oncological research, and ensure transparency and explainability—key elements to guarantee that every algorithm-supported decision is trustworthy.”

Laife Reply

Laife Reply is a Reply Group company operating in the Health, Welfare and Pharma sectors. It develops Artificial Intelligence solutions ranging from Medical Imaging, Drug Discovery and Digital Therapeutics to Natural Language Processing for the analysis of unstructured data. https://www.reply.com/laife-reply/en

IEO – Istituto Europeo di Oncologia

The European Institute of Oncology (IEO) is a Scientific Institute for Research, Hospitalisation and Healthcare (IRCCS) and an international reference centre in the field of oncology. The Institute has developed an innovative care model based on key principles such as patient centrality, full integration between research and clinical activity, early diagnosis and prevention. This is complemented by a data-driven strategy, enabling the rapid development of Artificial Intelligence algorithms to accelerate diagnosis and improve the efficiency of therapeutic pathways. https://www.ieo.it/en/

Reply

Reply [EXM, STAR: REY, ISIN: IT0005282865] specialises in the design and implementation of solutions based on new communication channels and digital media. Reply is a network of highly specialized companies supporting key industrial groups operating in the telecom and media, industry and services, banking, insurance and public administration sectors in the definition and development of business models enabled for the new paradigms of AI, cloud computing, digital media and the Internet of Things. Reply services include: Consulting, System Integration and Digital Services. www.reply.com

Contacts

Media contact:
Reply
Fabio Zappelli

f.zappelli@reply.com
Tel. +390117711594

Irene Caia

i.caia@reply.com
Tel. +39 02 535761

IEO – Istituto Europeo di Oncologia
Donata Francese

Donata.francese@dfpress.it
Tel + 39 02 535761

U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1




U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1

• This FDA Acceptance is a Milestone for People Living with Narcolepsy Type 1 Who Need New and Different Treatment Options
• Oveporexton is an Orexin Agonist Designed to Restore Orexin Signaling and Address the Underlying Orexin Deficiency that Causes Narcolepsy Type 1
• The Prescription Drug User Fee Act (PDUFA) Target Action Date is the Third Quarter of this Calendar Year

OSAKA, Japan & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) and granted Priority Review for oveporexton (TAK-861) for the treatment of narcolepsy type 1 (NT1). Oveporexton is an investigational oral orexin receptor 2 (OX2R)-selective agonist designed to address the underlying orexin deficiency that causes NT1 by restoring orexin signaling. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date in the third quarter of this calendar year. Takeda remains on track to potentially bring the first approved orexin agonist treatment to people living with NT1.

NT1 is a chronic, rare neurological disease caused by a loss of orexin and characterized by excessive daytime sleepiness and cataplexy (sudden loss of muscle tone). This results in a spectrum of physical, cognitive and psychosocial effects that can have a debilitating impact on many aspects of a person’s life, including work, education and social interactions. Despite existing therapies, the majority of patients continue to experience symptoms and are forced to cope with the continued impact of NT1.

“The FDA’s acceptance of our NDA is a milestone for people living with narcolepsy type 1,” said Andy Plump, M.D., Ph.D., president of R&D at Takeda. “Considering the high unmet need, this community deserves a new and different treatment approach that aims to address the underlying orexin deficiency that causes NT1 by restoring orexin signaling. We are one step closer to potentially transforming the current treatment paradigm and intend to deliver through our leading work in orexin science.”

The NDA filing is supported by a comprehensive data package including the FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) global Phase 3 studies. Key oveporexton data measuring objective and patient-reported improvements in wakefulness, excessive daytime sleepiness, cataplexy, ability to maintain attention, overall quality of life and daily life functions demonstrate statistically significant and clinically meaningful improvements achieving near normal ranges across the broad range of symptoms investigated. Oveporexton was generally well-tolerated with a safety profile consistent across clinical studies to date. The most common adverse events were insomnia, urinary urgency and urinary frequency. Learn more about the Phase 3 data results here.

Oveporexton previously received Breakthrough Therapy designation for the treatment of excessive daytime sleepiness in NT1 from the U.S. FDA and the Center for Drug Evaluation of China’s National Medical Products Administration. Oveporexton has also received Sakigake designation from the Japanese Ministry of Health, Labour and Welfare.

The NDA filing has no significant impact on the full year consolidated forecast for the fiscal year ending March 31, 2026.

About Takeda’s Orexin Franchise

Takeda is spearheading orexin science with the most advanced development program. The tailored portfolio of investigational orexin agonists could benefit a broad range of conditions where orexin biology plays a role. Oveporexton is the lead investigational orexin receptor 2 (OX2R)-selective agonist asset in Takeda’s orexin franchise, currently in late-stage development for the treatment of NT1. TAK-360 is the next oral OX2R agonist in Takeda’s orexin franchise, initially being developed for individuals with narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH). Additional orexin agonists are also in development, including TAK-495.

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question-and-answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including drug pricing, tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

Contacts

Japanese Media:

Tsuyoshi Tada

tsuyoshi.tada@takeda.com

U.S. and International Media:

Cassie Ercanbrack

cassie.ercanbrack@takeda.com

The 15-20 National Hospital and GenSight Biologics Announce the Treatment of the First Patient in the GS010/LUMEVOQ® REVISE Study




The 15-20 National Hospital and GenSight Biologics Announce the Treatment of the First Patient in the GS010/LUMEVOQ® REVISE Study

• First of 14 planned patients for the dose-ranging study approved by the ANSM in December 2025
• Clinical study marks continuing partnership between the 15-20 Hospital and GenSight Biologics to develop transformative treatments for rare diseases

PARIS–(BUSINESS WIRE)–Regulatory News:

The 15-20 National Hospital (l’Hôpital national des 15-20) in Paris and GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced the treatment of the first patient enrolled in the REVISE dose-ranging study. The open-label, single center study aims to enroll 14 patients in France.

With REVISE now underway, the hospital is currently the only institution in Europe with a clinical study involving GS010/LUMEVOQ^®, GenSight Biologics’ candidate gene therapy being developed as a treatment for Leber Hereditary Optic Neuropathy (LHON) caused by a mutated ND4 mitochondrial gene¹. The hospital is also the sole institution in Europe authorized to perform named patient early access (AAC) treatments with GS010.

“As a leading hospital specialized in the treatment of vision disorders, 15-20 National Hospital is committed to supporting the most promising scientific advances rigorously and in the service of patients affected by rare diseases,” said Nicolas Péju, Chief Executive Officer of the 15-20 National Hospital. “The start of the REVISE study testifies to this drive and to the trust given to our clinical and research teams.”

The REVISE study will investigate two doses of GS010 for the treatment of ND4-LHON. The study was requested by the French medicines agency ANSM (Agence nationale de sécurité du medicaments et des produits de santé) during the review of the application for a named patient early access program (AAC) for GS010 and was authorized in December 2025.

Reviewed in parallel with the REVISE study, the AAC program received the authorization from the ANSM later in December 2025 and is potentially open to patients from outside of France depending on regulatory requirements in their home country. In accordance with regulations, the first named patient requests for AAC were submitted to the ANSM last week. The named patient requests, each of which resulted from a multidisciplinary consultation, will be individually evaluated by the agency. Enrollment into REVISE is prioritized for patients eligible for both programs.

“We at GenSight are gratified that two avenues are now available for patients to be treated with GS010 in France,” said Dr. Magali Taiel, Chief Medical Officer of GenSight Biologics. “The unmet medical need among ND4-LHON patients and the urgency to treat the condition continue to animate our efforts to advance the clinical development of the gene therapy, including our push to begin a new Phase III clinical study by the end of this year.”

LHON is a rare, maternally inherited mitochondrial genetic disease, characterized by the degeneration of retinal ganglion cells, which results in precipitous and usually irreversible vision loss and typically leads to legal blindness. The ND4 mitochondrial mutation is the most common of the mutations that cause LHON and is associated with the worst prognosis among the leading mutations.

About the Hôpital national des 15-20 (the 15-20 National Hospital)

The 15-20 National Hospital is the leading French hospital in ophthalmology and the fight against vision pathologies. A hospital with national standing and university teaching, the 15-20 National Hospital brings together the best medical and care teams and provides dedicated care for visual diseases. In 2018, the hospital founded, with the Institut de la vision, the University Hospital Institute (IHU) FOReSIGHT, whose mission is to promote fundamental research to develop tomorrow’s ophthalmology care and provide access to therapeutic innovations through international partnerships and the development of companies involved in preventing and treating eye diseases.

www.15-20.fr

About GenSight Biologics

GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics’ pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics’ lead product candidate, GS010 (lenadogene nolparvovec) is in Phase III in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. GS010 is currently in clinical development, has not to date been granted marketing authorization in France or any other jurisdiction, and is therefore not available commercially. Using its gene therapy-based approach, GenSight Biologics’ product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery.

About GS010/LUMEVOQ^® (lenadogene nolparvovec)

GS010/LUMEVOQ^® (lenadogene nolparvovec) targets Leber Hereditary Optic Neuropathy (LHON) by leveraging a mitochondrial targeting sequence (MTS) proprietary technology platform, arising from research conducted at the Institut de la Vision in Paris, which, when associated with the gene of interest, allows the platform to specifically address defects inside the mitochondria using an AAV vector (Adeno-Associated Virus). The gene of interest is transferred into the cell to be expressed and produces the functional protein, which is then shuttled to the mitochondria through specific nucleotidic sequences in order to restore the missing or deficient mitochondrial function. GS010/LUMEVOQ^® (lenadogene nolparvovec) is in Phase III of its clinical development. It has not been granted marketing authorization in any country and is not available commercially.

¹ GS010/LUMEVOQ has not received marketing authorization in any jurisdiction and is not commercially available.

Contacts

The 15-20 National Hospital
Doriane Allain

Communications Director

dallain@15-20.fr
+33 (0)6 30 71 02 40

GenSight Biologics
Chief Financial Officer

Jan Eryk Umiastowski

jeumiastowski@gensight-biologics.com

4Moving Biotech Announces the Closing of a €12 Million Financing to Advance a First-in-Class DMOAD in Knee Osteoarthritis




4Moving Biotech Announces the Closing of a €12 Million Financing to Advance a First-in-Class DMOAD in Knee Osteoarthritis

– Funding secured, extending the financial runway to reach a proof-of-concept inflection point

– Company’s attractiveness reinforced through the onboarding of new investors

LILLE, France & PARIS–(BUSINESS WIRE)–4Moving Biotech (4MB), a clinical-stage biotechnology company and a spin-off of 4P-Pharma, developing a first-in-class disease-modifying osteoarthritis drug (DMOAD) for knee osteoarthritis, today announced the closing of a €12 million financing, completed through a structured and coordinated funding process.

This financing was secured from a pool of private investors and family offices, who chose to reinforce their commitment by investing directly at the subsidiary level in 4MB. The round includes a combination of equity and loans, reflecting a flexible capital structure aligned with long-term value creation.

This closing forms a natural continuum following the €7.6 million France 2030 i-Démo grant announced last year, and the very recent transatlantic extension of the INFLAM-MOTION Phase 2a clinical study to the US, reinforcing 4MB’s runway to execute its lead DMOAD program addressing a major unmet medical need in knee osteoarthritis.

“With this closing in place, we are well equipped to reach the next value creation milestone by delivering robust Phase 2a data, reaching a proof-of-concept inflection point, and creating strategic optionality for subsequent stages of development to address the needs of the 374 million patients suffering from osteoarthritis worldwide,” said Luc Boblet, CEO of 4MB.

Founded in 2020, 4MB has now received approximately €30 million in total funding to date, combining private financing and non-dilutive public support. This trajectory illustrates a strong long-term strategy led by 4P-Pharma and built on its proprietary drug regeneration model, addressing untreated serious diseases and implemented independently by each of its subsidiaries.

“The arrival of new investors in 4MB reflects the strength and coherence of the 4P-Pharma group’s platform, built on disciplined capital allocation and scientific rigor,” added Revital Rattenbach, CEO of 4P-Pharma and co-founder of 4MB. “By enabling our subsidiaries to independently define and execute their own trajectories, 4P-Pharma demonstrates the relevance of its start-up studio model.”

In the coming months, 4MB will focus on executing its clinical strategy in preparation for future regulatory agency interactions and on facilitating patient access to its molecule for those who need it most.

About 4Moving Biotech

Founded in 2020 as a spin-off of 4P-Pharma, 4Moving Biotech is a clinical-stage biotechnology company developing disease-modifying drugs for osteoarthritis, one of the world’s most burdensome chronic diseases, affecting more than 600 million people and lacking approved therapies that alter disease course. Headquartered on the Pasteur Institute campus in Lille, 4MB aims to deliver safe, sustainable therapeutic solutions for patients with high unmet medical needs.

Website: www.4movingbiotech.com
LinkedIn: https://www.linkedin.com/company/4moving-biotech/?viewAsMember=true
X : https://x.com/4Moving_Biotech

Contacts

Press
Emmanuel Dadjé

Communication Manager

Email : Emmanuel.dadje@4P-pharma.com
Phone : +33 6 30 06 12 13

ZCG-Backed Unimed Acquires Regenboog Shipping Pharmacy




ZCG-Backed Unimed Acquires Regenboog Shipping Pharmacy

Acquisition Expands Unimed’s Netherlands Footprint and Builds on Lagaay Integration

NEW YORK–(BUSINESS WIRE)–Universal Maritime Solutions (“Unimed” or “the Company”), a leading global provider of medical and compliance solutions to the maritime industry, today announced the acquisition of Regenboog Shipping Pharmacy, a Netherlands-based distributor of pharmaceutical products and medical devices serving the maritime sector. Unimed is backed by ZCG Private Equity, the private equity arm of Z Capital Group, LLC (“ZCG”), a privately held global firm.

Based in Rotterdam, Regenboog Shipping Pharmacy has been a trusted partner to the maritime industry since 1989, providing a broad portfolio of pharmaceutical products and medical devices across more than 1,000 SKUs. The business serves more than 300 customers, including ship managers, ship chandlers, and individual vessels operating globally.

“This acquisition represents an important step in our growth strategy, strengthens Unimed’s presence in the Netherlands and builds on the Company’s recent acquisition of Lagaay Medical Group, further expanding Unimed’s scale and capabilities in a core European market. The business brings a strong local presence, deep customer relationships, and a proven operating model. We are pleased to welcome the team to the group and look forward to supporting their continued success while maintaining the high standards of service their customers rely on,” said Adam Pang, Chief Revenue Officer of Unimed.

The transaction reflects Unimed’s broader strategy under ZCG ownership to pursue targeted, locally focused acquisitions that enhance regional coverage and access to operational resources while supporting long-term platform development.

“Unimed’s continued expansion in the Netherlands reflects our long-term approach to building market-leading platforms through disciplined, strategic acquisitions,” said James J. Zenni, Founder, President, and Chief Executive Officer of ZCG. “By investing in businesses with deep local roots and strong customer relationships, we are reinforcing Unimed’s regional leadership and supporting its ability to deliver comprehensive solutions to the global maritime industry.”

About Unimed

Unimed is a leading global provider of medical and compliance solutions to the maritime industry, specializing in the delivery of integrated medical equipment and supplies, healthcare services, and safety supply chain logistical solutions to clients worldwide.

Unimed is a portfolio company of ZCG Private Equity, the private equity arm of ZCG (www.zcg.com), a leading privately held global firm.

For more information, please visit https://universalmarinemedical.com/.

About ZCG

ZCG is a leading, privately held global firm comprised of private markets asset management, business consulting services, and technology development and solutions.

ZCG’s investors are some of the largest and most sophisticated global institutional investors including pension funds, endowments, foundations, sovereign wealth funds, central banks, and insurance companies.

For almost 30 years, ZCG Principals have invested tens of billions of dollars of capital. ZCG has a global team comprised of approximately 400 professionals. ZCG is headquartered in New York, with seven affiliated offices, across five countries. For more information on ZCG, please visit www.zcg.com.

You can also learn more about ZCGC, the business consulting services platform of ZCG, at www.zcgc.com, and explore ZCG’s technology affiliate, Haptiq, at www.haptiq.com.

Contacts

Nina Zenni

ZCG / Principal, Head of Media & Global Communications

Tel. 212-595-8400

Direct. 646-787-2365

Ethris and German Center for Infection Research (DZIF) Announce Strategic Collaboration to Develop mRNA-Based Vaccines




Ethris and German Center for Infection Research (DZIF) Announce Strategic Collaboration to Develop mRNA-Based Vaccines

• Collaboration combines Ethris’ proprietary technology platforms with DZIF’s infectious disease research expertise to advance mRNA-based vaccines across a broad range of pathogens
• Agreement enables manufacturing of mRNA vaccine material by Ethris’ partners Patheon and Evonik for DZIF-led vaccine research & development

MUNICH–(BUSINESS WIRE)–Ethris GmbH, a clinical-stage biotechnology company pioneering next-generation RNA therapeutics and vaccines, and the German Center for Infection Research (Deutsches Zentrum für Infektionsforschung, DZIF), today announced a strategic research collaboration to develop mRNA-based vaccines for the prevention and treatment of infectious diseases. The collaboration combines Ethris’ proprietary, clinically-validated mRNA technology platforms with DZIF’s translational vaccine research expertise spanning a broad spectrum of pathogens, including viruses, bacteria, and parasites.

“First-generation mRNA vaccines fundamentally changed how we prevent infectious diseases, but they represent only the first step,” said Dr. Carsten Rudolph, CEO of Ethris. “Together with DZIF, we are focused on developing a new generation of mRNA vaccines designed to provide broader and more durable protection beyond individual respiratory viruses. By combining enhanced stability with targeted delivery, these vaccines are intended to be variant-ready, and more easily deployed across different healthcare settings. Our goal is to move vaccination from a largely reactive response to emerging crises toward a proactive, sustainable approach to long-term protection.”

“Our mission is to translate cutting-edge infection research into medical solutions that benefit patients, especially where current prevention and treatment options fall short,” said Dr. Klaus Schwamborn, Head of Vaccine Development at DZIF. “The collaboration with Ethris provides access to an advanced mRNA technology platform that can be applied to emerging pathogens, antimicrobial resistance, and patient groups with limited vaccine response, while accelerating the path of promising concepts toward clinical evaluation.”

Under the agreement, Ethris will grant DZIF access to its Stabilized Non-Immunogenic mRNA (SNIM^®RNA) and Stabilized NanoParticle (SNaP LNP^®) technology platforms, with vaccine materials manufactured by Ethris’ partners, Patheon UK Limited (a Thermo Fisher Scientific company) and Evonik Operations GmbH. These platforms enable the delivery of stabilized, low-immunogenic mRNA across multiple administration routes, supporting the development of next-generation mRNA vaccines. The collaboration grants DZIF access to advanced mRNA and lipid nanoparticle technologies, backed by industrial-scale, quality-controlled manufacturing to support both preclinical and clinical development. With more than a decade of experience in stabilized mRNA therapeutics, Ethris has demonstrated the clinical applicability of its platform through its lead program, ETH47, which is currently in Phase 2a development.

DZIF unites more than 700 scientists and physicians from 35 research institutes across Germany to develop vaccines, diagnostics, and therapies for infectious diseases. With research programs spanning emerging infectious diseases, tuberculosis, hepatitis, HIV, malaria, gastrointestinal infections, and infections in immunocompromised patients, DZIF is dedicated to accelerating the translation of research findings into clinical practice.

About Ethris

Ethris, a clinical-stage biotechnology company, has paved a new path from genes to therapeutic proteins, using its proprietary RNA and lipidoid nanoparticle technology platform to discover, design, and develop innovative therapies. With more than a decade as an mRNA pioneer, Ethris is a global leader in delivering stabilized mRNAs directly to the respiratory system via optimized formulation and nebulization technologies. The company is rapidly advancing its mRNA pipeline of immunomodulation, protein replacement therapies, and differentiated vaccines, with the ultimate goal of improving patients’ lives.

For more information, visit www.ethris.com.

About the German Center for Infection Research (Deutsches Zentrum für Infektionsforschung, DZIF)

At the DZIF, more than 700 researchers from 35 institutions across Germany are working together to develop new approaches to the prevention, diagnosis, and treatment of infectious diseases. The goal is translation: the rapid, effective implementation of research results in clinical practice. Through this collaborative effort, the DZIF is paving the way for the development of new vaccines, diagnostics, and drugs against infections.

The DZIF organizes its projects into nine research areas, each focusing on a specific pathogen, disease, or topic within infection research. These areas include “Emerging Infections,” “Healthcare-Associated Infections,” “Novel Antibiotics,” “HIV,” “Hepatitis,” “Tuberculosis,” “Malaria and Neglected Tropical Diseases,” “Community-Acquired Infections at Mucosal Interfaces,” and “Infections of the Immunocompromised Host.” All of these areas aim to effectively transfer research results into clinical applications.

For more information, visit www.dzif.de.

Contacts

Ethris contact:
Dr. Philipp Schreppel

+49 89 244 153 042

schreppel@ethris.com

DZIF contact:
Dr. Klaus Schwamborn

Coordinator of the DZIF Product Development Unit

Head of the DZIF Translational Project Management Office (TPMO)— Vaccine

Coordinator Bridging Topic “Vaccines”

klaus.schwamborn@dzif.de