Prostate Cancer Foundation Expands Radiopharmaceutical Think Tank as Field Enters Pivotal Growth Phase




Prostate Cancer Foundation Expands Radiopharmaceutical Think Tank as Field Enters Pivotal Growth Phase

– PCF Think Tank aims to increase adoption of radiopharmaceuticals as major oncology therapeutic platform in prostate cancer treatment and to other tumor types –

– New members Orano Med, Telix and Siemens Healthineers join PCF and industry leaders at kickoff meeting at 2026 EANM Annual Congress to address key challenges impacting radiopharmaceutical development and patient access –

LOS ANGELES–(BUSINESS WIRE)–The Prostate Cancer Foundation (PCF) today announced the expansion of its Radiopharmaceutical Think Tank, adding new members and establishing its 2026-2027 agenda, which is focused on accelerating development and patient access of novel radiopharmaceutical drugs for cancer treatment. PCF is announcing the second year Think Tank program in conjunction with the European Association of Nuclear Medicine (EANM) Annual Congress, taking place October 17-21 in Vienna, Austria.

Radiopharmaceuticals have moved beyond their traditional role in specialized diagnostics to become an increasingly important therapeutic approach in cancer care. In prostate cancer, PSMA-targeted radioligand therapy has helped establish the clinical and commercial potential of this treatment approach, while continued development across prostate cancer and other tumor types is expanding the field. As radiopharmaceutical therapies move into earlier stages of disease and become available to larger patient populations, stakeholders from manufacturers and regulators to treatment centers and payers must work together to ensure patients can access these innovative medicines.

“The science around radiopharmaceuticals is moving quickly, and the systems needed to develop and deliver these therapies have to keep pace to optimize their benefits for patients across a broad range of cancers,” said Oliver Sartor, M.D., Director of the Translational Oncology Research Program at Tulane University School of Medicine and Chair of the Radiopharmaceutical Think Tank. “The Think Tank brings together medical professionals, government experts, and researchers who are on the leading edge of radiopharmaceutical research and clinical practice to solve challenges that will elevate one of oncology’s fastest-growing therapeutic fields.”

PCF established the Radiopharmaceutical Think Tank in October 2025 to bring together senior leaders from industry, medicine and other disciplines involved in radiopharmaceutical development and delivery. In its second year, the Think Tank will focus on identifying and prioritizing barriers to radiopharmaceutical development and access, bringing those issues to broader oncology, regulatory and payer communities, working toward potential solutions, and applying lessons from prostate cancer to radiopharmaceutical development across a variety of tumor types.

“By bringing together the primary drivers in a unique problem-solving forum, the Think Tank can direct unparalleled knowledge to solve the challenges that will take this innovative field to the next level,” said Phillip J. Koo, M.D., Executive Vice President and Chief Medical Officer of the Prostate Cancer Foundation. “Radiopharmaceuticals are creating important new opportunities in prostate cancer treatment, but realizing their full potential for patients with other cancers and diseases requires expertise and coordination from many different areas. PCF is ideally positioned to drive further progress in radiopharmaceuticals, sitting at the center of the research network that helped validate the potential of radioligand therapy.”

New Think Tank members for the 2026-2027 term include Orano Med, Telix Pharmaceuticals and Siemens Healthineers. They join existing members Actithera, Advancell, Artbio, AstraZeneca, Bayer, Bicycle Therapeutics, Clarity Pharmaceuticals, Curium and Novartis. Beginning with its kickoff meeting at the EANM Annual Congress this month, the Think Tank will convene four times during its new term.

About the Prostate Cancer Foundation

The Prostate Cancer Foundation^® (PCF^®) is the world’s leading philanthropic organization dedicated to funding life-saving prostate cancer research. Founded in 1993 by Mike Milken, PCF has raised more than $1.2 billion to fund cutting-edge research through more than 2,615 research projects at 312 leading cancer centers, with a global footprint spanning 29 countries. Since PCF’s inception, and through its efforts, patients around the world are living longer, suffering fewer complications, and enjoying better quality of life. PCF is committed to the mission of ending death and suffering from this disease. Learn more at PCF.org.

Contacts

MEDIA CONTACT:
Mike Beyer

Sam Brown Inc.

mikebeyer@sambrown.com

Stoke Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(C)(4)




Stoke Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(C)(4)

BEDFORD, Mass.–(BUSINESS WIRE)–Stoke Therapeutics, Inc. (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine and has a lead investigational medicine, zorevunersen, in development as a first-in-class potential disease-modifying treatment for Dravet syndrome. The Company today announced that, effective on October 15, 2026, it granted stock options to purchase shares of common stock to Stephen Aschettino, the Company’s newly-appointed Senior Vice President, Chief Information Officer, and seventeen other new employees, as a material inducement to their employment in accordance with Nasdaq Listing Rule 5635(c)(4).

The company granted Mr. Aschettino stock options to purchase 70,000 shares of common stock. The stock options that were granted have an exercise price of $24.61 per share, which is equal to the closing price of Stoke’s common stock on October 15, 2026. Each option will vest over a 4-year period, with 1/4^th of the shares underlying the employee’s option vesting on the one-year anniversary of the applicable vesting commencement date and the remaining shares thereafter vesting monthly at a rate of 1/48^th of the shares underlying each employee’s option over the following 36 months, subject to the employee’s continued employment with Stoke on such vesting dates. The options have a term of 10 years and are subject to the terms and conditions of the 2023 Inducement Plan and the stock option agreement covering the grant.

In addition, the company granted stock options to purchase an aggregate of 175,920 shares of common stock to seventeen new employees. The stock options that were granted have an exercise price of $24.61 per share, which is equal to the closing price of Stoke’s common stock on October 15, 2026. Each option will vest over a 4-year period, with 1/4^th of the shares underlying the employee’s option vesting on the one-year anniversary of the applicable vesting commencement date and the remaining shares thereafter vesting monthly at a rate of 1/48^th of the shares underlying each employee’s option over the following 36 months, subject to the employee’s continued employment with Stoke on such vesting dates. The options have a term of 10 years and are subject to the terms and conditions of the 2023 Inducement Plan and the stock option agreement covering the grant.

About Stoke Therapeutics

Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/ or follow us on LinkedIn.

Contacts

Stoke Media & Investor Contacts:
Susan Willson

Vice President, Corporate Communications

swillson@stoketherapeutics.com

415-509-8202

Investor Relations

IR@stoketherapeutics.com
508-642-6485

FDA Approves Alcon’s BRYTLY Redness Reliever Eye Drops for Up to 12 Hours of Whiter, Brighter-Looking Eyes




FDA Approves Alcon’s BRYTLY Redness Reliever Eye Drops for Up to 12 Hours of Whiter, Brighter-Looking Eyes

• One drop works to significantly reduce redness, with results lasting up to 12 hours¹
• Lasts up to 50% longer than Lumify^1-2,*
• Expands Alcon’s portfolio of consumer eye care solutions and will be available in major retailers nationwide and online in the coming months

GENEVA–(BUSINESS WIRE)–Regulatory News:

Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced that the U.S. Food and Drug Administration (FDA) has approved BRYTLY^® Redness Reliever Eye Drops. With one drop, BRYTLY works in just one minute to significantly reduce redness and delivers up to 12 hours of whiter, brighter-looking eyes.¹ Additionally, BRYTLY lasts up to 50% longer than Lumify.^1-2,* The approval brings a differentiated new option to the over the counter (OTC) redness-relief category and expands Alcon’s portfolio of trusted consumer eye care products.

Beauty and wellness routines are increasingly converging, with consumers looking for products that combine visible results, clinical validation and everyday convenience. Research has also found that visible eye redness can influence perceptions of healthiness and attractiveness, creating new relevance for the eyes as part of an overall appearance and wellness routine.³ BRYTLY brings a clinically proven option to this evolving space, by reducing redness and helping eyes look whiter and brighter with results that can last throughout the day, up to 12 hours.

“Consumers invest in products that help them look and feel their best, and the appearance of their eyes can be an important part of that,” said Jonathan Balch, General Manager, Ocular Health & Pharmaceuticals, Alcon. “This FDA approval marks an exciting milestone for Alcon. With BRYTLY, we’re bringing Alcon’s trusted eye care expertise to consumers who want to reduce eye redness and want their eyes to look whiter and brighter. BRYTLY is designed to deliver simple, long-lasting redness reduction that can help consumers feel confident in how their eyes look throughout the day.”

BRYTLY contains no bleaches or dyes and is clinically proven to be safe and effective when used as directed.¹ Studies also demonstrated a low risk of redness rebound and tachyphylaxis when used as directed.^4-5

“When patients ask about eye whiteners, they want a product they can trust to work effectively and fit into their day,” said Selina McGee^**, founder and chief optometrist of Bespoke Vision in Edmond, Oklahoma. “BRYTLY gives Eye Care Professionals a clinically proven option to recommend, with demonstrated safety and efficacy and long-lasting redness reduction from a single drop.”

BRYTLY is expected to be available at major retailers nationwide and online in the coming months, and in additional markets in the future.

About Alcon

Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, we offer the broadest portfolio of products to enhance sight and improve people’s lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries and territories each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 25,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care. Learn more at www.alcon.com.

*Based on label claim, BRYTLY up to 12 hours / Lumify up to 8 hours.

**Paid Alcon consultant.

References

1. Alcon- BRYTLY Label, 2026.
2. BAUSCH + LOMB Lumify Label. DailyMed. Published 2025. Accessed February 19, 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=022de945-0b26-40ae-8e88-d3fe2464d106.
3. Provine RR, Cabrera MO, Nave-Blodgett J. Red, yellow, and super-white sclera: uniquely human cues for healthiness, attractiveness, and age. Human Nature. 2013;24:126–136. doi:10.1007/s12110-013-9168-x.
4. Alcon data on file, 2025; REF-27135.
5. Alcon data on file, 2025; REF-27136.

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Contacts

Investor Relations
Dan Cravens, Richard Bourne

+ 41 589 112 110 (Geneva)

+ 1 817 615 2789 (Fort Worth)

investor.relations@alcon.com

Media Relations
Steven Smith

+ 41 589 112 111 (Geneva)

+ 1 817 551 8057 (Fort Worth)

globalmedia.relations@alcon.com

Battelle, CMC Pharmaceuticals Advance Medical Countermeasure Program for U.S. Department of War




Battelle, CMC Pharmaceuticals Advance Medical Countermeasure Program for U.S. Department of War

COLUMBUS, Ohio–(BUSINESS WIRE)–Battelle and CMC Pharmaceuticals are advancing work with the United States Department of War to develop improved medical countermeasures intended to protect American warfighters from nerve agent threats.

The five-year, $40 million Acetylcholinesterase (AChE) Reactivator Development and Approval Pipeline (ARDAP) Prototype Program was awarded through the Defense Threat Reduction Agency, Joint Science and Technology Office (DTRA-JSTO). The program is focused on advancing a promising AChE reactivator candidate through the drug development pathway toward submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration.

“Battelle has a long history of working with the DOW to develop medical countermeasures that protect military personnel from chemical threats,” said Drew Cawthon, Business Line Director. “As the ARDAP program progresses toward IND submission, we are proud to continue supporting this important mission and to continue to drive next-generation solutions to emerging threats with a strong partner like CMC Pharmaceuticals.” Ohio-based CMC Pharmaceuticals is supporting chemistry, manufacturing, and controls (CMC) activities, including laboratory development, cGMP testing, formulation and process development, stability evaluation, and Contract Manufacturing Organization oversight required to support product development and regulatory submissions.

“We are excited to team with Battelle and provide our chemistry, manufacturing, and controls expertise to such an important program,” said Mike Radomsky, President of CMC Pharmaceuticals. “Providing drug development services to the U.S. Department of War to protect our troops against the threat of nerve agents is truly an honor. This program adds to our existing and growing portfolio of improved therapeutics and medical countermeasures for the U.S. government.”

ARDAP is intended to establish a development and approval pipeline for improved AChE reactivators as medical countermeasures for nerve agent exposure. Battelle, CMC Pharmaceuticals, and program partners have advanced key CMC, nonclinical, clinical, and regulatory planning activities to support IND submission and future clinical evaluation. The effort is designed to support the efficient development of a fieldable medical countermeasure that could enhance the current standard of care for warfighters exposed to chemical threats.

About Battelle

Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. Headquartered in Columbus, Ohio since its founding in 1929, Battelle serves the national security, health and life sciences, and energy and environmental industries. For more information, visit www.battelle.org.

About CMC Pharmaceuticals:

CMC Pharmaceuticals is a leading provider of drug product development services and manufacturing support to the pharmaceutical and biotechnology industries. Located in Solon, Ohio, CMC Pharma delivers specialized scientific expertise and services including pre-formulation, formulation development, analytical development, cGMP lab services, stability and compatibility studies, manufacturing process development, CMO oversight, and consulting services to clients globally. Decades of specialized scientific experience in the development and manufacture of a wide range of drug product types including sterile injectables, solid oral, long-acting, controlled release, and other complex dosage forms. CMC Pharma has successfully managed a wide variety of pharmaceutical development programs, including multi-year programs with the federal government. For more information, visit www.cmcpharm.com.

Contacts

Battelle Contact
For more information contact Katy Delaney at (614) 424-7208 or at delaneyk@battelle.org or Amanda Ensinger at (614) 424-4087 or at ensinger@battelle.org.

CMC Pharmaceuticals Contact
For more information contact Mike Radomsky at (415) 370-1139 or at mike.radomsky@cmcpharm.com or contact Jared Heimovitz at (440) 637-5865 or at jared.heimovitz@cmcpharm.com.

8 Bridge Group, LLC Announces Strategic Investment in 340BIntel, LLC; Expanding Its Healthcare Technology Portfolio




8 Bridge Group, LLC Announces Strategic Investment in 340BIntel, LLC; Expanding Its Healthcare Technology Portfolio

BIRMINGHAM, Ala.–(BUSINESS WIRE)–8 Bridge Group, LLC (“8 Bridge Group”) today announced its strategic investment and acquisition of a majority stake in 340BIntel, LLC (“340BIntel”), marking the firm’s expansion into the healthcare technology sector. The investment represents the first phase of a long-term initiative expected to exceed $2 billion in revenue over the next decade, supporting innovative software solutions that strengthen healthcare operations and improve financial sustainability for healthcare providers.

8 Bridge Group’s executive team has spent more than a decade assisting hospitals, health systems, and clinic networks. 340BIntel helps Covered Entities navigate increasing financial pressures and the growing complexity of the 340B drug pricing program.

“The company’s proprietary technology identifies and recovers previously unclaimed 340B savings, enabling Covered Entities to enhance program performance without disrupting existing workflows or operational models.” said Heath Echols, Chief Operating Officer of 8 Bridge Group.

8 Bridge Group brings financial backing and more than 100 developers to help expand 340BIntel’s offering locally and nationally. 340BIntel’s shareholders and management look forward to this expansion, helping nonprofit hospitals maximize eligible savings to better serve their communities and expand access to care. 340BIntel is in the process of adding 120 nonprofit hospitals to its network by the fourth quarter of 2027.

“We are pleased to welcome 340BIntel into the 8 Bridge Group portfolio as we expand our investments into the healthcare sector.” said Jaco van Niekerk, Chief Executive Officer of 8 Bridge Group. “This partnership aligns with our long-term vision to invest in software applications that strengthen healthcare organizations, improve operational efficiency, and support better care for the communities they serve.”

340BIntel’s platform complements existing 340B strategies by uncovering additional savings opportunities within prescription capture, patient eligibility, referral patterns, and pharmacy network performance. It integrates alongside existing third-party administrators and internal 340B teams without requiring system replacements or workflow changes.

“After more than ten years of developing operational efficiencies specifically for the healthcare sector, we are excited to begin this next chapter with 8 Bridge Group,” said Elton Wagnon, Chief Growth Officer of 8 Bridge Group. “Our mission is to help healthcare organizations recover every eligible dollar available through the 340B program so those resources can be reinvested into patient care and community services.”

The partnership aims to support transparency, accountability, and the healthcare safety net while helping providers strengthen care for low-income and uninsured patients.

Financial terms of the transaction were not disclosed.

About 8 Bridge Group, LLC

8 Bridge Group is a diversified investment company focused on identifying and accelerating high-growth technology businesses across strategic industries through long-term investments and operational expertise.

Contacts

Media Contact
Elton Wagnon
Chief Growth Officer
340BIntel / 8 Bridge Group
elton@8bridgegroup.com
(205) 533-4440
https://www.340bintel.com/

JCR Pharmaceuticals Receives Marketing Authorization in Kuwait for IZCARGO™, a Blood-Brain Barrier-Penetrating Enzyme Replacement Therapy for Hunter Syndrome




JCR Pharmaceuticals Receives Marketing Authorization in Kuwait for IZCARGO™, a Blood-Brain Barrier-Penetrating Enzyme Replacement Therapy for Hunter Syndrome

– This approval follows the recent marketing authorization for IZCARGO™ in the United Arab Emirates –

HYOGO, Japan–(BUSINESS WIRE)–JCR Pharmaceuticals Co., Ltd. (TSE 4552; “JCR”), a global specialty biopharmaceutical company dedicated to developing therapies for rare and genetic diseases, today announced that IZCARGO™ (pabinafusp alfa, or JR-141), a blood-brain barrier-penetrating enzyme replacement therapy (ERT) for Hunter syndrome developed using JCR’s proprietary J-Brain Cargo^® technology, received conditional marketing authorization in Kuwait.

Kuwait is the second market outside Japan where IZCARGO™ has received approval, following the United Arab Emirates in July 2026. IZCARGO™ was approved and launched in Japan in 2021 and is currently being evaluated in an ongoing global Phase III clinical trial.

JCR has been working to expand access to IZCARGO™ outside of Japan while advancing its global clinical development program. As part of this effort, JCR entered into a marketing and distribution agreement with Taiba Middle East FZ LLC (“Taiba”) and pursued regulatory approval in Kuwait based on the product’s marketing authorization in Japan. Under this agreement, JCR will also seek marketing authorization for IZCARGO™ in countries across the Middle East and North Africa (MENA) region, while Taiba will be responsible for sales and distribution in the relevant territories.

“The approval of IZCARGO™ in Kuwait is an important milestone for people living with Hunter syndrome, as they now have an option to manage this rare, life-limiting lysosomal storage disorder,” said Hiroyuki Sonoda, Ph.D., President and Chief Scientific Officer of JCR Pharmaceuticals. “This marks the second marketing authorization of IZCARGO™ outside Japan, following its recent approval in the United Arab Emirates. We will work with Taiba to bring this therapy to more patients with Hunter syndrome and to continue expanding access to IZCARGO™ internationally for the patients who need it. Obtaining approval in Kuwait marks an important step in the overseas expansion of IZCARGO™.”

“The approval of IZCARGO™ in Kuwait marks an important advancement in our efforts to broaden access to specialized treatments for rare diseases in the region,” said Dr. Saif Al Hasani, Taiba Group CEO. “Building on the UAE approval, this milestone highlights the value of strong partnerships between regional healthcare organizations and global innovators in translating medical advancements into meaningful progress for patients. At Taiba, we remain focused on supporting sustainable access to innovative therapies and strengthening the region’s capacity to address complex and underserved medical needs.”

The impact of this announcement on JCR’s consolidated financial results for this fiscal year (ending March 31, 2027) is expected to be minor.

About the J-Brain Cargo^® Platform Technology

JCR Pharmaceuticals has developed a proprietary blood-brain barrier (BBB)-penetrating technology, J-Brain Cargo^®, to bring biotherapeutics into the central nervous system (CNS). The first drug developed based on this technology is IZCARGO™ (INN: pabinafusp alfa), which is approved in Japan for the treatment of Hunter syndrome, a lysosomal storage disorder (LSD). With J-Brain Cargo^®, JCR seeks to address the unresolved clinical challenges of LSDs by delivering the enzyme to both the body and the brain.

About Hunter Syndrome (Mucopolysaccharidosis Type II, or MPS II)

Hunter syndrome (mucopolysaccharidosis type II, or MPS II) is an X-linked recessive lysosomal storage disorder caused by a deficiency of iduronate-2-sulfatase, an enzyme that breaks down complex carbohydrates called glycosaminoglycans (GAGs, also known as mucopolysaccharides) in the body. Hunter syndrome, which affects an estimated 2,000-3,000 individuals worldwide (according to JCR research), gives rise to a wide range of somatic and neurological symptoms. The current standard of care for Hunter syndrome is enzyme replacement therapy. Central nervous system symptoms related to MPS II have been unmet medical needs so far.

About Pabinafusp Alfa

Pabinafusp alfa (JR-141) is a recombinant fusion protein of an antibody against the human transferrin receptor and iduronate-2-sulfatase, the enzyme that is missing or malfunctioning in subjects with Hunter syndrome. It incorporates J-Brain Cargo^®, JCR’s proprietary blood-brain barrier (BBB)-penetrating technology, to cross the BBB through transferrin receptor-mediated transcytosis, and its uptake into cells is mediated through the mannose-6-phosphate receptor. This novel mechanism of action is expected to make pabinafusp alfa effective against the central nervous system (CNS) symptoms of Hunter syndrome.

In pre-clinical trials, JCR has confirmed both high-affinity binding of pabinafusp alfa to transferrin receptors and passage across the BBB into neuronal cells. In addition, JCR has confirmed enzyme uptake in various brain tissues. The company has also confirmed a reduction of substrate accumulation in the CNS and peripheral organs in an animal model of Hunter syndrome.^1,2

In several clinical trials of pabinafusp alfa, JCR obtained evidence of reducing heparan sulfate (HS) concentrations in the cerebrospinal fluid (CSF), a biomarker for assessing effectiveness against CNS symptoms; these results were consistent with those obtained in pre-clinical studies.³ Clinical studies have also demonstrated the positive effects of pabinafusp alfa on CNS symptoms.^4,5,6

Pabinafusp alfa was approved in Japan by the Ministry of Health, Labour and Welfare and marketed since May 2021 under the brand name “IZCARGO™ I.V. Infusion 10mg.”

Important Safety Information

INDICATION:

IZCARGO™ is indicated for the treatment of mucopolysaccharidosis type II (MPS II), which is also known as Hunter syndrome. IZCARGO™ is approved in Japan, the United Arab Emirates (UAE), and Kuwait.

CONTRAINDICATION:

IZCARGO™ is contraindicated in patients with a history of anaphylactic shock to its components.

WARNINGS AND PRECAUTIONS:

Warnings

Since serious anaphylaxis and shock may occur with use of IZCARGO™, adequate emergency measures should be made ready for execution before initiation of administration, and the patient should be closely monitored during and after the administration. If a serious infusion associated reaction (IAR) occurs, administration of IZCARGO™ should be discontinued, and appropriate actions should be taken.

When IZCARGO™ is administered to patients with severe respiratory failure or acute respiratory disease, an IAR may lead to acute exacerbation of symptoms. A patient’s condition should be closely monitored, and appropriate actions should be taken as needed.

Precautions for Use

IZCARGO™ is a protein medicinal product and may cause anaphylactic shock, for which close monitoring is required. If any signs of anaphylaxis are noted, discontinue the infusion, and take appropriate actions. Considering the onset of such symptoms, emergency measures should be made ready for execution.

IZCARGO™ may cause IARs such as headache, chills, syncope, fatigue, dizziness, pyrexia, rash, erythema, urticaria, or other symptoms. If an IAR occurs, reduce the rate or temporarily discontinue the infusion, and initiate appropriate drug treatment (e.g., corticosteroids, antihistamines, antipyretic analgesics, anti-inflammatory drugs) or emergency procedures (e.g., oxygen administration, securing of airway, adrenaline administration). Premedication with antihistamines, corticosteroids, etc., should be considered for the subsequent infusion of IZCARGO™.

ADVERSE REACTIONS:

The most commonly reported adverse reactions were pyrexia and urticaria.

About Taiba Middle East FZ LLC

Taiba is a regional leader in the marketing, distribution, and commercialization of orphan and rare disease therapies across the Middle East and North Africa (MENA). With two decades of trusted collaboration with clinicians, hospitals, and global partners.

Taiba combines deep regional expertise with robust commercial execution—from regulatory approvals and patient access programs to strategic partnerships and long-term brand lifecycle management. The company connects healthcare systems with breakthrough treatments through early access and commercialization initiatives. Driven by a mission to close the treatment gap.

Taiba empowers medical institutions with cutting-edge solutions and exceptional service, ensuring patients with unmet medical needs gain timely and sustainable access to life-changing therapies. Please visit: http://www.taibarare.com/.

About JCR Pharmaceuticals Co., Ltd.

JCR Pharmaceuticals Co., Ltd. (TSE 4552) is a global specialty pharmaceutical company that develops treatments that go beyond rare diseases to solve the world’s most complex healthcare challenges. We continue to build upon our 50-year legacy in Japan while expanding our global footprint into the U.S., Europe, and Latin America. We improve patients’ lives by applying our scientific expertise and unique technologies to research, develop, and deliver next-generation therapies. Our approved products in Japan include therapies for the treatment of growth disorder, MPS II (Hunter syndrome), Fabry disease, acute graft-versus host disease, and renal anemia. Our investigational products in development worldwide are aimed at treating rare diseases including MPS I (Hurler, Hurler-Scheie and Scheie syndrome), MPS II, MPS IIIA and B (Sanfilippo syndrome type A and B), and more. Our core values – Putting people first, Forging our own path, Always advancing, and Committed to excellence – mean that the work we do benefits all our stakeholders, including partners, patients and employees. We strive to expand the possibilities for patients while accelerating medical advancement at a global level. For more information, please visit JCR’s global website: https://jcrpharm.com/.

Cautionary Statement Regarding Forward-Looking Statements

This document contains forward-looking statements that are subject to known and unknown risks and uncertainties, many of which are outside our control. Forward-looking statements often contain words such as “believe,” “estimate,” “anticipate,” “intend,” “plan,” “will,” “would,” “target” and similar references to future periods. All forward-looking statements regarding our plans, outlook, strategy and future business, financial performance and financial condition are based on judgments derived from the information available to us at this time. Factors or events that could cause our actual results to be materially different from those expressed in our forward-looking statements include, but are not limited to, a deterioration of economic conditions, a change in the legal or governmental system, a delay in launching a new product, impact on competitors’ pricing and product strategies, a decline in marketing capabilities relating to our products, manufacturing difficulties or delays, an infringement of our intellectual property rights, an adverse court decision in a significant lawsuit and regulatory actions. This document involves information on pharmaceutical products (including those under development). However, it is not intended for advertising or providing medical advice. Furthermore, it is intended to provide information on our company and businesses and not to solicit investment in securities we issue. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the factors that could cause actual results to differ materially, even if new information becomes available in the future.

References

1: Sonoda, et al. A blood-brain-barrier-penetrating anti-human transferrin receptor antibody fusion protein for neuronopathic mucopolysaccharidosis II. Mol. Ther. 2018; 26(5): 1366-1374.

2: Morimoto, et al. Clearance of heparin sulfate in the brain prevents neurodegeneration and neurocognitive impairment in MPS II mice. Mol. Ther. 2021; 29(5): 1853-1861.

3: Okuyama, et al. Iduronate-2-sulfatase with Anti-human Transferrin Receptor Antibody for Neuropathic Mucopolysaccharidosis II: A Phase 1/2 Trial. Mol Ther. 2020; 27(2): 456-464.

4: Okuyama, et al. A Phase 2/3 Trial of Pabinafusp Alfa, IDS Fused with Anti-Human Transferrin Receptor Antibody, Targeting Neurodegeneration in MPS-II. Mol Ther. 2021; 29(2): 671-679.

5: Giugliani, et al. Iduronate-2-sulfatase fused with anti-human transferrin receptor antibody, pabinafusp alfa, for treatment of neuronopathic and non-neuronopathic mucopolysaccharidosis II: Report of a phase 2 trial in Brazil. Mol Ther. 2021; 29(7): 2378-2386.

6: Giugliani, et al. Enzyme Replacement Therapy with Pabinafusp Alfa for Neuronopathic Mucopolysaccharidosis II; an Integrated Analysis of Preclinical and Clinical Data. Int. J. Mol. Sci. 2021, Volume 22, Issue 20, 10938.

Contacts

Investors & Media:

JCR Pharmaceuticals Co., Ltd.

Corporate Communications

ir-info@jp.jcrpharm.com

Portal Innovations Venture Team Releases New Analysis on Capital Efficiency in Emerging Biotech Ecosystems




Portal Innovations Venture Team Releases New Analysis on Capital Efficiency in Emerging Biotech Ecosystems

Ten-year analysis of more than 11,000 life sciences companies finds that startups outside traditional biotech hubs reach clinical milestones faster, preserve more ownership, and generate higher returns on invested capital

CHICAGO–(BUSINESS WIRE)–Portal Innovations today announced the release of Biotech’s Next Frontier: Emerging Hubs Built for Efficiency and Outsized Returns, a new analysis developed by its venture team examining a decade of financing, clinical development, and exit data across the U.S. biotechnology industry.

Drawing on data covering more than 11,000 life sciences companies and nearly 30,000 financing deals from 2015 through 2025, the analysis compares established biotech hubs in California and Massachusetts with emerging ecosystems across the rest of the country. The findings challenge conventional measures of biotech ecosystem strength and highlight the potential of companies operating outside traditional centers of venture capital.

Key findings include:

• Greater capital efficiency: Companies in emerging ecosystems generated higher median returns on invested capital at exit than companies in established hubs.
• Faster clinical progress with less capital: Startups in emerging ecosystems reached their first clinical trial milestones faster, on average, while requiring less private capital.
• Greater resilience in changing markets: Between the COVID-era period (2018–2021) and the post-COVID period (2022–2025), capital raised by companies in emerging ecosystems increased 23.3%, while established hubs experienced a 14.7% decline.
• More ownership retained by founders: Companies in emerging ecosystems experienced less dilution, allowing founders to preserve a greater share of ownership.
• A complementary role for public funding: Companies outside traditional hubs accounted for nearly 70% of the startups receiving the SBIR/STTR grants analyzed, demonstrating the importance of non-dilutive funding in supporting early-stage innovation.

The findings underscore an opportunity to rethink how investors and ecosystem builders evaluate biotech markets. While established hubs benefit from deep capital networks, specialized talent, and mature commercialization infrastructure, emerging ecosystems demonstrate strengths in disciplined capital deployment, operational efficiency, and resilience.

The report concludes that the future of U.S. biotech innovation depends on building stronger connections across regional ecosystems, rather than simply replicating the established hub model. Improving access to follow-on capital, specialized infrastructure, and industry partnerships could help high-potential companies translate scientific discoveries into commercial success, regardless of where they are founded.

The full analysis is available for download here: https://hs.portalinnovations.com/2026-biotechs-next-frontier-article

About Portal Innovations

Portal Innovations is a venture development platform that provides early-stage capital, specialized lab space, and strategic resources to science-driven companies. With headquarters in Chicago and an expanding international footprint, Portal’s Crafted Capital model bridges the gap between scientific discovery and commercialization, helping entrepreneurs transform cutting-edge research into successful businesses.

To learn more about Portal Innovations and its work supporting science-driven startups, visit www.portalinnovations.com.

Contacts

Media Contact

Nick Pennebaker

Sr. Director of Marketing and Communications

nick.pennebaker@portalinnovations.com

Undecimal Bio launches with $18 million oversubscribed Seed financing to address ‘liver trap’ in siRNA therapeutic delivery




Undecimal Bio launches with $18 million oversubscribed Seed financing to address ‘liver trap’ in siRNA therapeutic delivery

• A spin-out focused on AI-enabled decoding of the deliverome
• Proprietary synthetic biology platform identifies conjugates that target RNA medicines beyond the liver, with initial focus on renovascular disease
• Round co-led by 4BIO Capital and IQ Capital, with participation from Verve Ventures, Harel Tech, Entree Capital, Kerna Ventures and Saras Capital

CAMBRIDGE, England & TEL AVIV, Israel–(BUSINESS WIRE)–Undecimal Bio (“Undecimal”), a platform biotechnology company advancing targeted delivery of siRNA therapeutics, today announced an oversubscribed $18 million USD seed financing. The Company, a spin-out from Eleven Therapeutics, will use the funding to expand DELiveri^®, its proprietary AI-enabled platform for identifying conjugates that can direct RNA medicines to defined cell types, addressing a major constraint in genetic medicine delivery.

RNA interference has transformed the treatment of liver-expressed diseases, but reaching tissues beyond the liver remains a key obstacle limiting the broader potential of the modality. DELiveri addresses this challenge as a groundbreaking technology that screens massive-scale combinatorial libraries of candidate ligands, converting cells to act as molecular radars that detect productive delivery at single molecule resolution. This high throughput data is analysed by agentic AI to decode the resulting structure-activity data and identify conjugates capable of carrying siRNA into target cells.

Undecimal is initially applying the DELiveri platform in renovascular diseases, which pose significant unmet clinical need. Existing treatments of these indications largely address symptoms rather than the underlying etiological factors. Targeted siRNA delivery holds the potential to bring the digital-like precision of genetic medicines, enabling durable, target-specific silencing of the disease-driving pathways.

The round was co-led by 4BIO Capital and IQ Capital, with participation from Verve Ventures, Harel Tech, Entree Capital, Kerna Ventures and Saras Capital. The funding will be used to further development of the DELiveri platform, progress Undecimal’s renovascular programmes and enable expansion of the team at the Company’s laboratories based at the Cancer Research UK Cambridge Institute.

Undecimal has entered several research collaborations with big pharma companies, which are yet to be disclosed.

The Board of Directors comprises representatives of 4BIO Capital, IQ Capital and Harel Technologies, together with co-founders Dr. Yaniv Erlich and Shaul Ilan. Alongside the financing, Verve Ventures joins the Board as an observer.

“The hard problem in RNAi was never the silencing, it was getting the molecule to the right cell,” said Dr. Yaniv Erlich, CEO and Co-Founder of Undecimal Bio. “Our in-vivo validated DELiveri platform can screen large chemical spaces at an unprecedented pace, generating massive data for our legions of AI agents to decipher the structure-activity relationship and score the best candidates. We are excited to bring these advances to develop the next generation of siRNA therapeutics for the benefit of patients.”

Contacts

Notes to Editors

For further information please contact:

Zyme Communications
Lily Jeffery
Tel: +44(0)7891 477 378
Email: lily.jeffery@zymecommunications.com

Undecimal Bio
Dr. Yaniv Erlich
Email: contact@undecimalbio.com

Mursla Bio Publishes Peer-Reviewed Validation of Tissue-Specific Extracellular Vesicle Platform for Liquid Biopsy




Mursla Bio Publishes Peer-Reviewed Validation of Tissue-Specific Extracellular Vesicle Platform for Liquid Biopsy

• Study published in Journal of Extracellular Vesicles validates platform for new class of liquid biopsy: multiomic disease biology of living cells from a chosen tissue, starting with the liver
• Platform underpins FDA Breakthrough Device-designated EvoLiver™ and precision medicine programs with pharmaceutical partners

CAMBRIDGE, England & BOSTON–(BUSINESS WIRE)–Mursla Bio, a precision medicine and diagnostics company built on tissue-specific extracellular vesicles (TS-EVs), today announced publication of a peer-reviewed study in the Journal of Extracellular Vesicles (impact factor 21.7), the founding journal of the International Society for Extracellular Vesicles. This validates the TS-EV platform for a new class of liquid biopsy: the multiomic disease biology of living cells in a chosen tissue, read from blood, starting with the liver.

In this study, which builds on work first released as a preprint in June 2025, Mursla Bio’s NEXPLOR technology selectively enriched hepatocyte-derived EVs (h-EVs) over EVs from other tissues (lung, kidney, breast, adipose and muscle) and from the blood cells that dominate plasma. The multiomic content of h-EVs was analyzed against bulk EV preparations of the same clinical plasma samples, each under 2 mL, from patients with hepatocellular carcinoma (HCC) or cirrhosis and from healthy donors.

H-EVs accessed a different part of the hepatocyte proteome, identifying 57% more proteins than those bulk EVs, with better reproducibility. Bulk EVs were dominated by the plasma proteins the liver secretes, such as albumin, while h-EVs were enriched in the internal machinery of hepatocytes: membrane, cytosolic and mitochondrial proteins, including EV-defining markers¹. The h-EV fraction revealed 86 proteins uniquely detected or significantly increased in liver disease against healthy donors, compared with 4 unique proteins and no significant differential signal in bulk EVs. These 86 reflected what cirrhosis and HCC shared: fibrosis, disordered fat metabolism and inflammation. Comparing HCC with cirrhosis, the h-EV fraction resolved HCC-defining proteins, and a wider set of proteins that cohered as a network. Paired bulk EVs yielded neither.

Small-RNA sequencing supported a similar conclusion in a second molecular layer. In the same comparison, the h-EV fraction yielded fewer differentially expressed microRNAs than paired bulk EVs, yet only the h-EV microRNAs mapped to HCC signaling, while the bulk set mapped to a more generalized inflammatory response. The same h-EVs were present in the bulk EV preparation, suggesting that the lack of tissue specificity holding back microRNAs as liquid biopsy biomarkers² could be overcome.

The NEXPLOR technology described in the manuscript is a core component of Mursla Bio’s broader TS-EV platform. The hepatocyte panel is Mursla Bio’s first; the discovery and orthogonal validation route behind it is designed to extend to other tissues, and further panels are in development.

The platform has wide applications across clinical diagnostics, from disease surveillance to molecular residual disease (MRD), and precision medicine, including patient stratification, pharmacodynamic biomarkers and companion diagnostics.

Dr Tomás Dias, Chief Scientific Officer of Mursla Bio, said: “EVs are released by virtually every tissue into the bloodstream. They carry health and disease markers that can be traced back to their origin, much as a tissue biopsy would. To our knowledge, this is the most comprehensive validation to date of a platform for tissue-specific EV isolation from human plasma.”

Pierre Arsène, Founder and CEO of Mursla Bio, added: “Much of liquid biopsy has focused on measuring more analytes. Our thesis is that biological context matters as much as analytical depth. That is the foundation of EvoLiver and of the precision medicine programs we are building with pharma partners.”

1. Tissue-specific isolation of hepatocyte extracellular vesicles from human plasma enables tissue-resolved proteomic and miRNA profiling, Journal of Extracellular Vesicles, 2026; 15:e70372. https://doi.org/10.1002/jev2.70372
2. MicroRNAs in oncology: a translational perspective in the era of AI, Nature Reviews Clinical Oncology, 2026.

Contacts

Media contact
Dr Ben Rutter
Zyme Communications
Tel: +44(0)7920 770 935
Email: ben.rutter@zymecommunications.com

New Galderma Research Reveals More Than Half of Women Mistake Menopause-Related Skin Changes for Signs of Ageing




New Galderma Research Reveals More Than Half of Women Mistake Menopause-Related Skin Changes for Signs of Ageing

New clinical data identify optimized injectable aesthetics treatment protocol for menopause-induced skin changes

• 56% of women have experienced ‘The Menopausal Skin Misread’, admitting they first put menopause-related skin changes down to ageing, while fewer than a third (29%) recognized menopause as the cause¹
• A significant knowledge gap remains: one in two women are unaware that hormonal changes during perimenopause and menopause can affect the skin, and 82% agree that better understanding the difference between menopause-related skin changes and general ageing would help them feel more informed and in control of their skincare decisions¹
• New data from an investigator-initiated trial (IIT) led by Dr. Andreas Nikolis and supported by Galderma, demonstrated that a sequenced treatment approach using Restylane Skinboosters followed by Sculptra delivered significant improvements in skin hydration and remodeling across the face and décolletage in menopausal women, highlighting the value of preconditioning the skin to optimize regenerative outcomes^2-4

ZUG, Switzerland–(BUSINESS WIRE)–Galderma (SIX: GALD) today announced new global research revealing that more than half (56%) of women first put menopause-related skin changes down to general ageing, while only less than a third of women (29%) initially recognized the link to menopause.¹ The research shines a light on ‘The Menopausal Skin Misread’, showing how aesthetic changes in the skin linked to menopause are still being misunderstood, mislabeled and too often attributed to ageing alone.¹ Ahead of World Menopause Day, Galderma is calling attention to the misunderstood impact of menopause on the skin, helping to close the knowledge gap and empower women with the understanding needed to recognize and navigate menopause-related skin and aesthetic changes.

“Too many women are navigating changes in their skin without recognizing that menopause may be playing a role. Our research shows the scale of this knowledge gap and the need to move beyond a one-size-fits-all ageing narrative. At Galderma, we are committed to advancing the understanding of menopausal skin and providing women with clear, trusted information and science-backed solutions, so they can make informed choices and feel confident in their skin throughout this important stage of life.”

ANNE-CÉCILE CHEVRIER

GLOBAL HEAD, INJECTABLE AESTHETICS

GALDERMA

New international survey uncovers a significant lack of awareness between menopause-related aesthetic changes in the skin and those associated with ageing

Despite the impact menopause can have on the skin, Galderma’s research reveals that the topic remains largely overlooked in the wider menopause conversation, leaving many women unaware of the role hormonal changes may be playing in the aesthetic changes they see in their skin.^1,2 More than half of women (56%) initially interpreted these changes as signs of ageing, while only 29% connected them to menopause.¹ One in two women remain unaware that hormonal fluctuations during perimenopause and menopause can have a significant impact on skin, underscoring the need for greater education in this area.¹

This misread is also influencing skincare purchases: 70% have bought products designed to address signs of ageing because they believed they would help with skin changes experienced during perimenopause or menopause.¹ Finding the right information can be challenging too: 62% of women have felt overwhelmed by skincare advice during the menopause or perimenopause, with almost half of those struggling to find clear information saying advice was too general and focused on ageing rather than menopause.¹

There is a clear appetite for greater clarity, with over 80% of women agreeing that better understanding the difference between general ageing and menopause-related skin changes would help them feel more informed and in control of their skincare decisions.¹

New clinical data identify optimized injectable aesthetics treatment protocol for menopause-induced skin changes

New results from an eight-month investigator-initiated trial (IIT) supported by Galderma and conducted by Dr. Andreas Nikolis, both on the face and the décolletage, demonstrated that the combination of Restylane Skinboosters and Sculptra delivered sustained improvements in skin hydration, quality, remodeling, as well as patient satisfaction in menopausal women.² Patients were divided into two groups and treated with either Restylane Skinboosters-first, Sculptra-second, or Sculptra-first, Restylane Skinboosters-second.²

Women treated with Restylane Skinboosters-first, followed by Sculptra, demonstrated an earlier visible clinical response and greater dermal remodeling, with facial dermal thickness increasing by 27.3% compared with 15.7% in the Sculptra-first, Restylane Skinboosters-second group, highlighting the value of preconditioning the skin to maximize regenerative outcomes.²

“This first-of-its-kind clinical study provides compelling evidence that sequencing treatments can deliver significantly greater benefits than either approach alone in menopausal skin. By first using Restylane Skinboosters to rapidly improve hydration and optimize the skin microenvironment, followed by Sculptra to stimulate collagen production and progressive tissue remodeling, more favorably, we are now able to address both the immediate and longer-term biologic changes associated with menopause. The result is a strongly supported scientific treatment strategy that combines rapid improvement in hydration with sustained enhancement in skin quality and remodeling, while achieving high levels of patient satisfaction. These findings provide clinicians with a new evidence-based framework for treating menopausal skin.”

DR. ANDREAS NIKOLIS

BOARD-CERTIFIED PLASTIC SURGEON

MONTREAL, CANADA

Both groups achieved meaningful hydration improvements and high satisfaction levels, with 98% reporting natural-looking results, 96% saying they would recommend the treatments and 92% stating they would undergo treatment again, highlighting the complementary benefits of both products in addressing the skin changes associated with menopause.²

As part of its commitment to support women during this transition, Galderma has announced the launch of a new ‘Rewriting the Future of Your Skin, Own your Menopause Story’ campaign, bringing together science and the real experiences of women to shine a light on menopausal skin and help close the knowledge gap revealed by the research. More information here.

Ahead of World Menopause Day on 18 October, Galderma is calling for a new conversation around menopausal skin: one that recognizes the role hormonal changes can play, separates menopausal skin and aesthetic changes from generic ageing narratives and gives women clearer information to understand what is happening to their skin to make more informed choices about what it needs.

ENDS

Notes to editors:

The research was conducted by Perspectus Global among a sample of 5,090 women who have experienced or are experiencing perimenopause or menopause across the UK, US, Brazil and China. The data was collected between 25 August and 1 September 2026.

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. Galderma. Data on file. Menopause patient survey; Wave 2 research. September 2026.
2. Nikolis A. Prospective evaluation of treatment sequencing in menopausal patients: The role of preconditioning. Data on file. September 2026
3. Restylane^® Skinboosters Vital Lidocane™. EU Instructions for Use.
4. Sculptra^®. EU Instructions for Use.

Contacts

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