Catalyst Pharmaceuticals to Participate in Jefferies Global Healthcare Conference




Catalyst Pharmaceuticals to Participate in Jefferies Global Healthcare Conference

CORAL GABLES, Fla., Nov. 03, 2025 (GLOBE NEWSWIRE) — Catalyst Pharmaceuticals, Inc. (“Catalyst” or “Company”) (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced that Rich Daly, President and CEO, along with other members of Catalyst’s management team, will participate in the Jefferies Global Healthcare Conference in London on Monday, November 17, 2025.

Presentation Day: Monday, November 17, 2025
Time: 2:00 pm (GMT)
Webcast Link

The webcast will be available under the Investors section on the Company’s website, www.catalystpharma.com, and a replay will be available for at least 30 days.

About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX), is a biopharmaceutical company committed to improving the lives of patients with rare diseases. With a proven track record of bringing life-changing treatments to the market, we focus on in-licensing, commercializing, and developing innovative therapies. Guided by our deep commitment to patient care, we prioritize accessibility, ensuring patients receive the care they need through a comprehensive suite of support services designed to provide seamless access and ongoing assistance. Catalyst maintains a well-established U.S. presence, which remains the cornerstone of our commercial strategy, while continuously evaluating strategic opportunities to expand our global footprint. Catalyst, headquartered in Coral Gables, Fla., was recognized on the Forbes 2025 list as one of America’s Most Successful Mid-Cap Companies and on the 2024 Deloitte Technology Fast 500™ list as one of North America’s Fastest-Growing Companies.

For more information, please visit Catalyst’s website at www.catalystpharma.com.

Forward-Looking Statements
This press release contains forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst’s actual results in future periods to differ materially from forecasted results. A number of factors, including those factors described in Catalyst’s Annual Report on Form 10-K for the fiscal year 2024 and its subsequent filings with the U.S. Securities and Exchange Commission (“SEC”), could adversely affect Catalyst. Copies of Catalyst’s filings with the SEC are available from the SEC, may be found on Catalyst’s website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.

Source: Catalyst Pharmaceuticals, Inc.

CONTACT: Investor Contact
Melissa Kendis, Catalyst Pharmaceuticals, Inc.
(305) 420-3200
IR@catalystpharma.com

Media Contact
David Schull, Russo Partners
(858) 717-2310
david.schull@russopartnersllc.com

Prime Medicine Appoints Matthew Hawryluk, Ph.D., M.B.A. as Chief Business Officer




Prime Medicine Appoints Matthew Hawryluk, Ph.D., M.B.A. as Chief Business Officer

CAMBRIDGE, Mass., Nov. 03, 2025 (GLOBE NEWSWIRE) — Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today announced the appointment of Matthew Hawryluk, Ph.D., M.B.A. as Chief Business Officer (CBO). Dr. Hawryluk will lead Prime’s corporate and business development initiatives, corporate strategy, and alliance management functions, advancing the company’s efforts to expand the reach of Prime Editing through strategic partnerships and collaborations.

“We are thrilled to welcome Matt to our leadership team,” said Allan Reine, M.D., Chief Executive Officer of Prime Medicine. “Business development has been – and will continue to be – a core pillar of our strategy, as we work to expand the reach and impact of Prime Editing through partnerships that complement our internal capabilities and accelerate our progress toward getting this important technology to more patients. Matt’s exceptional record of building companies, securing high-value strategic collaborations, and leading through multiple stages of growth makes him an ideal fit to help guide Prime Medicine through its next chapter.”

Dr. Hawryluk joins Prime Medicine with nearly two decades of leadership experience spanning business development, strategy, and corporate operations in the biotechnology industry. Most recently, he served as Chief Business Officer at AIRNA Corporation, where he led corporate and business development, finance, and investor relations, and played a key role in securing an oversubscribed $155 million Series B financing. Dr. Hawryluk served for nearly a decade as Executive Vice President and Chief Business Officer at Gritstone bio, Inc., guiding its growth from early stage to a public company and spearheading its expansion into infectious diseases. He led transactions totaling more than $2.5 billion in potential value, including landmark collaborations with Gilead Sciences, bluebird bio, and multiple government and nonprofit organizations such as BARDA, CEPI, NIAID, and the Bill & Melinda Gates Foundation.

Earlier in his career, Dr. Hawryluk held senior roles at Foundation Medicine, where he was instrumental in forging the company’s transformative strategic partnership and majority acquisition by Roche/Genentech. His experience also includes business development roles at Thermo Fisher Scientific and work in venture capital and translational science. Dr. Hawryluk holds a Ph.D. in Cell Biology and Protein Biochemistry from the University of Pittsburgh School of Medicine, an M.B.A. from the Carnegie Mellon University Tepper School of Business, and a B.S. in Biochemistry from the University of Notre Dame. Dr. Hawryluk serves on the Boards of Directors of Predictive Oncology Inc. and OuroTech, Inc. (Pear Bio).

“I am honored to join Prime Medicine at such an exciting and pivotal time,” said Matthew Hawryluk, Ph.D., M.B.A., Chief Business Officer of Prime Medicine. “Earlier this year, Prime Medicine announced the first ever clinical data supporting the safety and efficacy of Prime Editing in humans, reinforcing the power of this technology to correct pathogenic mutations and potentially change the course of life-limiting diseases. Prime Medicine’s mission to extend this benefit to patients with a wide range of rare and common conditions is inspiring, and I look forward to working with the team to expand our strategic partnerships and help realize the company’s vision of bringing the power of Prime Editing to patients worldwide.”

About Prime Medicine

Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is deploying its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated one-time curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. Taken together, Prime Editing’s versatile gene editing capabilities could unlock opportunities across thousands of potential indications.

Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: liver, lung, and immunology and oncology. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. Over time, the Company intends to maximize Prime Editing’s broad and versatile therapeutic potential, as well as the modularity of the Prime Editing platform, to rapidly and efficiently expand beyond the diseases in its current pipeline, potentially including additional genetic diseases, immunological diseases, cancers, infectious diseases, and targeting genetic risk factors in common diseases, which collectively impact millions of people. For more information, please visit www.primemedicine.com.

© 2025 Prime Medicine, Inc. All rights reserved. PRIME MEDICINE, the Prime Medicine logos, and PASSIGE are trademarks of Prime Medicine, Inc. All other trademarks referred to herein are the property of their respective owners.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about Prime Medicine’s beliefs and expectations regarding: the significance of data from its Phase 1/2 trial of PM359; the potential of Prime Editing to safely correct the causative mutations of, and to cure, diseases; the breadth of Prime Editing technology and the implementation of its strategic plans for its business, programs, and technology; and the potential of Prime Editing as a transformative gene editing technology and its ability to unlock opportunities across thousands of potential indications

Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: uncertainties related to Prime Medicine’s product candidates entering clinical trials; the authorization, initiation, and conduct of preclinical and IND-enabling studies and other development requirements for potential product candidates, including uncertainties related to opening INDs and obtaining regulatory approvals; risks related to the development and optimization of new technologies, the results of preclinical studies, or clinical studies not being predictive of future results in connection with future studies; the scope of protection Prime Medicine is able to establish and maintain for intellectual property rights covering its Prime Editing technology; Prime Medicine’s ability to identify and enter into future license agreements and collaborations; Prime Medicine’s expectations regarding the anticipated timeline of its cash runway and future financial performance; and general economic, industry and market conditions. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Prime Medicine’s most recent Annual Report on Form 10-K, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Prime Medicine’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Prime Medicine explicitly disclaims any obligation to update any forward-looking statements subject to any obligations under applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Investor and Media Contacts

Gregory Dearborn
Prime Medicine
857-209-0696
gdearborn@primemedicine.com

Hannah Deresiewicz
Precision AQ
212-362-1200
hannah.deresiewicz@precisionaq.com

Recludix Pharma to Present at Two Investor Conferences in November




Recludix Pharma to Present at Two Investor Conferences in November

SAN DIEGO, Nov. 03, 2025 (GLOBE NEWSWIRE) — Recludix Pharma, a leader in the discovery of inhibitors of challenging targets for inflammatory disease, today announced that members of Recludix’s management will participate in two investor conferences in November.

• Guggenheim Second Annual Healthcare Innovation Conference in Boston, MA
  • Presentation on Monday, November 10, 2025, at 1:30 p.m. ET
• Stifel 2025 Healthcare Conference in New York, NY
  • Presentation on Tuesday, November 11, 2025, at 11:20 a.m. ET

To access the live and archived webcasts of the presentations, visit the News & Events page of the company’s website at https://recludixpharma.com/news-events. The archived webcasts will be available for 30 days following each presentation.

About Recludix
Recludix is a leader in developing platform approaches to discover potent and selective inhibitors of challenging protein targets. The company’s management team includes industry veterans with a track record of success, including former leaders of Seagen, Blueprint Medicines, and Lilly. Recludix has developed a unique drug discovery platform that integrates custom generated DNA-encoded libraries, massively parallel determination of structure activity relationships, and a proprietary screening tool to ensure selectivity. The company is employing this approach first in the development of SH2 domain inhibitors. Recludix’s most advanced program is focused on STAT6 (signal transducer and activator of transcription 6) where abnormal activation is found in inflammatory diseases, such as atopic dermatitis, asthma, rheumatoid arthritis and chronic spontaneous urticaria. The company has a strategic collaboration with Sanofi for the development and commercialization of a STAT6 inhibitor, and it is planning to submit an Investigational New Drug application for its STAT6 inhibitor REX-8756 in 2025. Recludix is also advancing a potential first-in-class BTK SH2 domain inhibitor for B cell or mast cell-driven I&I diseases, as well as additional programs. Recludix was named a 2024 Fierce 15 biotech company. For more information, please visit the company’s website at https://recludixpharma.com.

Recludix Contacts
Matt Caldemeyer
Chief Business Officer
mcaldemeyer@recludix.com

Alexandra Santos
asantos@wheelhouselsa.com

Aljanae Reynolds
areynolds@wheelhouselsa.com

Avalyn to Participate in Multiple Upcoming Investor Conferences in November




Avalyn to Participate in Multiple Upcoming Investor Conferences in November

BOSTON, Nov. 03, 2025 (GLOBE NEWSWIRE) — Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on the development of inhaled therapies for the treatment of life-threatening pulmonary diseases, today announced that management will participate in the following upcoming investor conferences in November.

About Avalyn Pharma
Avalyn is reimagining the future of pulmonary fibrosis treatment with a pipeline of new inhaled formulations of approved medicines intended to reduce systemic exposure and deliver medication directly to the site of disease. Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, and reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn’s inhaled approach tackles the underlying pathophysiology of pulmonary fibrosis at its source and is designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s AP01 is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b study in progressive pulmonary fibrosis (PPF). AP01 has been assessed in over 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with promising signals of efficacy and safety compared to historical data with existing therapies, supporting continued clinical development. The company completed two Phase 1 studies for AP02, inhaled nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF) and is planning a Phase 2 clinical trial. For more information, please visit avalynpharma.com and follow us on LinkedIn.

Investor Contact:
Alex Straus, THRUST
alex@thrustsc.com
ir@avalynpharma.com

Media Contact:
Kat Lippincott, Deerfield Group
kat.lippincott@deerfieldgroup.com
media@avalynpharma.com

Sutro Biopharma Announces Participation at the 16th Annual World ADC Conference




Sutro Biopharma Announces Participation at the 16th Annual World ADC Conference

SOUTH SAN FRANCISCO, Calif., Nov. 03, 2025 (GLOBE NEWSWIRE) — Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), an oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced its participation at the 16th Annual World ADC Conference, taking place in San Diego, November 3-6, 2025.

“We look forward to presenting new preclinical data at this year’s World ADC conference that underscore the breadth of innovation emerging from Sutro’s platform and the meaningful progress we’re making toward advancing the next-generation of ADCs,” said Hans-Peter Gerber, Sutro’s Chief Scientific Officer. “Among the highlights, we’re excited to share results demonstrating how our dual-payload ADCs, including immunostimulatory ADCs, can potentially redefine treatment paradigms by enhancing therapeutic index and addressing tumor resistance—two of the biggest challenges in oncology today. Together with our unique cell-free platform, these advances reinforce Sutro’s leadership in ADC innovation and our commitment to driving long-term value through transformative science.” 

Presentation/Panel Discussion Details:

• Showcasing Development of Site-Specific, High-DAR Dual-Payload ADCs
  • Presenter: Daniel Calerese, Ph.D.
  • Date/Time: November 3, 2025, 12:00PM PT

• Developing Next-Generation Immunostimulatory Dual Payload ADCs to Enhance Therapeutic Index & Tackle Patient Resistance
  
  • Presenter: Gang Yin, Ph.D.
  • Date/Time: November 3, 2025, 12:30PM PT

• Exploring Supply Chain & CMC Advantages of Cell-Free Antibody Manufacturing to Design & Produce Unique ADCs
  
  • Presenter: Venkatesh Srinivasan, Ph.D.
  • Date/Time: November 4, 2025, 11:00AM PT

• Panel Discussion: Delving into Novel Design & Development to Strive for Next-Generation ADCs Providing Long-Term Benefit to Patients
  
  • Sutro Participant: Hans-Peter Gerber, Ph.D.
  • Date/Time: November 4, 2025, 5:00PM PT

• Developing Site-Specific Dual Payload ADCs Featuring Novel Linker Payloads to Overcome Resistance Mechanisms
  
  • Presenter: Krishna Bajjuri, Ph.D.
  • Date/Time: November 5, 2025, 11:00AM PT

• Panel Discussion: The Way Forward: What’s the New Path to the Next-Generation of ADCs?
  
  • Sutro Participant: Daniel Calarese, Ph.D.
  • Date/Time: November 5, 2025, 12:30PM PT

• Laying Out Discovery & Development of STRO-006: A Differentiated Topo1-ADC Targeting Integrin Beta-6
  
  • Presenter: Alice Yam, Ph.D.
  • Date/Time: November 5, 2025, 2:00PM PT

• Summary Panel Discussion: What is Showing the Most Promise & What Still Needs to be Proven in ADC Chemistry Innovation?
  
  • Sutro Participant: Hans-Peter Gerber, Ph.D.
  • Date/Time: November 5, 2025, 3:00PM PT

Following the event, the content will be made available in the Clinical/Scientific Presentation and Publication Highlights section of Sutro Biopharma’s website at www.sutrobio.com.

About Sutro Biopharma  
Sutro Biopharma, Inc. is advancing a next-generation antibody-drug conjugate (ADC) platform designed to deliver single- and dual-payload ADCs that enable meaningful breakthroughs for patients with cancer. By fully optimizing the antibody, linker, and payload, Sutro’s cell-free platform produces ADCs that are engineered to improve drug exposure, reduce side effects, and expand the range of treatable tumor types. With unique capabilities in dual-payload ADCs, Sutro aims to overcome treatment resistance and redefine what’s possible in cancer therapy. The Company’s pipeline of single- and dual-payload ADCs targets large oncology markets with limited treatment options and significant need for improved therapies.

For more information, follow Sutro on social media @Sutrobio or visit www.sutrobio.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated preclinical and clinical development activities; timing of announcements of IND submissions, clinical results, trial initiation, and other regulatory filings; outcome of discussions with regulatory authorities; potential benefits of the Company’s product candidates and platform; and potential market opportunities for the Company’s product candidates; . All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, the Company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the Company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the Company’s ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, the market size for the Company’s product candidates to be smaller than anticipated, clinical trial sites, supply chain and manufacturing facilities, the Company’s ability to obtain, maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, the Company’s ability to fund development activities and achieve development goals, the Company’s ability to protect intellectual property, and the Company’s commercial collaborations with third parties and other risks and uncertainties described under the heading “Risk Factors” in documents the Company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

CONTACT: Investor Contact
Emily White
Sutro Biopharma
(650) 823-7681
ewhite@sutrobio.com

Media Contact
Amy Bonanno
Lyra Strategic Advisory
abonanno@lyraadvisory.com

Actimed Therapeutics Further Expands Intellectual Property Portfolio for Lead Compound with New Composition of Matter Patent in Japan




Actimed Therapeutics Further Expands Intellectual Property Portfolio for Lead Compound with New Composition of Matter Patent in Japan

Patent expands IP protection for S-pindolol benzoate (ACM-001.1), reinforcing the global IP position of Actimed with granted patents in all key markets

London, UK – 3 November 2025. Actimed Therapeutics Ltd (“Actimed” or “the Company”), a UK-based clinical-stage specialty pharmaceutical company focused on the treatment of cancer cachexia and other muscle-wasting disorders, today announces that the Japan Patent Office (JPO) has granted a new composition of matter patent for S-pindolol benzoate (ACM-001.1), further strengthening the global intellectual property estate of the Company.

The Japanese patent provides broad protection relating to S-pindolol benzoate and its pharmaceutically acceptable forms, extending coverage beyond prior patents and complementing existing grants in the US and Europe. The protection in Japan encompasses the composition of matter for S-pindolol benzoate and is not restricted to specific therapeutic indications, ensuring long-term exclusivity for a wide range of potential clinical applications, including but not limited to cancer cachexia and other muscle-wasting conditions.

Robin Bhattacherjee, Actimed CEO, commented: “I am very pleased to announce the grant of this important patent in Japan, one of the world’s largest pharmaceutical markets. This award significantly strengthens our global IP position for S-pindolol benzoate and underscores the breadth of protection that we have secured for our lead compound. We continue to progress S-pindolol benzoate through clinical development, including the ongoing PROACT Phase 2a programme investigating it’s potential to reduce muscle-wasting in obese patients when used in combination with a GLP-1 receptor agonist. Robust patent coverage in key territories is a cornerstone of our strategy to bring innovative muscle-preserving therapies to patients who need them most.”

The newly granted Japanese patent joins a growing IP portfolio for Actimed, which includes multiple composition of matter and crystalline form patents already issued in the US and Europe. Together, these patents provide comprehensive protection for S-pindolol benzoate, a pro-anabolic and anti-catabolic transforming agent (ACTA) with a unique multi-modal mechanism of action targeting several key pathways involved in muscle wasting and cachexia.

***

About Actimed Therapeutics 
Actimed Therapeutics is a clinical stage specialty pharmaceutical company focused on advancing muscle health in cancer cachexia, obesity and other muscle wasting disorders.

Cachexia is a wasting disease associated with cancer and other serious chronic illnesses, characterised by severe weight loss and is associated with significant morbidity and mortality¹. Despite its prevalence in cancer patients and devastating clinical impact, there is no globally approved therapy for the treatment or prevention of cancer-related cachexia.

In obese patients receiving GLP-1RAs for weight management, reductions of lean muscle mass can occur alongside fat loss^2,3. Preserving muscle while achieving healthy weight reduction remains an important unmet need, highlighting the opportunity for novel approaches that support and preserve a healthy body composition.

Previous studies with S-pindolol have generated promising Phase 2a proof of concept data in cancer cachexia patients and Actimed has conducted a pharmacokinetic and pharmacodynamic (PK/PD) study of S-pindolol benzoate to characterise the benzoate salt of S-pindolol. In addition, early non-clinical data confirms a potential role for S-pindolol benzoate in preserving muscle mass when used in combination with a GLP-1 agonist for weight loss.

Actimed also owns the global rights to S-oxprenolol (ACM-002), which is being developed to treat the muscle wasting and loss of body mass seen in amyotrophic lateral sclerosis (ALS) where it may impact survival⁴. US Orphan Drug Designation has been granted to S-oxprenolol for the treatment of ALS. Actimed has licensed the global rights to develop and commercialise S-oxprenolol for all other indications outside of ALS to US company Faraday Pharmaceuticals.

FOR MORE INFORMATION
Actimed Therapeutics
www.actimedtherapeutics.com 

MEDiSTRAVA
Frazer Hall, Erica Hollingsworth
Tel: +44 (0)203 928 6900
Email: actimed@medistrava.com

___________________________
¹ Anker M et al., J. Cachexia, Sarcopenia and Muscle; 2019: 10: 22 – 24
²Wilding JPH, Batterham RL, Calanna S, et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity (2021) N Engl J Med.;384 (11):989–1002
³McCrimmon RJ, Catarig AM, Frias JP, et al. Effects of once-weekly semaglutide vs once-daily canagliflozin on body composition in type 2 diabetes: a substudy of the SUSTAIN 8 randomised controlled clinical trial. Diabetologia. 2020;63(3):473-485. doi:10.1007/s00125-019-05065-8
⁴ Wolf J et al., PMID 28184974 DOI: 10.1007/s00115-117-0293

VIVOLTA expands regenerative implant manufacturing capability with dedicated facility




VIVOLTA expands regenerative implant manufacturing capability with dedicated facility

VIVOLTA expands regenerative implant manufacturing capability with dedicated facility

New High Tech Campus Eindhoven site to enable electrospun medical implant production at scale

• Growth Momentum: Reflecting VIVOLTA’s sustained commercial growth and the increasing demand from customers for industrial-scale manufacturing of electrospun medical implants
• Customer-Centric Scaling: VIVOLTA is scaling to serve its customers’ next phase, providing reliable, high-quality manufacturing capabilities within an integrated CDMO model
• High Tech Campus Eindhoven, the perfect environment for VIVOLTA’s expansion: cutting-edge infrastructure, deep-tech ecosystem, and world-class talent

Eindhoven, the Netherlands – 31 October, 2025 – VIVOLTA, the specialist in electrospun medical implant manufacturing, has signed a long-term agreement for a dedicated production facility at High Tech Campus Eindhoven. The new site marks a major milestone in VIVOLTA’s growth, driven by increasing customer demand for industrial-scale manufacturing of regenerative medical implants.

Denis Leissing, CEO of VIVOLTA, said:
“This expansion reflects the next phase of our journey. We’re scaling our capabilities in step with our customers’ demands, ensuring they can rely on VIVOLTA for full development and large-scale manufacturing under one roof. High Tech Campus Eindhoven offers the infrastructure and ecosystem we need to make that possible.”

The new facility will host 400 square meters (4,300 square feet) of ISO Class 7-qualified cleanrooms and MediSpin™ production lines – VIVOLTA’s proprietary platform for high-throughput medical-grade electrospinning. The expansion adds much needed commercial manufacturing capacity to VIVOLTA’s existing ISO 13485-certified facility and reinforces VIVOLTA’s role as a fully integrated CDMO partner for next-generation implants across cardiovascular, wound care, orthopaedics, and soft tissue repair.

Positioned within Europe’s leading innovation Campus, the expansion strengthens VIVOLTA’s position in the deep-tech ecosystem, enabling greater collaboration, talent access, and operational capacity as the company continues to scale.

-ENDS –

Enquiries

About VIVOLTA
VIVOLTA is a leading contract development and manufacturing organization (CDMO) and end-to-end solutions provider of electrospun medical devices. Through its proprietary MediSpin™ platform, VIVOLTA enables global medtech innovators to bring advanced regenerative implants to market and greatly improve patient care.

www.VIVOLTA.com

About High Tech Campus Eindhoven

High Tech Campus Eindhoven is an ecosystem of 300 high tech companies and is home to more than 12,500 innovators, researchers and engineers who are creating the technologies and businesses of tomorrow.

www.hightechcampus.com

Avance Clinical Showcases Early Phase Expertise and the Australian Advantage for EU Biotechs at BIO-Europe Vienna




Avance Clinical Showcases Early Phase Expertise and the Australian Advantage for EU Biotechs at BIO-Europe Vienna

Helping European Biotechs Accelerate Early Phase Success With Faster Timelines, Lower Costs, and Globally Accepted Data

ADELAIDE, Australia, Nov. 03, 2025 (GLOBE NEWSWIRE) — Avance Clinical, the largest premium full-service Australian headquartered CRO with more than 30 years of early phase expertise, is highlighting its Early Phase Center of Excellence for Biotechs and the well-established Australian Advantage to European biotechs ahead of BIO-Europe in Vienna, November 3-5, 2025.

European biotechs under increasing investor and regulatory pressure are turning to Avance Clinical’s proven Australian pathway to achieve first-in-human (FIH) and early proof-of-concept studies with:

• Startup timelines in as little as 5-6 weeks from final protocol to study approval through Australia’s streamlined regulatory frameworks (CTN/CTA) and Avance Clinical’s deep early phase expertise
• Globally accepted trial data, recognized by EMA, FDA, and other regulators
• Up to 43.5% cash rebate through Australia’s R&D tax incentive program
• Seamless progression to global trials through Avance Clinical’s GlobalReady program and worldwide partner network of 2,000+ sites

“EU biotechs are often surprised to learn just how efficient Australia is for early phase research,” said Mark Harvill, CEO of Avance Clinical. “Our new Early Phase Center of Excellence for Biotechs underscores our commitment to scientific rigor, innovation, and helping sponsors reach critical milestones faster — without compromising quality.”

Avance Clinical has guided more than 710 emerging biotechs across 250+ therapeutic indications, supported by in-house scientific and regulatory affairs expertise, and best-in-class clinical operations. Its dedicated Early Phase Center of Excellence for Biotechs was designed specifically to meet the needs of international biotech sponsors navigating complex first-in-human and early development studies.

“With growing competition in biotech, speed and quality in early development are critical,” said Ben Edwards, Chief Operating Officer of Avance Clinical. “By combining the Australian Advantage, which offers up to 43.5% Australian Government R&D tax rebate, with our deep early phase expertise, EU sponsors can de-risk their programs and maintain capital efficiency while advancing quickly to global markets.”

Meet Avance Clinical at BIO-Europe Vienna

European biotechs attending BIO-Europe 2025 are invited to meet with Liahna Toy, Vice President, Commercial Business Development, and Dewald Jacobs, Director of Business Development, at Booth #C185 at the Vienna Congress & Convention Center (Messe Wien), November 3-5, 2025.

This is a unique opportunity for EU sponsors to discuss how Avance Clinical’s early phase expertise and the Australian Advantage can accelerate development pipelines.

Book a Meeting Now

About Avance Clinical

Avance Clinical is the largest premium full-service Australian headquartered CRO delivering high-quality clinical trials in Australia, New Zealand, Asia, North America, and Europe for international biotechs. The company has won multiple Frost & Sullivan CRO Market Leadership and Customer Value Leadership Awards.

With over 30 years of experience and cross-therapeutic expertise in more than 250 indications, Avance Clinical provides services from pre-clinical to late-phase trials, supported by best-in-class regulatory, clinical, and operational teams.

Find out more:

• Visit our website and submit a request for proposal: www.avancecro.com
• Discover the Australian Advantage
• Learn about our Early Phase Center of Excellence
• Book a meeting with our expert team
• Find out more about the EU Advantage

CONTACT:
Gabe Martinez
Director Content, Media, & PR
308-237-5567
Pr@scorrmarketing.com

A photo accompanying this announcement is available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/6bdfcdd6-822b-4af9-aa9a-832fc449ca24

AAVantgarde Closes $141 Million Series B Financing to Advance its Clinical Programs in Stargardt Disease and Usher 1B Syndrome




AAVantgarde Closes $141 Million Series B Financing to Advance its Clinical Programs in Stargardt Disease and Usher 1B Syndrome

LONDON and MILAN, Nov. 03, 2025 (GLOBE NEWSWIRE) — AAVantgarde Bio (AAVantgarde), a clinical-stage, biotechnology company pioneering therapies for inherited retinal diseases (IRDs), today announced the successful closing of a $141 million (€122 million) Series B financing round.

The round was co-led by a new lead, Schroders Capital, as well as existing investors Atlas Venture and Forbion. Other new investors included Amgen Ventures, Athos Capital, CDP Venture Capital through its Large Ventures Fund, Columbia IMC, Neva SGR, Sixty Degree Capital, XGen Venture, and Willett Advisors. AAVantgarde also received continued strong support from existing investors Longwood Fund and Sofinnova Partners.

The proceeds from the financing will support:

• Completion of clinical PoC of AAVantgarde’s AAVB-039 CELESTE study for Stargardt disease caused by a mutation in the ABCA4 gene and the completion of the > 100 patient STELLA natural history study.
• Completion of clinical PoC of AAVantgarde’s AAVB-081 LUCE phase 1/2 clinical trial for retinitis pigmentosa (RP) secondary to Usher 1B due to a mutation in the MYO7A gene.

Stargardt disease is the most prevalent macular dystrophy in young people, yet there are currently no approved treatments. AAVantgarde’s AAVB-039 program addresses the root genetic cause of this disease — mutations in the ABCA4 gene — through gene augmentation therapy that delivers the full-length ABCA4 protein, enabling treatment of any patient, regardless of the specific mutation.

Similarly, retinitis pigmentosa (RP) secondary to Usher syndrome 1B is a rare and devastating IRD caused by mutations in the MYO7A gene. Usher 1B causes progressive vision loss combined with congenital deafness, resulting in a double sensory disability. AAVantgarde’s AAVB-081 program targets the root genetic defect by delivering the full-length MYO7A protein by gene augmentation, offering a treatment potentially able to improve the lives of patients affected by this dual impairment.

“This investment is a strong endorsement of our team, our science, and two clinical IRD programs,” said Dr. Natalia Misciattelli, CEO of AAVantgarde. “Both programs address the root genetic causes of devastating conditions and offer hope of improvement to patients and families living with progressive vision loss.”

“We are proud to support AAVantgarde at this important stage of clinical development,” said Harry Raikes, Head of UK Venture Investments at Schroders Capital. “Its innovative platform could enable best-in-class treatments for inherited eye diseases like Usher 1B and Stargardt’s by overcoming key barriers in current AAV technologies and reaching patients who currently have limited treatment options.”

“Inherited Retinal Disorders (IRDs), such as Stargardt disease and RP secondary to Usher 1B, are among the leading causes of blindness in children and young adults worldwide” Dr. Peter Kaiser, Professor of Ophthalmology at the Cleveland Clinic Lerner College of Medicine and Aavantgarde Board member added: “This financing milestone represents a critical step forward in our ability to bring hope to patients affected by Usher 1B and Stargardt disease, two hereditary retinal disorders with urgent, unmet need and provides the potential to help these underserved patient populations and improving their lives.“

About AAVantgarde

AAVantgarde is a clinical stage, biotechnology company advancing best-in-class therapies for patients with inherited retinal diseases. The company’s lead programs target Stargardt disease and retinitis pigmentosa due to Usher syndrome type 1B, two severe, inherited retinal diseases with no approved treatments. With a strong foundation in translational science and a commitment to clinical excellence, AAVantgarde is working to bring transformative therapies to patients. For more information, please visit: www.aavantgarde.com

About Amgen Ventures

Since 2004, Amgen Ventures has invested in healthcare innovation to advance breakthrough medicines and technologies that will bring transformative medicines to patients. The team’s focus is on emerging, early-stage companies, which is a critical part of the biotech ecosystem. For more information please visit www.amgenbd.com

About Athos KG

With its heritage in healthcare and life sciences, ATHOS is a single-family office that supports entrepreneurs to positively impact health and well-being. Known to the broader public as the long-term majority investor of BioNTech, ATHOS remains committed to advancing medical innovation and building transformative companies for the future.

About Atlas Venture

Atlas Venture is a leading biotech venture capital firm. With the goal of doing well by doing good, we have been building breakthrough biotech startups for over 30 years. We work side by side with exceptional scientists and entrepreneurs to translate high impact science into medicines for patients. Our seed-led venture creation strategy rigorously selects and focuses investment on the most compelling opportunities to build scalable businesses and realize value. For more information, please visit www.atlasventure.com

About CDP Venture Capital

CDP Venture Capital is an asset management company where CDP Equity holds a 70% stake and Invitalia a 30% stake. It was set up with the goal of making Venture Capital a cornerstone of Italy’s economic development and innovation, creating the conditions for the overall, sustainable growth of the entire innovation ecosystem. CDP Venture Capital manages 15 investment funds, amounting to over EUR 4,7 billion in resources that support innovative companies at all stages of their life cycle, making both direct and indirect investments (funds of funds).
For more information, please visit: www.cdpventurecapital.it

About Columbia Investment Management Company

The Columbia Investment Management Company (IMC) is a wholly-owned subsidiary of Columbia University. The IMC is charged with managing the bulk of the University’s endowments, also known as managed assets. The formation of the IMC symbolizes the University’s dedication and commitment to the long-term investment management of the endowment with the highest professional standards. For more information please visit www.finance.columbia.edu/content/columbia-investment-management-company

About Forbion

Forbion is a leading global venture capital firm with deep roots in Europe and offices in Naarden, the Netherlands, Munich, Germany, and Boston, USA. Forbion invests in innovative biotech companies, managing approximately €5 billion across multiple fund strategies covering all stages of (bio)pharmaceutical drug development. In addition to its human health focus, Forbion also invests in planetary health solutions through its BioEconomy strategy. The firm’s team of over 30 investment professionals has a strong track record, with more than 130 investments across 11 funds, resulting in numerous approved therapies and successful exits. Forbion is a signatory to the UN Principles for Responsible Investment and operates a joint venture with BGV for seed and early-stage investments in the Benelux and Germany regions. For more information, please visit: www.forbion.com

About Longwood Fund

Longwood Fund is a venture capital firm dedicated to creating and investing in novel healthcare companies that develop important treatments to help patients while generating significant value for investors. The Longwood team has a long history of successfully launching and building important life science companies while providing operational leadership and strategic guidance. Collectively, the Partners at Longwood Fund have co-founded 25 companies with over 20 launched or marketed drugs and therapies, as well as over two dozen clinical stage assets, all focused on helping patients in need. Companies founded by Longwood Fund, or its principals prior to the founding of the Firm, as lead investor and CEO/CBO include Acceleron, Momenta, Alnylam, Vertex, Sirtris, Vor, TScan, Pyxis Oncology, Immunitas, Be Biopharma, Tome Bio, Photys, Carbon Biosciences, and DEM BioPharma. For more information, please visit www.longwoodfund.com

About Neva SGR

NEVA SGR is the venture-capital arm of the Intesa Sanpaolo Group — wholly owned by the Intesa Sanpaolo Innovation Center — dedicated to identifying, investing in and scaling the next generation of highly innovative companies that are addressing some of the world’s biggest challenges. Since its founding in 2020, NEVA SGR has backed breakthrough companies across four core domains: Climate Tech & Energy Transition, Life Sciences, Digital Transformation, and Aerospace & Manufacturing.

NEVA SGR leverages the financial strength, reputation and network of Intesa Sanpaolo, combined with the best practices of international venture capital, to provide strategic capital, market access, and operational support to its portfolio companies. NEVA SGR is also distinguished by its commitment to sustainability and impact: backing companies that deliver both strong growth potential and meaningful contributions to society and the planet. For more information, please visit www.nevasgr.com

About Schroders

Schroders Capital provides investors with access to a broad range of private market investment opportunities, portfolio building blocks and customised private market strategies. Its team focuses on delivering best-in-class, risk-adjusted returns and executing investments through a combination of direct investment capabilities and broader solutions in all private market asset classes, through comingled funds and customised private market mandates. The team aims to achieve sustainable returns through a rigorous approach and in alignment with a culture characterised by performance, collaboration and integrity.

With $111 billion (£81 billion; €94.5 billion)* assets under management, Schroders Capital offers a diversified range of investment strategies, including real estate, private equity, secondaries, venture capital, infrastructure, securitised products and asset-based finance, private debt, insurance-linked securities and BlueOrchard (Impact Specialists).

*Assets under management as at 30 June 2025 (including non-fee earning dry powder and in-house cross holdings)

About Sixty Degree Capital

Sixty Degree Capital (SDC) is a global venture capital firm headquartered in Toronto, dedicated to advancing innovation at the intersection of healthcare and technology. SDC partners with visionary entrepreneurs developing transformative therapeutics and healthcare solutions that have the potential to redefine standards of patient care. Through strategic guidance, deep industry expertise, and a world-class network, SDC empowers its portfolio companies to navigate complex challenges and translate breakthrough science into impactful products. For more information, please visit www.sixtydegreecapital.com

About Sofinnova Partners

Sofinnova Partners is a leading European venture capital firm in life sciences, specializing in healthcare and sustainability. Based in Paris, London, and Milan, the firm brings together a team of professionals from all over the world with strong scientific, medical, and business expertise. Sofinnova Partners is a hands-on company builder across the entire value chain of life sciences investments, from seed to later-stage. The firm actively partners with ambitious entrepreneurs as a lead or cornerstone investor to develop transformative innovations that have the potential to positively impact our collective future.

Founded in 1972, Sofinnova Partners is deeply established in Europe, with 50 years of experience backing over 500 companies and creating market leaders around the globe. Today, Sofinnova Partners manages over €4 billion in assets. For more information, please visit: sofinnovapartners.com.

About Willett Advisors LLC

Willett Advisors LLC (“Willett”) manages the philanthropic assets of Michael R. Bloomberg, including the assets of Bloomberg Philanthropies. The firm has its headquarters in New York. The firm’s objective is to achieve long-term capital appreciation through the construction of a diversified investment portfolio. Willett employs a flexible approach and has the ability, both through selected third-party managers and directly, to invest in a broad range of asset classes in order to achieve its goals. Similar to many endowments, foundations and family offices, Willett has historically focused on the following areas: public markets, hedge funds, private equity and credit, real assets and direct investments. For more information please visit www.willettadvisors.com

About XGen Venture SGR

XGEN Venture is a premier venture capital firm dedicated to advancing innovations in the life sciences sector. With nearly two decades of experience, the founding team has a proven track record of building breakthrough life sciences startups in Italy and internationally. XGEN is currently investing out of its first fund, XGEN Venture Life Science Fund, launched in 2022, and focusing on early-stage investments across biotechnology, medical devices, and diagnostics. For more information: www.xgenventure.com

Media Contact:

Barnaby Pickering

Director, 59 North Communications

Barnaby.Pickering@59north.bio

BOOST Pharma Adds Sound Bioventures to Investor Syndicate with SEK 34 Million Investment to Advance Stem Cell Therapy for Osteogenesis Imperfecta




BOOST Pharma Adds Sound Bioventures to Investor Syndicate with SEK 34 Million Investment to Advance Stem Cell Therapy for Osteogenesis Imperfecta

COPENHAGEN, Denmark, Nov. 03, 2025 (GLOBE NEWSWIRE) — BOOST Pharma ApS, a clinical-stage biopharmaceutical company focused on developing novel cell therapies for rare skeletal pediatric diseases, today announced that Sound Bioventures has joined its investor syndicate with a SEK 34 million investment. The financing will support continued clinical development of BT-101, BOOST Pharma’s pioneering stem cell-based therapy for osteogenesis imperfecta (OI), also known as brittle bone disease.

BOOST Pharma has made significant progress advancing BT-101, a novel mesenchymal stem cell therapy intended for children born with OI. BT-101 is designed for early intervention, administered to infants to address the underlying cause of OI and reduce fracture frequency in affected children. With this new investment, BOOST Pharma aims to accelerate clinical development and move closer to delivering the first disease-modifying therapy for OI, a devastating genetic condition with no currently approved treatments.

“We are honored to welcome Sound Bioventures to our syndicate—a collaborative, hands-on investor group that shares our vision of transforming care for children living with rare skeletal diseases,” said Ingelise Saunders, Chair of BOOST Pharma. “Their commitment strengthens BOOST Pharma’s position as a leader in cell therapy for genetic bone disorders and enables continued progress of BT-101 towards the clinic.”

“We believe BOOST Pharma’s innovative approach to treating osteogenesis imperfecta has enormous potential to deliver not only clinical impact for patients but also durable value creation. We look forward to working together to reach new milestones,” said Johan Kördel, Managing Partner at Sound Bioventures.

About BOOST Pharma
BOOST Pharma is a clinical-stage biopharmaceutical company focused on novel cell therapy treatments for rare pediatric diseases. The company’s lead therapy, BT-101, is designed to treat osteogenesis imperfecta (OI), a severe inherited condition that leads to significant physical disability. BOOST Pharma is supported by Industrifonden and Karolinska Development, Sweden.

About Sound Bioventures
Sound Bioventures is a specialist life sciences venture capital fund investing in about-to-be clinical or clinical stage private companies in Europe and the USA developing therapeutics in areas of significant clinical unmet need. The team has an active approach to investing and brings considerable operational and VC investment experience.

Forward Looking Statements
This press release contains forward-looking statements, which reflect BOOST Pharma’s current expectations regarding future events. Actual results may differ materially from those expressed or implied due to various factors. BOOST Pharma undertakes no obligation to update these statements.

Media Contact:
Jonathan Ilicki, Board Member
Email: jonathan.ilicki@industrifonden.com 
General inquiries: info@boostpharma.com