GenNx360 Capital Partners Portfolio Company Nutra-Med Packaging Appoints Hany Salama as Chief Executive Officer




GenNx360 Capital Partners Portfolio Company Nutra-Med Packaging Appoints Hany Salama as Chief Executive Officer

NEW YORK–(BUSINESS WIRE)–GenNx360 Capital Partners (“GenNx360”), a New York City-based private equity firm investing in middle-market industrial and business services companies, today announced the appointment of Hany Salama as Chief Executive Officer of its portfolio company, Nutra-Med Packaging (“Nutra-Med” or the “Company”), one of the leading contract development and manufacturing organizations serving the health, wellness, and pharmaceutical sectors. Mr. Salama succeeds Kunal Gupta, effective January 12, 2026.

Mr. Salama brings more than twenty years of global leadership experience across healthcare, biopharma, consumer health, and life sciences. He has held senior operational and commercial roles at some of the world’s most respected organizations, including Johnson & Johnson, Merck, Roche, and BASF. At Johnson & Johnson, he led end-to-end supply chain and manufacturing operations for major consumer brands across complex, highly regulated environments. Most recently, as Senior Vice President and General Manager at McKesson, Mr. Salama oversaw biopharma services, private-label strategy, commercialization, and specialty distribution, driving growth and operational transformation across large-scale, mission-critical platforms.

“Hany’s leadership experience at the intersection of regulated manufacturing, operational excellence, and commercial scale makes him exceptionally well suited to lead Nutra-Med into its next chapter,” said Marie Ffolkes, Managing Partner of GenNx360 Capital Partners. “As Nutra-Med continues to expand its capabilities and deepen customer partnerships, we are confident that Hany’s disciplined approach and strategic perspective will help accelerate growth and strengthen the Company’s market position.”

As Chief Executive Officer, Mr. Salama will focus on advancing Nutra-Med’s core manufacturing capabilities, expanding its service offerings, and scaling the platform to meet growing customer demand. He will work closely with the Company’s experienced leadership team to enhance quality systems, increase capacity, and further differentiate Nutra-Med as a trusted partner to customers across the health, wellness, and pharmaceutical markets.

“We are delighted to welcome Hany to Nutra-Med,” said Kunal Gupta, outgoing Chief Executive Officer. “I am incredibly proud of what our team has built over the past four years and believe Hany is the right leader to guide the Company through its next phase of growth. His experience, leadership style, and vision will be invaluable as Nutra-Med continues to evolve and pursue its significant market opportunity.” Mr. Gupta will transition into the role of President, where he will continue to support Nutra-Med’s long-term success.

“I am honored to join Nutra-Med at such a pivotal moment in the Company’s evolution,” said Mr. Salama. “I look forward to working with the talented Nutra-Med team to build on the Company’s strong foundation, continue delivering high-quality packaging solutions, and create lasting value for our customers and partners.”

About Nutra-Med

Nutra-Med is a Whippany, New Jersey-based company focused on contract packaging for the Pharmaceutical, Health & Wellness and Medical Devices industries. Nutra-Med’s primary service capabilities include bottling, blistering, kitting, and secondary packaging for domestic and global customers. For more information on Nutra-Med, please visit www.nutra-med.com.

About GenNx360 Capital Partners

GenNx360 Capital Partners is a private equity firm focused on acquiring middle market industrial and business services companies. GenNx360 invests in companies with proven and sustainable business models in expanding industries, with the objective of implementing value-enhancing operational improvements to accelerate growth, deliver efficiencies and generate strong financial returns. Target sectors include infrastructure & utility services, commercial & facility services, testing/environmental equipment/services, automation & industrial technology, industrial distribution/supply chain, packaging products/equipment services, food ingredients and equipment/services. GenNx360 was founded in 2006 and is headquartered in New York City. https://www.gennx360.com/

Contacts

Media Contact:
Edward Lopez

Profile Advisors

P: 646-818-9018

E: Elopez@profileadvisors.com

Abbelight Announces Successful Series B Investment led by AVANT BIO to Accelerate Imaging Innovation and Scale Adoption Across a Broader Customer Base




Abbelight Announces Successful Series B Investment led by AVANT BIO to Accelerate Imaging Innovation and Scale Adoption Across a Broader Customer Base

PARIS–(BUSINESS WIRE)–Abbelight, a global leader and a pioneer in super-resolution microscopy end-to-end solutions, today announced a successful Series B financing round led by AVANT BIO, a growth equity firm focused on enabling technologies shaping tomorrow’s therapeutics.

“With a decade of experience in the Life Science Research market, Abbelight has been transforming the way scientists see, quantify, and interpret all kinds of complex intracellular mechanisms. It’s now time to tailor our cutting-edge imaging toolbox to also address new key verticals, such as single cell phenotyping and mechanisms of action validation for drug discovery”, says Nicolas Bourg CTO and co-founder.

“Big things happen at the nanoscale – and Abbelight enables researchers to visualize precise sub-cellular structures like never before”, said Daniella Kranjac, Founding General Partner at AVANT BIO. “Their breakthroughs in super-resolution microscopy and sample-to-insight workflows embody the kind of enabling technologies that accelerate discovery and drive innovation across life sciences”.

“This is an exciting moment for Abbelight. The funding accelerates our commercial expansion and allows us to continue delivering best-in-class support to our 100+ installed base”, said Jean-Baptiste Marie, CEO and co-founder. “AVANT BIO’s support will be key to driving innovation and adoption across the broader bioindustry, including biopharma, biotech, and CROs”.

About Abbelight

Founded in 2016, Abbelight is a fast-growing company specializing in the development of microscopy and nanoscopy (SMLM) solutions. Its portfolio incorporates state-of-the-art chemistry, optics and data analysis enabling researchers at public research institutes and biotech companies to observe and understand complex biological mechanisms and interactions at nanoscale. Today, Abbelight employs around 60 people, all driven by the desire to provide innovative imaging solutions and to support its customers around the world. www.abbelight.com

About AVANT BIO

AVANT BIO is a growth equity firm focused on the enabling technologies which shape how tomorrow’s therapeutics are discovered, developed, and manufactured. With an investment focus engineered to accelerate new growth and innovation at various stages of company development, AVANT BIO is committed to amplifying value and unlocking the full potential of therapeutic enabling technologies, TechBio, and HealthTech. For further information, including opportunities to partner, visit www.avant.bio. Follow AVANT BIO on LinkedIn for the latest news and industry insights.

Contacts

Media:

Jean-Baptiste Marie, CEO

jbmarie@abbelight.com

Media:

Rich Ferraro

rich@avant.bio

Anaergia Appoints Sasha Rollings-Scattergood as Chief Technology Officer




Anaergia Appoints Sasha Rollings-Scattergood as Chief Technology Officer

Mr. Rollings-Scattergood will lead Anaergia’s end-to-end technology strategy, including R&D, product management, and the commercialization of proprietary systems

CARLSBAD, California & BURLINGTON, Ontario–(BUSINESS WIRE)–$ANRG #ANRG—Anaergia Inc. (TSX: ANRG) (OTCQX: ANRGF), a pioneering technology company and global leader in converting waste into renewable fuel, clean water, and fertilizer, appointed Sasha Rollings-Scattergood as Chief Technology Officer, effective January 1, 2026.

Mr. Rollings-Scattergood joined Anaergia in 2012 and progressed through increasingly senior leadership roles, most recently serving as Vice President Technology and Research and Development, while advancing the company’s proprietary technology platforms across global markets.

As Chief Technology Officer, Mr. Rollings-Scattergood will lead Anaergia’s product companies and centralized research and development organization, including stewardship of the company’s global intellectual property portfolio, with responsibility for advancing technologies into repeatable, commercially reliable platforms deployed across Anaergia’s global operations. In his new role, he will also lead Anaergia’s global technology profit and loss function and play an expanded role in shaping the company’s corporate direction and strategy, ensuring technology priorities align with Anaergia’s long-term growth and global expansion. Concurrently, he will continue to lead Anaergia’s end-to-end technology strategy, guiding research and development, product management, and the commercialization of proprietary systems across regions and markets.

“Sasha continues to play a vital role in building Anaergia’s technology leadership,” said Assaf Onn, Chief Executive Officer of Anaergia. “He successfully transforms innovation into systems that perform at commercial scale. His appointment strengthens our execution capabilities and reflects the critical role technology plays in Anaergia’s industry leadership.”

Under Mr. Rollings-Scattergood’s leadership, Anaergia has advanced core technology platforms, scaled proprietary processes from pilot to commercial deployment, and strengthened the integration between technology development and project delivery.

“Technology sits at the centre of Anaergia’s mission,” said Mr. Rollings-Scattergood. “I am proud of the teams we have built, and together we are advancing both breakthrough and continuously improving technologies that perform reliably at commercial scale, deliver measurable environmental benefits, and create durable, long-term value for our customers.”

An environmental engineer by training, Mr. Rollings-Scattergood holds a Bachelor of Science and a Master of Applied Science in Environmental Engineering from the University of Guelph. He is a licensed Professional Engineer in Ontario and has held senior technical and leadership roles with Anaergia in North America, Europe, and Asia. His work has supported the development and commercialization of several of Anaergia’s flagship systems, including OREX^® and other high-solids anaerobic digestion and nutrient recovery technologies.

Mr. Rollings-Scattergood has received industry recognition for his contributions to the clean energy sector, including being named to Forbes Magazine’s 30 Under 30: Energy list.

About Anaergia

Anaergia is a pioneering technology company in the RNG sector, with over 300 patents dedicated to converting organic waste into sustainable solutions such as RNG, fertilizer, and water. It is committed to addressing a significant source of greenhouse gas (GHG) emissions through cost-effective processes. Our proprietary technologies, combined with our engineering expertise and vast experience in facility design, construction, and operation, position Anaergia as a leader in the RNG industry. With a proven track record of delivering hundreds of innovative projects over the past decade, we are well-equipped to tackle today’s critical resource recovery challenges through diverse project delivery methods. As one of the few companies worldwide offering an integrated portfolio of end-to-end solutions, we effectively combine solid waste processing, wastewater treatment, organics recovery, high-efficiency anaerobic digestion, and biomethane production. Additionally, we operate RNG facilities owned by us, by third parties, or through joint ventures. This comprehensive approach not only reduces environmental impact but also significantly lowers costs associated with waste and wastewater treatment while mitigating GHG emissions.

For further information please see: www.anaergia.com

Contacts

For media and/or investor relations please contact: IR@Anaergia.com

EpiBiologics Closes $107M Series B to Advance Pipeline of Novel Bispecific Antibodies to Selectively Degrade Extracellular Protein Targets in Oncology and Immunology




EpiBiologics Closes $107M Series B to Advance Pipeline of Novel Bispecific Antibodies to Selectively Degrade Extracellular Protein Targets in Oncology and Immunology

Proceeds advance multiple programs, including EPI-326 into first-in-human clinical trial in early 2026 for EGFR-driven lung cancer and head and neck cancer

SAN MATEO, Calif.–(BUSINESS WIRE)–EpiBiologics, a leader in tissue-selective extracellular protein degradation, today announced the completion of a $107 million Series B financing co-led by GV (Google Ventures) and Johnson & Johnson, through its corporate venture capital organization, Johnson & Johnson Innovation – JJDC, Inc (JJDC).

Novartis Venture Fund (NVF), Aulis Capital, Avego BioScience Capital, and Samsara BioCapital joined JJDC as new investors. In addition to GV, existing investors Polaris Partners, Digitalis Ventures, Taiho Ventures, Vivo Capital, Codon Capital, and Mission BioCapital participated in the round.

“We’re delighted to work with this distinguished group of investors as we enter the next stage of EpiBiologics’ growth. This financing allows us to advance our pipeline of novel bispecific antibodies to selectively degrade disease-driving membrane and soluble targets in oncology and immunology,” said Ann Lee-Karlon, Ph.D., Chief Executive Officer of EpiBiologics. “Our lead program, EPI-326, is moving rapidly to the clinic as a highly differentiated therapeutic to address substantial unmet needs for patients with EGFR-driven cancers.”

EPI-326 is a tissue-selective bispecific antibody that degrades all oncogenic forms of EGFR, is mutation-agnostic, and overcomes limitations of existing EGFR therapies by localizing degradation to the tumor while sparing normal healthy tissue. In preclinical studies, EPI-326 drives strong and durable efficacy with favorable safety and pharmacokinetics, enabling both monotherapy and combination approaches for multiple cancer types.

EpiBiologics plans to initiate a first-in-human clinical trial of EPI-326 in early 2026 for non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC). The company continues to build key capabilities as it moves towards the clinic and appointed two new executives in 2025, Eric Humke, M.D. Ph.D., Chief Medical Officer, and Aaron Mishel, Chief Financial Officer, who both have deep biopharma leadership expertise.

Concurrent with Series B financing, the company welcomes new Board members: Anika Gupta Vatsa, Ph.D. (GV), Laura Brass, Ph.D. (NVF), Gaurav Aggarwal, M.D. (Vivo), and a representative from JJDC. Nisa Leung (Aulis), Eric Pham, Ph.D. (Avego), and Mitchell Mutz, Ph.D. (Samsara) will join as Board observers.

“As an early investor, I’ve been impressed by EpiBiologics’ rapid scientific and operational progress as they’ve built the EpiTAC platform and portfolio in oncology, immunology, and beyond,” said David Schenkein, M.D., General Partner at GV. “Anika and I are excited to co-lead this financing as the company translates this innovation into transformative medicines for patients.”

About EpiBiologics

EpiBiologics is advancing a next-generation protein degradation pipeline and platform that targets extracellular membrane and soluble proteins. EpiBiologics was founded on pioneering work from scientific founder Dr. Jim Wells of the University of California, San Francisco (UCSF). The Company’s proprietary EpiTAC platform is a modular bispecific antibody system that enables targeted degradation of disease-driving extracellular proteins in a tissue-specific manner. Headquartered in the San Francisco Bay Area, EpiBiologics is backed by leading healthcare investors and aims to develop first-in-class and best-in-class targeted therapies across multiple therapeutic areas, including oncology and immunology. For more information, please visit epibiologics.com and follow us on LinkedIn.

Contacts

Media Contact
Lisa Raffensperger

Ten Bridge Communications

lisa@tenbridgecommunications.com

FairJourney Bio to present at J.P. Morgan 2026 Healthcare Conference




FairJourney Bio to present at J.P. Morgan 2026 Healthcare Conference

PORTO, Portugal–(BUSINESS WIRE)–FairJourney Bio (FJBio), a global leader in antibody discovery and development, announced today that its Chief Executive Officer, Dr. Werner Lanthaler, will present at the J.P. Morgan 2026 Healthcare Conference, taking place from January 12 – 15, 2026 in San Francisco, CA.

With more than a decade of expertise, FJBio has supported over 250 clients across Pharma, Biotech and Academia and contributed to more than 19 antibodies advancing to clinical stage development or the market. During his presentation, Dr. Lanthaler will address FJBio’s strategic positioning as a highly efficient, integrated partner. He will showcase the Company’s antibody discovery and development solutions, with a focus on innovation, data-driven platforms and scalable collaboration models across the biopharmaceutical ecosystem.

In addition to the CEO presentation, members of FJBio’s Senior Management and Business Development teams will attend the conference for strategic discussions with representatives of global pharmaceutical companies, biotechnology innovators and other industry partners throughout the event.

Dr. Werner Lanthaler, Chief Executive Officer of FairJourney Bio, commented: “I look forward to presenting FairJourney Bio’s unique platform for partnered pipeline building at this year’s J.P. Morgan 2026 Healthcare Conference. This conference brings together a highly curated group of global healthcare leaders and innovators and I appreciate the opportunity to engage in meaningful dialogue around the future of efficient, data-enabled antibody discovery and development.”

Participation as a presenting company at this conference is highly selective and considered a significant distinction, reflecting FJBio’s growing global recognition and relevance within the international life sciences community. The conference provides an important platform for FJBio to strengthen existing relationships, explore new strategic partnerships and further position the Company as a trusted global partner across the full value chain.

Contacts

FairJourney Biologics
Hinnerk Rohwedder

Head of Marketing & Communications

hrohwedder@fjbio.com

Zyme Communications

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

Bayer and Soufflé Therapeutics Announce Strategic Collaboration to Advance Cell-Specific Heart-Targeted siRNA Therapy




Bayer and Soufflé Therapeutics Announce Strategic Collaboration to Advance Cell-Specific Heart-Targeted siRNA Therapy

Not intended for UK Media

• Collaboration focuses on developing potential best in class siRNA-based treatment for a form of dilated cardiomyopathy
• Bayer to further strengthen cardiovascular portfolio and enter dynamic field of siRNA by partnering with a leader in the field, Soufflé Therapeutics, to silence specific genes responsible for disease progression
• Soufflé leverages integrated proprietary technologies to engineer cell-selective siRNA therapy that targets cardiomyocytes to help address rare heart disease

BERLIN & BOSTON–(BUSINESS WIRE)–Bayer and Soufflé Therapeutics™, an innovative biotech company that discovers and develops cell-selective genetic therapies, today announced a strategic collaboration and global licensing agreement to advance a heart-targeted small interfering RNA (siRNA) therapy. The companies will collaborate to develop a siRNA-based treatment for a form of dilated cardiomyopathy, addressing a rare subset of heart disease.

“We are excited to partner with Soufflé and begin exploring the field of siRNA, an innovative therapeutic modality that can potentially silence specific genes responsible for disease progression,” said Juergen Eckhardt, M.D., Head of Business Development and Licensing at Bayer Pharmaceuticals and Head of Leaps by Bayer. “This new collaboration allows us to expand our relationship with Soufflé, beyond our initial investment via Leaps by Bayer, the strategic investment unit of Bayer, further reinforcing our commitment to innovation and patients.”

Soufflé engineers cell-specific ligands to facilitate the precise delivery of siRNA-based medicines across cell membranes and directly in to target cells. By combining proprietary methods for identifying cell-specific receptors, optimizing ligands, and engineering potent siRNA, Soufflé aims to create safer, stronger, and more durable therapeutic options.

The collaboration will leverage Soufflé’s integrated technologies and expertise to deliver a new siRNA-based medicine specifically to heart muscle cells. This approach aims to overcome traditional hurdles associated with delivery of genetic medicine to its target, which can lead to off-target effects or the need for more frequent dosing. Through precise targeted delivery to cells within heart tissues, Bayer and Soufflé are working to deliver transformative impact for patients suffering from dilated cardiomyopathies.

“Delivery of nucleic acids to specific cells has been a long-standing challenge in the development of effective RNA therapies. At Soufflé, we engineer siRNA therapies that are cell-selective and delivered to their target with precision,” said Amir Nashat, Sc.D., Chief Executive Officer, Soufflé Therapeutics. “This collaboration brings together Bayer’s expertise in cardiovascular disease, with Soufflé’s proprietary integrated technologies, to develop a potential new option for patients facing a rare heart disease and will further validate the potential of our technologies to help a broad range of patients.”

“Dilated cardiomyopathies represent a significant medical need, affecting many patients with limited treatment options,” said Andrea Haegebarth, Ph.D., Global Head of Research and Early Development for Cardiovascular, Renal, and Immunology at Bayer’s Pharmaceuticals Division. “Our collaboration with Soufflé is a strategic step forward in addressing this challenge, as it will enhance our precision cardiology portfolio with an innovative siRNA technology. Together we aim to develop a more effective therapy that can potentially make a difference in patients’ lives.”

Financial details of the collaboration have not been disclosed.

About Soufflé Therapeutics™

Soufflé Therapeutics is a biotech with a vision that potent, precise, and safe medicines can be designed and developed for all diseases. The company is redefining how medicines are made by combining proprietary technologies to identify cell-specific receptors, optimize ligands and engineer potent siRNA to develop safer, stronger, and more durable medicines which will help improve patient lives. Soufflés initial programs target skeletal muscle and cardiomyocytes to help people living with various muscle dystrophies, heart failure and metabolic disorders. To learn more about Soufflé, our expert team and our work to change the lives of patients, visit souffletx.com.

About Bayer’s Commitment in Cardiovascular and Kidney Diseases

Bayer is a leader in the area of cardiology and is advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The strategy is to unlock the strong potential of the future cardiovascular market by transforming Bayer’s portfolio into precision cardiology, addressing the high disease burden, and driving long-term growth. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated.

About Leaps by Bayer

Leaps by Bayer aims to solve ten huge challenges through scientific breakthroughs. As the strategic investment unit of Bayer, Leaps has invested over $2.1 billion in more than 65 companies pursuing breakthroughs in health and agriculture. Through these investments in emerging platforms and technologies, we aim to conquer ten significant challenges or ‘Leaps’. www.leaps.bayer.com

About Bayer

Bayer is a global company with core competencies in health and agriculture in the life sciences sector. The company is committed to helping people and the planet thrive through products and services that help people overcome the major challenges posed by a growing and aging global population. Bayer is committed to driving sustainability and making a positive impact on its business. At the same time, the Group is also improving profitability and creating value through technological innovation and business growth. Globally, the Bayer brand stands for trustworthiness, reliability and quality. In fiscal 2024, Bayer had approximately 93,000 employees and sales of 46.6 billion euros. R&D investment, excluding special projects, amounted to EUR 6.2 billion. See www.bayer.com for more information.

Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contacts

Bayer U.S. Media Contact:

Elaine Colón
Email: elaine.colon@bayer.com
Phone +1-732-236-1587

Soufflé Media Contact:
Arran Attridge
Email: arran.attridge@Souffletx.com

Allotex Advances from European Commercialization to U.S. Clinical Phase




Allotex Advances from European Commercialization to U.S. Clinical Phase

BOSTON–(BUSINESS WIRE)–#eye–Allotex Inc., a commercial-stage ophthalmic company with active European market adoption, today announced that the U.S. Food and Drug Administration (FDA) has conditionally approved its Investigational Device Exemption (IDE), authorizing the initiation of a U.S. clinical study for ALLO-1™, its proprietary tissue-based solution for presbyopia.

This conditional IDE approval represents a significant step-change in value, transitioning Allotex from commercialization in Europe, Canada, and other regions to FDA-governed U.S. clinical execution, and positioning the company for global scale.

“This is not an early science milestone — this is an expansion milestone,” said Michael Mrochen, Founder and CEO. “Allotex already has real-world clinical use in Europe, and with the FDA now allowing the clinical study to begin, we can translate that momentum into U.S. clinical data, materially accelerating our path toward creating a new category in surgical presbyopia correction. With commercialization outside the U.S. already underway, FDA approval to begin a U.S. clinical study, and multiple near-term value inflection points ahead, Allotex is selectively engaging investors to support its global scale-up strategy.”

About Allotex

Allotex is a commercial-stage ophthalmic company in Europe and a U.S. clinical-stage company pioneering Tissue Addition Technology—a new category of vision correction designed to restore vision using natural human tissue. The FDA’s conditional approval of an Investigational Device Exemption (IDE) permits the initiation of a clinical investigation but does not imply future regulatory approval in the United States. The Allo-1™ product is currently not approved for commercial use in the U.S.

Contacts

Press Contact:
Allotex Inc, Allotex, Inc. 27-43 Wormwood Street, Boston MA 02210

Email: info@allotex.com

4Moving Biotech Receives FDA IND Clearance for 4P004, Strengthening Its Position as a Leading Innovator in Disease-Modifying Osteoarthritis Therapeutics




4Moving Biotech Receives FDA IND Clearance for 4P004, Strengthening Its Position as a Leading Innovator in Disease-Modifying Osteoarthritis Therapeutics

• FDA IND clearance enabling the worldwide expansion of the INFLAM MOTION Phase 2a trial, involving major U.S. sites
• Advancing the first clinical proof of concept in OA with a first-in-class intra-articular GLP-1 agonist
• A holistic clinical strategy design establishing the foundation for a future accelerated approval pathway

LILLE, France & PARIS–(BUSINESS WIRE)–4Moving Biotech (4MB), a clinical stage biotechnology company developing next-generation, disease-modifying therapies for osteoarthritis (OA), today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for 4P004, enabling the expansion of the Phase 2a INFLAM MOTION clinical trial into the United States (US).

The U.S. Food and Drug Administration (FDA) approval marks another strategic step in 4MB’s global clinical deployment across Europe, Canada, and now the U.S., reinforcing the company’s role as a front-runner in the race to deliver the first disease-modifying osteoarthritis drug (DMOAD) to patients worldwide. Preclinical studies have shown that 4P004 can modulate multiple biological markers across the whole joint, supporting its potential as a first-in-class DMOAD capable of slowing structural impairment and improving joint function.

“FDA’s clearance of our IND represents a major validation of our program and enables the full execution of our clinical strategy across Europe, Canada, and the United States,” said Luc Boblet, Chief Executive Officer of 4Moving Biotech. “This milestone strengthens our position as one of the most advanced DMOAD developers globally and brings us closer to demonstrating the transformative potential of 4P004 for the millions of patients worldwide who currently have no disease-modifying options.”

The INFLAM MOTION trial is a 3-month, multicenter, randomized, double-blind, placebo-controlled Phase 2a study designed to enroll 129 patients suffering from knee osteoarthritis with synovitis. The trial includes:

• Pain assessment at Week 4 as the primary endpoint
• Pain, function, and contrast-enhanced MRI structural assessment of the synovial membrane at Week 12
• Exploratory surrogate biomarkers predictive of progression

This unique combination of clinical, imaging, and biomarker elements forms the foundation for future interactions with regulatory agencies on accelerated or conditional approval pathways, thereby strategically positioning 4P004 within the highest-priority segment of OA drug development.

“4P004, a GLP-1 receptor agonist administered intra-articularly, allows specific targeting of the diseased joint and joint tissues, aiming to relieve pain while also addressing the underlying disease process, thus offering an exciting novel approach for patients living with painful knee osteoarthritis. As the U.S. Coordinating Investigator, I am pleased to support the INFLAM MOTION study and look forward to evaluating this promising therapeutic approach for patients with knee osteoarthritis.” Thomas J. Schnitzer, MD, PhD, Professor of Medicine, Northwestern University

Professor Francis Berenbaum, MD, PhD, Chief Medical Officer of 4Moving Biotech, concluded: “The regulatory progress across three major regions underscores the scientific robustness of 4P004. INFLAM MOTION is designed to deliver clinically meaningful pain improvement while generating high-resolution structural and biological data to guide the next stage of development. We believe 4P004 has the potential to redefine how osteoarthritis is treated.”

4Moving Biotech will initiate patient enrollment in the United States in Q1 2026, following site activation and investigator onboarding.

About 4Moving Biotech

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

Website: www.4movingbiotech.com
LinkedIn: https://fr.linkedin.com/company/4moving–biotech
X : https://x.com/4Moving_Biotech

Contacts

Press Contact :

Emmanuel Dadje

Communication Manager

emmanuel.dadje@4P-Pharma.com
Phone : +33 6 30 06 12 13

Organon Enters into a Commercialization Agreement for Daiichi Sankyo’s Nilemdo® in France, Denmark, Iceland, Sweden, Finland and Norway




Organon Enters into a Commercialization Agreement for Daiichi Sankyo’s Nilemdo® in France, Denmark, Iceland, Sweden, Finland and Norway

The agreement builds on Organon’s cardiovascular disease portfolio, leveraging expertise to expand access to new treatments for patients with dyslipidemia, especially statin-intolerant patients.

This collaboration addresses a critical gap in care that disproportionately affects women, who are at a 47% higher risk of developing statin intolerance compared to men.ⁱ

JERSEY CITY, N.J.–(BUSINESS WIRE)–Organon today announced that it has entered into an agreement with Daiichi Sankyo Europe to commercialize Nilemdo^® (bempedoic acid) in France, Denmark, Iceland, Sweden, Finland and Norway. Nilemdo^® is a new, first-in-class drug indicated for patients with high cholesterol and cardiovascular disease risk. It provides an alternative treatment for patients that cannot be treated effectively with statins.ⁱⁱ

“This collaboration combines Organon’s commercial agility with Daiichi Sankyo’s expertise in cardiovascular innovation to bring Nilemdo^® to patients in France, Denmark, Iceland, Sweden, Finland and Norway,” says Thibault Crosnier Leconte, AVP & Managing Director at Organon Northwest Europe. “By offering a new treatment option for patients who cannot tolerate statins, we are helping to close a persistent gap in cardiovascular care—one that disproportionately affects women – whilst reinforcing our mission to deliver impactful treatments for a healthier every day.”

Cardiovascular disease is the leading cause of death in Europeⁱⁱⁱ and for women worldwide,^iv however it remains understudied, under-recognized, under-diagnosed and under-treated.^v

Nilemdo^® is the first and only treatment in its class available in these markets and provides healthcare professionals with a new therapy to reduce cardiovascular risk in patients unable to achieve adequate LDL-C reduction with statins or other lipid-lowering therapies, or in patients who are statin-intolerant or for whom statins are contraindicated.

Under the terms of the agreement, Organon will distribute and promote Nilemdo^® in France, Denmark, Iceland, Sweden, Finland and Norway. Daiichi Sankyo Europe will remain the marketing authorization holder for the product and Organon will be local representative in the territory.

About Nilemdo^®

Nilemdo^® is a lipid-lowering drug containing bempedoic acid, which inhibits ATP-citrate lyase, a key enzyme in the cholesterol biosynthesis pathway. It was approved by the European Medicines Agency (EMA) in February 2020.

Indications and use in the EU:

Hypercholesterolaemia and mixed dyslipidaemia

Nilemdo^® is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:

• in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach low-density lipoprotein cholesterol (LDL-C) goals with the maximum tolerated dose of a statin or,
• alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Cardiovascular disease

Nilemdo^® is indicated in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:

• in patients on a maximum tolerated dose of a statin with or without ezetimibe or,
• alone or in combination with ezetimibe in patients who are statin-intolerant, or for whom a statin is contraindicated.

The recommended dose is one 180 mg tablet taken orally once daily. Nilemdo^® can be taken with or without food. If a dose is missed, the patient should take the tablet immediately and resume the usual schedule the next day.

Nilemdo^® is intended for oral use only. Complete dosage and administration instructions are provided in the medication leaflet which can be found here: Nilemdo, INN-bempedoic acid. Please consult with your healthcare professional.

Patients should be monitored regularly to assess the effectiveness and safety of the treatment, with adjustments made as needed based on individual response and tolerance.

About Organon

Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets.

Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook.

Cautionary Note Regarding Forward-Looking Statements

Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon’s expectations about regarding its commercialization agreement for Daiichi Sankyo’s Nilemdo® in France, Denmark, Iceland, Sweden, Finland and Norway. Forward-looking statements may be identified by words such as “potential,” “mission,” “expects,” “will,” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the SEC, including Organon’s most recent Annual Report on Form 10-K (as amended), Quarterly Reports on Form 10-Q (as amended), Current Reports on Form 8-K, and other SEC filings, available at the SEC’s Internet site (www.sec.gov). Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

Media:

Karissa Peer

(614) 314-8094

Felicia Bisaro

(646) 703-1807

Investor:

Jennifer Halchak

(201) 275-2711

Azafaros to Present at J.P. Morgan’s 44th Annual Healthcare Conference




Azafaros to Present at J.P. Morgan’s 44th Annual Healthcare Conference

LEIDEN, Netherlands–(BUSINESS WIRE)–#Adults—Azafaros, a company building a portfolio to become a leader in lysosomal storage disorders with the goal of addressing neurological symptoms, today announced that it will present at J.P. Morgan’s 44^th Annual Healthcare Conference on Thursday, January 15.

The company’s presentation will begin at 9:30 am PT/12:30 am ET/6:30 am CET.

The presentation will focus on the company’s lead product, nizubaglustat, a potential treatment for rare lysosomal storage disorders with neurological involvement including GM1/GM2 gangliosidoses and Niemann-Pick type C disease ((NPC).

Two pivotal Phase 3 studies investigating nizubaglustat in GM1/GM2 gangliosidoses and NPC are currently enrolling, with data expected in 2027. The studies build on positive data from a robust clinical program including the Phase 2 RAINBOW study and the PRONTO natural history study. The Phase 3 studies are financed following the company’s successful completion of €132 million series B round completed in 1H 2025.

About nizubaglustat

Nizubaglustat is a small molecule, orally available and brain penetrant azasugar with a unique dual mode of action, developed as a potential treatment for rare lysosomal storage disorders with neurological involvement, including GM1 and GM2 gangliosidoses and Niemann-Pick type C disease (NPC).

Nizubaglustat has received Rare Pediatric Disease Designations (RPDD) for the treatment of GM1 and GM2 gangliosidoses and NPC, Orphan Drug Designations (ODD) for GM1 and GM2 gangliosidosis (Sandhoff and Tay-Sachs Diseases) and NPC, as well as Fast Track Designation and IND clearance for GM1/GM2 gangliosidoses and NPC from the US Food and Drug Administration (FDA). Additionally, nizubaglustat has been awarded Orphan Medicinal Product Designation (OMPD) for the treatment of GM1 and GM2 gangliosidoses by the European Medicines Agency (EMA) and Innovation Passport for the treatment of GM1 and GM2 gangliosidoses from the UK Medicines and Healthcare Products Regulatory Agency (MHRA).

About GM1 and GM2 gangliosidoses

GM1 gangliosidosis and GM2 gangliosidosis (Tay-Sachs and Sandhoff diseases) are lysosomal storage disorders caused by the accumulation of GM1 or GM2 gangliosides respectively, in the central nervous system (CNS). This results in progressive and severe neurological impairment and premature death. These diseases mostly affect infants and children, and no disease-modifying treatments are currently available.

About Niemann-Pick type C disease (NPC)

Niemann-Pick Type C disease is a progressive, life-limiting, neurological, lysosomal storage disorder, caused by mutations in the NPC1 or NPC2 gene and aberrant endosomal-lysosomal trafficking, leading to the accumulation of various lipids, including gangliosides in the CNS. The onset of the disease can happen throughout the lifespan of an affected individual, from prenatal life through adulthood.

About Azafaros

Azafaros is a clinical-stage company founded in 2018 with a deep understanding of rare genetic disease mechanisms using compound discoveries made by scientists at Leiden University and Amsterdam UMC and is led by a team of highly experienced industry experts. Azafaros aims to build a pipeline of disease-modifying therapeutics to offer new treatment options to patients and their families. By applying its knowledge, network and courage, the Azafaros team challenges traditional development pathways to rapidly bring new drugs to the rare disease patients who need them. Azafaros is supported by leading healthcare investors including Forbion, Jeito Capital, Seroba, Pictet Group, BioGeneration Ventures (BGV), BioMedPartners, Asahi Kasei Pharma Ventures, and Schroders Capital.

Contacts

For further information:
Azafaros B.V.

Email: info@azafaros.com
www.azafaros.com