Author Archives:

NRG Therapeutics Announces First Participants Dosed in its First-in-Human Phase 1 Clinical Trial of NRG5051 Which is Being Developed as a Disease-modifying Treatment for ALS/MND and Parkinson’s

Posted on by

NRG Therapeutics Announces First Participants Dosed in its First-in-Human Phase 1 Clinical Trial of NRG5051 Which is Being Developed as a Disease-modifying Treatment for ALS/MND and Parkinson’s




NRG Therapeutics Announces First Participants Dosed in its First-in-Human Phase 1 Clinical Trial of NRG5051 Which is Being Developed as a Disease-modifying Treatment for ALS/MND and Parkinson’s

STEVENAGE, United Kingdom, Jan. 08, 2026 (GLOBE NEWSWIRE) — NRG Therapeutics Ltd. (“NRG”), a clinical stage neuroscience company targeting a novel mechanism to rectify mitochondrial dysfunction in neurodegenerative diseases, is pleased to announce that the first participants have been dosed in its first-in-human Phase 1 clinical trial of its lead candidate NRG5051 which is being developed as a treatment for amyotrophic lateral sclerosis (ALS)/motor neuron disease (MND) and Parkinson’s.

NRG5051 is a first-in-class, orally bioavailable and CNS-penetrant next-generation inhibitor of the mitochondrial permeability transition pore (mPTP), acting through a novel undisclosed mitochondrially-localized protein regulator.

This Phase 1 randomized, double-blind trial is a combined single and multiple ascending dose trial of NRG5051 designed to assess safety, tolerability and pharmacokinetic parameters in healthy volunteers. It is being conducted at the Centre for Human Drug Research (CHDR) in Leiden, The Netherlands1. The clinical trial is expected to readout by the end of 2026 and will inform dose selection in future studies in ALS/MND and Parkinson’s patients.

The mPTP is a well-established driver of mitochondrial dysfunction, inflammation, and neuronal death in neurodegenerative disorders. Mitochondria are crucial for energy production, especially in substantia nigra neurons (Parkinson’s) and motor neurons (ALS/MND) which have high energy demands and consequently are particularly sensitive to mitochondrial health. The pathological proteins in ALS/MND (TDP-43) and Parkinson’s (a-synuclein) are toxic to mitochondria, driving mitochondrial dysfunction which is a common underlying pathology in these diseases. NRG5051 has been shown to be neuroprotective and anti-inflammatory in in vivo preclinical models of ALS/MND and Parkinson’s.

NRG Therapeutics’ co-founder and CEO Neil Miller said, “The start of our first clinical trial marks a proud moment for NRG as we transition into a clinical stage company. Our ultimate objective is to establish the therapeutic efficacy of our novel mPTP inhibitors as disease-modifying medicines that are designed to slow or prevent the progression of neurodegenerative diseases, and this first-in-human trial is a significant step toward that goal.”

ALS/MND is a rare, rapidly progressing neurodegenerative disease with high unmet medical need. In 2023 the FDA approved Qalsody (tofersen) as a disease-modifying treatment for a rare genetic form of ALS/MND based on a biomarker (reduction in neurofilament light chain) and clinical data. However, patients with sporadic disease remain poorly treated by existing medicines. Parkinson’s is one of the fastest growing neurodegenerative conditions with a global prevalence predicted to double by 2050. There is currently no treatment available to slow or halt progression of Parkinson’s, with existing medicines providing temporary symptomatic relief only.

  1. NRG5051-101 – Research into the safety of a new agent (NRG5051) in healthy adults and patients with Parkinson’s disease or ALS, EUCT number: 2025-523872-22-00, https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2025-523872-22-00]

Media enquiries (for NRG Therapeutics)
Sue Charles, Charles Consultants – +44 7968 726585 sue@charles-consultants.com

About NRG Therapeutics – https://www.nrgtherapeutics.com

NRG Therapeutics is a clinical stage neuroscience company building a pipeline of disease-modifying mitochondrial therapeutics to slow or halt the progression of neurodegenerative disorders such as amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND), and Parkinson’s.

The Company’s pipeline of small molecule assets is based on inhibiting the mitochondrial permeability transition pore (mPTP) through a novel mechanism of action. Inhibition of the mPTP has been shown to protect neurons, reduce neuroinflammation and improve motor function in pre-clinical disease models. Its lead candidate, NRG5051, is currently in a Phase 1 clinical trial.

Based at the Stevenage Bioscience Catalyst (SBC), UK, NRG Therapeutics is a private company with equity investment from Brandon Capital, British Business Bank, Criteria Bio Ventures, Dementia Discovery Fund, M Ventures, Novartis Venture Fund, Omega Funds and Parkinson’s UK. The company has also received awards from Innovate UK (Biomedical Catalyst Award), The Michael J. Fox Foundation, Target ALS and The ALS Association to support its innovative R&D programmes.

Follow us on LinkedIn.

Oculis to Showcase Transformative Late-stage Pipeline in Neuro-ophthalmology and Ophthalmology at the 2026 J.P. Morgan Healthcare Conference

Posted on by

Oculis to Showcase Transformative Late-stage Pipeline in Neuro-ophthalmology and Ophthalmology at the 2026 J.P. Morgan Healthcare Conference




Oculis to Showcase Transformative Late-stage Pipeline in Neuro-ophthalmology and Ophthalmology at the 2026 J.P. Morgan Healthcare Conference

  • Breakthrough therapy designation granted as Company advances the PIONEER registrational program in optic neuropathies to create a potential market of $7B+ in the U.S. alone
  • Multiple milestones anticipated from late-stage portfolio including topline results from DIAMOND Phase 3 trials with OCS-01 eye drops in diabetic macular edema (DME) expected in Q2 2026
  • Riad Sherif, M.D., Chief Executive Officer, will present at the J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 1.30pm PST

ZUG, Switzerland, Jan. 08, 2026 (GLOBE NEWSWIRE) — Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis”), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in ophthalmology and neuro-ophthalmology, today announced that the transformative potential of its late-stage pipeline, including breakthrough therapy Privosegtor, the novel neuroprotective candidate in development for optic neuropathies, and novel eye drop candidate, OCS-01, for diabetic macular edema, will be highlighted in its company presentation at the upcoming 44th Annual J.P. Morgan Healthcare Conference in San Francisco, California.

Oculis recently announced that Privosegtor, a neuroprotective candidate, has been granted breakthrough therapy designation by the U.S. FDA for the treatment of optic neuritis based on the successful ACUITY Phase 2 trial results. Privosegtor is a novel peptoid small molecule designed to cross both the blood–brain and retinal barriers and has the potential to become the first neuroprotective therapy for optic neuropathies. These serious conditions carry a significant unmet need as they can lead to permanent vision loss from nerve cell damage or death.

In the ACUITY trial, Privosegtor delivered substantial improvements in vision on the 2.5% ETDRS Low-Contrast Letter Acuity chart. Patients receiving Privosegtor 3mg/kg/day plus IV methylprednisolone gained an average of 18 letters at three months compared with placebo plus IV methylprednisolone. For context, a 15‑letter (three‑line) gain represents a two‑fold improvement in visual resolution and is considered clinically meaningful for patients. Privosegtor also showed anatomical preservation of retinal and optic nerve structure, which are typically damaged during acute optic neuritis. Additional analyses showed reduced neurofilament release, a biomarker of neuroaxonal damage, in conditions such as multiple sclerosis. The most common drug‑related adverse events (AEs) were headache and acne (each in two participants; 10.5%). No drug‑related serious AEs or AEs leading to treatment or study discontinuations occurred.

Following a successful meeting with the FDA in 2025, Oculis launched the PIONEER program, which includes three pivotal trials to support registration plans for Privosegtor in two indications: optic neuritis and a second rare neuro-ophthalmic disease, non-arteritic anterior optic neuropathy (NAION). These two optic neuropathies represent a potential market opportunity exceeding $7 billion in the U.S. alone, given the significant unmet medical need. The first trial in the program, PIONEER‑1 in optic neuritis, was initiated in Q4 last year. This global study spans three continents, sites activation is underway, and enrollment is expected to begin shortly.

Oculis’s most advanced product candidate, OCS-01, is currently in Phase 3 development and aims to be the first eye drop for diabetic macular edema (DME). In the U.S. alone, the diagnosed DME population is estimated to be around 1.8 million1 and currently represents a ~$3 billion market opportunity1 with high unmet medical needs for early intervention and for patients with inadequate response to standard of care, which could be addressed with OCS-01 eye drops, if approved. Topline results from both DIAMOND Phase 3 trials are expected in Q2 2026 with NDA submission to the FDA planned for Q4 2026.

Riad Sherif, M.D., Chief Executive Officer of Oculis, stated, “With Privosegtor advancing as a neuroprotective platform, starting with optic neuropathies as the initial focus, Oculis is uniquely positioned to transform the treatment landscape in areas with substantial unmet needs in neuro-axonal diseases, potentially creating a market exceeding $30 billion. 2026 is set to be a milestone-rich year across Oculis’ late-stage portfolio, including the much-anticipated OCS-01 DIAMOND Phase 3 trials readout in diabetic macular edema, which we look forward to in Q2 2026.”

Riad Sherif, M.D., Chief Executive Officer of Oculis, will present at the 44th Annual J.P. Morgan Healthcare Conference as below:

Date: Wednesday, January 14, 2026
Time: 1:30pm (PST)
Venue: Westin St. Francis Hotel, 335 Powell Street, San Francisco, CA94102 (USA)

An audio webcast and replay of the presentation will be available on the J.P. Morgan website. The presentation will also be posted to the Oculis website on the Events & Presentation page under the Investors & Media section.

About Privosegtor
Privosegtor, a novel peptoid small-molecule candidate that penetrates the blood-brain and retinal barriers, has the potential to become the first neuroprotective therapy for optic neuritis (ON) and other neuro-ophthalmic diseases. Positive results from the ACUITY Phase 2 trial demonstrated Privosegtor’s neuroprotective potential through anatomical preservation of the retina and improvements in visual function after an acute episode of optic neuritis. Consistent results were observed in animal models of neuroinflammation and neurodegeneration, where Privosegtor preserved retinal ganglion cell damage and was associated with improvements in mobility (clinical function disability). Privosegtor has received Breakthrough Therapy designation from the FDA and Orphan Drug designation from both the FDA and the EMA for ON and is now entering registrational trials for this indication, as well as a registrational trial in non-arteritic anterior ischemic optic neuropathy (NAION), as part of Oculis’ PIONEER (Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research) program. In addition to its potential neuroprotective effect on the optic nerve, Privosegtor could also have wide applicability in treating other neuro-ophthalmic and neurological indications.

Privosegtor is an investigational drug and has not received regulatory approval for commercial use in any country.

About Optic Neuritis
Optic Neuritis (ON) is a rare condition characterized by an acute inflammation of the optic nerve that can lead to permanent visual impairment. It affects up to 8 in 100,000 people worldwide with a U.S. incidence estimated to be >30,000 and often represents the first sign of multiple sclerosis2. It mainly occurs in adults between the age of 20 and 40 years and is more frequent in women (2:1)3. ON is a type of neuropathy (nerve disease) that happens when acute inflammation of the optic nerve affects the signals traveling from the eyes through the brain, causing pain, vision loss and other symptoms. The cells that make up the optic nerve have a lipid protective coating called a myelin sheath, which is preferentially damaged in ON. Without myelin, the optic nerve cells can’t send signals properly and axons can be irreversibly lost. To date there is no specific therapy approved for acute optic neuritis and the unmet needs remain for therapies that can prevent vision loss after an acute episode by reducing nerve cell permanent damage or death.

About Non-arteritic Anterior Ischemic Optic Neuropathy
Non-arteritic anterior ischemic optic neuropathy (NAION) is an acute optic nerve disorder that causes permanent visual impairment in >60% of affected patients4. It is the most common cause of acute optic nerve injury in individuals over 50 years old5 and affects up to 10.2 per 100,000 people worldwide5 with a U.S. incidence estimated to be >30,0005,7,8. In NAION, the optic nerve head region swells and there is painless sudden vision loss. The swelling eventually resolves, but the optic nerve axons and neuronal cell bodies (in the retina) are permanently lost, leading to significant irreversible visual impairment or even blindness9. There are no approved therapies for NAION and the unmet medical need is for therapies that preserve vision and provide neuroprotection for patients suffering from NAION.

About OCS-01 eye drops and the OPTIREACH® technology
Leveraging Oculis’ proprietary technology, OCS-01 is an OPTIREACH® formulation of high concentration dexamethasone eye drop. It is being developed as an eye drop to treat the retina to offer a non-invasive treatment alternative for diabetic macular edema (DME). This route of administration enables easy access to treatment in the early stages of the disease and can be used in combination with other therapies in later stages. In contrast, all currently available treatments require invasive delivery methods, such as intravitreal injections or ocular implants, to reach the retina. The OPTIREACH® solubilizing formulation technology addresses the main limitations of conventional eye drops by improving the solubility of lipophilic drugs, increasing the residence time on the eye surface and thereby, enabling the drug passage from the eye surface to the posterior segment of the eye. Oculis’ OCS-01 is being developed with the aim to transform the current treatment paradigm in DME as a non-invasive topical treatment option.

OCS-01 is an investigational drug in Phase 3 that has not received regulatory approval for commercial use in any country.

About Diabetic Macular Edema
Diabetic Macular Edema (DME) is the leading cause of visual loss and legal blindness in patients with diabetes. Currently, it is estimated to affect around 37 million people worldwide and, with the rise of diabetes, the prevalence is expected to increase to 53 million by 204010,11. DME is an irreversible and progressive complication of diabetic retinopathy and is related to consistently having high blood sugar levels that damage nerves and blood vessels in the macula, the area of the retina responsible for sharp vision. DME occurs when blood vessels in the retina swell, and then leak, leading to a fluid build-up (edema) into the retina. There remains a significant need for safe, efficacious, and less burdensome treatments for DME patients.

About Oculis
Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology and ophthalmology. Oculis’ highly differentiated late-stage clinical pipeline includes three core product candidates: Privosegtor, a breakthrough neuroprotective candidate in the PIONEER program which consists of studies intended to support registration plans for treatment in optic neuropathies like optic neuritis (ON) and non-arteritic anterior ischemic optic neuropathy (NAION), with potentially broad clinical applications in various other neuro-ophthalmic and neurological diseases; OCS-01, an eye drop in pivotal registration studies, aiming to become the first non-invasive topical treatment for diabetic macular edema (DME); and Licaminlimab, a novel, topical anti-TNFα in Phase 2, which is being developed with a genotype-based approach to drive precision medicine in dry eye disease (DED). Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors.
        
For more information, please visit: www.oculis.com

Oculis Contact
Ms. Sylvia Cheung, CFO
sylvia.cheung@oculis.com

Investor Relations
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com

Media Relations
ICR Healthcare
Amber Fennell / David Daley / Sean Leous
oculis@icrhealthcare.com

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of the Company’s product candidates, the initiation, timing, progress and results of current and future clinical trials, Oculis’ research and development programs, regulatory and business strategy, including planned interactions with the FDA; Oculis’ future development plans; the timing or likelihood of regulatory filings and approvals; statements about market opportunity, and the Company’s expected financial position and cash runway, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F and any other documents filed with the U.S. Securities and Exchange Commission (SEC). Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

References:

  1. Decision Resources Group: DME – DR Landscape Forecast – Disease Landscape Forecast 2020
  2. Martínez-Lapiscina EH, et al. (2014): Is the incidence of optic neuritis rising? Evidence from an epidemiological study in Barcelona (Spain) 2008-2012. J Neurol. 2014 Apr; 261(4): 759-767.
  3. Pérez-Cambrodí RJ, Gómez-Hurtado Cubillana A, Merino-Suárez ML, Piñero-Llorens DP, Laria-Ochaita C. Optic neuritis in pediatric population: a review in current tendencies of diagnosis and management. J Optom. 2014 Jul-Sep;7(3):125-30.
  4. Sing Hayreh S. (2008): Nonarteritic anterior ischemic optic neuropathy: natural history of visual outcome. Ophthalmology. 2088 Feb;115(2):298-305.
  5. https://www.aao.org/eyenet/article/naion-diagnosis-and-management
  6. Kupersmith, MJ et al. (2024): Ophthalmic and Systemic Factors of Acute Nonarteritic Anterior Ischemic Optic Neuropathy in the Quark207 Treatment Trial. 2024 July;131(7):790-802.
  7. Hattenhauer M G et al. (1997): Incidence of nonarteritic anterior ischemic optic neuropathy. American Journal of Ophthalmology. 1997 Jan;123(1):103-7.
  8. Lee M S et al. (2011): Incidence of nonarteritic anterior ischemic optic neuropathy: increased risk among diabetic patients. Ophthalmology 2011 Mar 24;118(5):959-963
  9. North American Neuro-Ophthalmology Society website: https://www.nanosweb.org
  10. Yau et al. Global Prevalence and Major Risk Factors of Diabetic Retinopathy, Diabetes Care 2012 Mar; 35(3): 556-564.
  11. International Diabetes Federation – diabetesatlas.org Estimated diabetes prevalence worldwide in 2021: 537m, reaching 783m in 2045.

Just – Evotec Biologics Receives Grant for AI-Driven Optimization of Monoclonal Antibody Developability for Affordable Access

Posted on by

Evotec SE

/ Key word(s): Miscellaneous

Just – Evotec Biologics Receives Grant for AI-Driven Optimization of Monoclonal Antibody Developability for Affordable Access

08.01.2026 / 07:30 CET/CEST

The issuer is solely responsible for the content of this announcement.

 
  • Just – Evotec Biologics will optimize monoclonal antibodies (“mAbs”) and other biologic modalities
  • Investment enables ten new J.MD™ projects encompassing molecular optimization including, but not limited to: improved titer, pharmacokinetics, immunogenicity, and stability, over the next three years
 

Hamburg, Germany, January 08, 2026:
Evotec SE (NASDAQ: EVO; Frankfurt Prime Standard: EVT) today announces that its Seattle-based subsidiary, Just – Evotec Biologics, Inc., has received a new grant from the Gates Foundation to enable global access to biotherapeutics utilizing Just – Evotec Biologics’ molecular design suite of computational technologies, called “J.MD™”.

Investment (INV072135) continues the support for selected Gates Foundation grantees to improve the developability and reduce the cost of goods of monoclonal antibodies to make them more affordable and accessible and prevent infectious disease in low- and middle-income countries.

Under the grant terms, Just – Evotec Biologics will leverage its J.MD™ Molecular Design service – a key component of its J.DESIGN™ platform, that integrates advanced computational tools and high-throughput methodologies to streamline the biologics development process. By optimizing molecular design from the earliest stages, J.MD™ ensures manufacturability, stability, and efficacy—critical factors for reducing costs and enabling expansion of global access to these therapies as well as limiting liabilities like immunogenicity and instability. The new investment will enable ten (10) new J.MD™ projects over the next three years, spanning the development of biotherapeutics targeting multiple global health disease indications of concern.

This grant extends the commitment of Just – Evotec Biologics, that began in 2014 and has since delivered multiple cGMP manufacturing campaigns for RSV, Malaria, and HIV monoclonal antibodies.

Dr. Linda Zuckerman, EVP and Global Head of Just – Evotec Biologics, commented: “We are thrilled to receive this new grant from the Gates Foundation which will strengthen our commitment to reducing the cost of biologics development to expand global access. By leveraging our J.DESIGN™ platform and innovative molecular design tools, we look forward to supporting the foundation in driving impactful solutions across multiple disease areas and continuing to deliver therapies where they are needed most.”

Dr. Cord Dohrmann, Chief Scientific Officer of Evotec, added: “We are proud to continue our collaboration with the foundation through this new grant which enables us to harness Just – Evotec Biologics’ advanced platforms and scientific expertise to support the broader research ecosystem. This partnership strengthens our shared mission to accelerate the development of biotherapeutics that address urgent and unmet medical needs.”

For expert insights about the importance of thoughtful antibody design driving global access, watch our virtual roundtable, Antibody Design to Support Global Health Initiatives, featuring key voices from the Gates Foundation and global health researchers.

 

About Just – Evotec Biologics
Just – Evotec Biologics, wholly owned by Evotec SE, is a first-to-industry biologics platform company that leverages AI/ML technologies and world-leading molecular design, cell line development, process intensification and continuous manufacturing strategies to advance biotherapeutics from discovery through clinical stages to commercial launch. The Just – Evotec Biologics team combines deep industry experience in the fields of data, protein, process, and manufacturing sciences including automation with highly integrated and flexible capabilities to break through the scientific and economic barriers associated with the development of protein therapeutics. Our focus is to accelerate and expand access to biotherapeutics through scientific and technological innovation for our proprietary projects and on behalf of our partners. Learn more at www.just-evotecbiologics.com.

About Evotec SE
Evotec is a life science company that is pioneering the future of drug discovery and development. By integrating breakthrough science with AI-driven innovation and advanced technologies, we accelerate the journey from concept to cure — faster, smarter, and with greater precision.

Our expertise spans small molecules, biologics, cell therapies and associated modalities, supported by proprietary platforms such as Molecular Patient Databases, PanOmics and iPSC-based disease modeling.

With flexible partnering models tailored to our customers’ needs, we work with all Top 20 Pharma companies, over 800 biotechs, academic institutions, and healthcare stakeholders. Our offerings range from standalone services to fully integrated R&D programs and long-term strategic partnerships, combining scientific excellence with operational agility.

Through Just – Evotec Biologics, we redefine biologics development and manufacturing to improve accessibility and affordability.

With a strong portfolio of over 100 proprietary R&D assets, most of them being co-owned, we focus on key therapeutic areas including oncology, cardiovascular and metabolic diseases, neurology, and immunology.

Evotec’s global team of more than 4,800 experts operates from sites in Europe and the U.S., offering complementary technologies and services as synergistic centers of excellence. Learn more at www.evotec.com and follow us on LinkedIn and X/Twitter @Evotec.

Forward-looking statements
This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec’s securities. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding Evotec’s expectations for revenues, Group EBITDA and unpartnered R&D expenses. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

08.01.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Language: English
Company: Evotec SE
Manfred Eigen Campus / Essener Bogen 7
22419 Hamburg
Germany
Phone: +49 (0)40 560 81-0
Fax: +49 (0)40 560 81-222
E-mail: info@evotec.com
Internet: www.evotec.com
ISIN: DE0005664809
WKN: 566480
Indices: SDAX, TecDAX
Listed: Regulated Market in Berlin, Frankfurt (Prime Standard); Regulated Unofficial Market in Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange; Nasdaq
EQS News ID: 2256286

 
End of News EQS News Service

2256286  08.01.2026 CET/CEST

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

Posted on by

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

Posted on by

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

Posted on by

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

Posted on by

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.

_____________________________

i Bytyçi I, Penson PE, Mikhailidis DP, et al. Prevalence of statin intolerance: a meta-analysis. Eur Heart J. 2022;43(34):3213-3223. doi:10.1093/eurheartj/ehac015

ii European Medicines Agency, Nilemdo (bempedoic acid) Summary of product characteristics, available here: Nilemdo, INN-bempedoic acid [last accessed: January 2026]

iii WHO, Cardiovascular diseases, available here: Cardiovascular diseases EURO [last accessed: December 2025]

iv European Society of Cardiology, Cardiovascular disease in women, available here: Cardiovascular Disease in Women [last accessed: December 2025]

v Vogel B, Acevedo M, Appelman Y, et al. The Lancet women and cardiovascular disease Commission: reducing the global burden by 2030. Lancet. 2021;397(10292):2385-2438. doi:10.1016/S0140-6736(21)00684-X

 

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

Posted on by

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 44th 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

Alumis Announces Pricing of Upsized Public Offering of Common Stock

Posted on by

Alumis Announces Pricing of Upsized Public Offering of Common Stock




Alumis Announces Pricing of Upsized Public Offering of Common Stock

SOUTH SAN FRANCISCO, Calif., Jan. 07, 2026 (GLOBE NEWSWIRE) — Alumis Inc. (Nasdaq: ALMS), a clinical-stage biopharmaceutical company developing next-generation targeted therapies for patients with immune-mediated diseases, today announced the pricing of an upsized underwritten public offering of 17,650,000 shares of its common stock at a price to the public of $17.00 per share. The gross proceeds to Alumis from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $300.0 million. All shares in the offering are being sold by Alumis. The offering is expected to close on January 9, 2026, subject to the satisfaction of customary closing conditions.

In addition, Alumis has granted the underwriters a 30-day option to purchase up to an additional 2,647,500 shares of common stock at the public offering price, less underwriting discounts and commissions.

Morgan Stanley, Leerink Partners, Cantor and Wells Fargo Securities are acting as joint book-running managers for the offering. Baird and Oppenheimer & Co. are acting as co-lead managers for the offering. 

The public offering is being made pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed with the Securities and Exchange Commission (the “SEC”) and declared effective by the SEC on August 19, 2025. A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering were filed with the SEC and are available for free on the SEC’s website located at http://www.sec.gov. A final prospectus supplement and accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available for free on the SEC’s website located at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, by telephone at (866) 718-1649, or by email at prospectus@morganstanley.com; Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525 ext. 6105, or by email at syndicate@leerink.com; Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by email at prospectus@cantor.com; or Wells Fargo Securities, LLC, Attention: Wells Fargo Securities, 90 South 7th Street, 5th Floor, Minneapolis, MN 55402, at 800-645-3751 (option #5) or email a request to WFScustomerservice@wellsfargo.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Alumis

Alumis is a clinical-stage biopharmaceutical company developing next-generation targeted therapies with the potential to significantly improve patient health and outcomes across a range of immune-mediated diseases. Leveraging its proprietary data analytics platform and precision approach, Alumis is developing a pipeline of oral tyrosine kinase 2 inhibitors, consisting of envudeucitinib (or envu, formerly known as ESK-001) for the treatment of systemic immune-mediated disorders, such as moderate-to-severe plaque psoriasis and systemic lupus erythematosus, and A-005 for the treatment of neuroinflammatory and neurodegenerative diseases. In addition, the pipeline includes lonigutamab, a subcutaneously delivered anti–insulin-like growth factor 1 receptor therapy for the treatment of thyroid eye disease, as well as several preclinical programs identified through this precision approach.

CONTACT: Alumis Contact Information 
Teri Dahlman 
Red House Communications 
teri@redhousecomms.com

Phathom Pharmaceuticals Announces Pricing of $130 Million Public Offering of Common Stock and Pre-Funded Warrants

Posted on by

Phathom Pharmaceuticals Announces Pricing of $130 Million Public Offering of Common Stock and Pre-Funded Warrants




Phathom Pharmaceuticals Announces Pricing of $130 Million Public Offering of Common Stock and Pre-Funded Warrants

FLORHAM PARK, N.J., Jan. 07, 2026 (GLOBE NEWSWIRE) — Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, announced today the pricing of an underwritten public offering of 6,875,000 shares of its common stock and pre-funded warrants to purchase 1,250,078 shares of common stock. The shares of common stock are being sold to the public at a price of $16.00 per share and the pre-funded warrants are being sold at a price of $15.999 per pre-funded warrant, which represents the per share price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant. The gross proceeds to Phathom from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be approximately $130 million. In addition, Phathom has granted the underwriters a 30-day option to purchase up to an additional 1,218,761 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about January 9, 2026, subject to satisfaction of customary closing conditions.

Phathom intends to use the net proceeds from the offering for general corporate purposes, including for working capital and commercialization and research and development expenses.

Guggenheim Securities and Cantor are acting as joint bookrunning managers for the offering. Raymond James, Needham & Company, H.C. Wainwright & Co. and Craig-Hallum are acting as co-managers for the offering.

The securities described above are being offered by Phathom pursuant to a shelf registration statement that was filed with the Securities and Exchange Commission (SEC) on January 7, 2026 and became effective automatically upon filing. The proposed offering is being made only by means of a written prospectus, including a prospectus supplement, forming a part of an effective registration statement. A preliminary prospectus and accompanying prospectus were filed with the SEC and is available on the website of the SEC at http://www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by email at prospectus@cantor.com.   Electronic copies of the final prospectus supplement and accompanying prospectus will also be available on the website of the SEC at http://www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

About Phathom
Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases. Phathom has in-licensed the exclusive rights to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB), for the U.S., Europe and Canada. Phathom currently markets vonoprazan in the United States as VOQUEZNA® (vonoprazan) tablets for the relief of heartburn associated with Non-Erosive GERD in adults, the healing and maintenance of healing of Erosive GERD in adults and relief of associated heartburn, and as part of VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) for the treatment of H. pylori infection in adults.

Forward-Looking Statements
Phathom cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements relating to the satisfaction of customary closing conditions related to the offering, the expected closing of the offering and the anticipated gross proceeds from the offering and Phathom’s intended use of the net proceeds therefrom. The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the offering, as well as risks and uncertainties inherent in Phathom’s business described in the Company’s prior press releases and the Company’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Phathom undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

CONTACTS

Media Contact:
Nick Benedetto
1-877-742-8466
media@phathompharma.com

Investor Contact:
Eric Sciorilli
1-877-742-8466
ir@phathompharma.com

© 2026 Phathom Pharmaceuticals. All rights reserved. VOQUEZNA, VOQUEZNA DUAL PAK, VOQUEZNA TRIPLE PAK, Phathom Pharmaceuticals, and their respective logos are registered trademarks of Phathom Pharmaceuticals, Inc.