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News and Press Releases

MindMed Rebrands to Definium Therapeutics, Advancing a Leading Late-Stage Psychiatry Pipeline with Three Phase 3 Readouts Expected in 2026

Topline Data from Three Phase 3 Studies Evaluating DT120 Orally Disintegrating Tablet (ODT) for GAD and MDD Expected in 2026: Voyage in 2Q, Panorama in 2H, and Emerge Mid-Year Company...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 12, 2026

Definium Therapeutics
Media@definiumtx.com
One World Trade Center Suite 8500 New York, NY 10007, United States

AskBio Announces FDA Acceptance of Investigational New Drug (IND) Application for AB-1009 Gene Therapy for Treatment of Late-Onset Pompe Disease (LOPD)

AB-1009 program advances to Phase 1/Phase 2; clinical trial initiated in the United States Therapy granted United States Food and Drug Administration (FDA) Fast Track and Orphan Drug designations Pompe...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 8, 2026

AskBio
info@askbio.com
20 T.W. Alexander Drive Suite, 110 Research Triangle Park, NC 27709

Newron Further Expands Intellectual Property Portfolio for Evenamide with New EU Composition of Matter Patent

EP4615820 – “Crystalline Forms of Evenamide” is expected to extend asset exclusivity in EU into 2044 Evenamide is currently being investigated in Newron’s global ENIGMA-TRS Phase III development program, enrolling...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 6, 2026

Newron Pharmaceuticals
info@newron.com
via Antonio Meucci 3 20091 Bresso (Mi) Italy

MapLight Therapeutics Receives Fast Track Designation for ML-007C-MA for Alzheimer’s Disease Psychosis

5 January 2026 -- California and Massachusetts, US -- MapLight Therapeutics, Inc today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ML-007C-MA, an...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 5, 2026

MapLight Therapeutics
info@maplightrx.com
800 Chesapeake Drive, Redwood City, California 9406

GH Research Announces FDA Lifts Clinical Hold on GH001, Clearing Path for Global Phase 3 Initiation in 2026

GH001 cleared by FDA for U.S. clinical investigation, enabling U.S. subject enrollment Company to seek FDA alignment on global Phase 3 program replicating Phase 2b design Phase 3 initiation targeted...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 5, 2026

GH Research
info@ghres.com
Joshua Dawson House Dawson Street Dublin 2, D02 RY95 Ireland

New Study Shows Extended-Release Buprenorphine Safely Delivers Rapid, Clinically Meaningful Reductions in Opioid Use and Supports Abstinence in High-Risk Populations

Both monthly maintenance doses (100 mg and 300 mg) improved opioid abstinence and were well-tolerated with no new safety signals identified Post-hoc analyses indicated the 300-mg monthly maintenance dose performed...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 17, 2025

Indivior
North Chesterfield, Virginia, USA

FDA Clears NUZ-001 for Entry into HEALEY ALS Platform Trial

FDA has completed their review of the Neurizon NUZ-001 regimen to the HEALEY ALS Platform Trial Master Protocol This marks the official entry of NUZ-001 as Regimen I in the...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 11, 2025

Neurizon Therapeutics
enquiries@neurizon.com
Level 4, 96-100 Albert Road South Melbourne, VIC 3205 Australia

Astellas To Present New Data on XOSPATA (gilteritinib) Across the FLT3m+ AML Disease Continuum at ASH 2025 Annual Meeting

Presentations include pooled post-hoc analysis of the Phase 3 ADMIRAL and COMMODORE data on post-transplant gilteritinib resumption in relapsed or refractory FLT3m+ AML Findings from the Phase 3 MORPHO trial...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 5, 2025

Astellas
2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo 103-8411, Japan

Evotec-partner Bayer starts Phase 2 study for treatment of patients with Alport syndrome

Phase 2 clinical trial initiated to evaluate SEMA3A mAb as potential treatment for Alport syndrome Milestone payment to Evotec expected upon first dosing of first study participant in early 2026...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 4, 2025

Just – Evotec Biologics
info@evotec.com
Just – Evotec Biologics, Inc. 401 Terry Avenue North Seattle, WA 98109, US

Groundbreaking myalgic encephalomyelitis study identifies over 250 core genes, shared biology with long COVID, and dozens of drug repurposing opportunities

The study reinforces that ME is a complex multisystemic condition with a clear genetic basis and lays the foundation for future clinical trials that could be faster to recruit and...

Category: BioManufacturing, Clinical Trials, Other, Pharmaceutical
Posted: December 4, 2025

PrecisionLife
info@precisionlife.com
8b Bankside Hanborough Business Park Oxford, OX29 8LJ

Vandria Reports Positive Phase 1 Target Engagement Data for VNA-318, Supporting Further Development in Alzheimer’s Disease

Results presented at the 18th Clinical Trials in Alzheimer's Disease (CTAD) meeting, San Diego, December 1-4 VNA-318, an oral brain-penetrant small molecule therapeutic modulates a novel target to reduce inflammation...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 2, 2025

Vandria
info@vandria.com
Route de la Corniche 8 1066 Epalinges Switzerland

Axoltis Pharma raises €18 million to accelerate development of Amyotrophic Lateral Sclerosis (ALS) drug candidate

2 December 2025 -- Clermont-Ferrand, France -- Axoltis Pharma, a biotech company dedicated to developing novel therapeutic solutions for neurodegenerative diseases, today announces the closing of a Series A funding...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 2, 2025

Axoltis Pharma
contact@axoltis.com
15 – 17, Rue du Pré la Reine, 63100 Clermont-Ferrand

VarmX to present at the American Society of Hematology (ASH) Annual Meeting & Exposition

Poster presentation highlights Phase 1 data showing VMX-C001 has no effect on the anticoagulant function of heparin in healthy subjects 1 December 2025 -- Leiden, The Netherlands -- VarmX, a...

Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: December 1, 2025

VarmX
info@varmx.com
Emmy Noetherweg 2, 
 2333 BK Leiden, 
 The Netherlands

Telomir and Mira Pharmaceuticals advance through key development milestones with Recipharm support

Telomir-1 has now entered GMP preparation, and Ketamir-2 has completed the Phase 1 SAD stage, reflecting steady advancement of both programmes These milestones mark tangible progress in development and demonstrate...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 26, 2025

Recipharm

Alzheon to Present Multiple Clinical, Neuroimaging and Modeling Results for Oral Valiltramiprosate/ALZ-801 from Phase 2 and 3 Studies at CTAD Conference in San Diego, December 1–4, 2025

Valiltramiprosate Demonstrates Potential as the First Oral Disease-Modifying Agent to Slow Alzheimer’s Pathology, Indicated by Both Clinical and Volumetric MRI Data Nine Posters Showcase Consistent Benefits of Oral Valiltramiprosate in...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 19, 2025

Alzheon
111 Speen Street, Suite 306 Framingham, MA 01701