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News and Press Releases

Samsung Epis Holdings Delivers Business Updates at the 44th J.P. Morgan Healthcare Conference

Samsung Bioepis plans to secure 20 biosimilars in its products and pipeline by 2030 The new pipeline will include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab, in addition to...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 15, 2026

Samsung Bioepis
76, Songdogyoyuk-ro, Yeonsu-gu, Incheon

Alto Neuroscience Strengthens Intellectual Property Portfolio with Issuance of New Method-of-Treatment Patent for ALTO-207 in Depression

Issued and pending claims expected to protect ALTO-207 into the mid-2040s 14 January 2026 -- California, US -- Alto Neuroscience, Inc, a clinical-stage biopharmaceutical company focused on the development of...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 14, 2026

Alto Neuroscience
info@altoneuroscience.com
650 Castro Street, Suite 450 Mountain View, CA 94041

Adial Pharmaceuticals Announces Publication of International PCT Patent Application to Protect Core Assets and Extend IP Exclusivity to at least 2045

New patent based on treatment of populations identified to be particularly responsive to ondansetron treatment after examination of Adial’s clinical data and information 14 January 2026 -- Virginia, US --...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 14, 2026

Relmada Therapeutics Provides Regulatory Update Confirming FDA Alignment on Registrational Studies Design for NDV-01 for Two Separate Indications

FDA written feedback supports: a single-arm, open-label registrational trial in 2nd-line refractory high-grade NMIBC with CIS a randomized vs observation single trial in intermediate-risk NMIBC in the adjuvant setting Phase...

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

Relmada Therapeutics
info@relmada.com
2222 Ponce de Leon Blvd. Floor 3 Coral Gables, FL 33134

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

VectorY Therapeutics Receives FDA Fast Track Designation for VTx-002, a Firstin-Class Vectorized Antibody Targeting Underlying Disease Biology in ALS

Designation enables an enhanced development path for VTx-002 and underscores its disease-modifying potential in ALS, a universally fatal disease with no cure Milestone follows recent IND clearance and supports continued...

Category: BioManufacturing, Drug Discovery, Other, Pharmaceutical
Posted: January 8, 2026

VectorY Therapeutics
info@vectorytx.com
Science Park Matrix Innovation Center 408 1098 XH Amsterdam

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

MindMaze Therapeutics: Consolidating a Global Approach to Reimbursement for Next-Generation Therapeutics

23 December 2025 -- Geneva, Switzerland -- MindMaze Therapeutics Holding SA, a commercial-stage company delivering evidence-based, precision digital treatments for neurological diseases, today outlined the evolution of its global reimbursement...

Category: Logistics, Other, Pharmaceutical
Posted: December 23, 2025

MindMaze Therapeutics
info@mindmaze.com
Chemin de Roseneck 5 1006 Lausanne, Switzerland

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

T-CURX Announces $20M Series A First Closing Led by BiomedVC to Fund Pipeline of Clinical-Stage CAR-T Programs and Advance Proprietary Non-Viral In Vivo CAR-T Platform

17 December 2025 -- Würzburg, Germany -- T-CURX GmbH (T-CURX) today announces the first closing of a $20M (€ 17.7M) Series A financing with a syndicate of European and Asian investors...

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

T-CURX
info@t-curx.com
Innovations- und Gründerzentrum Würzburg Friedrich-Bergius-Ring 15 97076 Würzburg Deutschland/Germany

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