News and Press Releases

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

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

Chemin de Roseneck 5 1006 Lausanne, Switzerland

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

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

Level 4, 96-100 Albert Road South Melbourne, VIC 3205 Australia

VectorY Therapeutics Receives FDA Clearance of IND to Proceed with the PIONEER-ALS Phase 1/2 Trial of VTx-002, a First-in-Class Vectorized Antibody Targeting TDP-43 Pathology in ALS

3 December 2025 -- Amsterdam, The Netherlands and Massachusetts, US -- VectorY Therapeutics, a leader in vectorized antibody therapies for neurodegenerative diseases, announced today that the U.S. Food and Drug...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 3, 2025

Science Park Matrix Innovation Center 408 1098 XH Amsterdam

Annovis To Present at the 2025 Annual Meeting of the Parkinson Study Group

3 December 2025 -- Pennsylvania, US -- Annovis Bio, Inc, a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease...

Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: December 3, 2025

101 Lindenwood Drive, Suite 225 Malvern, PA 19355

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

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

15 – 17, Rue du Pré la Reine, 63100 Clermont-Ferrand

Xlife Sciences AG Delivers Breakthrough in Early Alzheimer’s Detection, Unlocking Major Market Opportunity

1 December 2025 -- Zurich, Switzerland -- Xlife Sciences AG, together with saniva diagnostics GmbH, today announced a landmark achievement: NeuroMex is the world’s first certified and clinically validated medical device for...

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

Talacker 35 8001 Zürich Switzerland

Annovis Announces FDA Meeting to Discuss Parkinson’s Disease Dementia Program; Reaffirms FDA Alignment on Pivotal Phase 3 Alzheimer’s Disease Study

18 November 2025 -- Pennsylvania, US -- Annovis Bio, Inc, a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 18, 2025

101 Lindenwood Drive, Suite 225 Malvern, PA 19355

ONWARD Medical Receives FDA 510(k) Clearance Expanding ARC-EX System Indication for Home Use

US FDA clearance now allows use of the ARC-EX System both in clinics and homes ARC-EX is the first and only FDA-cleared technology demonstrated to improve hand strength and sensation...

Category: Biotechnology, Other, Pharmaceutical
Posted: November 17, 2025

Schimmelt 2. 5656 AE, Eindhoven, the Netherlands

Heidelberg Pharma’s Lead ADC Candidate HDP-101 Granted Fast Track Designation by US FDA for the Treatment of Multiple Myeloma

Recognizes the potential of HDP-101 to address a serious or life-threatening condition with high unmet medical needs Enables more frequent engagement with FDA and eligibility for rolling review to support...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 23, 2025

Gregor-Mendel-Straße 22 68526 Ladenburg Deutschland

SOM Biotech secures clear registrational path for SOM3355 in Huntington’s disease after FDA End‑of‑Phase 2 Meeting

20 October 2025 -- Barcelona, Spain -- SOM Biotech, a clinical-stage company dedicated to the discovery and development of innovative therapies for rare central nervous system disorders, announces today that it...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 20, 2025

Baldiri Reixac, 4 (08028) Barcelona, Spain

Lundbeck and Contera Pharma announce research collaboration to advance RNA-targeting medicines for serious neurological conditions

20 October 2025 -- Valby, Denmark -- H. Lundbeck A/S and Contera Pharma today announced a strategic research collaboration aiming to accelerate the discovery and development of innovative oligonucleotide-based medicines...

Category: Biotechnology, Drug Discovery, Logistics, Other, Pharmaceutical
Posted: October 20, 2025

Iveco House Station Road Watford Hertfordshire WD17 1ET

ONWARD Medical Provides Preliminary Q3 2025 Update Highlighting Accelerating ARC-EX Adoption in the United States

13 October 2025 -- EINDHOVEN, the Netherlands -- ONWARD Medical N.V., the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries (SCI)...

Category: Drug Discovery, Other, Pharmaceutical
Posted: October 13, 2025

Schimmelt 2. 5656 AE, Eindhoven, the Netherlands