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News and Press Releases

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

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

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

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

Xlife Sciences
info@xlifesciences.ch
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

Annovis
info@annovisbio.com
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

ONWARD Medical
investors@onwd.com
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

Heidelberg Pharma
info@hdpharma.com
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

SOM Biotech
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

Lundbeck
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

ONWARD Medical
investors@onwd.com
Schimmelt 2. 5656 AE, Eindhoven, the Netherlands

Nilo Therapeutics launches with $101 million Series A financing to advance a new class of medicines targeting neural circuits in immune disease and appoints Kim Seth as Chief Executive Officer

Series A led by The Column Group, DCVC Bio, and Lux Capital, with participation from the Gates Foundation and Alexandria Venture Investments 8 October 2025 -- New York, New York...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 8, 2025

Nilo Therapeutics
info@nilotx.com

Pharming Group announces U.S. FDA acceptance and Priority Review of supplemental New Drug Application forleniolisib in children with APDS aged 4 to 11 years

If approved, leniolisib will be first and only treatment indicated for children with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS), a rare primary immunodeficiency Decision based on positive data from...

Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: October 1, 2025

Pharming Group NV
info@pharming.com
Pharming Group N.V. Vondellaan 47 2332 AA Leiden The Netherlands

Sanofi’s SAR402663 earns fast track designation in the US for neovascular age-related macular degeneration

Designation earned for a one-time intravitreal gene therapy with the potential to eliminate treatment burden for people living with neovascular age-related macular degeneration Neovascular or “wet” age-related macular degeneration can...

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

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Iksuda Therapeutics receives FDA IND clearance for IKS014

FDA decision will enable Iksuda to expand its ongoing clinical trial in the US, Australia and Singapore Preliminary data from an ongoing dose-escalation study of IKS014 has shown meaningful clinical activity across...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: July 1, 2025

Iksuda
The Biosphere, Draymans Way, Newcastle Helix Newcastle upon Tyne NE4 5BX

SolasCure receives FDA Fast Track Designation for Aurase Wound Gel to treat calciphylaxis ulcers

Recognises the potential of Aurase Wound Gel to improve outcomes for individuals with calciphylaxis ulcers, a rare and life-threatening condition Represents a new indication for Aurase Wound Gel, currently in...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: June 16, 2025

SolasCure
wellington house East Rd, Petersfield, Cambridge CB1 1BH