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News and Press Releases

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

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

Eisai presents 4-year Leqembi (lecanemab) open-label extension data from post-hoc sub-group analysis at German neurology congress

Clarity AD open-label extension data show that after four years of continuous lecanemab treatment in apolipoprotein E ε4 (ApoE ε4*) non-carriers and heterozygotes, patients continued to accrue benefit relative to...

Category: Clinical Trials, Other, Pharmaceutical
Posted: November 12, 2025

Eisai
4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan

Commit Biologics achieves proof-of-concept for novel Complement Engager platform in non-human primates

Novel approach harnessing the power of the complement system to drive potent cell depletion Single-dose study shows rapid and sustained immune cell depletion in blood and tissues with a very...

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

Commit Biologics
info@commitbio.com
Universitetsbyen 83 8000 Aarhus C, Denmark

Heidelberg Pharma’s Lead ATAC Candidate HDP-101 Shows Progress in Phase I/IIa Trial in Multiple Myeloma

Evidence of clinical activity observed in Cohort 8, including stringent complete remission in two patients from Cohort 8 HDP-101 continues to demonstrate a favorable safety profile with no dose-limiting toxicities...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 6, 2025

Heidelberg Pharma
info@hdpharma.com
Gregor-Mendel-Straße 22 68526 Ladenburg Deutschland

Valneva Reports Positive Results for Phase 1 Trial of Second-Generation Zika Vaccine Candidate

Immune response successfully improved with second generation vaccine candidate4 November 2025 -- Saint-Herblain, France -- Valneva SE, a specialty vaccine company, today announced positive results of its Phase 1 clinical...

Category: BioManufacturing, Biotechnology, Clinical Trials, Drug Delivery, Other, Pharmaceutical
Posted: November 4, 2025

Valneva
communications@valneva.com
6 rue Alain Bombard, 44800 Saint-Herblain, France

Intellia Therapeutics Provides Update on MAGNITUDE Clinical Trials of Nexiguran Ziclumeran (nex-z)

27 October 2025 -- Massachusetts, US -- Intellia Therapeutics, Inc, a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced that the company has temporarily...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 27, 2025

Intellia Therapeutics
medicalinformation@intelliatx.com
40 Erie Street, Suite 130, Cambridge, MA 02139