News and Press Releases
Neurizon Receives Ethics Approval for Phase 1 NUZ-001 Oral Liquid Formulation Study
Bellberry Human Research Ethics Committee (HREC) approves Neurizon’s Phase 1 formulation study supporting development of the NUZ-001 oral liquid formulation and continued advancement of NUZ-001 for amyotrophic lateral sclerosis (ALS)...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 13, 2026
Level 4, 96-100 Albert Road South Melbourne, VIC 3205 Australia
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
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
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
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
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
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
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
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
Tiziana Life Sciences Announces Significant Reduction in Microglia Activation in PET Scan of Moderate Alzheimer’s Patient Treated with Intranasal Foralumab
9 May 2025 -- New York, US -- Tiziana Life Sciences, Ltd, a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human anti-CD3...
Category: Biotechnology, Other, Pharmaceutical
Posted: May 9, 2025
Tiziana Life Sciences 14/15 Conduit Street London W1S 2XJ United Kingdom
Leqembi ▼ (lecanemab) proposed Marketing Authorisation Variation for monthly intravenous maintenance dosing for the treatment of early Alzheimer’s disease in the UK is validated for evaluation by the MHRA
Proposed intravenous maintenance dosing application to reduce lecanemab infusion frequency from every two weeks to every four weeks for eligible adult UK patients after initial 18 months of treatment The...
Category: Other, Pharmaceutical
Posted: April 30, 2025
PLL Therapeutics enrolls first patient in phase I/II trial of drug candidate PLL001 for Amyotrophic Lateral Sclerosis (ALS)
Multi-stage Australian study will evaluate safety of PLL001 in 12 ALS patients, testing three different doses along with placebo 140 ALS patients will participate in second stage of study to...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 15, 2025
10 Avenue Roger Lapébie 33140 Villenave d’Ornon France
HEALEY ALS Platform Trial Preparation Shows Positive Respiratory Outcome of NUZ-001
Updates to HEALEY ALS Platform Trial Master Protocol have been made to enhance the potential of establishing a clinically meaningful outcome for patients, including: Treatment period extended from 24 to...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 24, 2025
Level 4, 96-100 Albert Road South Melbourne, VIC 3205 Australia
HUTCHMED Announces that it has Completed Enrollment of a Phase II Registration Study of Fanregratinib (HMPL-453) for Intrahepatic Cholangiocarcinoma in China
6 March 2025 -- Hong Kong, Shanghai and New Jersey, US -- HUTCHMED (China) Limitedtoday announces that it has completed enrollment of its a Phase II trial of fanregratinib (HMPL-453)...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: March 6, 2025
Tiziana Life Sciences Files Investigational New Drug Application with FDA for ALS Phase 2 Clinical Trial
4 March 2025 -- New York, US -- Tiziana Life Sciences, Ltd, a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 4, 2025
Tiziana Life Sciences 14/15 Conduit Street London W1S 2XJ United Kingdom
