News and Press Releases
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
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Fondazione Telethon Submits US Biological License Application for Etuvetidigene Autotemcel Gene Therapy for the Treatment of Wiskott-Aldrich Sydrome
11 March 2025 -- Milan, Italy -- Fondazione Telethon, an Italian biomedical charity focused on rare genetic diseases, announced that it has submitted the Biologics License Application (BLA) for the...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 11, 2025
OKYO Pharma Files for Fast Track Designation with FDA for Urcosimod to Treat Neuropathic Corneal Pain
10 March 2025 -- London, UK and New York, US -- OKYO Pharma Limited, a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain, a severe...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 10, 2025
Bioxodes obtains Orphan Drug Designation for hemorrhagic stroke therapeutic candidate in US and Europe
FDA, EMA grant BIOX-101 ODD status to treat intracerebral hemorrhagic stroke (ICH) ODD status may expedite drug candidate development and approvals BIOX-101 interim Phase 2a data in ICH imminent. 5...
Category: Drug Discovery, Other, Pharmaceutical
Posted: March 5, 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
Boehringer’s nerandomilast meets primary endpoint in Phase III study FIBRONEER-ILD, in progressive pulmonary fibrosis
Topline data from FIBRONEER™-ILD show that the investigational compound nerandomilast met its primary endpoint, which was the absolute change from baseline in forced vital capacity [mL] at week 52 versus...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: February 10, 2025
Opella reaches study milestone for Cialis
21 January 2025 -- Paris, France -- Opella, Sanofi’s Consumer Healthcare business, announced that the US Food and Drug Administration (FDA) has lifted a clinical hold on its planned actual...
Category: Clinical Trials, Other, Pharmaceutical
Posted: January 21, 2025
PureTech Receives FDA Fast Track Designation for LYT-200 in Acute Myeloid Leukemia (AML)
Single agent and combination data from Phase 1b AML/MDS trial presented at ASH 2024 showed potential of LYT-200 to serve broad range of patients across various lines of treatment LYT-200...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 9, 2025
Capsida Announces AbbVie Opt-in for First Genetic Medicine Program from Neurodegenerative Disease Collaboration
Capsida to receive a $40 million license payment and is eligible for additional milestones and royalties 7 January 2025 -- California, US -- Capsida Biotherapeutics today announced that AbbVie has...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 7, 2025
Alzheon Announces Appointment of Renowned Investor and Financial Executive Muneer A. Satter to Board of Directors
Mr. Satter’s Extensive Investment, Company-Building, and Transaction Experience Strengthens Alzheon’s Board Leadership Valiltramiprosate/ALZ-801 Has Potential to Become the First Oral Agent to Slow Alzheimer’s Pathology in Patients APOLLOE4 Pivotal Phase...
Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: January 7, 2025
Tiziana Life Sciences Announces First Patient with Moderate Alzheimer’s Disease Dosed with Intranasal Foralumab
17 December 2024 -- New York, US -- Tiziana Life Sciences, a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal...
Category: Biotechnology, Clinical Trials, Pharmaceutical
Posted: December 17, 2024
Tiziana Life Sciences 14/15 Conduit Street London W1S 2XJ United Kingdom
PTC Therapeutics Announces FDA Acceptance for Filing of NDA for Sepiapterin for the Treatment of Pediatric and Adult Phenylketonuria Patients
1 October 2024 -- New Jersey, US -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the FDA has accepted for filing the New Drug Application (NDA) of sepiapterin for the treatment of...
Category: Biotechnology, Drug Discovery, Pharmaceutical
Posted: October 1, 2024
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PureTech-Invented KarXT Receives U.S. Food and Drug Administration Approval for the Treatment of Schizophrenia in Adults
Milestone triggers payments to PureTech totaling $29 million under agreements with Royalty Pharma and PureTech’s Founded Entity, Karuna Therapeutics, which was acquired by Bristol Myers Squibb in March 2024, and...
Category: Other, Pharmaceutical
Posted: September 27, 2024
Tiziana Life Sciences Announces $4 Million Grant Awarded by National Institutes of Health to Study Anti-CD3 in Alzheimer’s Disease
19 September 2024 -- 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, Clinical Trials, Pharmaceutical
Posted: September 19, 2024
Tiziana Life Sciences 14/15 Conduit Street London W1S 2XJ United Kingdom
AC Immune Receives Second Milestone Payment Following Progress in Phase 2b ReTain Trial of ACI-35.030 in Preclinical Alzheimer’s Disease
Prescreening rate of Phase 2b ReTain trial triggers clinical development milestone payment in September Potentially registrational trial is targeting enrollment of approximately 500 participants with pre-symptomatic AD FDA Fast Track...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: September 17, 2024
