Core Insights - NeuroSense Therapeutics has received FDA authorization to initiate a pivotal Phase 3 clinical trial for its lead drug candidate, PrimeC, aimed at treating amyotrophic lateral sclerosis (ALS) [1][2][3] Company Overview - NeuroSense is a late-clinical stage biotechnology company focused on developing treatments for severe neurodegenerative diseases, including ALS, Alzheimer's disease, and Parkinson's disease [7] - The company aims to address significant unmet medical needs in the neurodegenerative disease space, where effective therapeutic options are limited [7] Clinical Trial Details - The Phase 3 trial, named PARAGON, will include 300 ALS patients randomized in a 2:1 ratio (PrimeC : Placebo) and is designed to achieve over 95% power to meet its primary endpoint [2][3] - The trial will be conducted in the U.S. and EU, featuring a double-blind, 12-month placebo-controlled design with an open-label extension to assess safety and efficacy [3] - An adaptive design will allow for interim analyses to optimize sample size and evaluate early efficacy and futility boundaries [3] Drug Candidate Information - PrimeC is an extended-release oral formulation combining two FDA-approved drugs: ciprofloxacin and celecoxib, targeting mechanisms involved in ALS and Alzheimer's disease [6] - The drug aims to inhibit the progression of ALS and Alzheimer's by addressing motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation [6] ALS Background - ALS is an incurable neurodegenerative disease leading to complete paralysis and death within 2-5 years of diagnosis, with over 5,000 new cases diagnosed annually in the U.S. [5] - The annual disease burden of ALS in the U.S. is approximately $1 billion, and the number of individuals living with ALS is projected to increase by 24% by 2040 in the U.S. and EU [5]

MALVERN, Pa., Nov. 24, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced two presentations at the 18th Clinical Trials on Alzheimer's Disease (CTAD) conference, taking place December 1-4, 2025 in San Diego, California. The presentations will highlight progress across the Alzheimer’s an ...

NEW YORK, Nov. 19, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced that it will present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14th ...

Webcast and Conference Call To be Held Tuesday, November 25, 2025, 8:30 am ETNEW YORK, Nov. 18, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced that it will issue fina ...

As the U.S. Food and Drug Administration (FDA) proposed, Clene is concluding analyses of its ALS biomarker data with completion planned shortly The FDA advised Clene to request a Type C meeting to review these further ALS biomarker data analysesThe Company plans to submit a New Drug Application (NDA) in the first quarter of 2026 under an accelerated approval pathwayThe Company expects to have the first patient dosed in the confirmatory Phase 3 RESTORE-ALS trial of CNM-Au8 in the first half of 2026The FDA an ...

Core Insights - BioArctic is expanding its portfolio through new projects and partnerships, particularly highlighting its collaboration with Novartis, which is expected to enhance its treatment offerings for neurodegenerative diseases [3][10]. Financial Performance - For the third quarter of 2025, BioArctic reported net revenues of SEK 133.3 million, a significant increase from SEK 76.6 million in the same period last year. Royalties from Leqembi accounted for SEK 117.2 million, up from SEK 69.8 million [6]. - The company experienced an operating loss of SEK 28.8 million, compared to a loss of SEK 26.1 million in the previous year. The profit for the period was SEK -86.9 million, compared to SEK -19.6 million [6]. - Cash flow from operating activities improved to SEK -41.2 million from SEK -80.3 million, with cash and cash equivalents at SEK 1,882.0 million, up from SEK 804.5 million [6]. Product Development and Market Expansion - Leqembi sales showed a quarter-on-quarter growth of approximately 14%, adjusted for stocking effects in China. The drug is now approved in over 50 countries, with recent approvals in Australia, Canada, and India [4]. - Regulatory approval for monthly intravenous maintenance treatment in China was achieved, marking the fifth market for this dosing regimen. The US also approved weekly subcutaneous maintenance dosing for Leqembi Iqlik [5][6]. - BioArctic's pipeline includes ongoing studies for Exidavnemab and other early projects targeting neurodegenerative diseases, with expectations for results after summer 2026 [11]. Strategic Collaborations - The collaboration with Novartis includes an upfront payment of USD 30 million and aims to combine BioArctic's BrainTransporter technology with Novartis' proprietary antibody for neurodegenerative treatments [6][10]. - The partnership is seen as a significant step in enhancing treatment options for patients and expanding the company's reach in the neurodegenerative disease market [7][10]. Research and Development - New data on lecanemab was presented at the AAIC congress, focusing on long-term efficacy and safety, as well as real-world evidence [6]. - BioArctic is also venturing into Huntington's disease research, aiming to develop disease-modifying treatments, which currently have no available options [12].

MELBOURNE, Australia and SAN FRANCISCO, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that David Stamler, M.D., Chief Executive Officer of Alterity, will deliver a corporate update at the Bell Potter Healthcare Conference, a virtual event showcasing Australia’s best healthcare companies. Presentation details AUSTRALIA ...

– Data highlights symptom stability and enhanced efficacy signals in higher dose group – – Analysis offers valuable insights to guide ongoing development and planning of Phase 3 – MELBOURNE, Australia and SAN FRANCISCO, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that analyses on the baseline characteristics related t ...

Core Insights - MediciNova, Inc. has been awarded the "Contract Research and Development Innovation Award" at the Fifth Annual BioTech Breakthrough Awards for its innovative work on MN-166 (ibudilast) [1][2][3] Company Overview - MediciNova is a clinical-stage biopharmaceutical company focused on developing small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases [4] - The company has a late-stage pipeline that includes 11 clinical programs, with MN-166 being the lead asset currently in Phase 3 trials for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) [4] - MN-166 is also being evaluated in Phase 2 trials for Long COVID and substance dependence, while MN-001 (tipelukast) is in Phase 2 trials for idiopathic pulmonary fibrosis (IPF) and non-alcoholic fatty liver disease (NAFLD) [4] Product Development - MN-166 is designed to inhibit neuroinflammation and promote neuroprotection, targeting several neurological diseases with limited treatment options, including ALS [2][3] - The ongoing Phase 2/3 COMBAT-ALS trial of MN-166 reflects the company's commitment to addressing unmet medical needs in ALS [3] Industry Recognition - The BioTech Breakthrough Awards program recognizes innovative companies and technologies in the life sciences and biotechnology sectors, highlighting excellence in biopharma, therapeutics, genomics, diagnostics, and research tools [3]

Core Insights - NeuroSense Therapeutics is hosting an investor update meeting on December 8, 2025, to discuss its near-term milestones and objectives [1] Company Overview - NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on developing treatments for severe neurodegenerative diseases, including ALS, Alzheimer's, and Parkinson's disease [2] - The company aims to address significant unmet medical needs in neurodegenerative diseases by developing combined therapies that target multiple pathways [2] Upcoming Developments - The company plans to initiate the Phase 3 PARAGON study for ALS and submit a Notice of Compliance with conditions (NOC/c) in Canada [5] - Updates will also include the status of a binding term sheet executed in December 2024 and the RoAD Phase 2 program for Alzheimer's disease [5]