Core Viewpoint - Clene Inc. has announced a registered direct offering priced above market, raising over $28 million from new and existing investors to support its clinical-stage biopharmaceutical efforts in treating neurodegenerative diseases, particularly ALS and MS [1][2][3] Financing Details - The offering includes an oversubscribed registered direct offering to new, existing, and insider investors, with an initial financing tranche of over $6 million expected to fund operations into Q3 2026 [3] - Two additional financing tranches totaling over $22 million are contingent on the acceptance and approval of the New Drug Application (NDA) by the FDA, providing sufficient capital into early 2027 for potential commercialization of CNM-Au8 in ALS [3] - The gross proceeds from the offering are expected to be approximately $28 million, with BTIG, LLC acting as the sole placement agent [7] Warrant Details - The offering includes Series A Warrants and Series B Warrants, both with an initial exercise price of $6.00 per share, which can increase based on specific conditions related to the company's stock price and FDA announcements [4][5][6] - The potential gross proceeds from the exercise of the Series A Warrants total approximately $6.7 million, while the Series B Warrants could generate around $15.6 million, expected to fund commercialization efforts [5][6] Company Overview - Clene Inc. is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including ALS, Parkinson's disease, and MS [10] - CNM-Au8 is an investigational therapy designed to enhance neuronal health by increasing energy production and reducing oxidative stress [11]

NEW YORK, Dec. 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 has requested the European Medicines Agency (“EMA”) to re-examine its opinion on blarcamesin ...

Core Insights - Alector, Inc. has appointed Neil Berkley as Chief Financial Officer (CFO), effective December 10, 2025, while he continues to serve as Chief Business Officer (CBO) [1][2] Company Overview - Alector is a clinical-stage biotechnology company focused on developing therapies for neurodegenerative diseases, utilizing genetics, immunology, and neuroscience [3] - The company aims to address conditions such as Alzheimer's disease, Parkinson's disease, and frontotemporal dementia through its innovative product candidates [3] - Alector is developing the Alector Brain Carrier (ABC) platform to enhance therapeutic delivery across the blood-brain barrier, aiming for improved patient outcomes and cost reduction [3] Leadership Insights - Neil Berkley has over two decades of experience in corporate strategy, finance, business development, and operations within the biotech sector [2] - His leadership has been pivotal in advancing Alector's strategic priorities and strengthening partnerships since joining the company in 2024 [2] - Berkley's background includes founding two companies and serving on multiple biotech boards, showcasing his extensive industry experience [2]

Core Insights - NeuroSense Therapeutics is resuming regulatory advancement for its drug candidate PrimeC in Canada for the treatment of amyotrophic lateral sclerosis (ALS) following a productive discussion with Health Canada [1][2][3] Company Overview - NeuroSense Therapeutics is a late-clinical stage biotechnology company focused on developing treatments for severe neurodegenerative diseases, including ALS, Alzheimer's disease, and Parkinson's disease [6] - The company aims to address significant unmet medical needs in neurodegenerative diseases, which currently have limited effective therapeutic options [6] Product Information - PrimeC is NeuroSense's lead drug candidate, an extended-release oral formulation combining two FDA-approved drugs: ciprofloxacin and celecoxib [5] - The drug is designed to target multiple mechanisms contributing to motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation, potentially inhibiting the progression of ALS and Alzheimer's disease [5] Regulatory Progress - Health Canada has outlined the remaining requirements for NeuroSense, confirming that the company's proposed next steps align with the Agency's expectations [2] - NeuroSense is preparing for a pre-New Drug Submission (NDS) meeting with Health Canada, anticipated in April 2026, with a potential NDS submission expected by mid-2026 [2][3] ALS Overview - ALS is an incurable neurodegenerative disease that leads to complete paralysis and death within 2-5 years from diagnosis, with over 5,000 new cases diagnosed annually in the U.S. [4] - 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 [4]

Core Viewpoint - Clene Inc. is set to provide an update on its CNM-Au8 program for ALS during a webcast on December 3, 2025, highlighting its focus on neurodegenerative diseases [1][2]. Company Overview - Clene Inc. is a late clinical-stage biopharmaceutical company dedicated to enhancing mitochondrial health and protecting neuronal function to treat neurodegenerative diseases such as ALS, Parkinson's disease, and multiple sclerosis [3]. - The company operates from Salt Lake City, Utah, with research and development as well as manufacturing facilities located in Maryland [3]. Product Information - CNM-Au8 is an investigational first-in-class therapy designed to improve the survival and function of central nervous system cells by targeting mitochondrial function and the NAD pathway while reducing oxidative stress [3]. - CNM-Au8 is an oral suspension of gold nanocrystals aimed at restoring neuronal health and function by increasing energy production and utilization, thereby promoting neuroprotection and remyelination [4].

Core Viewpoint - Alpha Cognition Inc. is actively engaging in commercialization efforts and research initiatives to enhance the adoption of its therapies for neurodegenerative diseases, particularly through participation in a virtual fireside chat hosted by Titan Partners [1][2]. Company Overview - Alpha Cognition Inc. is a commercial-stage biopharmaceutical company focused on developing treatments for neurodegenerative diseases, including Alzheimer's disease and cognitive impairment associated with mild traumatic brain injury (mTBI) [2][9]. - The company is dedicated to addressing the unmet medical needs in these areas, where currently no approved treatment options exist [2]. Product Information - ALPHA-1062, marketed as ZUNVEYL, is an FDA-approved new generation acetylcholinesterase inhibitor designed for the treatment of Alzheimer's disease, with minimal gastrointestinal side effects expected [3]. - ZUNVEYL's active metabolite uniquely binds to neuronal nicotinic receptors, particularly the alpha-7 subtype, which is associated with cognitive enhancement [3]. - The product is also being developed in combination with memantine for moderate to severe Alzheimer's dementia and as a sublingual formulation for cognitive impairment with mTBI [3]. Upcoming Events - Alpha Cognition will participate in a virtual fireside chat on December 2, 2025, featuring CEO Michael McFadden, focusing on commercialization strategies and research initiatives [2]. - The company is set to report its third quarter 2025 financial results and provide a business update on November 13, 2025, after market close [9].

Group 1 - Alector, Inc. is a clinical-stage biotechnology company focused on developing therapies for neurodegenerative diseases [3] - The company will participate in a fireside chat at the Bank of America CNS Therapeutics Conference on December 8, 2025 [1] - Alector's product candidates aim to treat conditions such as Alzheimer's disease, Parkinson's disease, and frontotemporal dementia [3] Group 2 - Alector is leveraging genetics, immunology, and neuroscience to advance its therapeutic programs [3] - The company is developing a proprietary blood-brain barrier platform called Alector Brain Carrier (ABC) to enhance therapeutic delivery [3] - Alector's goal is to improve patient outcomes while reducing costs through deeper brain penetration and efficacy at lower doses [3]

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 ...

Core Insights - Anavex Life Sciences Corp. will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026, highlighting its focus on innovative treatments for CNS disorders [1][3] - The company is dedicated to developing therapeutics for Alzheimer's disease, Parkinson's disease, schizophrenia, and other neurodegenerative and neurodevelopmental disorders [4] Company Overview - Anavex Life Sciences Corp. is a clinical-stage biopharmaceutical company listed on Nasdaq under the ticker AVXL [1][4] - The company's lead drug candidate, ANAVEX®2-73 (blarcamesine), has completed multiple clinical trials for Alzheimer's disease and is also being studied for Parkinson's disease dementia and Rett syndrome [4] - ANAVEX®2-73 is designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors, showing potential to halt or reverse Alzheimer's disease progression [4] - The company is also developing ANAVEX®3-71, which targets SIGMAR1 and M1 muscarinic receptors, demonstrating disease-modifying activity against Alzheimer's disease in preclinical studies [4]