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Altimmune: Competitor Buyouts Plus Regulatory And Clinical Progress (NASDAQ:ALT)
Seeking Alpha· 2025-10-30 11:59
Altimmune, Inc. ( ALT ) has multiple trials of pemvidutide underway providing it with the ability to differentiate its asset, but it hasn't yet landed a partner or been bought out. In July I rated ALT a hold, noting theScientist and trader of biotech stock. Focus on trading around events such as trial results and NDA/BLA approvals. Also covering companies in industries regulated by the FDA. Articles present my opinion on stocks, but don't constitute investment advice.Analyst’s Disclosure:I/we have no stock, ...
Clearmind Medicine Completes First Cohort Treatment in its FDA-Approved Phase I/IIa Clinical Trial for Alcohol Use Disorder
Globenewswire· 2025-10-30 11:55
Core Insights - Clearmind Medicine Inc. is advancing its Phase I/IIa clinical trial for CMND-100, a MEAI-based oral drug candidate aimed at treating Alcohol Use Disorder (AUD), with the last patient in the first cohort having received treatment [1][5] - The global alcohol-dependency treatment market is projected to grow from approximately $13.2 billion in 2024 to about $20 billion by 2032, indicating a significant unmet need for effective treatments [4] Company Overview - Clearmind is a clinical-stage biotech company focused on developing psychedelic-derived therapeutics to address major health issues, including AUD [6] - The company holds a portfolio of nineteen patent families with 31 granted patents and aims to expand its intellectual property [7] Clinical Trial Details - The Phase I/IIa trial is designed to assess the safety, tolerability, and pharmacokinetic profile of CMND-100, while also exploring preliminary efficacy signals such as reductions in alcohol cravings and consumption [3] - The trial includes six patients treated at prestigious institutions like Johns Hopkins University and Yale School of Medicine, with additional sites activated in Israel [2][3] Market Opportunity - The urgent need for more effective AUD treatments is highlighted by the projected growth of the treatment market, emphasizing the commercial potential for new therapeutic approaches [4]
Intensity Therapeutics, Inc. Announces Publication of Clinical Results of INT230-6 for the Treatment of Metastatic or Refractory Cancers in eBioMedicine, a Lancet Discovery Science Journal
Prnewswire· 2025-10-30 11:30
Accessibility StatementSkip Navigation The paper features a comprehensive evaluation of data, including disease control rate, overall survival, immune activation, abscopal effects, tumor necrosis, dose ranging, and safety The manuscript is open access The Company will host a webinar with the paper's lead and senior authors from the University of Southern California to discuss the results on Friday, October 31, 2025, at 9:00 AM (see below) SHELTON, Conn., Oct. 30, 2025 /PRNewswire/ -- Intensity Therapeutics, ...
Foghorn Therapeutics Announces Updates for Selective ARID1B, Selective CBP and Selective EP300 Degrader Programs
Globenewswire· 2025-10-30 11:30
- Data presented at the TPD and Induced Proximity Summit demonstrate that novel Selective ARID1B degrader selectively binds and degrades ARID1B; potentially relevant in up to 5% of all solid tumors - Selective CBP degrader is on track for non-GLP toxicology studies in Q4 2025 with potential in EP300-mutant cancers and in ER+ breast cancer; IND-ready in 2026 - Selective EP300 degrader demonstrates efficacy and favorable tolerability in preclinical models in hematological malignancies with significant differ ...
Turn Therapeutics Enters Global Supply, Development, and License Agreement with Leading Medical-Surgical Product Manufacturer and Distributor Medline
Globenewswire· 2025-10-30 11:30
WESTLAKE VILLAGE, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Turn Therapeutics (Nasdaq: TTRX) (“Turn” or the “Company”), a clinical-stage biotechnology company developing next-generation dermatology, wound, and anti-infective therapies, today announced it has entered into a global supply, development, and license agreement with Medline, the largest provider of medical-surgical products and supply chain solutions serving all points of care. The agreement establishes a long-term collaboration to develop, manuf ...
REGENXBIO Announces Completion of Pivotal Enrollment and Initiates Commercial Production in Duchenne Gene Therapy Program
Prnewswire· 2025-10-30 11:05
Accessibility StatementSkip Navigation ROCKVILLE, Md., Oct. 30, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the completion of enrollment in the AFFINITY DUCHENNE pivotal trial of RGX-202, an investigational gene therapy for the treatment of Duchenne muscular dystrophy, as well as the successful production of the first batches intended for commercial supply. "The Duchenne community urgently needs new treatment options that provide durable, safe outcomes and can meaningfully change the ...
Unicycive Therapeutics Announces Upcoming Presentation of New Data Reinforcing the Potential of Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia at the American Society of Nephrology Kidney Week 2025 Conference
Globenewswire· 2025-10-30 11:05
Analysis of the data from the open-label pivotal trial of oxylanthanum carbonate (OLC) highlights that pill burden was significantly reduced in terms of both pill volume (7x) and pill count (2x) from pre-trial phosphate binder therapyLOS ALTOS, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that it will present new oxylanthanum c ...
Seres Therapeutics to Announce Third Quarter 2025 Financial Results and Business Updates on November 5, 2025
Globenewswire· 2025-10-30 11:00
CAMBRIDGE, Mass., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading live biotherapeutics company, today announced that management will host a conference call and live audio webcast on November 5, 2025 at 8:30 a.m. ET to discuss third quarter 2025 financial results and provide business updates. To access the conference call, please dial 800-715-9871 (domestic) or 646-307-1963 (international) and reference the conference ID number 8471287. To join the live webcast, please vi ...
PreveCeutical Closes Second Tranche of Non-Brokered Private Placement
Newsfile· 2025-10-30 11:00
NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATESVancouver, British Columbia--(Newsfile Corp. - October 30, 2025) - PreveCeutical Medical Inc. (CSE: PREV) (OTCQB: PRVCF) (FSE: 18H) (the "Company" or "PreveCeutical"), is pleased to announce that, further to its news releases of August 5, 2025, September 5, 2025 and October 10, 2025 it has closed a second tranche (the "Second Tranche") of its previously announced $1,200,000 non-brokered private placement (the " ...
NLS Pharmaceutics Expands CNS Pipeline With AEX-6xx Series Developed by Aexon Labs
Prnewswire· 2025-10-30 11:00
Core Insights - NLS Pharmaceutics and Aexon Labs announced the expansion of their DOXA platform with the AEX-6xx series, focusing on small molecules that target arousal stability, cognition, and neuroprotection [1][4] - AEX-635, a lead compound, modulates MRP1, enhancing neuroprotective effects and improving CNS drug bioavailability, particularly in conditions like Parkinson's disease [1][3] Platform Expansion - The AEX-6xx program broadens the translational scope of the DOXA platform, integrating dual orexin receptor agonism with cathepsin H inhibition to address sleep-wake regulation and neuronal resilience [3][4] - The DOXA series aligns with the mission of NewCelX, the combined entity of NLS and Kadimastem, to innovate in neuroscience and cell therapy for neurological and metabolic disorders [4] Financial Position - NLS raised approximately $7 million in equity financing and secured a $25 million equity line of credit, strengthening its cash position for upcoming operations [5][6] - The financing is expected to support clinical programs and ensure the company is well-capitalized for at least the next 12 months [5] Preclinical Highlights - The DOXA platform shows up to 80% reduction in cataplexy and over 70% increase in wakefulness in narcolepsy models, demonstrating sustained efficacy without orexin receptor desensitization [9] - The platform exhibits robust neuroprotective activity under stress conditions, with potential applications in Type 1 Narcolepsy, ADHD, and neurodegenerative diseases [9][10] Intellectual Property - The AEX-6xx series is protected under international patent applications, advancing through national phases in key markets including the US, EU, and Japan [11] Strategic Next Steps - NLS and Aexon Labs are preparing for preclinical partnering discussions and plan to launch a unified brand identity under NewCelX, emphasizing their cross-continental model [12]