THE WOODLANDS, TX, July 07, 2025 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company dedicated to advancing precision nerve-targeted treatments, today announced the next CEO Corner segment has been published on the Company’s website. For the CEO Corner segment, Brad Hauser, CEO of Autonomix, elaborates on the Company’s recently announced planned follow-on market expansion study phase (“PoC 2”) of its proof-of-concept trial. The CEO Corner segme ...

Hello ladies and gentlemen, my name is Helena and today I will try to invite you to come to my word, word of the body, body language, connection with the body through we can um use our potential better and um make a better connection with the others. So before I start, I would like to explain the name of my the title of my uh speech corporality. I found that word no I found a word in Polish language but it was impossible to translate it into English.So it won't be a secret if I tell you that helps me. So I ...

Lead Author: Richard Bogan, MD, FCCP, FAASM, Associate Clinical Professor at the University of South Carolina School of Medicine in Columbia, SC NEW YORK, June 11, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced seven presentations, including two featured oral plenary sessions, on AXS-12 and solriamfetol, at SLEEP 2025, the 39th annual meeting of the Associated Profess ...

NEW HAVEN, Conn., June 10, 2025 (GLOBE NEWSWIRE) -- Bexorg, Inc., a pioneering techbio company working to decode the human brain and advance new therapies for central nervous system (CNS) disorders, today announced a multi-program research collaboration with Biohaven Ltd. (NYSE: BHVN) to identify, de-risk, and advance next-generation therapies for CNS disorders. As part of the collaboration, Bexorg’s novel whole-brain discovery platform will be used to demonstrate target engagement in relevant cell types an ...

* Tonix's product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication. Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners. This press release and further information about Tonix can be found at www.tonixpharma.com. CHATHAM, N.J., June 10, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (To ...

Axsome Therapeutics (AXSM) FY Conference Summary Company Overview - **Company**: Axsome Therapeutics - **Focus**: Development of innovative medicines for central nervous system (CNS) disorders, addressing significant unmet needs in psychiatry and neurology [2][3] Industry Context - **CNS Disorders**: Over 150 million people in the U.S. are affected by serious CNS conditions, which have been historically underserved by the biopharma industry [2][3] - **Key Conditions**: Major depressive disorder (MDD), Alzheimer's disease agitation, smoking cessation, ADHD, binge eating disorder, obstructive sleep apnea, migraine, narcolepsy, fibromyalgia, and shift work disorder [3][4] Core Strategies - **Five Pillars of Innovation**: 1. **Novel Mechanisms of Action**: Focus on distinct treatment outcomes in areas with multiple existing products [4] 2. **Multi-Mechanistic Modes of Treatment**: Examples include Ovelity and Cymbravo [5] 3. **Clinical Trial Innovation**: Designing trials to effectively detect signals from active molecules [5] 4. **Molecular Drug Delivery**: Innovative delivery methods for CNS-active molecules [6] 5. **Diversified Pipeline**: A singular neuroscience pipeline with three commercial products and multiple late-stage programs [6][7] Financial Highlights - **Potential Peak Sales**: Total potential peak sales across the pipeline estimated at $16.5 billion, with approved products like Avelity, Synoscience, and Bravo projected to reach $2 billion to $4.5 billion [8] - **Cash Position**: $300 million in cash resources as of the end of Q1, sufficient to reach cash flow positivity [39][40] Product Updates - **Ovelity**: Rapid growth with an annualized run rate of $400 million; over 50% of prescriptions are first-line treatments [11][14] - **Sunosi**: Steady growth with an annualized run rate of $100 million, focusing on potential label expansion [17] - **Simbravo**: Newly approved for acute migraine treatment, launching imminently [12][18] Clinical Trials and Regulatory Updates - **Cymbravo**: Approved earlier in the year, with positive Phase III clinical trial readouts [9] - **AXS-five**: NDA submission for Alzheimer's disease agitation on track for Q3; high unmet need with 7 million adults affected [21][22] - **Salriamfetol**: Exploring additional indications including ADHD and major depressive disorder, with ongoing trials [25][28] - **AXS-twelve**: NDA submission planned for narcolepsy in the second half of the year [33] - **AXS-fourteen**: Focused on fibromyalgia, with plans for a new 12-week fixed-dose trial following FDA feedback [35][36] Intellectual Property - **Patent Portfolio**: Broad coverage for pipeline programs, with settlements reached with multiple first filers [38] Conclusion - **Leadership and Future Outlook**: Strong leadership team and board, with a focus on providing updates throughout the year [40]

Axsome Therapeutics (AXSM) FY Conference June 03, 2025 11:40 AM ET Speaker0 To the the William Blair forty fifth Annual Growth Stock Conference. My name is Miles Minto. I'm a senior biotech analyst here at the firm. I cover the neurosciences and genetic medicines, and Axsome has been a day one coverage company for me. So early two thousand seventeen before before the Ascend data actually was when picked up coverage there. You know, obviously a bona fide growth story with a Vality well underway, launch of a ...

Details of the presentations are as follows: AUVELITY Title: Initiating Dextromethorphan 45 mg - Bupropion 105 mg (AUVELITY) in Patients with Major Depressive Disorder (MDD): Expert Panel Consensus Recommendations Lead Author: Anita Clayton, MD, Wilford W. Spradlin Professor and Chair of Psychiatry & Neurobehavioral Sciences and Professor of Clinical Obstetrics & Gynecology at the University of Virginia Presentation Date and Time: Wednesday, May 28, 11:15 a.m. - 1 p.m. Mountain Standard Time Session Name: P ...

Positive initial Phase 2 proof-of-concept data for NDV-01 at AUA 2025 showing a 90% overall response rate at any time in non-muscle invasive bladder cancer (US prevalence 600K patients) The Phase 2 study for NDV-01 continues with updates at 6, 9 and 12 month data follow-up over the course of 2025. Plans to start Phase III registration trial in H1 2026 Expecting to initiate a Phase 2 study for sepranolone in Prader-Willi syndrome in H1 2026 (US prevalence 20,000 patients) Conference Call and Webcast Today at ...

License agreement and recent leadership appointments position Cassava to advance development of simufilam in TSC-related epilepsy $117.3 Million in Cash and Cash Equivalents at March 31, 2025 AUSTIN, Texas, May 08, 2025 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, “Cassava”, the “Company”), a clinical-stage biotechnology company focused on developing novel, investigational treatments for central nervous system (CNS) disorders, today reported financial results for the first quarter ended March 3 ...