Latest news with #Itruvone
Yahoo
4 days ago
- Business
- Yahoo
Vistagen Therapeutics Inc (VTGN) Q4 2025 Earnings Call Highlights: Strategic Advancements Amid ...
Research and Development Expenses: $39.4 million for the fiscal year ended March 31, 2025, up from $20 million the previous year. General and Administrative Expenses: $17.1 million for the fiscal year ended March 31, 2025, compared to $14.1 million the previous year. Net Loss: $51.4 million for the fiscal year ended March 31, 2025, compared to $29.4 million the previous year. Cash, Cash Equivalents, and Marketable Securities: $80.5 million as of March 31, 2025. Warning! GuruFocus has detected 3 Warning Signs with VTGN. Release Date: June 17, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Vistagen Therapeutics Inc (NASDAQ:VTGN) has five clinical-stage pherine product candidates with differentiated mechanisms of action, showing positive results in controlled trials. The company's lead product candidate, Fasedienol, is in Phase III development for social anxiety disorder (SAD), aiming to become the first FDA-approved acute treatment for SAD. Vistagen is advancing Itruvone for major depressive disorder (MDD), showing promise without common side effects of traditional antidepressants. PH80, a pherine product candidate for women's health, is progressing as a potential hormone-free treatment for menopausal hot flashes and premenstrual dysphoric disorder (PMDD). The company has $80.5 million in cash, cash equivalents, and marketable securities as of March 31, 2025, providing a solid financial position to support ongoing development. Research and development expenses increased significantly to $39.4 million for the fiscal year ended March 31, 2025, compared to $20 million the previous year. General and administrative expenses rose to $17.1 million, up from $14.1 million, due to increased headcount and professional fees. The net loss attributable to common shareholders was $51.4 million, a substantial increase from $29.4 million the previous year. The timeline for PALISADE-4 trial results has been modestly delayed due to stringent subject eligibility requirements and operational adjustments. There is uncertainty regarding the FDA's evolving regulatory landscape and its impact on Vistagen's product approvals, despite positive interactions with the agency. Q: Have you noticed any changes in FDA interactions due to leadership turnover, and what caused the timing adjustment for PALISADE-4? A: Shawn Singh, CEO, noted that no FDA reviewers were affected by the recent staff changes, and they are hiring more experts. The timing adjustment for PALISADE-4 was due to stringent subject eligibility requirements and enhanced study execution, which are now showing positive results in screening visits. Q: Will you announce enrollment completion for PALISADE-3, and how long until top-line data is reported? A: Shawn Singh, CEO, confirmed they will announce when the last patient completes the study. It typically takes about six to eight weeks from database lock to report top-line data. Q: Can we expect placebo effects in PALISADE-3 and 4 to be similar to PALISADE-2? A: Shawn Singh, CEO, stated that PALISADE-3 and 4 are designed to replicate PALISADE-2's success by limiting variability and enhancing study execution, although actual results will depend on study outcomes. Q: How are you ensuring proper patient disqualification and scoring consistency in the trials? A: Shawn Singh, CEO, explained that they have an internal secondary eligibility review team to ensure proper execution and scoring, focusing on stringent eligibility criteria and site conduct. Q: Is there alignment with the FDA on the unmet need for social anxiety disorder treatments like Fasedienol? A: Shawn Singh, CEO, mentioned that while specific program discussions were not allowed at the FDA forum, they have Fast Track designation, indicating FDA's recognition of the unmet need and potential benefits of Fasedienol. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
23-05-2025
- Health
- Yahoo
Vistagen to Present at the 2025 American Society of Clinical Psychopharmacology Conference
Posters Highlight New Insights into Social Anxiety Disorder and the Novel Mechanism of Action of Itruvone to Treat Major Depressive Disorder SOUTH SAN FRANCISCO, Calif., May 23, 2025--(BUSINESS WIRE)--Vistagen (Nasdaq: VTGN), a clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced it will present at the American Society of Clinical Psychopharmacology (ASCP) Conference in Scottsdale, Arizona from May 27-30, 2025. The Company's poster presentations will explore the age of onset of social anxiety disorder (SAD) from participants in fasedienol clinical trials, and the impact of itruvone – the company's investigational pherine for the treatment of major depressive disorder – on the electrogram of nasal chemosensory receptors (EGNR) and the olfactory bulb electrogram (EBG), both biomarkers of itruvone's effect on nasal chemosensory neurons and olfactory bulb physiologic activation. Poster Presentations: Date: Wednesday, May 28, 2025, 11:15 a.m. – 1:00 p.m. Eastern TimeTitle: Age of Onset of Social Anxiety Disorder (SAD) in Trials of Fasedienol (PH94B) Nasal SprayAuthors: Ester Salmán, MPH; Ross A. Baker, PhD; Stephen D. Coffey, BA; Rita Hanover, PhD; Michael R. Liebowitz, MD; and Louis Monti, MD, PhDPoster Number: W5 Date: Thursday, May 29, 2025, 11:30 a.m. - 1:00 p.m. Eastern TimeTitle: Antidepressant Itruvone Nasal Spray Depolarizes Nasal Chemosensory Receptors Followed by Increased Gamma Power Spectral Density of the Olfactory Bulb in Healthy SubjectsAuthors: Louis Monti, MD, PhD; Danajane Katz, BS; Ester Salmán, MPH; Weiping Zhang, PhD; Ross A. Baker, PhD; and Rita Hanover, PhDPoster Number: T73 These posters will be available on the Publications page of Vistagen's website on Monday, June 2, 2025. About Vistagen Headquartered in South San Francisco, CA, Vistagen (Nasdaq: VTGN) is a clinical-stage biopharmaceutical company leveraging a deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of clinical-stage product candidates from a new class of intranasal therapies called pherines. Pherines specifically and selectively bind as agonists to peripheral receptors in human nasal chemosensory neurons, rapidly activating olfactory bulb-to-brain neurocircuits which regulate brain areas involved in behavior and autonomic nervous system activity. They are designed to achieve therapeutic benefits without requiring absorption into the blood or uptake into the brain, giving them the potential to be a safer alternative to other pharmacological options. Vistagen's neuroscience pipeline also includes an oral prodrug with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent indications, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause. Connect at View source version on Contacts Investor Inquiries: Mark A. McPartlandmarkmcp@ Media Inquiries: Michelle P. Wellingtonmwellington@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
23-05-2025
- Health
- Business Wire
Vistagen to Present at the 2025 American Society of Clinical Psychopharmacology Conference
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Vistagen (Nasdaq: VTGN), a clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced it will present at the American Society of Clinical Psychopharmacology (ASCP) Conference in Scottsdale, Arizona from May 27-30, 2025. The Company's poster presentations will explore the age of onset of social anxiety disorder (SAD) from participants in fasedienol clinical trials, and the impact of itruvone – the company's investigational pherine for the treatment of major depressive disorder – on the electrogram of nasal chemosensory receptors (EGNR) and the olfactory bulb electrogram (EBG), both biomarkers of itruvone's effect on nasal chemosensory neurons and olfactory bulb physiologic activation. Poster Presentations: Title: Age of Onset of Social Anxiety Disorder (SAD) in Trials of Fasedienol (PH94B) Nasal Spray Authors: Ester Salmán, MPH; Ross A. Baker, PhD; Stephen D. Coffey, BA; Rita Hanover, PhD; Michael R. Liebowitz, MD; and Louis Monti, MD, PhD Poster Number: W5 Date: Thursday, May 29, 2025, 11:30 a.m. - 1:00 p.m. Eastern Time Title: Antidepressant Itruvone Nasal Spray Depolarizes Nasal Chemosensory Receptors Followed by Increased Gamma Power Spectral Density of the Olfactory Bulb in Healthy Subjects Authors: Louis Monti, MD, PhD; Danajane Katz, BS; Ester Salmán, MPH; Weiping Zhang, PhD; Ross A. Baker, PhD; and Rita Hanover, PhD Poster Number: T73 These posters will be available on the Publications page of Vistagen's website on Monday, June 2, 2025. About Vistagen Headquartered in South San Francisco, CA, Vistagen (Nasdaq: VTGN) is a clinical-stage biopharmaceutical company leveraging a deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of clinical-stage product candidates from a new class of intranasal therapies called pherines. Pherines specifically and selectively bind as agonists to peripheral receptors in human nasal chemosensory neurons, rapidly activating olfactory bulb-to-brain neurocircuits which regulate brain areas involved in behavior and autonomic nervous system activity. They are designed to achieve therapeutic benefits without requiring absorption into the blood or uptake into the brain, giving them the potential to be a safer alternative to other pharmacological options. Vistagen's neuroscience pipeline also includes an oral prodrug with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent indications, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause. Connect at
