PH10

Vistagen Provides Corporate Update and Reports Fiscal Year 2023 Financial Results

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星期三, 六月 28, 2023
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, Columbia University, Hot, Depression, Central nervous system, Liebowitz social anxiety scale, Anxiety, New Drug Application, COVID-19, Fear, Calendar, NDA, Woman, SAD, Fast Track, CNS, New York State Psychiatric Institute, Science, Phase 1, PALISADE, MDD, PH10, Patient, LSAS, Anxiety disorder, Menopause, Principal, PH94B, FDA, Safety, Pharmaceutical industry

Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other central nervous system (CNS) disorders, today provided a corporate update and reported financial results for its fiscal year 2023 ended March 31, 2023.

Key Points: 
  • Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other central nervous system (CNS) disorders, today provided a corporate update and reported financial results for its fiscal year 2023 ended March 31, 2023.
  • Positive results reported from Phase 2A study of PH80 in women diagnosed with vasomotor symptoms (hot flashes) due to menopause.
  • Vistagen will host a conference call and live audio webcast this afternoon at 4:30 p.m. Eastern Time to provide a corporate update for its fiscal year 2023 ended March 31, 2023.
  • In addition, a telephone playback of the call will be available after approximately 8:00 p.m. Eastern Time on Wednesday, June 28, 2023.

Vistagen Announces Results of Successful U.S. Phase 1 Study of Itruvone (PH10), Enabling U.S. Phase 2B Development for Treatment of Major Depressive Disorder

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星期三, 六月 21, 2023
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, Hallucination, Central nervous system, Depression, Prevalence, Week, Anxiety, Aes, Medication, DSM-IV codes, CNS, Șaeș, Gallup, MDD, PH10, Hamilton Rating Scale for Depression, Itruvone, Headache, Environment, Medical research, Safety, Fatigue, Pharmaceutical industry

Phase 1 clinical trial of itruvone (PH10), the Company’s investigational rapid-onset pherine nasal spray for the treatment of major depressive disorder (MDD).

Key Points: 
  • Phase 1 clinical trial of itruvone (PH10), the Company’s investigational rapid-onset pherine nasal spray for the treatment of major depressive disorder (MDD).
  • Phase 1 study build on successful Phase 1 studies and a positive randomized, double-blind, placebo-controlled Phase 2A study of itruvone nasal spray in MDD previously conducted in Mexico and enable Phase 2B development of itruvone in the U.S. as an innovative stand-alone rapid-onset product candidate for treatment of MDD.
  • There were no reported serious adverse events (SAEs) or discontinuations due to adverse events (AEs) in the study.
  • Phase 1 study, along with the results of Vistagen’s nonclinical studies and three prior clinical studies, inform Phase 2B development of itruvone as a potential rapid-onset stand-alone treatment of MDD with a favorable safety profile.

Coherent Introduces PowerLine FL Series of Cost-Effective Laser Subsystems for Precision Welding and Cutting

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星期四, 六月 15, 2023
Powerline, COHR, Laser World Championship, Public expenditure, Laser, PH10, Coherent Corp., NYSE, Coherence, Welding, Photonics

PITTSBURGH, June 15, 2023 (GLOBE NEWSWIRE) -- Coherent Corp. (NYSE: COHR), a leader in industrial lasers, today introduced the PowerLine FL series of fiber laser subsystems that are fully integrated, easy to install, and simple to operate for precision welding and cutting.

Key Points: 
  • PITTSBURGH, June 15, 2023 (GLOBE NEWSWIRE) -- Coherent Corp. (NYSE: COHR), a leader in industrial lasers, today introduced the PowerLine FL series of fiber laser subsystems that are fully integrated, easy to install, and simple to operate for precision welding and cutting.
  • This is driving the demand for cost-efficient, fully configured, simple to integrate subsystems that offer a compelling cost of ownership model.
  • The new PowerLine FL series greatly minimizes capital expenditures with new lower output power options that excel at a wide range of precision welding and cutting applications.
  • These laser subsystems can be configured with either scan heads or fixed optic precision focus heads.

Vistagen Announces Completion of Last Patient, Last Visit in Phase 1 Clinical Trial of Itruvone (PH10), an Investigational Pherine Nasal Spray for Major Depressive Disorder

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星期三, 三月 8, 2023
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, DSM-IV codes, Central nervous system, CNS, Depression, MDD, PH10, Anxiety, Safety, Weight gain, Pharmaceutical industry

Phase 1 clinical trial of itruvone (PH10), the Company’s investigational pherine nasal spray for the treatment of major depressive disorder (MDD).

Key Points: 
  • Phase 1 clinical trial of itruvone (PH10), the Company’s investigational pherine nasal spray for the treatment of major depressive disorder (MDD).
  • The primary objective of this U.S. single-center, randomized, double-blind, placebo-controlled Phase 1 study is to investigate the safety and tolerability of itruvone in healthy adult subjects.
  • “With the treatment protocol for our final enrolled participant complete, we look forward to reviewing the data and advancing Phase 2B development plans for itruvone as an innovative treatment for major depressive disorder,” said Shawn Singh, Chief Executive Officer of Vistagen.
  • Phase 1 trial will build on itruvone’s exceptional safety and tolerability profile as demonstrated in all prior clinical studies to date.”

Vistagen Provides Corporate Update and Reports Fiscal 2023 Third Quarter Financial Results

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星期二, 二月 7, 2023
Biotechnology, Pharmaceutical, Health, Mental Health, New Drug Application, PIN, Hot, PALISADE, DSM-IV codes, Probenecid, Safety, PH94B, Acquisition, NMDA, SAD, Patient, PH10, Depression, Food, LSAS, CNS, Fear, G&A, Anxiety, Social anxiety disorder, MDD, Liebowitz social anxiety scale, Migraine, FDA, Research, Calendar, Central nervous system, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, COVID-19, Cognition, Fast Track, FTD, R, IND, Pharmaceutical industry, Medical device, Cryptocurrency, Broadcasting, Ajda

“Since our last quarterly update, Vistagen has met several important business objectives,” said Shawn Singh, Chief Executive Officer of Vistagen.

Key Points: 
  • “Since our last quarterly update, Vistagen has met several important business objectives,” said Shawn Singh, Chief Executive Officer of Vistagen.
  • Should Vistagen resume PALISADE-2, the proposed amendments are intended to address various methodological issues believed to have contributed to the unexpected results of PALISADE-1.
  • Vistagen anticipates reporting topline results from this exploratory Phase 2A AjDA trial by the end of the first quarter of calendar 2023.
  • Vistagen will host a conference call and live audio webcast this afternoon at 5:00 p.m. Eastern Time to discuss its financial results for its third quarter fiscal year 2023 ended December 31, 2022 and provide a corporate update.

Vistagen Announces Closing of Pherin Pharmaceuticals Acquisition

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星期四, 二月 2, 2023
Biotechnology, Pharmaceutical, Health, Mental Health, Additive effect, DSM-IV codes, Drug development, PH94B, Acquisition, SAD, PH10, Depression, Mixed anxiety–depressive disorder, CNS, Anxiety, Social anxiety disorder, MDD, Ajda, Migraine, Central nervous system, Cognition, Hot, Pharmaceutical industry, Pherine

Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other central nervous system (CNS) disorders, today announced the closing of its acquisition of Pherin Pharmaceuticals, Inc., a privately held drug development company focused on neuropsychiatric and neuroendocrine conditions (Pherin).

Key Points: 
  • Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other central nervous system (CNS) disorders, today announced the closing of its acquisition of Pherin Pharmaceuticals, Inc., a privately held drug development company focused on neuropsychiatric and neuroendocrine conditions (Pherin).
  • Vistagen’s acquisition of Pherin eliminates all future royalty payment obligations related to its five pherine nasal spray drug candidates.
  • “This acquisition is another important step in our plan to develop and commercialize PH94B and PH10 as innovative treatments for millions of individuals struggling with anxiety and depression disorders,” stated Shawn Singh, Chief Executive Officer of Vistagen.
  • This acquisition significantly improves the potential future commercial profile of each drug candidate.”
    Additional details regarding the closing of Vistagen’ acquisition of Pherin can be found in the Company’s Current Report on Form 8-K, filed with the U.S. Securities and Exchange Commission today and available in the Investors section of Vistagen’s website.

Vistagen Announces First Participants Dosed in Phase 1 Clinical Trial of PH10, an Investigational Pherine Nasal Spray for Major Depressive Disorder

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星期二, 一月 24, 2023
Mental Health, Health, General Health, Clinical Trials, Research, Science, Pharmaceutical, FDA, DSM-IV codes, CNS, Safety, Central nervous system, Anxiety, MDD, PH10, Depression, Pharmaceutical industry

Phase 1 clinical trial of PH10, the Company’s investigational pherine nasal spray in development for the treatment of major depressive disorder (MDD).

Key Points: 
  • Phase 1 clinical trial of PH10, the Company’s investigational pherine nasal spray in development for the treatment of major depressive disorder (MDD).
  • The primary objective of this U.S. single center, randomized, double-blinded, placebo-controlled Phase 1 study is to investigate the safety and tolerability of PH10 in healthy adult subjects (n=12).
  • Phase 1 study of Vistagen’s novel pherine nasal spray, PH10, represents a major milestone for our team as well as for the millions of individuals left struggling with major depressive disorder,” stated Shawn Singh, Chief Executive Officer of Vistagen.
  • “We expect this Phase 1 trial to augment our record of favorable safety and tolerability data for PH10 across all prior clinical studies.

Vistagen Advances Intellectual Property Program to Expand Patent Protection for PH94B to Include Treatment of Adjustment Disorder

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星期五, 十二月 30, 2022
Biotechnology, Pharmaceutical, Health, Mental Health, Migraine, Anxiety, SAD, Flash, Central nervous system, Facilitated diffusion, MDD, PH94B, Patent, Depression, CNS, Acquisition, Ajda, Cognition, Social anxiety disorder, PH10, Pharmaceutical industry

These new filings are intended to provide a global exclusivity platform for PH94B in AjD, similar to the Company’s patent protection for PH94B for the treatment of social anxiety disorder (SAD), and for its other late-clinical stage product candidate, PH10, for the treatment of major depressive disorder (MDD).

Key Points: 
  • These new filings are intended to provide a global exclusivity platform for PH94B in AjD, similar to the Company’s patent protection for PH94B for the treatment of social anxiety disorder (SAD), and for its other late-clinical stage product candidate, PH10, for the treatment of major depressive disorder (MDD).
  • Vistagen recently announced its pending acquisition of Pherin Pharmaceuticals, Inc.
  • Vistagen will also gain full ownership of three new early clinical-stage pherine product candidates: PH15 for cognition improvement; PH284 for appetite-related disorders and PH80 for migraine and hot flashes.
  • When the acquisition is completed, Vistagen's global patent portfolio for novel pherine class compounds will further expand to include U.S. and foreign counterpart patent applications related to the use of PH80 for the treatment of migraine and for the treatment of hot flashes.

Vistagen to Acquire Pherin Pharmaceuticals

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星期三, 十二月 21, 2022
Biotechnology, Neurology, Health, Pharmaceutical, Clinical Trials, Migraine, Anxiety, SAD, Flash, Disorder, Central nervous system, MDD, PH94B, Depression, CNS, Acquisition, Patient, Ajda, Cognition, Social anxiety disorder, PH10, Pharmaceutical industry, Pherine

Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other central nervous system (CNS) disorders, and Pherin Pharmaceuticals, Inc., a clinical-stage drug development company focused on the discovery and development of investigational pherine compounds for treatment of neuropsychiatric and neuroendocrine conditions (Pherin), today announced that the companies have entered into a definitive agreement under which Vistagen will acquire Pherin for approximately 12.4 million shares of Vistagen common stock and a nominal amount of cash.

Key Points: 
  • Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other central nervous system (CNS) disorders, and Pherin Pharmaceuticals, Inc., a clinical-stage drug development company focused on the discovery and development of investigational pherine compounds for treatment of neuropsychiatric and neuroendocrine conditions (Pherin), today announced that the companies have entered into a definitive agreement under which Vistagen will acquire Pherin for approximately 12.4 million shares of Vistagen common stock and a nominal amount of cash.
  • Upon closing of the acquisition, which is subject to certain customary closing conditions, Vistagen will acquire Pherin’s entire pherine pipeline, resulting in Vistagen gaining full ownership of intellectual property rights to its two most advanced drug candidates, PH94B, currently in Phase 3 development for social anxiety disorder (SAD) and Phase 2 development for adjustment disorder with anxiety (AjDA), and PH10, in clinical development for major depressive disorder (MDD).
  • Vistagen will also expand its pipeline with three new early clinical-stage pherine product candidates: PH15 for cognition improvement; PH80 for migraine and hot flashes; and PH284 for appetite-related disorders.
  • “Since 2018, we have observed the experienced Vistagen team working diligently to advance all aspects of development for PH94B and PH10.

Vistagen Receives FDA Fast Track Designation for Development of PH10 to Treat Major Depressive Disorder

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星期二, 十二月 6, 2022
Mental Health, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Fast Track, KBT, Standard of care, Neuron, Therapy, Catecholamine, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Central nervous system, Major depressive disorder, Patient, PH10, Anxiety, Annual report, Nasal spray, Central nervous system disease, MOA, Hamilton Rating Scale for Depression, FDA, Ketamine, COVID-19, PH94B, Safety, Risk, Brain, United, Medication, Depression, Hallucination, Medical research, CNS, MDD, Grammatical mood, Pharmaceutical industry

Vistagen is laser focused on bringing an innovative treatment option to individuals suffering with debilitating depression.

Key Points: 
  • Vistagen is laser focused on bringing an innovative treatment option to individuals suffering with debilitating depression.
  • The FDAs grant of the Fast Track designation for the development of PH10 in major depressive disorder is a significant regulatory milestone, aligned with our belief in PH10s potential to improve the standard of care in a significant market where new and differentiated treatments are urgently needed, stated Shawn Singh, Chief Executive Officer of Vistagen.
  • With 21 million adults in the U.S. suffering at least one major depressive episode in the past year, potentially millions of individuals are not getting the help they need.
  • We look forward to working with the FDAs Fast Track program as we advance development of PH10 in the United States.