Probenecid

Vistagen Reports Second Quarter Financial Results and Provides Corporate Update

Retrieved on: 
목요일, 11월 10, 2022
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Review, Data analysis, Liebowitz social anxiety scale, PIN, LSAS, NMDA, IND, Risk, Adult, Calendar, Nasal spray, PALISADE, Probenecid, Depression, Central nervous system disease, Food, Nasdaq, Research, Fear, Anxiety, PH94B, COVID-19, Neuron, MDD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, R, Hallucination, SEC, Annual report, Brain, Social anxiety disorder, SAD, Safety, U.S. Securities and Exchange Commission, Time, Company, Grammatical mood, PH10, Clinical trial, Patient, OLS, Therapy, Drug discovery, Hamilton Rating Scale for Depression, Central nervous system, Major depressive disorder, Industry, Decision-making, CNS, FDA, Trial of the century, Pharmaceutical industry, Fine chemical, G&A, Ajda

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 reported financial results for its fiscal year 2023 second quarter ended September 30, 2022 and provided a corporate update.

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 reported financial results for its fiscal year 2023 second quarter ended September 30, 2022 and provided a corporate update.
  • During the past quarter, Vistagen achieved several important milestones to advance our CNS pipeline.
  • Vistagen anticipates topline results from this exploratory Phase 2A AjDA trial during 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 second quarter fiscal year 2023 ended September 30, 2022 and provide a corporate update.

Iterum Announces First Patient Dosed in REASSURE, a Phase 3 Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections

Retrieved on: 
목요일, 10월 20, 2022
CRL, U.S. Securities and Exchange Commission, SPA, Urinary tract infection, SEC, Therapy, Woman, Hand, Infection, QIDP, Amoxicillin/clavulanic acid, NDA, Probenecid, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Penem, IV, Renewable Energy and Energy Efficiency Partnership, Security (finance), UTI, Nasdaq, Food, Legislation, Adult, Safety, Bacteria, Phrase, ITRM, GLOBE, Medical microbiology, Clinical trial, Forward-looking statement, Public policy, FDA, COVID-19, Pharmaceutical industry, Vaccine

DUBLIN, Ireland and CHICAGO, Oct. 20, 2022 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage pharmaceutical company developing antibiotics to treat infections caused by multi-drug resistant pathogens, today announced that the first patient has been dosed in its Phase 3 clinical trial, known as REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales (REASSURE), comparing oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral Augmentin® (amoxicillin/clavulanate) in adult women with uncomplicated urinary tract infections (uUTI).

Key Points: 
  • With positive results, we would resubmit our new drug application (NDA) to the FDA in the second half of 2024.
  • The REASSURE trial is designed as a non-inferiority trial comparing oral sulopenem and Augmentin in the Augmentin susceptible population and is entitled A prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem etzadroxil/probenecid versus oral amoxicillin/clavulanate for treatment of uncomplicated urinary tract infections (uUTI) in adult women.
  • Patients will be randomized to receive either oral sulopenem twice daily for 5 days or Augmentin twice daily for 5 days.
  • The primary endpoint is the overall response (clinical and microbiologic combined response) at Day 12 of the trial.

Iterum Therapeutics announces Issuance of Allowance for a U.S. Patent Covering Oral Sulopenem

Retrieved on: 
월요일, 9월 19, 2022
Penem, Infection, IV, COVID-19, China International Search and Rescue Team, FDA, Food, ITRM, Legislation, Company, Public policy, Therapy, U.S. Securities and Exchange Commission, Hand, Forward-looking statement, Clinical trial, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Phrase, Probenecid, United States Patent and Trademark Office, QIDP, Bacteria, Nasdaq, Patent, Urinary tract infection, Security (finance), GLOBE, SEC, Pharmaceutical industry

This Notice of Allowance concludes the substantive examination of the patent application and will result in the issuance of a U.S. patent after administrative processes are completed.

Key Points: 
  • This Notice of Allowance concludes the substantive examination of the patent application and will result in the issuance of a U.S. patent after administrative processes are completed.
  • Existing patent protection for sulopenem etzadroxil is scheduled to expire in 2029, subject to potential extension.
  • Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation.
  • Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

VistaGen Therapeutics Reports First Quarter Financial Results and Provides Corporate Update

Retrieved on: 
목요일, 8월 11, 2022
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, FDA, U.S. Securities and Exchange Commission, Social anxiety disorder, MDD, Depression, Lists of diseases, Liebowitz social anxiety scale, Probenecid, Subjective units of distress scale, NDA, SUDS, Industry, CNS, Trial of the century, R, PH10, Neuron, Major depressive disorder, SEC, Brain, IND, Social anxiety, Anxiety, Research, Annual report, LSAS, Adjustment disorder, Patient, Therapy, SAD, COVID-19, Company, State, Calendar, Central nervous system disease, Central nervous system, PH94B, Safety, PIN, Risk, Investigational New Drug, Nasdaq, Time, NMDA, PALISADE, Pharmaceutical industry, Fine chemical, G&A, Ajda

Our mission is to transform lives, and we have a strong pipeline and team in place to accomplish that goal, added Singh.

Key Points: 
  • Our mission is to transform lives, and we have a strong pipeline and team in place to accomplish that goal, added Singh.
  • VistaGen will host a conference call and live audio webcast this afternoon at 5:00 p.m. Eastern Time to provide a corporate update and discuss its financial results for its first quarter fiscal year 2023 ended June 30, 2022.
  • VistaGen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety and depression.
  • The Company explicitly disclaims any obligation to update any forward-looking statements, other than as may be required by law.

VistaGen Therapeutics Reports Fiscal Year 2022 Financial Results and Provides Corporate Update

Retrieved on: 
목요일, 6월 23, 2022
Mental Health, Health, FDA, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Consensus, Depression, FDA, Biological Psychiatry (journal), Society, Safety, CNS, U.S. Securities and Exchange Commission, NMDA, Disorder, Post-traumatic stress disorder, PH10, MDD, MOA, SAD, Ajda, COVID-19, Brain, Food, Annual general meeting, Therapy, Social anxiety disorder, PTSD, Neuron, G&A, Medscape, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Annual report, Decision-making, Industry, Risk, Consensus decision-making, Central nervous system disease, PALISADE, IND, Marketing, Mental health, Nasdaq, HAP, PIN, Lists of diseases, Central nervous system, Anxiety, SEC, State, R, Â, Time, Research, PH94B, Probenecid, Company, ASCP, NDA, Drug development, Investigational New Drug, Pharmaceutical industry, Online gambling

VistaGen Therapeutics, Inc. (Nasdaq: VTGN), a late clinical-stage, central nervous system (CNS)-focused biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other CNS disorders, today reported its financial results for its fiscal year ended March 31, 2022 and provided a corporate update.

Key Points: 
  • VistaGen Therapeutics, Inc. (Nasdaq: VTGN), a late clinical-stage, central nervous system (CNS)-focused biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other CNS disorders, today reported its financial results for its fiscal year ended March 31, 2022 and provided a corporate update.
  • VistaGen continued consistent progress across its nasal spray, pherine-based platform and novel oral NMDA (N-methyl-D-aspartate) receptor programs.
  • VistaGen will host a conference call and live audio webcast this afternoon at 5:00 p.m. Eastern Time to provide a corporate update and discuss its financial results for its fiscal year 2022 ended March 31, 2022.
  • The Company explicitly disclaims any obligation to update any forward-looking statements, other than as may be required by law.

VistaGen Therapeutics Reports Third Quarter Financial Results and Provides Corporate Update

Retrieved on: 
목요일, 2월 10, 2022
CNS, Patient, Epilepsy, Food, Depression, Company, MOA, G&A, Research, Brain, SEC, Anxiety, Neuropathic pain, R, Nasdaq, PH94B, Annual report, Safety, Probenecid, Regulation of tobacco by the U.S. Food and Drug Administration, Therapy, Leadership, PH10, Levodopa-induced dyskinesia, GLOBE, Lists of diseases, Mental health, MDD, LinkedIn, U.S. Securities and Exchange Commission, Twitter, Social anxiety disorder, FDA, Central nervous system disease, Risk, SAD, Suicidal ideation, Marketing, Central nervous system, NDA, NMDA, COVID-19, Program, Ajda, Fast Track, Trial of the century, Benzodiazepine, Industry, PALISADE, Pharmaceutical industry, Facebook

SOUTH SAN FRANCISCO, Calif., Feb. 10, 2022 (GLOBE NEWSWIRE) -- VistaGen Therapeutics, Inc .

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Feb. 10, 2022 (GLOBE NEWSWIRE) -- VistaGen Therapeutics, Inc .
  • Our third quarter results reflect strong execution and progress against our strategy to realize the promise of our differentiated CNS pipeline, stated Shawn Singh, Chief Executive Officer of VistaGen .
  • VistaGen continued consistent progress across its nasal spray, pherine-based platform and novel oral NMDA (N-methyl-D-aspartate) receptor program.
  • VistaGen will host a conference call and live audio webcast this afternoon at 5:00 p.m. Eastern Time to provide a corporate update and discuss its financial results for its fiscal year 2022 third quarter ended December 31, 2021.

VistaGen Therapeutics Reports Fiscal Year 2022 Second Quarter Financial Results and Provides Corporate Update

Retrieved on: 
수요일, 11월 10, 2021
NDA, Suicidal ideation, NMDA, Central nervous system disease, Industry, Therapy, Depression, Food, SAD, COVID-19, Neuropathic pain, Probenecid, Anxiety, Regulation of tobacco by the U.S. Food and Drug Administration, Levodopa-induced dyskinesia, Board of directors, Review, Prevalence, Fast Track, PIN, Safety, Epilepsy, MBA, Trial of the century, Social anxiety disorder, Mental health, Research, GLOBE, PH10, Marketing, FDA, G&A, PH94B, MDD, U.S. Securities and Exchange Commission, R, NASDAQ, COVID, Goal, United, Program, Benzodiazepine, Risk, Twitter, SEC, Central nervous system, Lists of diseases, MOA, PALISADE, Annual report, CNS, Board, Company, LinkedIn, Post-traumatic stress disorder, Pharmaceutical industry, Animal

SOUTH SAN FRANCISCO, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a late-stage biopharmaceutical company committed to developing and commercializing a new generation of medicines with the potential to go beyond the current standard of care for anxiety, depression, and other central nervous system (CNS) disorders, today reported its financial results for the fiscal year 2022 second quarter ended September 30, 2021 and provided a review of the Company’s recent accomplishments.

Key Points: 
  • We continued our strong performance throughout the quarter with notable advances in all programs for our lead product candidate, PH94B.
  • During the quarter, VistaGen initiated PALISADE-2, the second Phase 3 trial in its PALISADE Phase 3 Program for PH94B in social anxiety disorder (SAD).
  • The Company expects topline data for PALISADE-1 in mid-2022 and PALISADE-2 topline data in the second half of 2022.
  • VistaGen will host a conference call and live audio webcast this afternoon, Wednesday, November 10, 2021, at 5:00 p.m. Eastern Time to provide a corporate update and discuss its financial results for its fiscal year 2022 second quarter ended September 30, 2021.

TrippBio announces publication of data supporting the antiviral potency of TD-213 against SARS-CoV-2 in Scientific Reports

Retrieved on: 
월요일, 9월 13, 2021
Hyperuricemia, Nature, Probenecid, Cloxacillin, FDA, Methicillin, Orthomyxoviridae, CEO, University, Plasma, Doctor of Philosophy, Manuscript, Patient, Doctor of Pharmacy, Infection, Severe acute respiratory syndrome coronavirus 2, Pharmacokinetics, COVID-19, Ampicillin, Gout, Degenerative disease, Scientific Reports, Oxacillin, Pharmaceutical industry, Vaccine

These results are being used to design appropriate clinical trials to evaluate the efficacy of TD-213 as a treatment for mild-to-moderate COVID-19.

Key Points: 
  • These results are being used to design appropriate clinical trials to evaluate the efficacy of TD-213 as a treatment for mild-to-moderate COVID-19.
  • "These data demonstrate a very potent antiviral effect of TD-213 against SARS-CoV-2," said Ralph Tripp, PhD.
  • Probenecid is a favorable antiviral drug candidate as it is commercially available and has high plasma concentrations with a benign clinical safety profile.
  • TrippBio is founded on the scientific research of Ralph Tripp, Ph.D., Georgia Research Alliance Chair and professor at the University of Georgia.

VistaGen Therapeutics Reports Fiscal Year 2022 First Quarter Financial Results and Provides Corporate Update

Retrieved on: 
목요일, 8월 12, 2021
NMDA, MDD, Calendar, Major depressive disorder, PH94B, Lists of diseases, Epilepsy, Leadership, CNS, G&A, Board of directors, PH10, United, Safety, Johnson & Johnson, Industry, PALISADE, Awareness, Central nervous system, Post-traumatic stress disorder, Company, Food, LinkedIn, Mental health, Therapy, SEC, FDA, Annual report, Public relations, Depression, Regulation of tobacco by the U.S. Food and Drug Administration, Anxiety, Fast Track, PIN, COVID-19, U.S. Securities and Exchange Commission, Ajda, NDA, Suicidal ideation, Board, Cigna, Levodopa-induced dyskinesia, Trial of the century, NASDAQ, Social anxiety disorder, Research, SAN, Risk, Central nervous system disease, Russell, Program, Twitter, Neuropathic pain, GLOBE, Marketing, SAD, Probenecid, R, Pharmaceutical industry, Animal, Communications satellite

SOUTH SAN FRANCISCO, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) -- VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a biopharmaceutical company committed to developing and commercializing a new generation of medicines with the potential to go beyond the current standard of care for anxiety, depression and other central nervous system (CNS) disorders, today reported financial results for its fiscal year 2022 first quarter ended June 30, 2021 and provided a corporate update.

Key Points: 
  • We expect to initiate that study in the U.S. before year end, said Shawn Singh, Chief Executive Officer of VistaGen.
  • Appointed Maggie FitzPatrick to our Board of Directors, bringing extensive leadership in healthcare consumer-focused engagement, marketing and public relations.
  • VistaGen will host a conference call and live audio webcast this afternoon at 2:00 p.m. Pacific Time to provide a corporate update and discuss its financial results for its fiscal year 2022 first quarter ended June 30, 2021.
  • We explicitly disclaim any obligation to update any forward-looking statements, other than as may be required by law.

TrippBio receives Notice of Allowance from the U.S. Patent Office for Therapeutic Treatment of COVID-19 Infections

Retrieved on: 
목요일, 7월 15, 2021
Intellectual property law, Patent offices, International Searching and Preliminary Examining Authorities, Patent law, European Patent Organisation, United States Patent and Trademark Office, Patent application, Patent office, European Patent Office, Term of patent

JACKSONVILLE, Fla., July 15, 2021 /PRNewswire-PRWeb/ --TrippBio, Inc. (TrippBio), a clinical development-stage company developing antiviral treatments with an initial focus on COVID-19, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for patent application No.

Key Points: 
  • JACKSONVILLE, Fla., July 15, 2021 /PRNewswire-PRWeb/ --TrippBio, Inc. (TrippBio), a clinical development-stage company developing antiviral treatments with an initial focus on COVID-19, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for patent application No.
  • 16/875,487, and the European Patent Office (EPO) has issued a favorable opinion in a counterpart European application.
  • The availability of safe and effective treatment options can reduce the rate of hospitalizations and hopefully the long-term effects of COVID-19."
  • TrippBio is founded on the scientific research of Ralph Tripp, Ph.D., Georgia Research Alliance Chair and professor at the University of Georgia.