Revive Therapeutics Ltd. - RVVTF STOCK NEWS

Revive Therapeutics announced updates on their Type C meeting with the FDA regarding a proposed clinical study of Bucillamine as a treatment for Long COVID. The FDA recommended submitting a new IND application, incorporating data from Revive's previous Phase 3 clinical trial on mild to moderate COVID-19. The FDA provided feedback on study design, population, and measures to assess therapeutic benefits. CEO Michael Frank expressed optimism about advancing Bucillamine's clinical development. The CDC estimates 7.5% of U.S. adults have Long COVID, costing up to $3.7 trillion. Revive aims to finalize their study protocol and submit the IND soon.

Results from a previous Phase 3 trial showed Bucillamine (600mg/day) prevented hospitalizations, while a lower dose (300mg/day) had one hospitalization compared to three in the placebo group. Bucillamine also improved oxygen saturation by 29.1% over placebo. These findings support further investigation of Bucillamine for Long COVID.

On June 10, 2024, Revive Therapeutics announced an update from the FDA regarding their Long COVID Diagnostic Product, the Revive LC POC Lateral Flow Test Kit. The FDA recommended the product follow the De Novo regulatory pathway, necessitating a clinical study for possible approval. CEO Michael Frank confirmed alignment with the FDA's recommendations and plans to discuss development and timelines with potential contract manufacturers. The product, developed under Revive Diagnostics, aims to detect long COVID via blood biomarkers identified by Dr. Douglas Fraser's research, recently published in Molecular Medicine. Currently, no FDA-approved diagnostic exists for long COVID, which affects at least 10% of SARS-CoV-2 infections and involves over 200 symptoms impacting multiple organ systems.

Revive Therapeutics announces FDA granting Type C meeting request for clinical study of Bucillamine to treat Long COVID. The meeting is scheduled for June 9, 2024. Bucillamine has shown potential in treating long COVID and has anti-inflammatory and antiviral properties. The Company aims to leverage previous research to advance clinical development.

Revive Therapeutics announced that the FDA has accepted the meeting request for their Revive LC POC Lateral Flow Test Kit, a potential blood biomarker diagnostic for long COVID. The meeting date is set for June 7, 2024. The Company aims to develop an in vitro diagnostic device to aid in the detection of post COVID-19 conditions, addressing the lack of an FDA-approved clinical diagnosis for long COVID, which affects at least 10% of SARS-CoV-2 infections. Revive has entered into a license agreement for the intellectual property of novel blood biomarkers that characterize long COVID.

Revive Therapeutics provides an update on a clinical study evaluating oral psilocybin for methamphetamine use disorder. The study shows promising initial efficacy, with potential for future commercial initiatives and exclusive access to valuable intellectual property.

Revive Therapeutics submits Type C meeting request package to FDA for evaluation of Bucillamine as a potential treatment for long-term COVID. The Company aims to address long COVID symptoms and potential economic costs through leveraging previous clinical trial data.

Revive Therapeutics announced that the FDA advised the Company to submit a Type C meeting request to discuss evaluating a proposed Phase 2 clinical study of Bucillamine as a potential treatment for long COVID. The Company expects to submit the request soon. Bucillamine has shown promise in previous studies for COVID-19 treatment, and research suggests its potential for long COVID. These developments could have significant implications for medical treatment and the economic impact of long COVID.

Revive Therapeutics Ltd. provides a corporate update on research initiatives with Bucillamine for long COVID and nerve agent exposure. The company aims to develop Bucillamine as a treatment for nerve agent exposure and explore its potential for long COVID. Additionally, Revive is advancing the development of a blood biomarker diagnostic for long COVID.

Revive Therapeutics Ltd. announced its initiative in Bucillamine, an oral thiol-based drug with anti-inflammatory and antiviral properties, as a potential treatment for long COVID. The company aims to advance the clinical development of Bucillamine by leveraging existing data from its previous Phase 3 clinical trial and is preparing a clinical package for presentation to the FDA and international health regulatory bodies. The CDC estimates that 7.5 percent of U.S. adults have long COVID symptoms, and the economic cost could be as much as $3.7 trillion. The results of the Study evaluating the safety and efficacy of oral Bucillamine in patients with mild to moderate COVID-19 showed promising outcomes, with no deaths and a low hospitalization rate. Thiol-based drugs like Bucillamine have shown potential in inhibiting SARS-CoV-2 cell entry and live virus infection, providing a rationale for testing them as a novel treatment for COVID-19.