Revive Therapeutics Ltd - RVVTF STOCK NEWS

Revive Therapeutics Ltd. (OTCQB: RVVTF) announced that the FDA has approved its Type C meeting request to discuss revised protocol endpoints for its Phase 3 clinical trial testing Bucillamine for mild to moderate COVID-19. The written response from the FDA is expected by March 7, 2023. Revive emphasizes it does not claim that the drug can cure COVID-19. The company is also developing Psilocybin-based therapeutics and has received FDA orphan drug designation for Cannabidiol aimed at treating autoimmune hepatitis.

Revive Therapeutics Ltd. (RVVTF) has submitted a Type C meeting request to the FDA to discuss revised protocol endpoints for its Phase 3 clinical trial evaluating Bucillamine's efficacy in treating mild to moderate COVID-19. This step is crucial for progressing the trial and the company anticipates a meeting date from the FDA soon. Revive is focused on developing therapeutics for rare disorders and infectious diseases, including severe influenza and COVID-19, while holding several FDA designations aimed at fast-tracking drug development.

Revive Therapeutics is expanding its private placement, aiming to raise between $3 million and $5 million at a price of $0.15 per Unit, which includes one common share and one common share purchase warrant. The offering will now include investors from Quebec and is expected to close in tranches by January 13, 2023. The net proceeds will be utilized for general working capital and clinical development. Finder’s fees up to 8% of gross proceeds will be paid, with the first tranche expected to close by December 30, 2022.

Revive Therapeutics is initiating a private placement to raise between $3 million and $5 million, offering units at $0.15 each. Each unit consists of one common share and one warrant, allowing purchase of an additional share at $0.20 for three years. The offering is expected to close around December 14, 2022, pending regulatory approvals. Proceeds will be used for working capital and clinical development. The company is advancing therapeutic research focusing on infectious diseases and rare disorders, with significant FDA designations for its drug development efforts.

Revive Therapeutics (OTCQB: RVVTF) is set to submit its Type C meeting request to the FDA by mid-December 2022, outlining the development plan for its Phase 3 clinical trial of Bucillamine in treating mild to moderate COVID-19. The submission will include Pre-Dose selection data supporting revised endpoints for the study. Following this, Revive expects a firm date for the FDA meeting to discuss the trial.

The company does not claim that Bucillamine can eliminate or cure COVID-19 at this time.

Revive Therapeutics Ltd. (RVVTF) announced that the FDA has suggested a Type C meeting to discuss the development plan and revised endpoints for its Phase 3 clinical trial evaluating Bucillamine for COVID-19. The FDA has requested additional clinical data to move forward with the Study's revised endpoints, which focus on symptom improvement in participants. The DSMB will later review the data to determine the Study's continuation based on efficacy. Revive emphasizes that there is no claim that Bucillamine can eliminate or cure COVID-19.

Revive Therapeutics has amended its Phase 3 clinical trial protocol with the FDA for Bucillamine, aimed at treating mild to moderate COVID-19. The revised primary efficacy endpoint assesses participant symptom improvement by Day 14. Additional endpoints may include PCR resolution time and clinical outcomes. The Data Safety Monitoring Board will evaluate results to recommend the study’s continuation or halt based on significance trends. Revive does not claim Bucillamine can eliminate COVID-19. The company is advancing therapeutics in infectious diseases and rare disorders.

Revive Therapeutics Ltd. (OTCQB: RVVTF) provided an update on its Phase 3 FDA clinical trial for Bucillamine, addressing COVID-19 treatment. The FDA is reviewing the amended protocol which includes a revised primary endpoint that has not yet been accepted. The Data Safety Monitoring Board will evaluate data from approximately 500 subjects to determine the study's continuation based on statistical significance. Revive aims to present a comprehensive data package to the FDA to support Bucillamine's clinical advancement.

Revive Therapeutics Ltd. (OTCQB: RVVTF) has announced progress in its Phase I/II clinical study of oral psilocybin for treating methamphetamine use disorder, in collaboration with the University of Wisconsin-Madison. The study has secured FDA approval and is focused on evaluating safety and feasibility. Additionally, Revive is developing a proprietary oral psilocybin thin film strip for various mental health issues, with an expected first-in-human study in 2023. The company benefits from exclusive intellectual property access from the study, which supports future clinical trials.