Revive Therapeutics Ltd Stock Price, News & Analysis

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.

Revive Therapeutics Ltd. (OTCQB: RVVTF) has amended its Phase 3 clinical trial protocol submitted to the FDA to evaluate the efficacy of Bucillamine for treating COVID-19. The new protocol introduces primary and secondary efficacy endpoints that aim to reflect changes in COVID-19 outcomes observed during the pandemic. If accepted, the Data Safety Monitoring Board will assess the revised protocol's potential for statistical significance and may recommend proceeding with the Study. Revive seeks regulatory approval from the FDA based on these results.

Revive Therapeutics Ltd. (OTCQB: RVVTF) announced updates on its FDA Phase 3 clinical trial evaluating Bucillamine for mild to moderate COVID-19. The company will amend the study protocol based on newly analyzed data, proposing new primary efficacy endpoints such as time to symptom resolution and sustained clinical recovery. This aligns with evolving COVID-19 treatment needs, particularly with the rise of the Omicron variant. Revive emphasizes that it does not claim Bucillamine can cure COVID-19.

Revive Therapeutics Ltd. (OTCQB: RVVTF) provides an update on its Phase 3 clinical trial evaluating Bucillamine for mild to moderate COVID-19. The company has unblinded pre-dose selection data to support an amended study protocol with new efficacy endpoints, focusing on sustained clinical resolution of symptoms, which may enhance chances for FDA Emergency Use Authorization. The urgent need for effective treatments is underscored by the dominance of the Omicron variant. Revive maintains it does not claim Bucillamine can cure COVID-19 at this time.

Revive Therapeutics Ltd. announced that the FDA has accepted its Data Access Plan (DAP) for the Phase 3 clinical trial of Bucillamine in treating mild to moderate COVID-19. This acceptance allows for the unblinding of pre-dose selection data, which will support the amendment of the study's primary efficacy endpoints. The updated endpoints will focus on the sustained resolution of COVID-19 symptoms, critical as the Omicron variant becomes dominant. The FDA’s feedback may facilitate potential Emergency Use Authorization for the drug.

Revive Therapeutics Ltd. (OTCQB: RVVTF) has submitted a Data Access Plan to the FDA to establish new clinical endpoints for potential Emergency Use Authorization of Bucillamine, an oral drug for COVID-19. Following positive feedback from the FDA on the trial’s new primary efficacy endpoints, the plan aims to unblind pre-dose selection data for the trial's initial 210 patients. The Data Safety and Monitoring Board supports the continuation of the study, with no serious safety concerns reported. The company emphasizes the urgent need for treatment amid the ongoing COVID-19 pandemic.