Revive Therapeutics Ltd Stock Price, News & Analysis

Revive Therapeutics Ltd. (OTCQB: RVVTF) recently provided an update on its FDA Phase 3 clinical trial, evaluating Bucillamine for treating mild to moderate COVID-19. Following discussions with the FDA, the company has opted to have the Data Safety Monitoring Board (DSMB) review efficacy data from around 500 subjects. The DSMB's recommendation could lead to either continuation or early termination of the study based on statistical significance trends. Revive aims to explore regulatory pathways for Bucillamine, including potential collaborations for international approvals and clinical studies targeting Long COVID and related conditions. The company will also work on reformulating Bucillamine to expand its therapeutic applications, while not making any claims of curing COVID-19.

Revive Therapeutics Ltd. (OTCQB: RVVTF) announced the purchase of MDMA from PharmAla Biotech to support upcoming IND-enabling studies for its novel transdermal microneedle patch. The patch aims to deliver 3,4-Methylenedioxymethamphetamine (MDMA) and is expected to offer flexible drug delivery capacities and improved pharmacokinetics compared to oral dosing. Additionally, Revive is finalizing clinical development plans and collaborating with PharmaTher to enhance its research efforts. Results from recent studies will be crucial for regulatory discussions and potential commercial opportunities in mental health treatment.

Revive Therapeutics Ltd. (OTCQB: RVVTF) announced the enrollment of its first patient in a Phase I/II clinical study evaluating oral psilocybin for treating methamphetamine use disorder. Conducted at the University of Wisconsin-Madison, initial results are expected in Q3-2023. The study aims to provide data on the safety and efficacy of psilocybin, with potential implications for future products, including oral thin film strips and transdermal microneedle patches. Currently, there are no approved medications for this disorder. CEO Michael Frank emphasized the commitment to advancing psilocybin applications for substance abuse treatment.

Revive Therapeutics Ltd. (OTCQB: RVVTF) provided an update on its FDA Phase 3 clinical trial for Bucillamine, an oral drug targeting mild to moderate COVID-19. Following FDA feedback on March 8, the company will maintain its original primary endpoint: hospitalization or death within 28 days post-randomization. This decision aims to preserve the integrity of the trial data. Revive plans to enhance recruitment of high-risk patients and explore further studies on COVID-related conditions. The company is committed to pursuing regulatory pathways with the FDA while avoiding any unblinding of data.

Revive Therapeutics Ltd. (RVVTF) announced updates following a Type C meeting with the FDA regarding its Phase 3 Study of Bucillamine for mild to moderate COVID-19. The FDA recommended revised primary symptom-based endpoints focusing on sustained recovery and symptom resolution. Revive is set to amend its statistical analysis plan (SAP) to incorporate these suggestions, enabling potential evidence of Bucillamine's efficacy. The Data Safety Monitoring Board will review data from approximately 500 subjects to determine next steps, including possible unblinding of data. Revive may also explore Bucillamine for Long COVID and related conditions.