Revive Therapeutics Ltd - RVVTF STOCK NEWS

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.

Revive Therapeutics Ltd. (OTCQB: RVVTF) has signed a supply agreement with PharmAla Biotech Holdings Inc. to acquire LaNeo, a GMP source of MDMA, for its microneedle patch development aimed at treating mental health disorders. The collaboration enables Revive to advance its clinical development plans, particularly as countries like Australia explore MDMA's therapeutic uses. PharmAla is notable for being the first publicly traded company manufacturing GMP MDMA, enhancing Revive's capabilities in this niche market. The deal is expected to propel Revive's innovative therapeutic solutions forward, particularly in addressing mental health and abuse disorders.

Revive Therapeutics Ltd. (OTCQB: RVVTF) has entered a research collaboration with PharmaTher Holdings to study the delivery of MDMA using PharmaTher's innovative microneedle patch technology. This collaboration aims to advance the MDMA patch program, potentially addressing mental health disorders such as PTSD, depression, and anxiety. Preliminary research results will be available in Q2-2023 and could lead to further clinical studies. Revive is also advancing its psilocybin programs, including trials for methamphetamine use disorder and developing a biosynthetic version of psilocybin. The microneedle patch offers advantages over oral dosing, enhancing safety and efficacy.

Revive Therapeutics Ltd. (OTCQB: RVVTF) has submitted an updated briefing package to the FDA for its Phase 3 clinical trial of bucillamine as a treatment for COVID-19. This submission includes revised primary and efficacy endpoints, following the FDA's agreement on a Type C meeting request. The trial aims to assess bucillamine's impact on clinical symptoms by comparing patients' conditions at baseline and Day 14. The FDA's response is expected by March 7, 2023. Revive is focusing on outpatient management of mild to moderate COVID-19 cases, with bucillamine potentially mitigating disease burden through its anti-inflammatory and antiviral properties.

Revive Therapeutics Ltd. (OTCQB: RVVTF) announced plans to submit an updated briefing package to the FDA, incorporating data from a University of Toronto study on Bucillamine's effects against COVID-19 Omicron variants. Recently, the FDA granted Revive a Type C meeting to discuss revised protocol endpoints for its Phase 3 clinical trial evaluating Bucillamine for mild to moderate COVID-19. The FDA's written response is expected by March 7, 2023. Notably, Revive does not assert that its product can eliminate or cure COVID-19.

Revive Therapeutics Ltd. (CSE: RVV; OTCQB: RVVTF) has successfully closed a private placement, issuing 28,676,064 units at $0.15 each, yielding gross proceeds of $4,301,409. Each unit consists of one common share and one warrant, allowing the purchase of an additional common share at $0.20 until January 12, 2026. The funds will be used for working capital and clinical development. The offering involved finder’s fees totaling $304,112.75 and 2,294,085 finder warrants. The company's share count now stands at 353,560,075, pending acceptance by the Canadian Securities Exchange.