Revive Therapeutics Ltd - RVVTF STOCK NEWS

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.

Revive Therapeutics Ltd. (OTCQB: RVVTF) has received FDA orphan drug designation for Bucillamine and Cannabidiol in treating liver-related disorders. This comes amid a surge of 650 probable cases of acute hepatitis in children globally, reported by WHO. The company aims to advance its drug pipeline targeting inflammatory liver conditions and plans to relocate its headquarters to the US to better support its growing programs. Revive is also exploring Bucillamine's potential to prevent ischemia-reperfusion injury during liver transplantation.

Revive Therapeutics Ltd. (OTCQB: RVVTF) has received positive feedback from the FDA regarding the Phase 3 clinical trial of Bucillamine for mild to moderate COVID-19 patients. The FDA agreed to potential new primary efficacy endpoints aimed at improving clinical outcomes. The company will unblind data from the first 210 patients after submitting a Data Access Plan. The Data Safety and Monitoring Board previously supported the study's continuation, citing no serious safety concerns. The firm emphasizes the urgent need for effective treatments amid the ongoing COVID-19 pandemic.

Revive Therapeutics Ltd. has submitted a request to the FDA for new clinical endpoints in a Phase 3 trial evaluating Bucillamine for COVID-19 treatment. The request aims for primary efficacy endpoints focused on sustained symptom resolution. With COVID-19 hospitalizations declining, the Company emphasizes the need for effective symptom management. A Data Safety and Monitoring Board meeting is scheduled for June 2022 to assess interim data, possibly recommending continuation or early halting of the study. The Company clarifies it does not claim to eliminate COVID-19.

Revive Therapeutics (OTCQB: RVVTF) provided an update on its FDA Phase 3 clinical trial for Bucillamine, targeting mild to moderate COVID-19. The company is engaged with BARDA to explore funding options for advanced development. Revive aims to establish primary and secondary endpoints for FDA consideration, possibly leading to Emergency Use Authorization. CEO Michael Frank noted promising discussions with BARDA, reinforcing Bucillamine's potential as a treatment. However, there are no claims that Bucillamine can cure COVID-19 at this stage.

Revive Therapeutics Ltd. (OTCQB: RVVTF) has published a new scientific article that evaluates the impact of medications, particularly Bucillamine, on the antibody response to SARS-CoV-2 mRNA vaccines among Japanese patients with rheumatic diseases. The study found that antibody levels were significantly lower in patients treated with TNF inhibitors compared to those receiving Bucillamine. Bucillamine, currently in a Phase 3 clinical trial for COVID-19, displays anti-inflammatory and antiviral properties. The company plans to seek FDA Emergency Use Authorization.