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NeuroRx announced that its Phase 2b/3 trial for ZYESAMI™ (aviptadil) demonstrated a 35% higher likelihood of recovery from respiratory failure in critically ill COVID-19 patients treated with High Flow Nasal Oxygen. The study, conducted at 10 U.S. hospitals, reported interim data showing a significant median recovery time difference of 10 days compared to placebo. NeuroRx plans to seek Emergency Use Authorization based on these findings. Collaborative efforts with RELIEF THERAPEUTICS continue, and further evaluations will address the efficacy of ZYESAMI in patients requiring mechanical ventilation.
NeuroRx announced positive interim results for ZYESAMI™ (aviptadil) in a Phase 2b/3 trial for treating respiratory failure in critically ill Covid-19 patients. The drug showed a 35% higher likelihood of recovery by day 28 compared to placebo, with a median 10-day acceleration in recovery time. As High Flow Nasal Oxygen becomes the main treatment for such patients, NeuroRx plans to apply for Emergency Use Authorization if positive trends continue. The trial involved 10 U.S. hospitals and is part of a collaboration with RELIEF THERAPEUTICS. NeuroRx is also completing a business combination with Big Rock Partners Acquisition Corporation (BRPA).
NeuroRx reported preliminary Phase 2b/3 trial results for ZYESAMI™ (aviptadil) in COVID-19 patients with respiratory failure. The study showed a statistically significant reduction in hospital stay for patients receiving ZYESAMI alongside standard care, with a median reduction of 11 days for High Flow Nasal Cannula users. ZYESAMI may become the first authorized treatment for critically ill COVID-19 patients. The trial highlighted the importance of early intervention and plans for further studies and FDA discussion on Emergency Use Authorization.
On February 9, 2021, NeuroRx and Relief Therapeutics announced preliminary results from a Phase 2b/3 trial of ZYESAMI™ (aviptadil) for critically ill COVID-19 patients. The study indicated that ZYESAMI combined with standard care led to significantly shorter hospital stays compared to placebo. Patients treated with ZYESAMI experienced up to 13 fewer days in ICU. While secondary endpoints showed promise, the primary endpoint regarding recovery from respiratory failure remains unconfirmed. The companies plan to seek Emergency Use Authorization for ZYESAMI, which could be the first approved treatment specifically for COVID-19-related respiratory failure.
On February 9, 2021, NeuroRx and Relief Therapeutics announced preliminary results from the Phase 2b/3 trial of ZYESAMI™ in COVID-19 patients experiencing respiratory failure. The trial indicated significant improvements for patients receiving ZYESAMI compared to those on placebo, including earlier hospital discharge and reduced ICU time. The data suggests a potential Emergency Use Authorization submission for ZYESAMI, indicating its importance as the first drug specifically targeting critically ill COVID-19 patients. However, primary endpoint results are still pending.
NeuroRx and Relief Therapeutics have partnered with Quantum Leap Healthcare Collaborative to include ZYESAMI™ (RLF-100™) in the I-SPY COVID-19 Clinical Trial. This trial aims to evaluate multiple drugs for Critical COVID-19 patients. ZYESAMI™, which has received Fast Track designation from the FDA, targets Respiratory Failure in critically ill COVID-19 patients. The inclusion follows requests from the U.S. Department of Health and Human Services for investigational drugs. NeuroRx is also concluding a Phase 2b/3 trial for aviptadil and hopes this collaboration will enhance recovery data.
NeuroRx and RELIEF THERAPEUTICS have completed enrollment in a critical phase 2b/3 trial for ZYESAMI™ (RLF-100) targeting respiratory failure in COVID-19 patients. The enrollment increased from 165 to gather extensive safety data with no serious adverse events reported. Top line results are expected between January and February 2021. The FDA previously denied Emergency Use Authorization but remains engaged in product development. ZYESAMI™ is administered under expanded access protocols for critically ill patients, aiming to replicate existing encouraging results.
Big Rock Partners Acquisition Corp. (NASDAQ:BRPA) has entered a merger agreement with NeuroRx, Inc., a clinical stage pharmaceutical company focused on therapeutics for COVID-19 and bipolar depression. The transaction values the combined company at over $500 million, assuming a share price of at least $10. NeuroRx's prominent products include RLF-100 (ZYESAMI™) for COVID-related respiratory failure and NRX-101 for suicidal bipolar depression. This merger is anticipated to enhance access to capital and accelerate drug development, with completion expected in Q1 or Q2 of 2021.