Nrx Pharmaceuticals Inc Stock Price, News & Analysis

NRx Pharmaceuticals (Nasdaq: NRXP) announced that the Independent Data Safety Monitoring Board (DSMB) found no safety concerns in the ongoing Phase 2 clinical trial of NRX-101 for treating Severe Bipolar Depression and Subacute Suicidal Ideation. The trial continues with no treatment-related Serious Adverse Events reported among the first 50 participants. This study targets outpatient settings and represents a significant opportunity for patients with bipolar depression and suicidality, a group of over 7 million in the U.S. The DSMB will further review the unblinded data in March 2023.

NRx Pharmaceuticals (Nasdaq: NRXP) announced a significant step towards its lead compound, NRX-101, with a meeting and written FDA response about its development. The FDA provided written guidance on January 10, 2023, concerning the chemistry, manufacturing, and controls (CMC) for NRX-101, indicating alignment on the registration manufacturing plan. A Type B meeting occurred on January 11, 2023, with minutes expected within 30 days. The company aims to develop treatments for bipolar depression and suicidal ideation, with NRX-101 currently in a Phase 3 trial under Breakthrough Therapy Designation and a Special Protocol Agreement.

NRx Pharmaceuticals (Nasdaq: NRXP) will present a scientific update on its NRX-101 program for treating suicidal bipolar depression at the 6th Annual Neuroscience Innovation Forum on January 8, 2023, in San Francisco. This event occurs during the annual J.P. Morgan Healthcare Conference. NRX-101, currently in Phase 3 trials, is being developed under a FDA Special Protocol Agreement. The company also has a Phase 2b trial for Sub-Acute Suicidality. Interested investors can contact investor relations for meetings during the conference.

NRx Pharmaceuticals has initiated a Phase 3 trial for NRX-101, targeting Severe Bipolar Depression with Acute Suicidal Ideation/Behavior (SBD-ASIB). The trial has received Breakthrough Therapy Designation and a Special Protocol Assessment from the FDA, aimed at expediting its development. The first clinical site has been contracted, with patient dosing expected in early 2023. NRx aims to replicate the positive risk/benefit seen in previous trials, as the company addresses a significant unmet medical need in treating this critical condition.

NRx Pharmaceuticals (Nasdaq: NRXP) announced Dr. Carrie M. Carretta as the new Senior Vice President of Clinical Development and Medical Affairs. Dr. Carretta, an accomplished leader with extensive experience in clinical development and psychiatric care, is expected to drive the company’s mission to advance its lead drug candidate, NRX-101, aimed at treating suicidal depression and PTSD. The company is currently investigating NRX-101 in a Phase 3 trial with FDA Breakthrough Therapy Designation due to promising results in earlier studies.

NRx Pharmaceuticals has regained compliance with Nasdaq's minimum bid price requirement, as confirmed by a notice received on December 1, 2022. The company maintained a closing bid price above $1.00 per share for 10 consecutive business days from November 16 to November 30, 2022. This compliance is crucial for NRx Pharmaceuticals as it ensures continued listing on the Nasdaq exchange, potentially boosting investor confidence and stabilizing stock performance.

NRx Pharmaceuticals announced progress in its clinical development plans for NRX-101, a drug targeting bipolar depression and PTSD. The company has submitted a new manufacturing file to the FDA and is set to initiate a registrational Phase 3 trial for NRX-101 by year-end 2022. It reported an net loss of $9.1 million for Q3 2022, down from $37 million the previous year, with cash reserves of $18.2 million. Partnering inquiries for NRX-101 have increased, indicating potential interest in the drug.

Relief Therapeutics Holding SA and NRx Pharmaceuticals have reached settlement agreements to resolve litigation. Within the next 30 days, NRx will transfer assets used in aviptadil development to Relief. Relief will gain exclusive rights to develop and commercialize aviptadil while continuing the Right to Try Program for two years. They will pay NRx milestone payments for successful product approvals and royalties up to $30 million based on sales. NRx will refrain from future competition in aviptadil development. The success of aviptadil commercialization is uncertain.

NRx Pharmaceuticals announced that it will report its third quarter 2022 financial results on November 14, 2022, before the market opens. A conference call and webcast will take place at 8:00 AM ET on the same day to discuss the results and provide updates on clinical and corporate matters. Interested participants can access the call via telephone or through a live webcast on the company's website. The company is known for its lead program, NRX-101, which targets bipolar depression and has received regulatory designations aimed at expediting its development.