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On May 25, 2021, NeuroRx announced its successful merger with Big Rock Partners Acquisition Corp., resulting in the formation of NRx Pharmaceuticals, Inc. The new entity will trade on the Nasdaq under the symbol NRXP. The company plans to use the public capital to advance the development of two investigational drugs: ZYESAMI™ for COVID-19 related respiratory failure and NRX-101 for suicidal bipolar depression. Both drugs are currently in FDA-approved Phase 3 trials. NRx aims to seek Emergency Use Authorization for ZYESAMI™ in May 2021.
Big Rock Partners Acquisition Corp. (BRPA) has confirmed its Annual Meeting of Stockholders will be held on May 24, 2021, to vote on a merger agreement with NeuroRx, Inc.. Stockholders recorded as of April 23, 2021, are eligible to participate and vote. The SEC has approved the registration statement related to this merger, and Big Rock urges stockholders to vote 'FOR' all proposals. Additionally, holders of Public Shares can now demand conversion rights for cash from the trust account, where approximately $6.0 million or $10.80 per share is available.
NeuroRx has announced the initiation of an Expanded Access Program (EAP) for its phase 3 drug, ZYESAMI (aviptadil acetate), aimed at critically ill COVID-19 patients in Georgia. Approved by the Georgian Ministry of Health and the US FDA, the EAP will collaborate with Denk Pharma Georgia and the Lugar Center for Public Health Research. NeuroRx is also merging with Big Rock Partners Acquisition Corp (NASDAQ:BRPA), signaling potential growth in COVID-19 therapeutic strategies in the Caucasus region.
NeuroRx announced the dosing of the first patient in a Phase 3 clinical trial for ZYESAMI (aviptadil acetate) in severely ill COVID-19 patients, part of the ACTIV-3b study led by the NIH. This trial, which includes a randomized, placebo-controlled design, marks a significant step in exploring new COVID-19 therapeutics. The trial will be conducted in multiple countries, and results will be shared with international regulators. NeuroRx is set to merge with Big Rock Partners Acquisition Corp (NASDAQ: BRPA), with an S-4 registration statement filed with the SEC.
NeuroRx has addressed concerns raised by Relief Therapeutics, emphasizing its commitment to developing ZYESAMI despite Relief's nonpayment of development costs. NeuroRx reassures stakeholders that this financial issue has not affected its pursuit of Emergency Use Authorization or New Drug Approval. The company is working closely with NIH to provide necessary data for regulatory approval and plans to release upcoming clinical trial results. NeuroRx remains focused on resolving issues with Relief amicably and continues to advance its drug development efforts.
Big Rock Partners Acquisition Corp. (Nasdaq:BRPA) announced the process for stockholder redemptions related to its upcoming special meeting. The meeting, scheduled to approve an extension of the deadline for its initial business combination from April 23, 2021, to May 24, 2021, requires stockholders to affirmatively demand conversions to receive a portion of the trust account funds, estimated at $10.86 per share. As of March 31, 2021, BRPA's stock closed at $35.42, suggesting a significant loss for those converting. Approval requires a majority vote.
NeuroRx reported promising outcomes from its Phase 2b/3 trial of ZYESAMI™ (aviptadil acetate) for COVID-19-induced respiratory failure. The trial, involving 196 patients across 10 sites, met its primary endpoints at 28 days (P = .014) and 60 days (P = .013). Notably, patients treated with ZYESAMI™ had a 75% recovery rate by day 60, outperforming 55% in the placebo group (P = .036). The drug also significantly increased survival rates, particularly among patients receiving High Flow Nasal Cannula (P = .007). NeuroRx plans to submit an EUA application to the FDA and expand its trials further.
NeuroRx has completed top-line data analysis from its Phase 2b/3 clinical trial of ZYESAMI™ for treating COVID-19 respiratory failure. The trial, conducted under FDA Fast Track Designation, evaluated recovery and survival up to 60 days. Results are undergoing final review, with a conference call planned for March 29, 2021. Additionally, NeuroRx has announced a merger agreement with Big Rock Partners Acquisition Corp (NASDAQ:BRPA) and seeks to list under the symbol NRXP on NASDAQ.
NeuroRx, Inc. and Big Rock Partners Acquisition Corp. (NASDAQ:BRPA) have secured a $10 million private investment in public equity (PIPE) from institutional investors, allowing for enhanced product development in the combined company. This transaction coincides with the planned business merger, where NeuroRx will become a wholly-owned subsidiary of Big Rock. Upon closing, Big Rock will adopt the name NeuroRx, Inc. and list its shares on NASDAQ. The merger is anticipated to finalize in Q2 2021, pending shareholder approval.
NeuroRx and TFF Pharmaceuticals announced a feasibility and material transfer agreement to develop a long-term stable inhalable formulation of ZYESAMI™. This agreement involves testing ZYESAMI™, a synthetic peptide, aimed at treating COVID-19 by potentially improving lung function. The collaboration leverages TFF's thin film freezing technology to enhance aerosol delivery of the drug to patients. ZYESAMI™ has shown significant results in reducing hospital discharge times for COVID-19 patients, emphasizing its therapeutic potential for respiratory distress.
