- NRX Pharmaceuticals, Inc. (NASDAQ: NRXP) files for Breakthrough Therapy Designation (BTD) for Zyesami (aviptadil) with the US Food and Drug Administration (FDA).
- The study for the ZYESAMI (Aviptadil) application showed two-fold increased odds of survival in a randomized trial of 196 patients.
- The stock was added to theNasdaq Biotechnology Index on Dec 20, 2021.
Shares of NRX Pharmaceuticals, Inc. (NASDAQ: NRXP) rose more than 6% after announcing filing for a Breakthrough Therapy Designation (BTD) for covid drug Zyesami with the FDA.
The Delray Beach, Florida-based company said Zyesami is critical for Covid-19 patients with immediate risk of death. It claims the treatment is more effective than other therapies.
The NRXP stock was up 6.67% to US$4.80 at 9:40 am ET on Wednesday after the news.
The company said it has filed for a Breakthrough Therapy Designation (BTD) for Zyesami (aviptadil) with the US Food and Drug Administration (FDA).
Test results showed Zyesami (Aviptadil) helped lessen Covid-related respiratory issues. It showed “two-fold increased odds of survival” in a randomized trial of 196 patients, it said.
Earlier, FDA had declined NRX’s BTD and Emergency Use Authorization (EUA) requests and asked the company to produce clinical data showing the effectiveness of Zyesami in comparison with Remdisivir and other therapies in high-risk patients. Consequently, NRX has filed for BDA again with clinical data showing Zyesami’s effectiveness.
NRX business, stock performance
The Florida-based company develops novel therapies for central nervous system disorders and life-threatening pulmonary diseases.
It has a market capitalization of US$264 million. Its stock price oscillated between US$64.20 and US$4.07 in the last 52 weeks. It fell 81.11% YTD.
On Dec 20, 2021, it was added to the Nasdaq Biotechnology Index.
For the nine months ended Sept 30, 202, the company earned no revenue. Its net loss attributable to common shareholders was US$318 million for the first nine months of 2021, compared to the net loss of US$6.65 million in the corresponding period of 2020.
The cash and cash equivalents were US$38.9 million as of Sept 30, 2021, versus US$1.29 million as of Sept 30, 2020.
NRX Chairman and CEO Jonathan Javitt said around 2,000 Americans died of COVID-19 on Christmas eve. Hence, it necessitates better efforts to curb its spread. NRX’s application for Breakthrough Therapy Designation is an attempt to save lives, he added.