NRx Pharma Shares Drop Premarket After FDA Declines Emergency OK for Covid Treatment

By Robb M. Stewart

NRx Pharmaceuticals Inc.'s shares look headed for a sharp drop at the open after the U.S. Food and Drug Administration declined emergency-use authorization for the biopharmaceutical company's Zyesami as a treatment for patients with critical Covid-19 with respiratory failure.

The regulator stated it was unable to issue the authorization due to insufficient data regarding the known and potential benefits of the medicine and the known and potential risks of Zyesami in critical Covid-19 patients, NRx said late Thursday. The company said the FDA in a letter noted it has reviewed safety in 131 randomized patients treated with Zyesami.

In premarket trading, NRx's shares were 36% lower after ending the previous session at $8.92, down almost 9% since the end of last year.

NRx said it would attempt to coordinate a review by the FDA of the 150 or more additional patients already treated with Zyesami in its NIH ACTIV-3b trial. Last week, the study's data safety and monitoring board reviewed the ongoing trial and found no new safety issues, it said.

The company said it requested a "type A" meeting with the FDA last week and it plans to work actively with the regulator to deliver the data it has requested. It said it also is actively engaged with regulators and potential partners on multiple continents to advance Zyesami towards regulatory approval.

The U.S. National Institutes of Health has enrolled more than 300 patients in the ACTIV-3b trial, a confirmatory study that randomizes patients with Covid-19 respiratory failure to Zyesami versus remdesivir and a placebo in a factorial design trial, NRx said. A second nationwide trial to determine if similar benefits may be achieved in critically ill patients with inhaled Zyesami is being conducted on the I-SPY platform, maintained by the Quantum Leap Healthcare Collaborative.

On Friday, the company said it was negotiating for financing and manufacturing capacity in Europe for a Covid-19 vaccine, BriLife, that was developed by the Israel Institute for Biological Research and which the company this year secured the exclusive worldwide right to develop and market. It said it has been granted an operating company business license by the Luxembourg government and has established a commercial banking relationship in the country, and has agreed to a technology transfer and scale-up contract with a viral vector, contract research and manufacturing organization in the Luxembourg region.

Write to Robb M. Stewart at robb.stewart@wsj.com

(END) Dow Jones Newswires

November 05, 2021 08:21 ET (12:21 GMT)

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