FDA Grants Expanded Access for NRX-101 to Treat Depression, Augmenting TMS
NRXP has more than doubled off its 52-week low of $1.62.
Summary
The FDA has granted NRx Pharmaceuticals an Expanded Access Protocol (EAP) for its drug NRX-101, allowing its use to augment Transcranial Magnetic Stimulation (TMS) in treating depression. This EAP provides early access to NRX-101 for patients with serious conditions while pivotal clinical trials are underway. The move is a positive regulatory signal, offering a regulated and stable D-cycloserine-based therapy, which addresses concerns about compounded versions. This follows recent positive FDA interactions for the company's pipeline, though it also comes after a dilutive $20 million public offering and a 'going concern' warning in Q1.
At the time of this announcement, NRXP was trading at $3.98 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $166.5M. The 52-week trading range was $1.62 to $5.06. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.