Why Did NRXP Stock Surge 21% Pre-Market Today?

The company is using a large US real-world evidence dataset to support its accelerated FDA approval for its ketamine-based drug.

• The move is a major step toward FDA approval of NRX-100, its investigational drug.
• Currently, no FDA-approved medications exist specifically to treat suicidal thoughts, with electroshock therapy remaining the only sanctioned option.
• Earlier, Osmind presented data from a 20,000-patient subset at the 2024 American Society of Clinical Psychopharmacology meeting.

NRx Pharmaceuticals, Inc. (NRXP) on Wednesday announced that it has licensed Real World Evidence (RWE) from more than 70,000 U.S. patients who received either intravenous ketamine or nasal S-ketamine as part of their treatment.

The move is a major step toward FDA approval of its investigational drug, NRX-100 (preservative-free ketamine), aimed at treating suicidal ideation in patients with depression and suicidal tendencies. 

Collaboration With Osmind

The RWE data comes from Osmind, a neuropsychiatry technology platform used across U.S. clinics, providing detailed, regulatory-grade patient records. This joint effort allows NRx to submit a comprehensive dataset to the FDA in support of Accelerated Approval for NRX-100 under its Fast Track Designation. 

The approach could mark a breakthrough, as currently no FDA-approved medications exist specifically to treat suicidal thoughts, with electroshock therapy remaining the only sanctioned option.

Following the update, NRx Pharmaceuticals' stock traded over 21% higher in Wednesday’s premarket. On Stocktwits, retail sentiment around the stock jumped to ‘bullish’ territory from ‘bearish’ the previous day. Message volume shifted to ‘high’ from ‘normal’ levels in 24 hours. 

Preliminary Findings And Expectations

Earlier, Osmind presented data from a 20,000-patient subset at the 2024 American Society of Clinical Psychopharmacology meeting. Results suggested rapid improvement in depression and suicidal ideation with intravenous ketamine. 

NRx anticipates that analysis of the full 70,000-patient dataset will provide even stronger evidence to support the FDA submission.

“An American commits suicide every 11 minutes and ketamine has become widely used off label as a drug that has been seen to reduce suicidal ideation in clinical trials.”

-Jonathan Javitt, Chairman and CEO, NRx Pharmaceuticals

NRXP stock has declined by over 58% in the last 12 months. 

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