- Clinical-stage pharma NRX Pharmaceuticals ( NASDAQ: NRXP ) traded higher in the pre-market Thursday after announcing FDA comments on its plans to develop the lead candidate NRX-101 for suicidal bipolar depression.
- Citing FDA’s written responses on the program, NRX (NRX) said that the company “has reached alignment with the FDA regarding its proposed registration manufacturing plan.”
- The feedback follows the company’s request for Type C guidance from the FDA regarding the chemistry, manufacturing, and controls (CMC) aspects of the NRX-101.
- NRX (NRX) has also conducted a Type B meeting with the regulator on Jan. 11. This event typically occurs right after or right before submitting a marketing application or clinical data. Minutes of the meeting are expected within about 30 data, NRX (NRX) said.
- NRX-101 is currently undergoing a Phase 3 trial for patients with bipolar depression and suicidal ideation, which according to Seeking Alpha contributor Bret Jensen indicates a ~$1.6B market opportunity in the U.S.
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NRx Pharma gains on FDA comments regarding lead asset