- Micro-cap pharma NRx Pharmaceuticals ( NASDAQ: NRXP ) added ~14% pre-market Tuesday after announcing the initiation of a Phase 3 trial for NRX-101, an investigational therapy targeted at severe bipolar depression with acute suicidal ideation and behavior ("SBD-ASIB").
- The company has contracted the first trial site with plans to start doing the first patients in early 2023.
- According to NRx ( NRXP ), NRX-101 is the first experimental medicine designed to treat SBD-ASIB for which electroconvulsive therapy is the only approved treatment currently.
- The company further said that it has scheduled a Type B meeting with the FDA in mid-Jan-2023 to align the registrational plans for NRX-101 to target adults with SBP-ASIB .
- "We at NRx aim to replicate by year end a positive risk/benefit in our Phase 3 study as was achieved in the STABIL-B trial," Chief Executive of NRx ( NRXP ) Stephen Willard remarked.
- Read: In November, the company shares gained after announcing the release of the first commercially produced batch of NRX-101.
For further details see:
NRx Pharma gains as Phase 3 trial for bipolar candidate starts