FDA granted Fast Track designation to NRX-100 on September 4, 2025.
9 reports, 6 independent
Updated Sep 4
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- Reports
- 9
- Developments
- 2
- Repetition
- 78%
New informationRepeats or wire copies
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What happened
FDA granted Fast Track designation to NRX-100 on September 4, 2025.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.FDA granted Fast Track designation to NRX-100.1 source
NRX-100 received Fast Track designation from FDA; HOPE Therapeutics secured regulatory clearance.1 source
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The entities involved
Related events
- Iovance Biotherapeutics listed its stock on Nasdaq and received Fast Track designation from the FDA.
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- Decoy Therapeutics is listed on the Nasdaq stock exchange and is currently seeking expedited regulatory approval via FDA pathways.
- FDA approval enables commercial opportunity involving CBRE Group.
- On August 18, 2026, Gergen received his B.A. from Minot State University, while RNDP-001 received Fast Track designation from the FDA.
Coverage
Newest first; wire copies grouped- NewMediaWireNRx Pharmaceuticals (NRXP) Secures FDA Fast Track for IV Ketamine Formulation NRX-100 in Suicidal Depression LOS ANGELES, CA - September 3, 2025 (NEWMEDIAWIRE) - NRx Pharmaceuticals (NASDAQ: NRXP), a
- GlobeNewswireNeuphoria Therapeutics Completes Target Enrollment in Phase 3 AFFIRM-1 Trial of BNC-210 in Social Anxiety Disorder (SAD) Topline data anticipated in early Q4 2025 BURLINGTON, Mass., Sept. 04, 2025 (G
- Insider MonkeyNRx Pharmaceuticals, Inc. (NRXP)’ NRX-100 Wins Expanded FDA Fast Track for Suicidal Depression We recently compiled a list of the 13 Best Psychedelic Stocks to Invest in Now. NRx Pharmaceuticals, Inc
- NewMediaWireNRx Pharmaceuticals (NASDAQ: NRXP) Announces Expanded Access Policy for NRX-100 Following FDA Fast Track Designation LOS ANGELES, CA - August 27, 2025 (NEWMEDIAWIRE) - NRx Pharmaceuticals (NASDAQ: NR
- GlobeNewswireNRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces Expanded Access Policy for NRX-100 (preservative-free ketamine) US Food and Drug Administration (FDA) has granted Fast Track designation for NRX-100
- GuruFocus.comNRX Pharmaceuticals Inc (NRXP) Q2 2025 Earnings Call Highlights: Strategic Advancements Amid ... This article first appeared on GuruFocus. Net Loss: $17.5 million for Q2 2025, compared to $7.9 millio
- GlobeNewswireNRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reports Second Quarter 2025 Financial Results and Provides Corporate Update NRx Drug Development Grant of expanded Fast Track Designation for NRX-100 from the
- ACCESS NewswireNew to The Street Client NRx Pharmaceuticals (NASDAQ:NRXP) Secures FDA Fast Track Designation for NRX-100, Expanding Reach to 13 Million Americans Confronting Suicidal Ideation NEW YORK, NY / ACCESS
- PR NewswireNRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Granted FDA Fast Track Designation for NRX-100 for Suicidal Ideation in Patients with Depression, including Bipolar Depression This designation expands the add