New Drug Application

7 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Securities Lawsuit Filed Against Aquestive Over Anaphylm Drug Application Misstatements

Rosen Law Firm seeks lead plaintiffs in securities lawsuit against Aquestive Therapeutics over alleged false statements regarding Anaphylm drug application.
AQSTsecurities class actionlead plaintiff
GlobeNewswire Inc.GlobeNewswire Inc.··Nrx Pharmaceuticals, Inc.

NRx Pharmaceuticals to Unveil 2025 Results, Update on Breakthrough Psychiatric Drug Pipeline

NRx Pharmaceuticals to report 2025 results March 24, 2026, updating on FDA-designated ketamine and PTSD programs with significant clinical potential.
NRXPNRXPWfinancial resultsclinical-stage biopharmaceutical
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Corcept Therapeutics Faces Securities Lawsuit Over Relacorilant Clinical Trial Claims

Rosen Law Firm seeks lead plaintiffs in securities class action against Corcept Therapeutics, alleging misrepresentation of FDA communications and clinical trial data for relacorilant drug.
CORTsecurities class actionrelacorilant
GlobeNewswire Inc.GlobeNewswire Inc.··Rosen Law Firm

Class Action Filed Against Aquestive Therapeutics Over Anaphylm Drug Application Disclosures

Rosen Law Firm files securities class action against $AQST over alleged misleading statements regarding its Anaphylm drug application between June 2025 and January 2026.
AQSTsecurities fraudclass action lawsuit
GlobeNewswire Inc.GlobeNewswire Inc.··Pmv Pharmaceuticals, Inc.

PMV Pharma's Rezatapopt Shows Promise, But Cash Clock Ticks Toward 2027

PMV Pharmaceuticals reports 50% response rate for ovarian cancer drug rezatapopt, but faces funding pressure with cash runway extending only to Q2 2027.
PMVPclinical trial resultsorphan drug designation
The Motley FoolThe Motley Fool··Howard Smith

Compass Pathways Surges on Positive Phase 3 Psilocybin Trial Results

Compass Pathways stock surged 44% after positive Phase 3 trial results for psilocybin depression therapy. FDA application expected by end of 2024.
CMPSFDA approvaltreatment-resistant depression
GlobeNewswire Inc.GlobeNewswire Inc.··Faruqi & Faruqi, Llp

Aquestive Therapeutics Faces FDA Setback on Anaphylm Application; Investor Claims Under Review

Aquestive Therapeutics' stock plunged 40% after FDA cited major deficiencies in its Anaphylm anaphylaxis treatment application. Shareholder lawsuit investigation underway over disclosure adequacy.
AQSTstock declinesecurities investigation