New Drug Application

Aquestive Therapeutics ($AQST) investors have until May 4, 2026 to join a securities fraud lawsuit alleging the company concealed human factors issues with its Anaphylm sublingual film product.

PMV Pharmaceuticals appoints Laurie Stelzer as Board Chair effective June 2026, succeeding Rich Heyman. Transition occurs amid ongoing clinical trials for ovarian cancer treatment.

Belite Bio begins rolling NDA submission to FDA for tinlarebant, a potential breakthrough oral therapy for rare Stargardt disease, targeting 2027 commercialization.

Rosen Law Firm alerts AQST investors of May 4, 2026 deadline to join class action alleging Aquestive Therapeutics concealed human factors issues with its Anaphylm drug application.

Rosen Law Firm urges Corcept Therapeutics investors with losses exceeding $100K to join securities class action before April 21, 2026 deadline over alleged FDA application misrepresentations.

Aquestive Therapeutics faces securities lawsuit after FDA Anaphylm deficiency notice triggers 37% stock decline from $6.21 to $3.91 on January 9, 2026.

Rosen Law Firm urges Aquestive Therapeutics investors to secure legal counsel before deadlines in securities class action alleging false product and disclosure statements.

Rosen Law Firm files securities fraud class action against Corcept Therapeutics, alleging misrepresentation of relacorilant drug trial data. Lead plaintiff deadline: April 21, 2026.

Rosen Law Firm files class action against Aquestive Therapeutics for allegedly concealing human factors issues in Anaphylm NDA. Investors have until May 4, 2026 deadline.

Monopar reports $13.7M net loss, $140.4M cash reserves funding operations through 2027. Company plans mid-2026 NDA submission for Wilson disease treatment ALXN1840.

Palvella COO sells ~$508K in shares via pre-planned trading arrangement amid 340% annual surge, driven by strong Phase 3 QTORIN rapamycin data and upcoming NDA submission.

Rosen Law Firm seeks lead plaintiffs in securities lawsuit against Aquestive Therapeutics over alleged false statements regarding Anaphylm drug application.

NRx Pharmaceuticals to report 2025 results March 24, 2026, updating on FDA-designated ketamine and PTSD programs with significant clinical potential.

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.

Rosen Law Firm files securities class action against $AQST over alleged misleading statements regarding its Anaphylm drug application between June 2025 and January 2026.

PMV Pharmaceuticals reports 50% response rate for ovarian cancer drug rezatapopt, but faces funding pressure with cash runway extending only to Q2 2027.

Compass Pathways stock surged 44% after positive Phase 3 trial results for psilocybin depression therapy. FDA application expected by end of 2024.

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