Plano ng Mineralys na magsumite ng NDA para sa lorundrostat sa huling bahagi ng 2025/Q1 2026

Inihayag ng kumpanya ang kanilang plano na magsumite ng NDA para sa lorundrostat sa huling bahagi ng 2025 o Q1 2026 kasunod ng pre-NDA feedback mula sa FDA. Nakumpleto na ang enrollment sa Explore-OSA Phase 2 trial at inaasahan ang topline data sa Q1 2026. Susuportahan ang NDA ng data mula sa maraming trial kabilang ang pivotal Launch-HTN at Advance-HTN studies.

Mahahalagang fact

Na-file: Nob 10, 2025, 09:06 PM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Positibo
Kumpanya: MLYSMineralys
Asset: lorundrostat
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

EX-99.1 2 mlys2025q38kex991.htm EX-99.1 Document Exhibit 99.1 Mineralys Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update – Submission of New Drug Application (NDA) for lorundrostat planned for late-2025/Q1 2026 – – Completed enrollment in Explore-OSA trial; topline results anticipated in Q1 2026 – – Conference call today at 4:30 p.m. ET – RADNOR, PA – November 10, 2025 – Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced financial results for the third quarter ended September 30, 2025, and provide

SEC 8-K