Mineralys: Tinanggap ng FDA ang lorundrostat NDA, itinakda ang Dec 22 2026 PDUFA

Tinanggap ng FDA ang lorundrostat NDA para sa hypertension at itinalaga ang PDUFA target action date na December 22, 2026. Ang pagtanggap ay naglalagay sa asset sa aktibong regulatory review na may tinukoy na deadline ng desisyon. Ang mga pre-commercial launch activities ay kasalukuyang isinasagawa bago ang target date.

Mahahalagang fact

Na-file: May 6, 2026, 08:07 PM
Kaganapan: Tinanggap ang aplikasyon
Direksyon: Positibo
Kumpanya: MLYSMineralys
Asset: lorundrostat
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Dis 22, 2026 · Positibo

Sipi mula sa source

EX-99.1 2 mlys2026q18kex991.htm EX-99.1 Document Exhibit 99.1 Mineralys Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update – NDA for lorundrostat in adults with hypertension accepted by FDA; assigned PDUFA target date of December 22, 2026 – – Conference call today at 4:30 p.m. ET – RADNOR, PA – May 6, 2026 – Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a 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 first quarter ended March 31, 2026, and provided a corporate update. “We continue to make strong progress advancing lorundrostat tow

SEC 8-K