Mineralys: Itinakda ng FDA ang petsa ng PDUFA para sa lorundrostat sa Disyembre 22, 2026

Itinakda ng FDA ang target na petsa ng aksyon ng PDUFA sa Disyembre 22, 2026 para sa NDA ng lorundrostat para sa hypertension. Ang kumpanya ay nagpapatuloy sa mga paghahanda para sa komersyal na paglulunsad bago ang petsang ito at nananatiling nasa tamang landas.

Mahahalagang fact

Na-file: Ago 11, 2026, 08:08 PM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Neutral
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 3 mlys2026q28kex991.htm EX-99.1 Document Exhibit 99.1 Mineralys Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update – PDUFA target date of December 22, 2026 for lorundrostat; commercial preparations on-track for launch upon approval – – Appoints accomplished cardiovascular medicine executive Dr. Terry Ferguson as Chief Medical Officer to lead the Company’s medical and late-stage clinical activities – – Strengthened balance sheet and enhanced the long-term economics of lorundrostat through strategic financing initiatives and the repurchase of the Tanabe royalty obligation – – Conference call today at 4:30 p.m. ET – RADNOR, Pa. — August 11, 2026 — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medi

SEC 8-K