Mineralys submits NDA for lorundrostat, receives Dec 2026 PDUFA date; removes tariff risks

Filed May 6, 2026 · Period ending March 31, 2026 · Compared to 10-Q May 12, 2025 · ~1 min read

Key Changes

• high

  NDA for lorundrostat submitted Dec 2025 and accepted by FDA with PDUFA target date of Dec 22, 2026, advancing the lead asset from clinical development to final regulatory review for hypertension treatment.

  MD&A: NDA submission verify on EDGAR →
• high

  Cash position strengthened to $646M (from $343M year-ago) via $189M public offering and $20M ATM sales at $35.66/share, providing runway through PDUFA date and potential commercial launch.

  MD&A: Cash position verify on EDGAR →
• high

  Detailed tariff and inflation risk disclosures removed from Risk Factors section despite adding tariff language to forward-looking statement risks in MD&A, creating inconsistency in how trade policy exposure is characterized.

  Risk Factors verify on EDGAR →