Mineralys Therapeutics Q1 net loss $39.3M; FDA accepts lorundrostat NDA with Dec 22, 2026 PDUFA

Mineralys Therapeutics, Inc.

2026-Q1 EPS reported -$0.47

Net loss $39.3M for Q1 2026 vs $42.2M Q1 2025; cash $646.1M, sufficient into 2028.
FDA accepted NDA for lorundrostat in hypertension; PDUFA target date Dec 22, 2026.
R&D expenses $24.4M (down 36% YoY) due to conclusion of pivotal program; G&A $21.0M (up 218% YoY) on pre-commercial costs.
Pre-commercial activities underway: market access, medical advocacy, sales prep for potential launch.
Conference call at 4:30 p.m. ET today; webcast available on company website.

item 2.02 item 9.01

Key facts

Extracted from this filing and checked against the source text.

Earnings Releases SEC 8-K Item 2.02 confidence 0.9

Mineralys Therapeutics, Inc. reported the first quarter ended March 31, 2026 results: net income Net loss was $39.3 million for the quarter ended March 31, 2026.

Period: the first quarter ended March 31, 2026
Net income: Net loss was $39.3 million for the quarter ended March 31, 2026
Result: reported results

Exact text from the filing

On May 6, 2026, Mineralys Therapeutics, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2026 and provided a corporate update.

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Source: SEC EDGAR

accession 0001933414-26-000082

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