MLYS · Mineralys Therapeutics, Inc.

Summary

Mineralys Therapeutics, Inc. filed an 8-K on March 9, 2026, disclosing that on March 6, 2026, the FDA notified the Company regarding its NDA for lorundrostat for treating adult patients with hypertension in combination therapy under Item 8.01, with a press release attached as Exhibit 99.1 under Item 9.01 and Item 7.01 information not deemed filed.

Key takeaways

• FDA notification received on March 6, 2026
• NDA for lorundrostat for adult hypertension patients in combination therapy
• Press release issued on March 9, 2026 as Exhibit 99.1
• Item 7.01 including Exhibit 99.1 not deemed filed under Section 18
• Filing dated March 9, 2026