Mineralys Therapeutics, Inc. 8-K

What Happened Mineralys Therapeutics, Inc. announced in a press release dated January 6, 2026 (filed as an 8‑K), that it filed a new drug application (NDA) for lorundrostat with the U.S. Food and Drug Administration in late 2025. The company also disclosed it remains on track to report topline results from its Phase 2 Explore‑OSA trial — evaluating lorundrostat for participants with moderate to severe obstructive sleep apnea (OSA) and hypertension — in the first quarter of 2026. The release also noted Mineralys will participate in the LifeSci Partners Corporate Access event on January 12–14, 2026. The press release was furnished as Exhibit 99.1 and the 8‑K included a Regulation FD disclosure.

Key Details

• NDA for lorundrostat was submitted to the FDA in late 2025 (disclosed Jan 6, 2026).
• Phase 2 Explore‑OSA topline results are expected in Q1 2026.
• Press release announcing these items was issued on January 6, 2026 and attached as Exhibit 99.1.
• Company to participate in LifeSci Partners Corporate Access event on January 12–14, 2026.

Why It Matters Filing an NDA is a major regulatory milestone that formally begins the FDA review process for potential approval of lorundrostat. The upcoming Phase 2 topline data (expected Q1 2026) is a near‑term clinical readout that investors commonly view as a catalyst for valuation changes. The disclosures are material operational updates (also covered under Regulation FD), giving investors timely information about development progress and upcoming public engagement.