Key Highlights

● Mineralys closed at $24.49 on Tuesday, September 29, down 4.45% from the prior close of $25.63.

● The FDA set a December 22, 2026 target action date for lorundrostat in adults with hypertension.

● The Explore-OSA trial did not reduce the apnea-hypopnea index but showed clinically meaningful blood pressure reductions.

● The trailing twelve-month net loss was $349.58 million, and the next Earnings report is expected on November 9.

Mineralys Therapeutics, Inc. (NASDAQ:MLYS) fell 4.45% on Tuesday, September 29, 2026, closing at $24.49 from $25.63. The clinical-stage biopharmaceutical company slipped as the Nasdaq Composite eased 0.09% to 26,797.54.

Lorundrostat and the FDA Timeline

Mineralys is developing lorundrostat, an aldosterone synthase inhibitor, for hypertension. Aldosterone is a hormone that raises blood pressure by promoting salt and fluid retention, and drugs in this class aim to reduce its production. The FDA accepted the company's new drug application for the treatment of adult patients with hypertension in combination with other antihypertensive drugs, and set a target action date of December 22, 2026 under the Prescription Drug User Fee Act, the date by which the agency aims to complete its review.

The Explore-OSA Result

Alongside the application acceptance, the company reported topline results from the Explore-OSA trial in obese patients with moderate-to-severe sleep apnea. The trial did not reduce the apnea-hypopnea index, the primary endpoint, but demonstrated clinically meaningful blood pressure reductions and favorable safety.

Financial Profile

Mineralys has no product Revenue yet, and its trailing twelve-month net loss was $349.58 million. The stock closed within a 52-week range of $22.30 to $47.65, about 9.8% above the low and about 49% below the high. Earnings are next expected on November 9.

Decision Date in December

With the FDA's target action date set for December 22, the company's calendar runs from the November earnings report to the regulatory decision. Tuesday's decline of 4.45% left the shares at $24.49, near the lower part of the yearly range.