Mineralys Therapeutics, Inc. Stock Price, News & Analysis

Mineralys Therapeutics (Nasdaq: MLYS) announced on November 26, 2025 that its Compensation Committee granted an inducement stock option covering 146,000 shares to one new non-executive employee on November 24, 2025.

The award was made under the company’s 2025 Employment Inducement Incentive Award Plan and was granted as an inducement material to the employee entering employment in accordance with Nasdaq Listing Rule 5635(c)(4). The option vests over four years: 25% on the first anniversary of the vesting commencement date (November 24, 2026) and 1/48th monthly thereafter, subject to continued service.

Mineralys Therapeutics (Nasdaq: MLYS) reported Q3 2025 results and a corporate update on Nov 10, 2025. Key clinical milestones include a planned NDA submission for lorundrostat in late‑2025 or Q1 2026 and completed enrollment in the Explore‑OSA Phase 2 trial with topline data expected Q1 2026.

Financial highlights: $593.6M cash, cash equivalents and investments as of Sep 30, 2025 (vs. $198.2M at Dec 31, 2024), and a completed public equity financing raising approximately $287.5M gross on Sep 4, 2025. Q3 net loss was $36.9M; R&D expense was $31.5M (Q3 2024: $54.0M). Management expects cash to fund operations into 2028.

Mineralys Therapeutics (Nasdaq: MLYS) reported clinical data for lorundrostat at ASN Kidney Week 2025, including a late-breaking Phase 2 Explore-CKD presentation and recognition of the Phase 3 Launch-HTN trial in the “Best of JAMA and NEJM” session.

Explore-CKD (lorundrostat 25 mg QD added to standard care) met its primary endpoint at week 4: AOSBP -9.3 mmHg (placebo-adjusted -7.5 mmHg, p=0.0024) and UACR -25.6% placebo-adjusted (p=0.0015). Launch-HTN showed SBP reductions up to 19 mmHg (11.6 mmHg placebo-adjusted at week 12, p<0.0001). Safety: SAEs occurred in 3% on lorundrostat vs 0% placebo; discontinuations 3% vs 2%. The company plans an NDA filing in Q4 2025 or Q1 2026.

Mineralys Therapeutics (NASDAQ: MLYS) announced that senior management will participate in fireside chats at three investor conferences in November–December 2025.

Event schedule:

• Guggenheim Healthcare Innovation Conference — Tuesday, November 11, 2025 at 9:30am ET
• Stifel Healthcare Conference — Thursday, November 13, 2025 at 2:00pm ET
• 8th Annual Evercore Healthcare Conference — Wednesday, December 3, 2025 at 3:25pm ET

Mineralys Therapeutics (NASDAQ: MLYS) will report third quarter 2025 financial results for the period ended September 30, 2025 after market close on Monday, November 10, 2025.

The company will host a conference call and live webcast on Monday, November 10, 2025 at 4:30 p.m. ET. Domestic dial-in is 1-877-704-4453, international dial-in is 1-201-389-0920, and the conference ID is 13756051. The webcast will be available on the company’s Investor Relations "News & Events" page.

Mineralys Therapeutics (Nasdaq: MLYS) announced late-breaking presentations of clinical data for lorundrostat at ASN Kidney Week 2025 in Houston, Nov 6–9, 2025. The company said Phase 2 Explore-CKD trial data evaluating the safety and efficacy of 25 mg lorundrostat in participants with hypertension and comorbid CKD will be presented in a late-breaking clinical trials session on Nov 7, 2025, 5:06–5:18 PM CST by Matthew Weir, MD.

Separately, Phase 3 Launch-HTN pivotal trial results will be featured in ASN’s “Best of JAMA and NEJM” program on Nov 7, 2025, 2:00–4:00 PM CST; those Phase 3 data were published in JAMA earlier in 2025.

Mineralys Therapeutics (NASDAQ:MLYS) has completed enrollment in its Phase 2 EXPLORE-OSA clinical trial, evaluating lorundrostat in patients with moderate-to-severe obstructive sleep apnea (OSA) and hypertension. The company expects to report topline results in Q1 2026.

The trial aims to assess lorundrostat's effectiveness when administered at bedtime, targeting aldosterone suppression during sleep to maintain 24-hour blood pressure control. This approach addresses the significant unmet need in treating nocturnal hypertension, particularly in OSA patients where current treatments like weight loss and positive airway pressure may be insufficient.

If successful, these results will complement the company's previously positive EXPLORE-CKD trial data, potentially expanding lorundrostat's treatment scope for hypertension patients with these comorbidities.

Mineralys Therapeutics (NASDAQ:MLYS) announced positive subgroup analyses from its Phase 3 Launch-HTN trial for lorundrostat, a novel aldosterone synthase inhibitor for treating uncontrolled or resistant hypertension. The trial, the largest of its kind, demonstrated significant blood pressure reductions across diverse patient populations, including Black/African American (29%), adults ≥65 years (41%), women (47%), and participants with obesity (63%).

The 50mg lorundrostat dose showed clinically meaningful results, with a 16.9 mmHg reduction in blood pressure at Week 6 (-9.1 mmHg placebo adjusted; p<0.0001) and 19.0 mmHg reduction at Week 12 (-11.6 mmHg placebo adjusted; p<0.0001). The drug demonstrated a favorable safety profile with minimal adverse events. Mineralys plans to file a New Drug Application (NDA) with the FDA in Q4 2025 or Q1 2026.

Mineralys Therapeutics (NASDAQ: MLYS) has successfully closed its upsized public offering of common stock, raising $287.5 million in gross proceeds. The offering included 11,274,509 shares at $25.50 per share, with the underwriters exercising their full option to purchase an additional 1,470,588 shares.

The biopharmaceutical company, which focuses on developing treatments for hypertension and related conditions like chronic kidney disease and obstructive sleep apnea, plans to use the proceeds to fund the clinical development of its drug candidate lorundrostat, including R&D, manufacturing, and pre-commercialization activities. The offering was managed by several prominent investment banks, including BofA Securities, Evercore ISI, Goldman Sachs, Stifel, and Wells Fargo Securities.