Mineralys Therapeutics (NASDAQ:MLYS) Issues Earnings Results

Mineralys Therapeutics (NASDAQ:MLYS) released its quarterly earnings results on Thursday. The company reported ($0.40) EPS for the quarter, beating analysts’ consensus estimates of ($0.57) by $0.17, FiscalAI reports.

Here are the key takeaways from Mineralys Therapeutics’ conference call:

• FDA accepted the NDA for lorundrostat with a PDUFA action date set for December 22, 2026, marking a material regulatory de?risking event ahead of potential commercialization.
• Company cites a comprehensive clinical package — five trials including Launch?HTN and Advance?HTN — demonstrating consistent, clinically meaningful blood pressure reductions and a favorable safety profile, which management says supports differentiated positioning for uncontrolled/resistant hypertension.
• Mineralys ended 2025 with $656.6 million in cash and investments, which management expects is sufficient to fund operations and planned activities into 2028, reducing near?term financing risk.
• Management is actively engaging payers, expanding medical affairs/MSL capabilities and preparing market access ahead of launch while continuing to explore partnership options; timing and structure of any deal remain uncertain and could affect OUS strategy.
• Explore?OSA missed its primary endpoint (AHI) despite showing blood pressure benefit, and a direct competitor (AstraZeneca) may launch earlier in 2026 — signaling potential label/indication and competitive risks that could require further data or strategic responses.

Mineralys Therapeutics Stock Down 3.0%

NASDAQ:MLYS opened at $26.19 on Friday. Mineralys Therapeutics has a 52 week low of $10.44 and a 52 week high of $47.65. The company’s 50 day moving average price is $30.45 and its 200-day moving average price is $35.37. The stock has a market cap of $2.07 billion, a price-to-earnings ratio of -11.05 and a beta of 0.57.

Key Stories Impacting Mineralys Therapeutics

Here are the key news stories impacting Mineralys Therapeutics this week:

• Positive Sentiment: NDA accepted by FDA and PDUFA set (Dec. 22, 2026) for lorundrostat — formal regulatory review underway, which de-risks timing for potential approval and commercialization. GlobeNewswire: Q4 results & NDA acceptance
• Positive Sentiment: Q4 results surprised to the upside — reported EPS of ($0.40) vs. consensus ($0.57), suggesting operational execution beat expectations and reducing near-term downside to estimates. MarketBeat: Q4 earnings summary
• Positive Sentiment: Management is actively preparing for launch and payer engagement ahead of the regulatory decision — signaling commercialization planning and market-access work that could speed uptake if approved. Seeking Alpha: Launch & payer engagement
• Neutral Sentiment: Conference call and transcript provide management’s roadmap and data context (Q4 call reviewed NDA strategy, clinical data and next steps); useful for modeling but not a surprise item. Seeking Alpha: Earnings call transcript
• Neutral Sentiment: Press coverage highlights steady progress with FDA interactions and public messaging; these articles reiterate facts rather than deliver new catalysts. Yahoo Finance: FDA progress TipRanks: NDA acceptance overview
• Negative Sentiment: Critical commentary warns of potential interference from larger pharma interests that could complicate the approval or market dynamics — introduces regulatory and competitive risk that can pressure shares. Seeking Alpha: Concerns over big pharma pressure

Wall Street Analysts Forecast Growth

Several brokerages have recently weighed in on MLYS. Jefferies Financial Group reiterated a “hold” rating and issued a $30.00 price target on shares of Mineralys Therapeutics in a research report on Friday. HC Wainwright set a $56.00 target price on Mineralys Therapeutics and gave the company a “buy” rating in a research note on Tuesday. Bank of America upped their price objective on Mineralys Therapeutics from $46.00 to $51.00 and gave the stock a “buy” rating in a report on Friday. Stifel Nicolaus raised their price objective on Mineralys Therapeutics from $45.00 to $52.00 and gave the company a “buy” rating in a report on Friday, December 19th. Finally, Wall Street Zen lowered Mineralys Therapeutics from a “hold” rating to a “sell” rating in a research note on Saturday, March 7th. Six analysts have rated the stock with a Buy rating, one has given a Hold rating and one has assigned a Sell rating to the stock. According to data from MarketBeat.com, the stock presently has an average rating of “Moderate Buy” and an average target price of $49.14.

Insider Buying and Selling at Mineralys Therapeutics

In other Mineralys Therapeutics news, CFO Adam Scott Levy sold 10,758 shares of Mineralys Therapeutics stock in a transaction that occurred on Monday, January 12th. The shares were sold at an average price of $32.14, for a total value of $345,762.12. Following the completion of the sale, the chief financial officer owned 8,638 shares of the company’s stock, valued at approximately $277,625.32. The trade was a 55.47% decrease in their position. The transaction was disclosed in a document filed with the SEC, which is accessible through this hyperlink. Also, CEO Jon Congleton sold 16,236 shares of the business’s stock in a transaction on Monday, January 12th. The shares were sold at an average price of $32.62, for a total transaction of $529,618.32. Following the sale, the chief executive officer owned 639,151 shares of the company’s stock, valued at approximately $20,849,105.62. This represents a 2.48% decrease in their ownership of the stock. The disclosure for this sale is available in the SEC filing. In the last 90 days, insiders have sold 342,919 shares of company stock worth $11,755,439. Company insiders own 25.56% of the company’s stock.

Institutional Inflows and Outflows

A number of institutional investors have recently bought and sold shares of MLYS. RA Capital Management L.P. grew its position in Mineralys Therapeutics by 19.1% during the third quarter. RA Capital Management L.P. now owns 7,323,750 shares of the company’s stock valued at $277,717,000 after buying an additional 1,176,470 shares during the period. State Street Corp lifted its holdings in Mineralys Therapeutics by 144.4% in the 4th quarter. State Street Corp now owns 3,184,999 shares of the company’s stock worth $115,584,000 after purchasing an additional 1,881,976 shares in the last quarter. Caligan Partners LP boosted its holdings in shares of Mineralys Therapeutics by 37.4% during the 3rd quarter. Caligan Partners LP now owns 2,772,654 shares of the company’s stock valued at $105,139,000 after purchasing an additional 755,302 shares during the last quarter. Franklin Resources Inc. grew its holdings in shares of Mineralys Therapeutics by 0.3% in the third quarter. Franklin Resources Inc. now owns 1,809,768 shares of the company’s stock valued at $68,626,000 after purchasing an additional 6,171 shares in the last quarter. Finally, Orbimed Advisors LLC raised its position in shares of Mineralys Therapeutics by 93.3% during the 3rd quarter. Orbimed Advisors LLC now owns 1,469,494 shares of the company’s stock valued at $55,723,000 after buying an additional 709,143 shares in the last quarter. Institutional investors own 84.46% of the company’s stock.

About Mineralys Therapeutics

Mineralys Therapeutics, Inc, a clinical-stage biopharmaceutical company that develops therapies for the treatment of hypertension and chronic kidney diseases. It clinical-stage product candidate is lorundrostat, a proprietary, orally administered, highly selective aldosterone synthase inhibitor for the treatment of cardiorenal conditions affected by abnormally elevated aldosterone. The company was formerly known as Catalys SC1, Inc and changed its name to Mineralys Therapeutics, Inc in May 2020. The company was incorporated in 2019 and is headquartered in Radnor, Pennsylvania.