Mineralys Therapeutics (NASDAQ:MLYS) Releases Earnings Results, Beats Estimates By $0.04 EPS

Key Points

• FDA accepted the NDA for lorundrostat with a PDUFA target date of December 22, 2026, and Mineralys says a comprehensive clinical data package supports durable blood‑pressure reductions, tolerability, and potential guideline/payer value as it builds commercial capabilities for a 4th‑line/resistant hypertension launch.
• Mineralys reported Q1 EPS of ($0.47), beating estimates by $0.04, and ended the quarter with $646.1M in cash and investments (projected runway into 2028) while posting a Q1 net loss of $39.3M and higher G&A as it scales commercial readiness.
• The stock traded up ~2.9% to $30.12 after the report, and insider Ra Capital bought 310,700 shares (~$7.35M), increasing its stake; institutional ownership remains high at about 84%.

Mineralys Therapeutics (NASDAQ:MLYS - Get Free Report) issued its quarterly earnings results on Wednesday. The company reported ($0.47) EPS for the quarter, topping analysts' consensus estimates of ($0.51) by $0.04, FiscalAI reports.

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

• The FDA accepted the NDA for lorundrostat with a PDUFA target date of December 22, 2026, moving the program meaningfully closer to a potential U.S. launch.
• Mineralys cites a comprehensive data package (Launch‑HTN, Advance‑HTN, Transform‑HTN, Target‑HTN, Explore‑CKD) showing durable, clinically meaningful blood pressure reductions and a favorable tolerability profile that management believes supports guideline inclusion and payer value arguments.
• The company is actively building commercial capabilities (sales, MSLs, payer engagement) with an initial launch focus on the 4th‑line/resistant hypertension population while continuing strategic partner discussions and considering additional development opportunities.
• Mineralys ended Q1 with $646.1M in cash and investments—positioning the company to fund operations into 2028—but reported higher G&A as it scales commercial readiness and a Q1 net loss of $39.3M.

Mineralys Therapeutics Stock Up 2.9%

NASDAQ:MLYS traded up $0.84 during trading hours on Wednesday, reaching $30.12. The company had a trading volume of 1,002,965 shares, compared to its average volume of 1,063,670. The stock has a 50-day moving average of $27.16 and a two-hundred day moving average of $33.24. Mineralys Therapeutics has a one year low of $12.59 and a one year high of $47.65. The firm has a market capitalization of $2.48 billion, a PE ratio of -12.71 and a beta of 0.49.

Insider Buying and Selling

In related news, Director Ra Capital Management, L.P. purchased 310,700 shares of the stock in a transaction on Friday, March 27th. The shares were purchased at an average cost of $23.67 per share, for a total transaction of $7,354,269.00. Following the completion of the transaction, the director directly owned 5,767,221 shares of the company's stock, valued at approximately $136,510,121.07. The trade was a 5.69% increase in their position. The acquisition was disclosed in a legal filing with the Securities & Exchange Commission, which is available through the SEC website. Also, Director Daphne Karydas sold 3,000 shares of the stock in a transaction on Tuesday, March 31st. The stock was sold at an average price of $25.00, for a total value of $75,000.00. Following the sale, the director owned 6,200 shares in the company, valued at $155,000. The trade was a 32.61% decrease in their position. The disclosure for this sale is available in the SEC filing. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Over the last ninety days, insiders have sold 162,291 shares of company stock valued at $4,336,414. 18.94% of the stock is currently owned by insiders.

Institutional Trading of Mineralys Therapeutics

Several large investors have recently made changes to their positions in the business. Royal Bank of Canada lifted its stake in Mineralys Therapeutics by 262.3% in the fourth quarter. Royal Bank of Canada now owns 1,529 shares of the company's stock valued at $56,000 after buying an additional 1,107 shares during the period. Russell Investments Group Ltd. grew its holdings in shares of Mineralys Therapeutics by 14,091.3% during the third quarter. Russell Investments Group Ltd. now owns 3,264 shares of the company's stock worth $124,000 after buying an additional 3,241 shares in the last quarter. The Manufacturers Life Insurance Company grew its holdings in shares of Mineralys Therapeutics by 29.8% during the second quarter. The Manufacturers Life Insurance Company now owns 14,775 shares of the company's stock worth $200,000 after buying an additional 3,390 shares in the last quarter. Victory Capital Management Inc. bought a new position in shares of Mineralys Therapeutics during the third quarter worth about $216,000. Finally, Federated Hermes Inc. grew its holdings in shares of Mineralys Therapeutics by 38.3% during the second quarter. Federated Hermes Inc. now owns 16,528 shares of the company's stock worth $224,000 after buying an additional 4,577 shares in the last quarter. Institutional investors own 84.46% of the company's stock.

Analyst Upgrades and Downgrades

MLYS has been the subject of a number of research analyst reports. HC Wainwright set a $56.00 price target on Mineralys Therapeutics and gave the stock a "buy" rating in a report on Tuesday, March 10th. Jefferies Financial Group reiterated a "hold" rating and set a $30.00 price target on shares of Mineralys Therapeutics in a report on Friday, March 13th. Weiss Ratings reiterated a "sell (d-)" rating on shares of Mineralys Therapeutics in a report on Tuesday, April 21st. Bank of America upped their price target on Mineralys Therapeutics from $46.00 to $51.00 and gave the stock a "buy" rating in a report on Friday, March 13th. Finally, Wall Street Zen upgraded Mineralys Therapeutics from a "sell" rating to a "hold" rating in a report on Sunday, March 15th. Seven equities research analysts have rated the stock with a Buy rating, one has issued a Hold rating and one has issued a Sell rating to the company. According to MarketBeat, the company presently has an average rating of "Moderate Buy" and a consensus target price of $49.14.

Mineralys Therapeutics Company Profile

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.

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