Mineralys Therapeutics (NASDAQ:MLYS) Announces Quarterly Earnings Results

Mineralys Therapeutics (NASDAQ:MLYS) issued its quarterly earnings data on Wednesday. The company reported ($0.47) earnings per share (EPS) for the quarter, topping the consensus estimate 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 Performance

Shares of NASDAQ:MLYS traded up $0.15 during mid-day trading on Friday, reaching $29.50. 429,497 shares of the company’s stock were exchanged, compared to its average volume of 1,218,846. The business’s fifty day moving average price is $27.15 and its 200-day moving average price is $33.14. Mineralys Therapeutics has a twelve month low of $12.59 and a twelve month high of $47.65. The firm has a market capitalization of $2.43 billion, a price-to-earnings ratio of -14.45 and a beta of 0.49.

Analyst Ratings Changes

MLYS has been the subject of several research reports. Bank of America raised their price objective on shares of Mineralys Therapeutics from $46.00 to $51.00 and gave the stock a “buy” rating in a research report on Friday, March 13th. Jefferies Financial Group reaffirmed a “hold” rating and set a $30.00 target price on shares of Mineralys Therapeutics in a report on Friday, March 13th. Wall Street Zen raised shares of Mineralys Therapeutics from a “sell” rating to a “hold” rating in a report on Sunday, March 15th. TD Cowen initiated coverage on shares of Mineralys Therapeutics in a report on Monday, April 27th. They set a “buy” rating on the stock. Finally, Weiss Ratings reaffirmed a “sell (d-)” rating on shares of Mineralys Therapeutics in a report on Tuesday, April 21st. Seven equities research analysts have rated the stock with a Buy rating, one has assigned a Hold rating and one has given a Sell rating to the company. According to data from MarketBeat.com, the company has an average rating of “Moderate Buy” and a consensus target price of $49.14.

Insiders Place Their Bets

In other Mineralys Therapeutics news, Director Daphne Karydas sold 3,000 shares of the stock in a transaction dated Tuesday, March 31st. The stock was sold at an average price of $25.00, for a total transaction of $75,000.00. Following the completion of the sale, the director directly owned 6,200 shares in the company, valued at approximately $155,000. This trade represents a 32.61% decrease in their position. The sale was disclosed in a legal filing with the SEC, which is accessible through this link. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, CEO Jon Congleton sold 15,730 shares of the stock in a transaction dated Monday, April 13th. The stock was sold at an average price of $26.83, for a total value of $422,035.90. Following the sale, the chief executive officer owned 689,321 shares of the company’s stock, valued at approximately $18,494,482.43. The trade was a 2.23% decrease in their ownership of the stock. Additional details regarding this sale are available in the official SEC disclosure. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. In the last 90 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.

Hedge Funds Weigh In On Mineralys Therapeutics

Several institutional investors have recently made changes to their positions in MLYS. AQR Capital Management LLC acquired a new position in shares of Mineralys Therapeutics during the first quarter valued at about $550,000. MIRAE ASSET GLOBAL ETFS HOLDINGS Ltd. raised its holdings in shares of Mineralys Therapeutics by 4.3% during the first quarter. MIRAE ASSET GLOBAL ETFS HOLDINGS Ltd. now owns 17,085 shares of the company’s stock valued at $271,000 after purchasing an additional 702 shares during the period. Goldman Sachs Group Inc. raised its holdings in shares of Mineralys Therapeutics by 166.6% during the first quarter. Goldman Sachs Group Inc. now owns 298,395 shares of the company’s stock valued at $4,739,000 after purchasing an additional 186,480 shares during the period. Woodline Partners LP acquired a new position in shares of Mineralys Therapeutics during the first quarter valued at about $757,000. Finally, Creative Planning acquired a new position in shares of Mineralys Therapeutics during the second quarter valued at about $336,000. Institutional investors and hedge funds own 84.46% of the company’s stock.

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.