Mineralys Therapeutics (NASDAQ:MLYS) Announces Earnings Results

Mineralys Therapeutics (NASDAQ:MLYS) announced its earnings results on Wednesday. The company reported ($0.47) earnings per share (EPS) for the quarter, beating 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

NASDAQ:MLYS traded up $0.84 during mid-day trading on Wednesday, hitting $30.12. 1,002,965 shares of the company’s stock traded hands, compared to its average volume of 1,063,670. The company has a fifty day moving average of $27.16 and a 200 day moving average of $33.24. Mineralys Therapeutics has a twelve month low of $12.59 and a twelve month high of $47.65. The company has a market capitalization of $2.48 billion, a P/E ratio of -12.71 and a beta of 0.49.

Insiders Place Their Bets

In other news, CEO Jon Congleton sold 15,730 shares of the business’s stock in a transaction dated Monday, April 13th. The stock was sold at an average price of $26.83, for a total transaction of $422,035.90. Following the sale, the chief executive officer owned 689,321 shares in the company, valued at approximately $18,494,482.43. The trade was a 2.23% decrease in their ownership of the stock. The sale was disclosed in a legal filing with the Securities & Exchange Commission, which is accessible through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, Director Daphne Karydas sold 3,000 shares of the company’s stock in a transaction dated Tuesday, March 31st. The shares were sold at an average price of $25.00, for a total transaction of $75,000.00. Following the transaction, the director owned 6,200 shares in the company, valued at approximately $155,000. This trade represents a 32.61% decrease in their position. The SEC filing for this sale provides additional information. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Insiders sold a total of 162,291 shares of company stock worth $4,336,414 in the last three months. Insiders own 18.94% of the company’s stock.

Institutional Inflows and Outflows

A number of hedge funds have recently bought and sold shares of MLYS. State Street Corp lifted its stake in shares of Mineralys Therapeutics by 144.4% during the fourth quarter. State Street Corp now owns 3,184,999 shares of the company’s stock worth $115,584,000 after buying an additional 1,881,976 shares during the period. Price T Rowe Associates Inc. MD increased its position in shares of Mineralys Therapeutics by 6,097.1% in the 4th quarter. Price T Rowe Associates Inc. MD now owns 1,325,120 shares of the company’s stock valued at $48,089,000 after acquiring an additional 1,303,737 shares during the period. Janus Henderson Group PLC raised its stake in Mineralys Therapeutics by 6,012.8% in the 4th quarter. Janus Henderson Group PLC now owns 1,213,265 shares of the company’s stock worth $44,005,000 after acquiring an additional 1,193,417 shares during the last quarter. RA Capital Management L.P. raised its stake in Mineralys Therapeutics by 19.1% in the 3rd quarter. RA Capital Management L.P. now owns 7,323,750 shares of the company’s stock worth $277,717,000 after acquiring an additional 1,176,470 shares during the last quarter. Finally, Polar Capital Holdings Plc acquired a new stake in Mineralys Therapeutics during the 3rd quarter worth about $40,149,000. Institutional investors and hedge funds own 84.46% of the company’s stock.

Analyst Ratings Changes

A number of equities research analysts recently weighed in on the company. TD Cowen started coverage on Mineralys Therapeutics in a research note on Monday, April 27th. They set a “buy” rating for the company. Jefferies Financial Group reiterated a “hold” rating and issued a $30.00 target price on shares of Mineralys Therapeutics in a research note on Friday, March 13th. HC Wainwright set a $56.00 price target on shares of Mineralys Therapeutics and gave the company a “buy” rating in a research report on Tuesday, March 10th. Wall Street Zen upgraded shares of Mineralys Therapeutics from a “sell” rating to a “hold” rating in a report on Sunday, March 15th. Finally, Bank of America lifted 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. 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 stock. According to data from MarketBeat, Mineralys Therapeutics currently has a consensus rating of “Moderate Buy” and an average 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.