Mineralys Therapeutics posts Q3 loss as FDA sets December 22 PDUFA date for lorundrostat
Mineralys Therapeutics reported a third‑quarter net loss of $57.3 million, or $0.64 per share, widening year‑over‑year. Analysts expect the loss to be $0.75 per share, an improvement from the prior quarter’s $2.85 loss. The FDA has accepted the hypertension NDA for lorundrostat and assigned a PDUFA target date of December 22 2026, which is the primary near‑term catalyst. The company held about $646 million in cash and investments at the end of the first quarter, enough to fund operations into 2028.
Why it matters
The widened loss signals higher spending as the firm moves toward launch preparation, while the cash balance suggests it can sustain operations through 2028. The upcoming PDUFA decision will likely drive the stock’s volatility and could determine whether the drug reaches the market.
Key facts
- 1Net loss was $57.3 million, compared with $36.9 million in the same quarter a year earlier. tradingview.com
- 2Basic and diluted loss per share was $0.64, versus $0.52 in the prior‑year quarter. tradingview.com
- 3Analysts expect a loss of $0.75 per share for the quarter, better than the $2.85 loss reported in the prior quarter. investing.com
- 4The FDA set a PDUFA target date of December 22 2026 for lorundrostat. tradingview.com
- 5The company held approximately $646 million in cash and investments as of the first quarter. investing.com
- 6No revenue was reported in the quarter. tradingview.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.