Mineralys Therapeutics Q4 Earnings Call Highlights [Yahoo! Finance]
Mineralys Therapeutics, Inc. (MLYS)
Company Research
Source: Yahoo! Finance
Mineralys Therapeutics (NASDAQ:MLYS) used its fourth-quarter and full-year 2025 earnings call to highlight a key regulatory milestone for lorundrostat and to review new clinical and financial updates as it prepares for a potential commercial launch. FDA accepts lorundrostat NDA; PDUFA date set for December 2026 Chief Executive Officer Jon Congleton said the company recently announced the U.S. Food and Drug Administration's acceptance of its new drug application (NDA) for lorundrostat to treat adult patients with hypertension in combination with other antihypertensive drugs. The FDA assigned a PDUFA target action date of December 22, 2026 ? Microsoft Positioned to Win AI Race With Dual-Model Strategy Congleton said the NDA was supported by a clinical program that included “five positive clinical trials,” which he said consistently demonstrated clinically meaningful blood pressure reduction, 24-hour control, and a favorable safety profile. The NDA includes data from the company
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MLYS
News
- R1 starts up with $78M, aiming for a better kidney drug [Yahoo! Finance]Yahoo! Finance
- Mineralys Therapeutics Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswire
- Mineralys Therapeutics (MLYS) was upgraded by <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=MLYS&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall Street Zen</a> from "sMarketBeat
- Mineralys Therapeutics (MLYS) had its "hold" rating reaffirmed by Jefferies Financial Group Inc..MarketBeat
- Mineralys Therapeutics (MLYS) Makes Progress With FDA For Hypertension [Yahoo! Finance]Yahoo! Finance
MLYS
Earnings
- 3/12/26 - Beat
MLYS
Sec Filings
- 3/17/26 - Form 144
- 3/17/26 - Form 4
- 3/16/26 - Form 4
- MLYS's page on the SEC website