Mineralys Therapeutics Announces FDA Acceptance of NDA for Lorundrostat for Treatment of Adults with Hypertension and Topline Explore-OSA Trial Results
Mineralys Therapeutics, Inc. (MLYS)
Company Research
Source: GlobeNewswire
– The FDA assigned a PDUFA target action date of December 22, 2026 – – The NDA is based on positive data from a successful clinical program demonstrating favorable safety and blood pressure reduction in adults with hypertension – – Topline results from the Phase 2 Explore-OSA exploratory trial did not reduce AHI; demonstrated a clinically meaningful reduction in blood pressure and favorable safety and tolerability in this population with difficult to control hypertension – RADNOR, Pa., March 09, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for lorundrostat for the treatment of adult patients with hypertension in combinat
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MLYS
News
- Mineralys Therapeutics Appoints Jeffrey A. Munsie as Chief Legal OfficerGlobeNewswire
- Is It Time To Reassess Mineralys Therapeutics (MLYS) After The Recent Share Price Pullback? [Yahoo! Finance]Yahoo! Finance
- 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
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