RegulatoryCompany release

Mineralys readies lorundrostat launch as FDA hypertension decision due 22 December

🇺🇸 Mineralys Therapeutics, Inc. (MLYS) · Wed 04 Nov 2026

Mineralys Therapeutics reports a $57.3m third-quarter net loss as the FDA reviews its aldosterone synthase inhibitor NDA, with a PDUFA date of 22 December 2026.

Mineralys Therapeutics said on 4 November 2026 that the US Food and Drug Administration is still reviewing its new drug application for lorundrostat, with a PDUFA target action date of 22 December 2026. The company is seeking approval for the aldosterone synthase inhibitor to treat hypertension in combination with other antihypertensive medicines.

Alongside its third-quarter results, the company presented new analyses from the Launch-HTN study. In these, 46% of treated participants achieved a systolic blood pressure below 130 mmHg at Week 12. Long-term extension data from the Transform-HTN study are due to be presented at the American Heart Association (AHA) Scientific Sessions.

Mineralys reported cash of $624.7 million, which it expects to fund operations into 2028. The quarterly net loss was $57.3 million, with higher spending on launch preparation contributing to the increase.

As general context, a PDUFA date is the goal date by which the FDA aims to complete its review of an application. It is not a guarantee of approval.

What it means for your team

  • Regulatory teams tracking the hypertension pipeline should note the 22 December 2026 PDUFA date as the next key milestone for lorundrostat.
  • Market-access teams may wish to watch the AHA presentation of long-term Transform-HTN data, which could inform later evidence and payer discussions.
  • The company's reported cash runway into 2028 and rising launch spending indicate commercial preparations are under way ahead of the FDA decision.

Company's press release (SEC filing): Mineralys Therapeutics, Inc. ↗

Article written by VigiEye from the official source (Mineralys Therapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

More Regulatory All →