Mineralys Therapeutics

Lorundrostat is the only product candidate. The 10-K says the company's future depends entirely on it, and the FDA target date is Dec 22, 2026. No advisory committee is expected.

A yes starts sales in 2027; a delay or a no would hit a company built around this launch, including the field team now being hired.

AstraZeneca's baxdrostat, the same drug class, was approved by the FDA in May 2026 for adults whose blood pressure is not controlled on other drugs.

Mineralys will launch second against one of the biggest drug sellers in the world, so doctor reach and payer deals matter more than being first.

Q2 2026 R&D of $221.4M includes a $200.0M upfront payment that ended royalties on lorundrostat sales. Up to $100M of new milestones were added.

That is why Q2 shows a $241M loss. It is a one-time buyout, not a jump in trial spending, and it raises future margins if sales come.

Milestones are due on first commercial sale and on annual sales targets, plus up to $10M for a second indication. A $100M change-of-control payment was part of the old terms.

These are paid only if the drug sells, but they claim a slice of early revenue. Tanabe keeps a first look at Japan rights.

Pharmakon funds lent $100M of up to $500M at SOFR plus 5.50% (9.91% effective). Maturity is June 2031, or June 30, 2028 if FDA approval is not met by Sept 30, 2027. Sales covenants start in FY2028.

Debt is small next to the cash, but it ties the lender's patience to the FDA clock and to early sales.

Shares went from 49.8M at end of 2024 to 81.5M at end of 2025, and 88.4M by Aug 2026, after offerings in March and Sept 2025 and June 2026 plus at-the-market sales.

Typical for a biotech before launch. Each raise shrinks existing holders' slice; $187.2M of the at-the-market program is still unused.

Jon Congleton sold 75,000 shares at about $25.46 on Sept 30, 2026, under a 10b5-1 plan set up Dec 23, 2025. He still holds 528,621 shares directly.

Pre-planned sales are routine and he kept most of his stake. Former CMO David Rodman also filed to sell 3,542 option shares in October.

The 10-K says its Radnor, PA corporate office is held under a virtual office lease. Every job posting says it is a fully remote company.

For job seekers this is about as remote-first as a drug company gets: there is no office to be called back to.

Confirmed potassium above 6.0 was 0.6% on the 50 mg dose in Launch-HTN, but 5% versus 0% in the small Explore-CKD kidney study. The 10-K names it and kidney function changes as key risks.

Low in the main trial; the kidney disease group is where the label and future trials will be tested.