Mineralys Therapeutics reports 48‑week blood-pressure reduction

Blood pressure remained 17.8 mmHg below baseline at 48 weeks as Mineralys Therapeutics, Inc. NASDAQMLYS reported long-term lorundrostat results on Sunday. The treatment remains under U.S. Food and Drug Administration review, with a Dec. 22 decision target.

The Nov. 8 release describes an open-label extension in which participants continued lorundrostat alongside existing hypertension medicines. Its efficacy analysis included 504 participants, and the reported reduction was measured against the parent trial's baseline, without a concurrent placebo comparison at the final visit.

Mineralys is a Pennsylvania-based drug developer focused on hypertension and related diseases driven by dysregulated aldosterone. Lorundrostat is an oral inhibitor of aldosterone synthase, the enzyme responsible for producing that hormone.

Shares closed at US$15.33 on Nasdaq on Nov. 6, up 0.59 per cent, according to NASDAQMLYS at 4 p.m. EST. That close preceded Sunday's disclosure; Mineralys separately reported US$624.7 million in cash, cash equivalents and investments at Sept. 30 to support operations and potential commercialization.

Follow-Up Extends The Controlled Trial

The Transform-HTN results presented at the American Heart Association meeting in Chicago followed participants from the active-treatment arms of the Phase 3 Launch-HTN trial. Of the 808 participants in those arms, 632 enrolled in the extension.

They received another 36 weeks of lorundrostat while continuing their background medicines. The starting extension dose was 50 mg daily, or 25 mg for participants whose previously blinded dose had been reduced.

Participants had a mean age of 61, and 46 per cent were women. A quarter were Black or African American, while 39 per cent were Hispanic or Latino, according to the Nov. 8 release.

The efficacy analysis excluded participants assigned to placebo during a randomized withdrawal substudy. That substudy ran between weeks 24 and 28, so the reported efficacy population differs from the extension's safety population.

At the final visit, 56 per cent reached automated office systolic blood pressure below 130 mmHg. The change from baseline was statistically significant (p less than 0.0001), but that calculation does not establish the treatment's benefit over placebo at the same visit.

The earlier Launch-HTN trial met its primary endpoint, Mineralys reported on May 24, 2025. At six weeks, lorundrostat lowered systolic pressure by 9.1 mmHg more than placebo (p less than 0.0001).

Both active regimens began at 50 mg daily; one allowed escalation to 100 mg after six weeks. The parent trial therefore supplies the controlled efficacy comparison, while Sunday's results add longer follow-up.

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Of the extension's 632 participants, 583 completed follow-up through week 48. Serious adverse events occurred in 27 participants, with investigators judging two treatment-related.

Thirty-seven participants discontinued treatment because of adverse events, including 10 for hyperkalemia. Serum potassium rose and estimated kidney filtration declined early in treatment, then remained stable through the open-label period, the company said.

Hyperkalemia required a dose reduction, interruption or discontinuation in 32 participants, or 5.1 per cent of the safety population. Mineralys reported no new clinically relevant safety findings compared with Launch-HTN, although this follow-up does not supply a parallel placebo safety rate.

"As we advance toward a potential FDA approval, these findings further strengthen the evidence supporting lorundrostat as an important new treatment option, with demonstrated durability of blood pressure reduction in the patients who need additional treatment options most," Mineralys chief executive Jon Congleton said in the release.

An Approved Rival Sets The Commercial Backdrop

AstraZeneca LONAZN announced U.S. approval of Baxfendy, or baxdrostat, on May 18. It is another aldosterone synthase inhibitor, approved in combination with other antihypertensive medicines for adults whose pressure is inadequately controlled.

AstraZeneca reported a 9.8 mmHg placebo-adjusted reduction with its higher dose at the pivotal trial's primary endpoint. That separate trial does not establish how baxdrostat compares directly with lorundrostat.

Mineralys said on Nov. 4 that its September liquidity should fund planned operations, including a commercial launch, into 2028. Its sales force was in place, but launch preparations remain contingent on approval.

Commercial preparation has increased spending: general and administrative expenses reached US$37.4 million in the third quarter of 2026. The comparable prior-year expense was US$9.7 million, with the increase primarily reflecting commercialization preparations, including professional fees and personnel costs.

The company is also working on brand marketing and a full-service patient support programme intended to ease access for physicians, office staff and patients. Its quarterly update described an expanded medical affairs team and ongoing engagement with hypertension specialists and payers.

The next dated regulatory catalyst is Dec. 22, when the FDA is targeted to act on lorundrostat's application for hypertension treatment alongside other blood-pressure medicines.