FDA approves lorundrostat for hypertension on or before the disclosed PDUFA goal date of 2026-12-22

The proposition

What was claimed

The FDA takes an approval action on Mineralys Therapeutics' New Drug Application for lorundrostat for the treatment of adults with hypertension in combination with other antihypertensive drugs, with an approval action date on or before 2026-12-22, the PDUFA target date disclosed in Exhibit 99.1 to Mineralys Therapeutics' Form 8-K filed 2026-08-11.

Authority

US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US)

Target rungA step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung

Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc.

Forecast classThe group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates

FDA action by goal date

Scope

Hypertension, in combination with other antihypertensive drugs

The clock

Dates that constrain the record

resolution window

Today

Evidence cutoff2026-10-15 Registered2026-10-15 Window opens2026-10-16 Deadline2026-12-22

Evidence cutoff

2026-10-15

Registered

2026-10-15

Window opens

2026-10-16

Deadline

2026-12-22

Evidence cutoff

2026-10-15
Nothing after this date informed the estimate.

Registered

2026-10-15
Frozen and hashed.

Resolution window

2026-10-16 → 2026-12-22
When the adjudicator can read the outcome.

Event by

2026-12-22
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar

ledger 44b1dd75f68f58f6cbca5c7e8c96d7e47592152e153061faf20a6a112851d076 Copy · operator record jc-1792036248384-a2c3e7b3

Resolution

The rule that settles the forecast

Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22lorundrostat%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22LORUNDROSTAT%22&limit=100, read together (openFDA does not always fill the generic-name field for a new application), contain an application whose ORIG submission has submission_status AP and a submission_status_date on or before 2026-12-22, and the Drugs@FDA approval letter or label for that application names hypertension in its indication. An approval for a narrower hypertension population than the applicant sought still resolves YES. Resolves NO if no approval action is dated on or before 2026-12-22: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-12-22 resolves NO as occurred_after_deadline. Read no earlier than 2027-01-05. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name lorundrostat) governs. The application number was not public at the cutoff, so the rule reads by name; a suffix on the nonproprietary name or a proprietary name does not change the identification. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands.

Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22lorundrostat%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22LORUNDROSTAT%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/

Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far.

What this record will show once it resolves

Frozen covariatesThe facts about the evidence and the authority's process that were frozen with the forecast at its cutoff

The state of the record at the cutoff

Recorded as they stood on 2026-10-15.

review pathway

Not stated in the archived sources. NDA submitted December 2025 with a PDUFA date of December 22, 2026 (SRC-004); a ~12-month timeline is consistent with a standard review of a new molecular entity (drafter's understanding, unverified). Center CDER is the drafter's understanding, unverified.

submission type

Original NDA (SRC-004).

evidence class

Two pivotal randomized, double-blind, placebo-controlled trials: Phase 3 Launch-HTN and Phase 2 Advance-HTN, plus Phase 2 Explore-CKD and Explore-OSA (SRC-003, SRC-002).

pivotal n

Launch-HTN n=1,083 randomized; Advance-HTN n=285 randomized (SRC-003).

endpoint type

Blood pressure (surrogate): Launch-HTN primary endpoint = change in automated office systolic BP vs placebo at week 6; Advance-HTN primary endpoint = change in 24-hour ambulatory systolic BP at week 12 (SRC-003).

approved competitors in class

BAXFENDY (baxdrostat; AstraZeneca), NDA219878, ORIG 1 approved 2026-05-15 (SRC-007), an aldosterone synthase inhibitor indicated, in combination with other antihypertensive drugs, for hypertension in adults not adequately controlled on other agents (SRC-008). The 10-K names competing programmes without naming it (SRC-003).

months since last guideline revision

not applicable — no guideline is the subject of this proposition

panel cycle position

not applicable — the act is an FDA approval action

sponsor request status

NDA submitted December 2025; FDA acceptance announced March 9, 2026 (SRC-002, SRC-004).

odac referral

Stated not anticipated: 10-Q lists "supporting a potential advisory committee meeting (not anticipated currently)" (SRC-004).

sponsor state change

None reported; Chief Medical Officer succession effective August 10, 2026 (SRC-001).