Mineralys Therapeutics (MLYS) pipeline and stated timing

Name in SEC filings: Mineralys Therapeutics, Inc.

Pipeline at a glance

Program	Event	Stage	Stated timing	Filing
lorundrostat	target date (company stated)	PDUFA	December 22, 2026	10-Q · Aug 11, 2026

Source: ORION, orionbiotechai.com/company/MLYS, data as of Oct 18, 2026
https://www.orionbiotechai.com/company/MLYS

Nearest upcoming stated timing: lorundrostat · PDUFA target date (company stated) · December 22, 2026

SEC sources last checked Oct 18, 2026.

Programs and stated timing

○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.

lorundrostat

Matched

PDUFA target date (company stated)December 22, 2026

Stage: PDUFASEC filing · “PDUFA) target date”

Public float: $676,000,000 · as of Jun 30, 2025 · SEC filing

The FDA accepted the NDA submission and provided us with a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026 for lorundrostat.

10-Q · Filed Aug 11, 2026 · Last checked Oct 18, 2026

Source details

Accession 0001933414-26-000114

Alert me · Calendar: same stage and window-end month (2026-12)

How this date was described over time

Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of Oct 19, 2026.

Program / event	Stated period and SEC wording	Disclosure in stated period
lorundrostatFDA decision	December 22, 2026 “The FDA accepted the NDA submission and provided us with a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026 for lorundrostat.” Filed Aug 11, 2026 · 10-Q	Period not started The stated period has not started yet, so there is nothing to compare.
lorundrostatFDA decision	December 22, 2026 “The FDA accepted the NDA submission and provided us with a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026 for lorundrostat.” Filed May 6, 2026 · 10-Q	Period not started The stated period has not started yet, so there is nothing to compare.
lorundrostatFDA decision	December 22, 2026 “The FDA accepted the NDA submission and provided the Company with a Prescription Drug User Fee Act target date of December 22, 2026 for lorundrostat.” Filed May 6, 2026 · 10-Q	Period not started The stated period has not started yet, so there is nothing to compare.
lorundrostatFDA decision	December 22, 2026 “Food and Drug Administration (FDA) accepted the NDA for lorundrostat for the treatment of hypertension in combination with other antihypertensive drugs and assigned a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026.” Filed May 6, 2026 · EX-99.1	Period not started The stated period has not started yet, so there is nothing to compare.
lorundrostatFDA decision	December 22, 2026 “The FDA accepted the NDA submission and provided us with a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2026.” Filed Mar 12, 2026 · 10-K	Period not started The stated period has not started yet, so there is nothing to compare.
lorundrostatFDA decision	December 22, 2026 “The FDA accepted the NDA submission and provided us with a PDUFA target action date of December 22, 2026.” Filed Mar 12, 2026 · 10-K	Period not started The stated period has not started yet, so there is nothing to compare.
lorundrostatFDA decision	December 22, 2026 “The FDA accepted the NDA submission and provided the Company with a Prescription Drug User Fee Act target action date of December 22, 2026.” Filed Mar 12, 2026 · 10-K	Period not started The stated period has not started yet, so there is nothing to compare.

“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.

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Reading these records

First stated window: The timing wording in the earliest company statement located within the sources checked, quoted as written (for example “2H 2026”). An earlier statement may exist outside those sources.
Disclosure date: The date of the filing or company release that disclosed the readout. “None found” means no such disclosure was located in the sources checked. SEC filings were searched through the “SEC filings searched through” date shown.
1H, 2H, 1Q–4Q: First or second half, or first to fourth quarter, of the year named, as the company wrote it. Equivalent notations are compared together; the original wording stays visible.
SEC original: The filing as published on the SEC EDGAR system. “Company original” is the release on the company's own investor site.
Status: One of seven labels set by founder review of the original filings. Definitions: Methodology.

See MLYS in the calendar · Review labels and methodology