Name in SEC filings: Mirum Pharmaceuticals, Inc.
| Program | Event | Stage | Stated timing | Filing |
|---|---|---|---|---|
| volixibat | /data readout | Stage not stated | 2026 | EX-99.1 · |
| zilurgisertib | target date (company stated) | PDUFA | September 26, 2026 | SEC filing · |
| brelovitug | Topline/data readout | Phase 3 | Q3 and Q4 2026 | EX-99.1 · |
| brelovitug | Topline/data readout | Phase 3 | fourth quarter of 2026 | 8-K · |
| maralixibat | Topline/data readout | Phase 3 | Q4 2026 | EX-99.1 · |
| MRM-3379 | Topline/data readout | Stage not stated | 2027 | 10-Q · |
Source: ORION, orionbiotechai.com/company/MIRM, data as of Oct 18, 2026
https://www.orionbiotechai.com/company/MIRM
brelovitug · Topline/data readout · fourth quarter of 2026
SEC sources last checked .
○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.
Topline/data readoutQ2 2026
Stage: Not stated
Public float: $2,300,000,000 · as of · SEC filing
Volixibat VISTAS study in PSC topline data expected Q2 2026
EX-99.1 · Filed · Last checked
Resolution filing: · SEC filing
Alert me · Calendar: same stage and window-end month (2026-06)
fibrodysplasia ossificans progressiva
PDUFA target date (company stated)September 26, 2026
Stage: PDUFASEC filing · “PDUFA) target action date”
Public float: $2,300,000,000 · as of · SEC filing
Prescription Drug User Fee Act (PDUFA) target action date for the zilurgisertib NDA is September 26, 2026
SEC filing · Filed · Last checked
Resolution filing: · SEC filing
Alert me · Calendar: same stage and window-end month (2026-09)
Topline/data readoutQ3 and Q4 2026
Stage: Phase 3SEC filing · “Phase 3”
Public float: $2,300,000,000 · as of · SEC filing
Brelovitug AZURE-1 and AZURE-4 Phase 3 studies in chronic hepatitis delta virus (HDV) topline results expected in Q3 and Q4 2026, respectively.
EX-99.1 · Filed · Last checked
Resolution filing: · SEC filing
Alert me · Calendar: same stage and window-end month (2026-09)
Topline/data readoutfourth quarter of 2026
Stage: Phase 3SEC filing · “Phase 3”
Public float: $2,300,000,000 · as of · SEC filing
Topline results from the Phase 3 AZURE-4 study, the second of the two pivotal studies supporting the U.S. registration package, are expected in the fourth quarter of 2026
8-K · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2026-12)
Topline/data readoutQ4 2026
Stage: Phase 3SEC filing · “Phase 3”
Public float: $2,300,000,000 · as of · SEC filing
EXPAND Phase 3 study in cholestatic pruritus due to additional rare cholestatic conditions topline results expected in Q4 2026
EX-99.1 · Filed · Last checked
Company reported on: · SEC filing
Alert me · Calendar: same stage and window-end month (2026-12)
Topline/data readout2027
Stage: Not stated
Public float: $2,300,000,000 · as of · SEC filing
Fragile-X Syndrome (“FXS”) and expect topline data in 2027
10-Q · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-12)
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 .
| Program / event | Stated period and SEC wording | Disclosure in stated period |
|---|---|---|
| brelovitugClinical results | fourth quarter of 2026“Topline results from the Phase 3 AZURE-4 study, the second of the two pivotal studies supporting the U.S. registration package, are expected in the fourth quarter of 2026” Filed · 8-K | Still within period As of Oct 19, 2026 |
| brelovitugClinical results | Q3 and Q4 2026“Brelovitug AZURE-1 and AZURE-4 Phase 3 studies in chronic hepatitis delta virus (HDV) topline results expected in Q3 and Q4 2026, respectively.” Filed · EX-99.1 | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| brelovitugClinical results | Q3 and Q4 2026“Brelovitug AZURE-1 and AZURE-4 Phase 3 studies in chronic hepatitis delta virus (HDV) topline results expected in Q3 and Q4 2026, respectively.” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| maralixibatClinical results | Q4 2026“EXPAND Phase 3 study in cholestatic pruritus due to additional rare cholestatic conditions topline results expected in Q4 2026” Filed · EX-99.1 | Disclosure present SEC filing date within the stated period Filed · 8-K “On October 12, 2026, Mirum Pharmaceuticals, Inc. (the “Company”) announced topline results from the Phase 3 EXPAND study evaluating LIVMARLI (maralixibat) (“Livmarli”) for the treatment of cholestatic pruritus in patients aged 6 months or older with ultra-rare cholestatic liver diseases, including biliary atresia (“BA”).” |
| MRM-3379Clinical results | 2027“Fragile-X Syndrome (“FXS”) and expect topline data in 2027” Filed · 10-Q | Period not started The stated period has not started yet, so there is nothing to compare. |
| zilurgisertibFDA decision | September 26, 2026“Prescription Drug User Fee Act (PDUFA) target action date for the zilurgisertib NDA is September 26, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| zilurgisertibFDA decision | September 26, 2026“PDUFA date of September 26, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| zilurgisertibFDA decision | September 26, 2026“Prescription Drug User Fee Act (PDUFA) date of September 26, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| brelovitugClinical results | H2 2026“Completed enrollment in brelovitug AZURE-1 and AZURE-4 Phase 3 studies in HDV; topline results expected in H2 2026.” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| brelovitugClinical results | H2 2026“Completed enrollment in brelovitug AZURE-1 and AZURE-4 Phase 3 studies in HDV; topline results expected in H2 2026.” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| MRM-3379Clinical results | 2027“Fragile-X Syndrome (“FXS”) and expect topline data in 2027” Filed · 10-Q | Period not started The stated period has not started yet, so there is nothing to compare. |
| zilurgisertibFDA decision | September 26, 2026“PDUFA date of September 26, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| zilurgisertibFDA decision | September 26, 2026“Prescription Drug User Fee Act (PDUFA) date of September 26, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| brelovitugClinical results | H2 2026“AZURE-1 and AZURE-4 studies in HDV topline data expected H2 2026” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| brelovitugClinical results | H2 2026“AZURE-4 studies in HDV topline data expected H2 2026” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| maralixibatClinical results | Q4 2026“EXPAND study in additional cholestatic pruritus settings topline data expected Q4 2026” Filed · EX-99.1 | Disclosure present SEC filing date within the stated period Filed · 8-K “On October 12, 2026, Mirum Pharmaceuticals, Inc. (the “Company”) announced topline results from the Phase 3 EXPAND study evaluating LIVMARLI (maralixibat) (“Livmarli”) for the treatment of cholestatic pruritus in patients aged 6 months or older with ultra-rare cholestatic liver diseases, including biliary atresia (“BA”).” |
| MRM-3379Clinical results | 2027“Fragile-X Syndrome (“FXS”) and expect topline data in 2027” Filed · 10-K | Period not started The stated period has not started yet, so there is nothing to compare. |
| MRM-3379Clinical results | 2027“BLOOM Phase 2 clinical study of MRM-3379 in FXS and expect topline data in 2027” Filed · 10-K | Period not started The stated period has not started yet, so there is nothing to compare. |
| volixibatClinical results | Q2 2026“Volixibat VISTAS study in PSC topline data expected Q2 2026” Filed · EX-99.1 | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| maralixibatClinical results | Q4 2026“LIVMARLI ® EXPAND study in additional cholestatic pruritus settings timing accelerated; topline data now expected Q4 2026” Filed · EX-99.1 | Disclosure present SEC filing date within the stated period Filed · 8-K “On October 12, 2026, Mirum Pharmaceuticals, Inc. (the “Company”) announced topline results from the Phase 3 EXPAND study evaluating LIVMARLI (maralixibat) (“Livmarli”) for the treatment of cholestatic pruritus in patients aged 6 months or older with ultra-rare cholestatic liver diseases, including biliary atresia (“BA”).” |
| volixibatClinical results | Q2 2026“VISTAS study in primary sclerosing cholangitis (PSC) topline data expected Q2 2026” Filed · EX-99.1 | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| maralixibatClinical results | 2027“top-line data from the Phase 3 Livmarli EXPAND clinical trial for the treatment of other ultra-rare cholestatic pruritus indications, the Phase 2b volixibat clinical trial for the treatment of primary biliary cholangitis and the Phase 2 clinical trial of MRM-3379 for the treatment of Fragile-X Syndrome in 2027” Filed · 8-K | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| MRM-3379Clinical results | 2027“top-line data from the Phase 3 Livmarli EXPAND clinical trial for the treatment of other ultra-rare cholestatic pruritus indications, the Phase 2b volixibat clinical trial for the treatment of primary biliary cholangitis and the Phase 2 clinical trial of MRM-3379 for the treatment of Fragile-X Syndrome in 2027” Filed · 8-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.
Historical summaries and source dates are retained separately from the SEC timing quotes above. Earlier publications were collected retrospectively.
Historical catalog checked .
No historical announcement trail is retained for this company in this catalog.
Original ClinicalTrials.gov record · Open the selected study
These are selected linked records and dated source metadata, not a live registry recheck or the company’s full pipeline. Company announcements and the selected registry study are separate evidence sets. No stage or event timing is borrowed between them.
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