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Mirum Pharmaceuticals (MIRM) guidance and outlook
Mirum Pharmaceuticals (MIRM) raised its guidance on Nov 3, 2026: Revenue (segment) $715M–$720M for FY2026. Mirum Pharmaceuticals' 10-Q filed Nov 3, 2026 makes 26 forward-looking statements.
Guidance and outlook
Latest guidance
| Metric | Period | Range | Change |
|---|---|---|---|
| Revenue | FY2026 | $715M–$720M | raised |
From the earnings release filed Nov 3, 2026 (8-K on EDGAR).
Forward-looking statements, 10-Q filed Nov 3, 2026
- We plan to submit a supplemental New Drug Application (“sNDA”) for Livmarli based on the EXPAND study in the first half of 2027.
- We expect to submit a potential NDA to the FDA in the first half of 2027.
- We expect topline data from our PBC study of volixibat in the first quarter of 2027.
- We believe these results along with the results of AZURE-4 expected in the fourth quarter of 2026 may support a potential biologics license application (“BLA”) submission to the FDA in the first half of 2027 and, if approved, a U.S. commercial launch in the fourth quarter of 2027.
- Based on recent positive results for a cohort of patients aged 6 to less than 12 years, we expect to file an sNDA in the U.S. in the first half of 2027.
- We are currently enrolling patients in the BLOOM Phase 2 clinical study of MRM-3379 in Fragile-X Syndrome (“FXS”) and expect topline data in 2027.
- We plan to continue to expand our rare disease pipeline through business development.
- We anticipate we will continue to generate net losses for the foreseeable future as we continue commercial activities for our approved medicines, conduct our ongoing and planned clinical trials, seek regulatory approvals for our product candidates and make potential milestone payments to the licensors and other third parties from whom we have in-licensed or acquired our product candidates.
- We expect that total product sales of our approved medicines will continue to increase on an annual basis; however, due to large periodic orders from Takeda Pharmaceutical Company Limited (“Takeda”) and our distributors, our product revenue may experience quarterly fluctuations.
- If actual results vary from our estimates, we will make adjustments in the period when such variances become known.
- We expect to satisfy future cash needs through existing capital balances, revenue from our approved medicines and through a combination of equity offerings, debt financings or other capital sources, collaborations, licenses and other similar arrangements.
- We expect total product sales of our approved medicines will continue to increase on an annual basis.
Mirum Pharmaceuticals' latest quarter
Mirum Pharmaceuticals, Q3 2026: revenue $186M (+40% year over year), operating margin -32.2%, net loss $40.8M, operating cash flow −$4.3M. The chart follows the revenue to costs, profit and cash.
Questions
Did Mirum Pharmaceuticals raise or lower its guidance?
Mirum Pharmaceuticals (MIRM) raised its guidance on Nov 3, 2026: Revenue (segment) $715M–$720M for FY2026.
What does Mirum Pharmaceuticals expect?
We plan to submit a supplemental New Drug Application (“sNDA”) for Livmarli based on the EXPAND study in the first half of 2027. We expect to submit a potential NDA to the FDA in the first half of 2027. We expect topline data from our PBC study of volixibat in the first quarter of 2027.
Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.