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# Mirum's Livmarli Cuts Itch Versus Placebo In 52-Patient Phase 3 Trial, Sets 2027 Filing Plan
- URL: https://www.bullished.co/mirums-livmarli-cuts-itch-versus-placebo-in-52-patient-phase-3-trial-sets-2027-filing-plan-e1cf8237/
- Published: 2026-10-13T12:21:55.000Z
- Updated: 2026-10-28T22:19:45.000Z
- Description: The drug met the trial's main goal and all five secondary measures, and Mirum plans a U.S. supplemental application in the first half of 2027.
- Author: Matteo Parrino
- Tags: SEC Filings, MIRM, Industry: Healthcare

[Mirum Pharmaceuticals](https://www.bullished.co/tag/mirm/) said its drug Livmarli met the main goal of the [52-patient EXPAND trial](https://www.sec.gov/Archives/edgar/data/0001759425/000175942526000051/mirm-20261012.htm?ref=bullished.co) and was statistically significant on all five prespecified secondary measures, according to an [8-K](https://www.bullished.co/learn/8-k-items-explained/) filed Tuesday. The company announced the topline results Monday.

## What the 8-K says

The late-stage trial tested Livmarli (maralixibat) for itching in patients aged 6 months or older with ultra-rare cholestatic liver diseases, including biliary atresia. It enrolled [46 pediatric](https://www.fiercepharma.com/pharma/mirums-its-way-3rd-rare-liver-indication-livmarli?ref=bullished.co) and six adult patients, randomized to the drug or placebo for a 20-week double-blind period.

In the pediatric group, itch severity improved a mean [1.81 points](https://www.benzinga.com/news/health-care/26/10/62298668/why-is-mirum-pharmaceuticals-stock-gaining-monday?ref=bullished.co) on maralixibat versus 0.83 on placebo, a placebo-adjusted 0.98 points (p=0.0004). Serum bile acids in the overall population fell 70.1% versus 3.5% on placebo.

In patients with biliary atresia and a native liver, itch scores improved [2.16 points](https://www.fiercepharma.com/pharma/mirums-its-way-3rd-rare-liver-indication-livmarli?ref=bullished.co) versus 1.01 on placebo. Pruritus (itching) improved on 96.4% of days versus 52.2%.

Diarrhea occurred in 64.0% of drug patients versus 11.1% on placebo. Abdominal pain was 20.0% versus 14.8%. The company said safety matched prior experience with maralixibat and no new signals appeared; five serious events in drug-treated patients were all judged unrelated.

## What it changes

Mirum plans to file a supplemental New Drug Application in the United States in the first half of 2027, based on these results. Livmarli is already FDA-approved for itching tied to Alagille syndrome and progressive familial intrahepatic cholestasis, Fierce Pharma reported.

The company estimates about [2,000 biliary atresia](https://www.sec.gov/Archives/edgar/data/0001759425/000175942526000051/mirm-20261012.htm?ref=bullished.co) patients in the United States and Europe are addressable for Livmarli. MIRM closed at $86.06 on Monday, up 0.06% from the prior session.

## What to watch

The next dated items are the supplemental filing, planned for the first half of 2027, and topline results from a mid-stage volixibat trial, expected in the first quarter of 2027.

The filing's safety table puts diarrhea at 16 of 25 drug patients versus 3 of 27 on placebo, the largest gap among the adverse events it lists.

Learn

- [Item 8.01: other events →](https://www.bullished.co/learn/8-k-items-explained/#item-801-other-events)  
From 8-K Items Explained: What Every Item Code From 1.01 To 9.01 Tells You, With Examples

### Sources

- [8-K Filing — Mirum Pharmaceuticals, Inc. (MIRM)](https://www.sec.gov/Archives/edgar/data/0001759425/000175942526000051/mirm-20261012.htm?ref=bullished.co) — SEC EDGAR
- [Mirum on its way to 3rd rare liver indication for Livmarli | Fierce Pharma](https://www.fiercepharma.com/pharma/mirums-its-way-3rd-rare-liver-indication-livmarli?ref=bullished.co) — fiercepharma.com
- [Mirum Pharma Shares Gain After Liver-Disease Treatment Meets Primary Endpoint in Phase 3 Trial](https://www.marketwatch.com/story/mirum-pharma-shares-gain-after-liver-disease-treatment-meets-primary-endpoint-in-phase-3-trial-43015342?ref=bullished.co) — MarketWatch
- [Why Is Mirum Pharmaceuticals Stock Gaining Monday?](https://www.benzinga.com/news/health-care/26/10/62298668/why-is-mirum-pharmaceuticals-stock-gaining-monday?ref=bullished.co) — benzinga.com
- [Mirum Pharmaceuticals to Host Investor Call to Share Topline Results from the Phase 3 EXPAND Study of LIVMARLI® (maralixibat) in Ultra-Rare Cholestatic Liver Diseases](https://finance.yahoo.com/healthcare/articles/mirum-pharmaceuticals-host-investor-call-210000261.html?ref=bullished.co) — Yahoo Finance
- [Mirum Pharmaceuticals to report Livmarli trial results Monday (MIRM:NASDAQ) | Seeking Alpha](https://seekingalpha.com/news/4651951-mirum-pharmaceuticals-to-report-livmarli-trial-results-monday?ref=bullished.co) — seekingalpha.com

### More on Mirum Pharmaceuticals

- [No Treated Child Developed New Bone Lesions In Mirum's FOP Trial, While One On Placebo Did](https://www.bullished.co/no-treated-child-developed-new-bone-lesions-in-mirums-fop-trial-while-one-on-placebo-did-f05ba0cf/)
- [FDA Clears Mirum's Atebrioz For Rare Bone-Hardening Disease, And A Separate Hepatitis Delta Trial Hits Its Primary Goal](https://www.bullished.co/fda-clears-mirums-atebrioz-for-rare-bone-hardening-disease-and-a-separate-hepatitis-delta-0c48c39a/)

[All Mirum Pharmaceuticals (MIRM) coverage →](https://www.bullished.co/tag/mirm/)