Mirum Pharmaceuticals

NEWS
FDA
Wednesday’s FDA approval expands Mirum’s Livmarli into the rare genetic disorder that causes progressive liver disease. The biotech has also filed a supplemental New Drug Application for a higher dose of the drug and allowing its use in younger patients.
The FDA’s busy week ahead involves three decision dates for potential industry firsts and a highly anticipated advisory committee meeting for two CAR-T therapies.
Mirum Pharmaceuticals announced that Livmarli oral solution met its primary endpoint in the Phase III MARCH study in young patients with progressive familial intrahepatic cholestasis.
With the last full week before the Thanksgiving week in the U.S., companies had a fair amount of clinical trial news. Here’s a look.
LIVMARLI is indicated for ages one year and older and will now be accessible to patients with a prescription through Mirum Access Plus. Here’s more about it.
FDA
The U.S. Food and Drug Administration is wrapping up the end of September and beginning October with two PDUFA dates. Here’s a look.
As is typical, the second day of the JP Morgan Annual Healthcare Conference—conducted virtually this year because of the pandemic—had plenty of news from the largest biopharma companies globally.
The rolling NDA was somewhat expected after an end-of-phase meeting with the FDA earlier this year turned into a pre-NDA meeting with the regulatory agency.
Mirum Pharmaceuticals entered 2020 with a significant bounce after the U.S. Food and Drug Administration turned an end-of-phase meeting into a pre-New Drug Application meeting for its lead asset, maralixibat, an investigational treatment being evaluated for pediatric patients with Alagille syndrome.
AWARDS
  • NextGen Class of 2020
IN THE PRESS
Mirum Pharmaceuticals, Inc. has adopted a positive opinion of LIVMARLI® (maralixibat) oral solution for the treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) in patients three months of age and older.
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that new analyses from long-term treatment with LIVMARLI will be presented at the European Association for the Study of the Liver (EASL) Annual Congress taking place June 5-8, 2024, in Milan, Italy.
Mirum Pharmaceuticals, Inc. announced data presented during the 56th European Society for Paediatric, Gastroenterology, Hepatology, and Nutrition Annual Meeting which took place this week in Milan, Italy.
Mirum Pharmaceuticals, Inc. announced that on May 10, 2024, the Compensation Committee of Mirum’s Board of Directors granted inducement awards consisting of non-qualified stock options to purchase 38,600 shares of common stock and 19,300 restricted stock units to 11 new employees under Mirum’s 2020 Inducement Plan.
Mirum Pharmaceuticals, Inc. reported financial results for first quarter 2024 and provided a business update.
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that it will present at the Citizens JMP Life Sciences Conference in New York, NY on Tuesday, May 14th at 1:30 PM EDT.
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that data from the Phase 3 MARCH-PFIC study evaluating LIVMARLI® (maralixibat) oral solution in patients with PFIC was published in The Lancet Gastroenterology and Hepatology.
Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that it will report first quarter 2024 financial results on May 8, 2024.
Mirum Pharmaceuticals, Inc. announced that on April 10, 2024, the Compensation Committee of Mirum’s Board of Directors granted inducement awards consisting of non-qualified stock options to purchase 36,100 shares of common stock and 18,050 restricted stock units to nine new employees under Mirum’s 2020 Inducement Plan.
Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that the Canadian Agency for Drugs and Technologies in Health (CADTH) Canadian Drug Expert Committee (CDEC) has recommended public reimbursement for LIVMARLI® (maralixibat oral solution) for the treatment of cholestatic pruritus in patients with Alagille Syndrome (ALGS), with certain conditions.