Mirum Pharmaceuticals Submits European Marketing Authorization Application for Maralixibat in Alagille Syndrome Supported by New Positive Results from Natural History Study Comparison
Mirum Pharmaceuticals, Inc. - common stock (MIRM)
Last mirum pharmaceuticals, inc. - common stock earnings: 3/12 04:02 pm
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Source: Business Wire
- Marketing Authorization Application for treatment of cholestatic disease in Alagille syndrome submitted.- Natural history analysis shows significant improvement in event-free survival and transplant-free survival.- PFIC regulatory strategy in Europe to focus on results of MARCH-PFIC Phase 3 study, expected in second quarter of 2022. FOSTER CITY, Calif.--(BUSINESS WIRE)--Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced the submission of a Marketing Authorization Application (MAA) for the treatment of cholestatic liver disease in patients with Alagille syndrome (ALGS) to the European Medicines Agency (EMA). In conjunction with the ALGS submission, Mirum’s MAA for progressive familial intrahepatic cholestasis type 2 (PFIC2) was withdrawn with plans to re-submit after availability of results from the ongoing MARCH-PFIC Phase 3 study in a broader set of PFIC sub-types and with higher doses of maralixibat.The submission of the ALGS MAA presents an opportunity to deliver the f
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MIRM
Earnings
- 11/2/23 - Beat
MIRM
Sec Filings
- 4/23/24 - Form ARS
- 4/23/24 - Form DEFA14A
- 4/23/24 - Form DEF
- MIRM's page on the SEC website