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Mirum Pharmaceuticals to Report First Quarter 2021 Financial Results and Host Conference Call on May 6, 2021

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Mirum Pharmaceuticals (Nasdaq: MIRM) announced it will report financial results for the quarter ending March 31, 2021, on May 6, 2021. A conference call will follow at 1:30 PM PT/4:30 PM ET for a business update. The company focuses on developing therapies for liver diseases, with its lead candidate maralixibat currently under priority review by the FDA for cholestatic pruritus in ALGS patients, and a PDUFA action date set for September 29, 2021. Additionally, Mirum has secured options to develop gene therapy programs for PFIC2 and PFIC3.

Positive
  • Lead product candidate maralixibat is under FDA priority review.
  • NDA for maralixibat accepted with a PDUFA action date of September 29, 2021.
  • Acquired exclusive option to develop two gene therapy programs for PFIC2 and PFIC3.
Negative
  • None.

Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), today announced that the company will report financial results for the quarter ended March 31, 2021 on Thursday, May 6, 2021. That same day, Mirum will host a conference call and audio webcast at 1:30 p.m. PT/4:30 p.m. ET to provide a business update.

Conference Call Details:

U.S. toll-free:

877-261-8990

International:

847-619-6441

Passcode:

50157000

You may also access the call via webcast by visiting the Events & Presentations section on Mirum’s website. A replay of this webcast will be available for 30 days.

About Mirum Pharmaceuticals

Mirum Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a late-stage pipeline of novel therapies for debilitating liver diseases. Mirum’s lead product candidate, maralixibat, is an investigational oral drug in development for Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC), and biliary atresia. Mirum has submitted an NDA for maralixibat in the treatment of cholestatic pruritus in patients with ALGS. The NDA has been accepted for priority review by the FDA with a PDUFA action date of September 29, 2021. Additionally, Mirum’s marketing authorization application for the treatment of pediatric patients with PFIC2 has been accepted for review (validated) by the European Medicines Agency. Mirum is also developing volixibat, also an oral ASBT-inhibitor, in primary sclerosing cholangitis, intrahepatic cholestasis of pregnancy, and primary biliary cholangitis. For more information, visit MirumPharma.com.

To augment its pipeline in cholestatic liver disease, Mirum has acquired the exclusive option to develop and commercialize two gene therapy programs, VTX-803 and VTX-802 for PFIC3 and PFIC2, respectively, from Vivet Therapeutics, following preclinical evaluation and IND-enabling studies.

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FAQ

When will Mirum Pharmaceuticals report financial results for Q1 2021?

Mirum Pharmaceuticals will report financial results for the quarter ended March 31, 2021, on May 6, 2021.

What is the significance of the PDUFA action date for Maralixibat?

The PDUFA action date of September 29, 2021, is crucial as it indicates when the FDA will decide on the marketing application for maralixibat.

What are the gene therapy programs being developed by Mirum Pharmaceuticals?

Mirum has acquired an exclusive option to develop gene therapy programs VTX-803 and VTX-802 for PFIC3 and PFIC2, respectively.

Mirum Pharmaceuticals, Inc.

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