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Mirum Pharmaceuticals, Inc. develops and commercializes medicines for rare diseases, with recurring updates centered on product sales, clinical readouts, regulatory interactions and employee equity grants. The company’s commercial portfolio includes LIVMARLI® (maralixibat) for Alagille syndrome and progressive familial intrahepatic cholestasis, CHOLBAM® (cholic acid) for bile-acid synthesis disorders, and CTEXLI® (chenodiol) for cerebrotendinous xanthomatosis.
News about MIRM also covers clinical-stage programs including volixibat, an IBAT inhibitor for primary sclerosing cholangitis and primary biliary cholangitis; brelovitug, a monoclonal antibody designed to bind hepatitis B surface antigen for chronic hepatitis delta virus; and MRM-3379, a PDE4D inhibitor for Fragile X syndrome. Company updates report financial results, pipeline licensing activity and inducement awards under Nasdaq Listing Rule 5635(c)(4).
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) announced its financial results for Q3 2020, reporting a net loss of $21.5 million, or $0.86 per share, compared to a loss of $15.1 million, or $0.84 per share in Q3 2019. Total operating expenses rose to $21.7 million, driven by R&D costs of $16.0 million. The company is making strides in treating liver diseases, with a rolling NDA submission for maralixibat, and plans to launch it for Alagille syndrome.
Mirum also initiated an Expanded Access Program and received FDA Orphan Drug and Rare Pediatric Disease designations for maralixibat.
On November 10, 2020, Mirum Pharmaceuticals granted stock options for 36,300 shares to two new employees under its 2020 Inducement Plan. The exercise price is fixed at $17.96, based on the closing stock price on that date. The options will vest over four years, with 25% vesting after one year and the remainder vesting monthly thereafter. Mirum is focused on developing therapies for liver diseases, notably maralixibat, which is in the process of NDA submission for Alagille syndrome and plans for a marketing application for PFIC2.
Mirum Pharmaceuticals (Nasdaq: MIRM) has expanded its Expanded Access Program (EAP) for maralixibat, targeting cholestatic pruritus in Alagille syndrome (ALGS), to Australia and several European countries. This follows the EAP's initiation in the U.S. and Canada. Maralixibat, an investigational drug, aims to help patients manage severe symptoms associated with ALGS until regulatory approval. The EAP is now available to eligible patients in multiple countries, enhancing access to this promising therapy for a rare genetic disorder characterized by liver dysfunction.
Mirum Pharmaceuticals (Nasdaq: MIRM) announced the presentation of new data from maralixibat and volixibat studies at The Liver Meeting 2020, hosted by the AASLD from November 13-16. Key presentations include a late-breaker oral presentation on maralixibat's long-term effects in children with Alagille syndrome and several poster presentations discussing volixibat's impact on fecal bile acid excretion. Maralixibat aims to mitigate liver damage in rare cholestatic diseases, having been administered to over 1,600 individuals, showing promise for future FDA approvals.
Mirum Pharmaceuticals (Nasdaq: MIRM) recently announced that data from its maralixibat studies will be presented at the NASPGHAN Annual Meeting 2020 (November 1-7). Key presentations include long-term safety and efficacy data for maralixibat in children with Alagille syndrome and findings on genotype responses in patients with bile salt export pump deficiency. Mirum will also sponsor a symposium addressing pediatric cholestasis. The FDA has granted Breakthrough Therapy designation for maralixibat aimed at treating pruritus associated with Alagille syndrome.
Mirum Pharmaceuticals has partnered with EVERSANA to lead the U.S. market access, distribution, and patient services for maralixibat, an investigational treatment for cholestatic pruritus in patients with Alagille syndrome. Following the initiation of its rolling NDA in August 2020, Mirum anticipates completing the submission in early 2021 and plans to launch the drug in the second half of 2021. Maralixibat aims to alleviate severe symptoms associated with rare liver diseases, with current studies showing positive safety profiles and efficacy indicators.
Mirum Pharmaceuticals (MIRM) has partnered with EVERSANA to manage market access, distribution, and patient services for its investigational drug, maralixibat, aimed at treating cholestatic pruritus in Alagille syndrome (ALGS). Mirum plans to complete its New Drug Application (NDA) submission to the FDA in Q1 2021 and prepare for a potential launch in H2 2021. Maralixibat has received Breakthrough Therapy designation and has shown promising results in clinical trials, demonstrating significant reductions in bile acids and associated symptoms.
Mirum Pharmaceuticals (Nasdaq: MIRM) announced on October 9, 2020, the granting of non-qualified stock options to purchase 74,100 shares to seven new employees under its 2020 Inducement Plan. Each option has an exercise price of $19.84, vesting over four years. The company is focused on developing therapies for liver diseases, including its lead candidate, maralixibat, targeting conditions like Alagille syndrome and progressive familial intrahepatic cholestasis. Mirum plans to submit marketing applications for maralixibat in the U.S. and Europe by early 2021.