Mirum Pharmaceuticals Stock Price, News & Analysis

Mirum Pharmaceuticals has announced a public offering to sell $75 million in common stock, with a potential additional $11.3 million available for underwriters. The offering will be executed under a previously declared effective shelf registration statement. Leading this initiative are J.P. Morgan, SVB Leerink, and Evercore ISI as joint book-running managers. Mirum is focused on novel therapies for liver diseases, with key products like maralixibat for conditions such as Alagille syndrome and PFIC. Completion of the offering is subject to market conditions.

Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) has granted a stock option award of 11,300 shares to a new employee under its 2020 Inducement Plan. The options have an exercise price of $24.93 per share, vesting over four years with the first 25% on the one-year anniversary. Mirum focuses on novel therapies for liver diseases, with its lead candidate, maralixibat, in late-stage development for multiple conditions. The company is advancing a rolling NDA submission for maralixibat and has an application for PFIC2 under review by the European Medicines Agency.

Mirum Pharmaceuticals (Nasdaq: MIRM) announced a $200 million tiered, revenue-based funding agreement with Oberland Capital, inclusive of a $10 million equity investment. Milestones include $60 million by year-end 2020, $65 million upon FDA NDA acceptance for maralixibat in treating ALGS, and $35 million upon FDA approval. Mirum is advancing its rolling NDA submission for maralixibat and expects to launch in the U.S. in H2 2021. Additionally, it has submitted a marketing application to the EMA for PFIC2 treatment, validating its strategic pipeline development for rare liver diseases.

Mirum Pharmaceuticals (Nasdaq: MIRM) announced that its Marketing Authorization Application (MAA) for maralixibat, aimed at treating progressive familial intrahepatic cholestasis type 2 (PFIC2), has been validated by the European Medicines Agency. This acceptance allows the EMA to begin its review process. Maralixibat's efficacy was supported by Phase 2 INDIGO study data, which highlighted significant improvements in transplant-free survival and quality of life for patients. Additionally, a rolling NDA submission for maralixibat targeting cholestatic pruritus in Alagille syndrome has also been initiated.

Mirum Pharmaceuticals (Nasdaq: MIRM) announced its participation in upcoming virtual investor conferences. A fireside chat will be available on November 23, followed by one-on-one meetings on December 1 at the Piper 32nd Annual Virtual Healthcare Conference. The company will also present at the Evercore ISI 3rd Annual HealthCONx Conference on December 3 at 12:35 PM ET. Mirum is focused on developing therapies for liver diseases, with its lead product maralixibat in late-stage development for conditions including Alagille syndrome and progressive familial intrahepatic cholestasis.

Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) announced encouraging results from studies presented at the AASLD Annual Meeting, focusing on the long-term administration of maralixibat for children with Alagille syndrome. The studies indicated that 80% of patients experienced significant reductions in pruritus, with a mean reduction of -1.9 points at 48 weeks, deepening to -2.3 points at week 220. Maralixibat may provide an alternative to surgery with potential improvements in quality of life and growth parameters. The company is progressing towards its rolling NDA submission for the drug.

Mirum Pharmaceuticals (MIRM) recently presented findings from its clinical programs for maralixibat and volixibat at the Annual Meeting of the American Association for the Study of Liver Diseases. Maralixibat, an investigational therapy for Alagille syndrome, demonstrated significant correlations between pruritus intensity and cholestasis biomarkers in pediatric patients, emphasizing its potential benefits. The company is excited to initiate Phase 2 studies of volixibat, aimed at evaluating its efficacy in adult patients with cholestatic liver diseases. These developments may impact both clinical outcomes and market positioning for MIRM.

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.