Mirum Pharmaceuticals - MIRM STOCK NEWS

On April 10, 2023, Mirum Pharmaceuticals (NASDAQ: MIRM) announced the granting of inducement awards to five new employees, including non-qualified stock options for 25,950 shares and 12,960 restricted stock units (RSUs), under its 2020 Inducement Plan. The options have an exercise price of $24.96, equal to Mirum’s closing price on the grant date. The options will vest over four years, while the RSUs will vest over three years, both subject to continued employment. Mirum is focused on developing treatments for rare liver diseases, with its approved medication, LIVMARLI (maralixibat), and ongoing clinical trials for additional treatments. The awards aim to incentivize new talent critical to Mirum's growth.

Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) has appointed Tim Walbert to its Board of Directors, effective immediately. Walbert previously led Horizon Therapeutics and is recognized for his extensive experience in the biopharmaceutical industry. Niall O’Donnell, a director since November 2018, will step down during the upcoming 2023 Annual Meeting of Stockholders on June 12, 2023. Walbert aims to leverage his expertise in rare diseases to enhance Mirum's growth, particularly in developing therapies for debilitating liver conditions. The company’s existing product, LIVMARLI, is approved for cholestatic pruritus in patients with Alagille syndrome, with additional approvals pending. Chairman Mike Grey expressed confidence in Walbert’s contributions to bolster Mirum's market position in treating rare diseases.

Mirum Pharmaceuticals has submitted a variation application to the European Medicines Agency (EMA) to extend the Marketing Authorization for LIVMARLI (maralixibat) to treat progressive familial intrahepatic cholestasis (PFIC) in patients aged two months and older. This is based on data from the Phase 3 MARCH study, the largest trial for PFIC, showing significant improvements in serum bile acids, pruritus, bilirubin, and growth metrics. LIVMARLI is already approved for treating cholestatic pruritus associated with Alagille syndrome. The company also submitted a supplemental application to the U.S. FDA for similar use in PFIC patients three months and older.

Mirum Pharmaceuticals announced that the FDA has approved a label expansion for LIVMARLI® (maralixibat), lowering the age requirement for treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) from one year to three months. This change is supported by data from the RISE study on the safety and tolerability of LIVMARLI in infants. The approval allows early treatment for the majority of ALGS patients diagnosed before one year. Currently, LIVMARLI is also approved in Europe for patients aged two months and older. Mirum has also submitted a supplemental NDA for treating cholestatic pruritus in progressive familial intrahepatic cholestasis.

Mirum Pharmaceuticals (MIRM) announced on March 10, 2023, that its Compensation Committee granted inducement awards to four new employees, comprising stock options for 40,050 shares and 20,050 restricted stock units (RSUs) under its 2020 Inducement Plan. Each option has an exercise price of $22.30, matching the closing price on the grant date, and will vest over four years. The RSUs will vest over three years. Mirum is dedicated to treating rare liver diseases, with its chief product, LIVMARLI, approved for cholestatic pruritus in patients with Alagille syndrome. The company is advancing two investigational treatments for liver diseases.

Mirum Pharmaceuticals reported financial results for 2022, marking a successful first full year for LIVMARLI® with net product sales of $75.1 million. Total revenue reached $77.1 million, a significant increase from $3.1 million in 2021. The company anticipates a 50% year-over-year growth in net sales for 2023, fueled by recent launches in Germany and potential label expansions. The fourth quarter saw a 48% sales increase over Q3 2022. Strong data from the Phase 3 MARCH-PFIC study highlights LIVMARLI's efficacy in treating pruritus and serum bile acids. Mirum has raised $121.9 million in capital since January 2022, strengthening its balance sheet.

Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) will announce its fourth quarter and year-end 2022 financial results on March 8, 2023, at 4:30 p.m. ET. The company will host a conference call to discuss these results along with recent corporate developments. Participants can join the conference call by dialing 1 833 927 1758 in the U.S. or 1 929 526 1599 internationally, with the passcode 596100. The call will also be available via webcast on Mirum's website for 30 days post-event. Mirum focuses on treatments for rare liver diseases, including its approved medication LIVMARLI®.

Mirum Pharmaceuticals has submitted a supplemental New Drug Application (sNDA) for LIVMARLI (maralixibat) to treat cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) aged two months and older. This submission is based on significant findings from the MARCH Phase 3 study, which involved 93 patients and demonstrated high statistical significance (p<0.0001) in reducing itch severity. If approved, LIVMARLI will also treat cholestatic pruritus in Alagille syndrome (ALGS). Currently, LIVMARLI is already approved for ALGS in the U.S., Israel, and the European Union.

On February 10, 2023, Mirum Pharmaceuticals (NASDAQ: MIRM) granted inducement awards to a new employee, which included non-qualified stock options for 5,000 shares and 2,500 restricted stock units (RSUs). The stock options have an exercise price of $23.67, equal to the closing price on the grant date, and will vest over four years. The RSUs will vest over three years. These awards are part of Mirum’s 2020 Inducement Plan, adhering to Nasdaq Listing Rule 5635(c)(4). Mirum is focused on rare liver diseases with an approved treatment, LIVMARLI, and ongoing clinical trials for additional treatments.