Mirum Pharmaceuticals, Inc. - MIRM STOCK NEWS

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.

Mirum Pharmaceuticals has partnered with CANbridge Pharmaceuticals to license maralixibat for development and commercialization in Greater China. This investigational oral medication is aimed at treating Alagille syndrome, progressive familial intrahepatic cholestasis, and biliary atresia. Mirum will receive an $11 million upfront payment, R&D funding, and up to $109 million in milestone payments, alongside tiered royalties based on sales. FDA has accepted an NDA for maralixibat under priority review, and CANbridge will manage clinical sites in China to enhance study enrollment.

Mirum Pharmaceuticals (Nasdaq: MIRM) has received a Notice of Allowance from the USPTO for patent application No. 16/994,368, which covers treatment methods for Alagille syndrome using maralixibat. This patent is set to provide protection until 2040. Additionally, the FDA accepted Mirum's NDA for maralixibat for treating cholestatic pruritus in patients one year and older, with a PDUFA date of September 29, 2021. Maralixibat, a novel investigational drug, is also being studied for progressive familial intrahepatic cholestasis and biliary atresia, and has shown promising results in clinical trials.

Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) announced the grant of non-qualified stock options for 118,800 shares to 10 new employees on April 12, 2021. The exercise price is set at $18.18 per share, which aligns with the closing trading price on the same day. The options will vest over four years, contingent on employment status. Mirum is advancing its late-stage pipeline, including maralixibat for Alagille syndrome, with an NDA under priority review by the FDA, and a marketing application validated by the European Medicines Agency for pediatric PFIC2.

Mirum Pharmaceuticals (Nasdaq: MIRM) has secured an exclusive option to develop and commercialize Vivet Therapeutics' gene therapies, VTX-803 and VTX-802, for progressive familial intrahepatic cholestasis (PFIC) subtypes 3 and 2. Under this agreement, Vivet will continue preclinical studies while Mirum funds the research and takes over clinical development upon licensing. Both therapies aim to address liver dysfunction caused by PFIC, potentially transforming treatment outcomes. VTX-803 has received Orphan Drug Designation from the FDA and EMA, highlighting its significance for rare diseases.

Mirum Pharmaceuticals has announced that its New Drug Application (NDA) for maralixibat has been accepted for priority review by the U.S. FDA. Maralixibat is aimed at treating cholestatic pruritus in patients aged one and older with Alagille syndrome (ALGS), a rare liver disease lacking approved therapies. The FDA's decision on the NDA is expected by September 29, 2021. Maralixibat has shown effectiveness in reducing pruritus and other symptoms in clinical studies, with over 1,600 patients treated to date. The drug's approval could significantly benefit ALGS patients.

On March 10, 2021, Mirum Pharmaceuticals (Nasdaq: MIRM) granted stock options for 114,800 shares to five new employees under its 2020 Inducement Plan. Each option has an exercise price of $18.41, reflecting the closing price on the grant date. These options will vest over four years, with 25% vesting after one year. Mirum focuses on developing therapies for liver diseases, with its lead candidate, maralixibat, in late-stage development for conditions like Alagille syndrome and PFIC, with regulatory submissions pending.

Mirum Pharmaceuticals reported its fourth-quarter and year-end 2020 financial results, along with key business updates. The company aims to launch maralixibat for Alagille syndrome in 2021, pending FDA approval. Mirum secured approximately $400 million in capital to support operations over the next three years and has initiated several clinical studies for its pipeline products, including volixibat. Operating expenses surged to $37 million for Q4 2020, resulting in a net loss of $37.2 million. The company had cash and investments of $231.8 million by year-end.

Mirum Pharmaceuticals (Nasdaq: MIRM) announced its participation in several upcoming virtual investor conferences. Key dates include the SVB Leerink 10th Annual Global Healthcare Conference on February 26, 2021, and the Oppenheimer 31st Annual Healthcare Conference on March 17, 2021. Investors can access audio webcasts and presentations on Mirum’s Investor website. The company is focused on developing innovative treatments for liver diseases, with its lead candidate, maralixibat, in advanced stages for conditions like Alagille syndrome and PFIC.