Mirum Pharmaceuticals Stock Price, News & Analysis

Mirum Pharmaceuticals has appointed William C. Fairey to its Board of Directors, bringing nearly 30 years of experience in global commercial strategy, particularly in rare diseases. His appointment coincides with the resignation of Tiba Aynechi, effective August 19, 2021. Fairey’s role will be vital as Mirum prepares for the U.S. launch of its first medication and advances its pipeline of therapies for rare liver diseases. The company’s lead candidate, maralixibat, is under priority review by the FDA, with a decision expected by September 29, 2021.

Mirum Pharmaceuticals (Nasdaq: MIRM) announced on August 10, 2021, that it granted non-qualified stock option awards for 95,200 shares to eight new employees as an inducement under its 2020 Inducement Plan. The options have an exercise price of $14.05 per share, reflecting the closing price on the grant date, and will vest over four years. Furthermore, the company is advancing its pipeline, including maralixibat, which is under priority review for treating cholestatic pruritus, with a PDUFA date of September 29, 2021. Mirum also acquired options for two gene therapy programs from Vivet Therapeutics.

Mirum Pharmaceuticals (Nasdaq: MIRM) announced its financial results for Q2 2021, reporting a net loss of $43.9 million, or $1.45 per share, compared to a loss of $23.3 million in Q2 2020. Licensing revenue rose to $11.0 million, reflected in a collaboration with CANbridge Pharmaceuticals. Total operating expenses surged to $48.4 million, influenced by increased research and development costs. Looking ahead, the FDA has set a PDUFA date of September 29, 2021, for maralixibat, with a commercial opportunity exceeding $500 million. The company is advancing its clinical pipeline with multiple expected data releases in 2022.

Mirum Pharmaceuticals (Nasdaq: MIRM) will announce its financial results for Q2 2021 on August 5, 2021, at 1:30 p.m. PT/4:30 p.m. ET, followed by a conference call for business updates. The lead product, maralixibat, targets debilitating liver diseases and has a New Drug Application (NDA) under priority review by the FDA, with a PDUFA date of September 29, 2021. Additionally, Mirum is expanding its portfolio through exclusive options for gene therapy programs aimed at treating PFIC3 and PFIC2.

Mirum Pharmaceuticals has entered into an exclusive licensing agreement with GC Pharma for the development and commercialization of maralixibat in South Korea. Maralixibat is under investigation for treating Alagille syndrome, progressive familial intrahepatic cholestasis, and biliary atresia. Mirum will receive an upfront payment of $5 million along with potential milestone payments and tiered royalties based on net sales. The FDA has accepted a New Drug Application for maralixibat for cholestatic pruritus with a review due by September 29, 2021.

Mirum Pharmaceuticals (Nasdaq: MIRM) announced that its Board's Compensation Committee granted non-qualified stock options for 146,400 shares to 10 new employees as part of the 2020 Inducement Plan. The exercise price is set at $16.61, Mirum's closing price on July 12, 2021, with a four-year vesting schedule. Mirum is focused on developing therapies for liver diseases, with lead candidate maralixibat under FDA review for cholestatic pruritus in Alagille syndrome and ongoing projects in pediatric PFIC. The company is also expanding its pipeline through gene therapy programs.

Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) will participate in Piper Sandler’s Virtual EASL Takeaway Day on June 28, 2021, at 2:00 p.m. ET, featuring CEO Chris Peetz and CSO Pam Vig in a fireside chat. The company is focused on developing therapies for rare liver diseases, with its lead candidate maralixibat under priority review by the FDA, aiming for a PDUFA date of September 29, 2021. Mirum is also pursuing gene therapy options for PFIC2 and PFIC3. For more details, visit the company’s website.

Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) announced new findings at the EASL International Liver Congress™ on its rare liver disease treatments. The analysis of maralixibat, used for Alagille syndrome, indicated strong safety over five years in 86 patients. Additionally, data from a multinational survey revealed significant quality of life impacts from pruritus in intrahepatic cholestasis of pregnancy, with a median itch severity of 9 out of 10. This underscores the urgent need for effective therapies for these liver conditions.

Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) announces its participation in The International Liver Congress™ from June 23-26, 2021. Key presentations include an integrated safety analysis of maralixibat in 86 patients with Alagille syndrome and a survey on patient-reported outcomes from pregnant women with intrahepatic cholestasis of pregnancy. Maralixibat, which has received FDA Breakthrough Therapy designation, demonstrates potential in reducing bile acids and improving symptoms in patients. The company has also acquired gene therapy programs to enhance its pipeline for cholestatic liver diseases.