Welcome to our dedicated page for Mirum Pharmaceuticals news (Ticker: MIRM), a resource for investors and traders seeking the latest updates and insights on Mirum Pharmaceuticals stock.
Mirum Pharmaceuticals (MIRM) delivers innovative therapies for rare liver diseases through targeted IBAT inhibitor development. This page provides centralized access to official announcements, clinical trial updates, and strategic developments from the biopharmaceutical innovator.
Investors and healthcare professionals will find timely updates on regulatory milestones, partnership agreements, and pipeline advancements. Our curated feed includes verified press releases about Maralixibat approvals, Volixibat trial progress, and corporate initiatives addressing conditions like progressive familial intrahepatic cholestasis.
Key updates cover FDA communications, research collaborations, and commercialization strategies for orphan drug therapies. All content is sourced directly from Mirum’s disclosures to ensure accuracy and compliance with financial reporting standards.
Bookmark this page for streamlined access to Mirum’s latest advancements in minimally absorbed liver disease treatments. Check regularly for critical updates impacting clinical development timelines and therapeutic availability.
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.
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.
