Loading...
•
Dec 31, 2019
Mirum Pharmaceuticals Q4 2019 Earnings Report
Mirum Pharmaceuticals reported financial results for Q4 2019, highlighted by a net loss of $18.0 million and total operating expenses of $18.7 million.
Key Takeaways
Mirum Pharmaceuticals reported a net loss of $18.0 million for the quarter ended December 31, 2019, with total operating expenses amounting to $18.7 million. The company's cash, cash equivalents, and investments stood at $140.0 million before gross proceeds from a follow-on public offering in January 2020.
Mirum completed a pre-NDA meeting with the FDA for maralixibat, aligning on a rolling NDA submission starting in Q3 2020.
The FDA granted Breakthrough Therapy Designation for maralixibat for treating pruritus associated with Alagille syndrome in patients 1 year and older.
The FDA granted Rare Pediatric Disease Designation for Alagille syndrome, potentially entitling Mirum to a priority review voucher upon maralixibat's NDA approval before October 1, 2022.
Data presented demonstrated the long-term durability of maralixibat in children with cholestatic liver disease, showing significant effects on pruritus, xanthomas, and growth for up to four years in Alagille syndrome.
Historical Earnings Impact
Analyze how earnings announcements historically affect stock price performance
Avg. Return Before/After Earnings
Loading earnings performance data...
Loading earnings reaction data...