MIRM News and Press, Mirum Pharmaceuticals Inc. From 11/09/22

Mirum Pharmaceuticals press release ( NASDAQ: MIRM ): Q3 GAAP EPS of -$1.02 beats by $0.05 . Revenue of $18.78M (+275.6% Y/Y) misses by $2.03M . As of September 30, 2022, Mirum had cash, cash equivalents, restricted cash equivalents and investments of $285.3M. ...

- Net product sales for LIVMARLI ® (maralixibat) oral solution totaled $18.8 million in the third quarter of 2022 and $47.2 million year-to-date - Mirum raises 2022 full year net product sales guidance estimate for LIVMARLI to $70 million - Conference call to provide bu...

- Phase 3 MARCH study meets primary endpoint and demonstrates statistical significance across key endpoints in all PFIC types. Receives Best of Liver Meeting distinction. - RISE study in infants with ALGS shows safety and tolerability of LIVMARLI for ages ≥2 months. -...

Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that it will report third quarter financial results on Wednesday, November 9, 2022. Mirum will host a conference call to discuss the third quarter financial results and recent corporate progress. Mirum will be joined by gues...

Phase 3 MARCH PFIC study to be presented as oral late-breaker RISE infant safety study in ALGS to be presented as late-breaker poster Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), today announced that it will present new data from LIVMARLI® (maralixibat) oral ...

Commercial-stage biotech Mirum Pharmaceuticals ( NASDAQ: MIRM ) announced Monday that its FDA-approved therapy Livmarli reached the main goal in a pivotal Phase 3 trial for rare liver disease progressive familial intrahepatic cholestasis (PFIC). Livmarli is an oral therapy...

Met primary endpoint (p=0.0098); highly statistically significant effects in all PFIC subtypes. Significant improvements in total bilirubin and growth versus placebo at six months. Mirum plans to submit these data to regulatory agencies. Mirum to host conference call to di...

Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that data highlighting quality of life and sleep improvements from its pivotal ICONIC study evaluating LIVMARLI® (maralixibat) oral solution in patients with Alagille syndrome (ALGS), were published in the Journal of Pe...

A committee of the European Medicines Agency (EMA) recommended granting marketing authorization under exceptional circumstances to Mirum Pharmaceuticals' ( NASDAQ: MIRM ) Livmarli to treat cholestatic pruritus (itching) in patients two  months of age and older wi...

- CHMP opinion based on pivotal ICONIC study with more than five years of data demonstrating durable and clinically meaningful improvements in cholestatic pruritus and serum bile acids for patients with Alagille syndrome (ALGS). - Following CHMP recommendation, a decision by the Eur...