MIRM Stock Discussion (Mirum Pharmaceuticals, Inc.)

Mirum’s younger-child FOP results support a planned expansion filing

Mirum ($MIRM) reported new results for zilurgisertib in children aged six to under twelve with fibrodysplasia ossificans progressiva, a rare disease that causes abnormal bone formation. In the randomized Phase 2 PROGRESS cohort, twelve treated children had a mean 8.09-cubic-centimeter reduction in lesion volume after 24 weeks, while thirteen placebo recipients had a 9.14-cubic-centimeter increase. The comparison had a nominal p-value of 0.003. No treated child developed a new lesion, compared wi

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Mirum’s hepatitis-delta drug succeeds in Phase 3 AZURE-1

Mirum Pharmaceuticals ($MIRM) said brelovitug met the primary endpoint in the Phase 3 portion of AZURE-1, which enrolled 153 treatment-naive patients with chronic hepatitis delta. At 24 weeks, the combined viral-response and liver-enzyme-normalization endpoint was achieved by 56% receiving 300 mg weekly and 45% receiving 900 mg every four weeks, versus 0% in the delayed-treatment group. Both comparisons were statistically significant. The findings advance one of the two pivotal studies intended