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The raised FY guidance implies higher near-term revenue visibility; breakthroughs and NDA timing create concrete price-relevant milestones. Historically, raises in guidance near earnings news have driven multi-quarter re-ratings for biotech names with visible catalysts.
What happened, with direct paths to the underlying reporting
Mirum reported a solid Q2 2026 with $176.2 million in net product sales and raised full-year guidance to $680–$700 million. The FDA granted volixibat Breakthrough Therapy and Orphan Drug Designations for PSC, while a pre-NDA meeting has set an NDA submission target for H1 2027. Enrollment in the VANTAGE trial for PBC is complete, with topline data due in Q1 2027, underscoring near-term regulatory catalysts.
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