Madrigal Phase 3 MAESTRO-NASH meets dual primary endpoints; NDA planned H1 2023

MADRIGAL PHARMACEUTICALS, INC.

NASH resolution endpoint met: 30% on 100mg vs 10% placebo (p<0.0001); fibrosis improvement: 26% vs 14% (p=0.0002).
LDL-C lowering at 24 weeks: -16% on 100mg vs -1% placebo (p<0.0001); both doses statistically significant.
Safety similar across arms: SAEs 11.8-12.7%; discontinuation low (2.8-7.7%); common AEs mild diarrhea and nausea.
Company plans to file NDA for accelerated approval (Subpart H) in first half of 2023.

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