BridgeBio Phase 3 acoramidis hits primary endpoint in ATTR-CM; NDA planned by year-end 2023

BridgeBio Pharma, Inc.

Primary endpoint met with Win Ratio 1.8 (p<0.0001); 81% on-treatment survival vs 74% placebo.
50% relative risk reduction (p<0.0001) in frequency of cardiovascular-related hospitalization.
All secondary endpoints (NT-proBNP, KCCQ, 6-min walk) statistically significant at 30 months (p<0.0001).
No safety signals identified; NDA submission to FDA targeted by end of 2023.
Exploratory analysis suggests 42% greater increase in serum TTR vs tafamidis; 92% improvement in median NT-proBNP.

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