BridgeBio gets FDA Priority Review for encaleret in ADH1

 

 as new acoramidis (Attruby) data show lower events and hospitalizations vs tafamidis

• Independent Epic COSMOS real-world analysis and ATTRibute‑CM sub‑analyses evaluated acoramidis (Attruby) in transthyretin amyloid cardiomyopathy.
• These analyses found significantly lower composite clinical events and hospitalization rates versus tafamidis, supporting preferred TTR stabilizer potential.
• PDUFA date is May 8, 2027 for encaleret NDA in ADH1.
• New Phase 3 CALIBRATE data show encaleret improves bone turnover and ADH1 symptoms in treated patients.
• BridgeBio submitted an MAA filing to the EMA for review.
• BridgeBio began first dosing in the RECLAIM-HP Phase 3 hypoparathyroidism study.

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