BridgeBio Pharma

BridgeBio has treated the first participant in the ASCEND-ATTR phase-3b/4 trial with acoramidis. About 150 patients with ATTR-CM will be followed for 36 months; the primary endpoint is responder status defined by improvement in left ventricular systolic function versus baseline. Secondary endpoints include cardiac structure, function, amyloid burden, biomarkers and imaging at 12, 24 and 36 months. Earlier CMR substudies showed cardiac improvements and amyloid regression in a subgroup; known side effects of Attruby include diarrhea and upper abdominal pain. » Altro su de.investing.com

BridgeBio reported revenue of $243.7 million in Q2 2026, about 120% higher than a year earlier and roughly 10.7% above analyst expectations. Net product revenue from Attruby rose to $222.4 million (+211%), contributing materially to the growth and showing sequential momentum. Despite higher operating expenses, operating loss narrowed to $107.1 million; diluted loss per share was $0.78 and missed the forecast. BridgeBio ended the quarter with $720.2 million in cash, pro forma liquidity increases to about $1.7 billion after a $1.0 billion preferred financing, and management expects Attruby could reach blockbuster status in 2026 while several PDUFA dates for additional products are upcoming. » Altro su de.investing.com

The FDA has accepted the new drug application (NDA) for Encaleret to treat autosomal-dominant hypocalcemia type 1 (ADH1) and set a May 8, 2027 target date for a decision. The agency currently does not plan an advisory committee meeting. The application is supported by the Phase 3 CALIBRATE study, in which Encaleret met all pre-specified primary and key secondary endpoints; the drug has Fast Track and orphan drug designations in multiple regions. BridgeBio plans to submit an application to the EMA in the second half of 2026 and is conducting pediatric and additional Phase 3 studies of Encaleret in parallel. » Altro su de.investing.com