BridgeBio Phase 3: acoramidis cuts cardiovascular hospitalizations 34% vs tafamidis in indirect comp

 

BridgeBio Phase 3 ATTRibute-CM data show acoramidis cuts cardiovascular hospitalizations 34% vs tafamidis in indirect comparison

• New Phase 3 ATTRibute-CM data show acoramidis (Attruby) reduces TTR variability linked to mortality in ATTR-CM patients.
• Matching-adjusted indirect comparison shows acoramidis cuts cardiovascular hospitalizations 34% versus tafamidis, with a favorable mortality trend.
• Attruby U.S. net product revenue $180.6M, +24% QoQ and +392% YoY, remained the key growth driver.
• Total revenue reached $194.5M, up 67% YoY vs $116.6M, beating estimates despite lapping a $75M milestone.
• Non-GAAP EPS was -$0.84 in Q1 2026, improving 5% YoY but missing analyst expectations.
• Operating loss was $106M, but loss from operations has narrowed over 50% in five quarters.
• Management guides toward P&L breakeven in 2027 and sustainable cash flow positivity thereafter.
• Emerging real-world evidence shows Attruby outperforming tafamidis on outcomes, supporting continued frontline share gains.
• Three near-term launches progressing: LGMD2I/R9 NDA for BBP-418 submitted, ADH1 NDA on track, achondroplasia Phase III positive.
• Roughly 2,000 ADH1 and ~500 LGMD2I patients already identified, underpinning launch preparedness.
• Board authorized $500M repurchase and a $500M at-the-market equity program with Goldman Sachs, Leerink Partners, disclosed in SEC filing.
• ATTR-CM class new-to-brand starts topped 6,100; BridgeBio now convincingly the #2 brand by volume.
• Investors focused on ATTR-CM competition, tafamidis generic timing, sustaining Attruby differentiation, and executing three launches while controlling expenses.
• Strong quarter, driven by accelerating Attruby adoption and a clearer path to profitability and capital returns.

https://finviz.com/quote?t=BBIO&p=d