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BridgeBio Q3 revenue reaches $353.2m as three FDA decisions loom by May 2027

🇺🇸 BridgeBio Pharma, Inc. (BBIO) · Thu 29 Oct 2026

BridgeBio's third-quarter revenue was lifted by US Attruby sales and a Bayer milestone, while three priority-review FDA decisions and two EMA reviews approach.

BridgeBio Pharma reported third-quarter 2026 results on 29 October, with total revenue of $353.2 million. US sales of Attruby (acoramidis), its treatment for transthyretin amyloid cardiomyopathy (ATTR-CM), contributed $253.2 million. A $75 million milestone payment from Bayer was also included in the quarter's revenue.

The company now has three US regulatory decisions scheduled, all under priority review. The first is a Prescription Drug User Fee Act (PDUFA) date of 27 November 2026 for BBP-418, for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). Infigratinib for achondroplasia has a PDUFA date of 4 February 2027, and encaleret for autosomal dominant hypocalcaemia type 1 (ADH1) follows on 8 May 2027.

In Europe, the European Medicines Agency is reviewing infigratinib and encaleret. The summary available does not give timelines for those EMA procedures, and no further detail on the filings was provided.

What it means for your team

  • Regulatory teams tracking rare-disease approvals should note the staggered FDA calendar: 27 November 2026, 4 February 2027 and 8 May 2027.
  • Market-access teams may need to prepare for possible new rare-disease launches in the US, with EU reviews of infigratinib and encaleret running in parallel.
  • Pharmacovigilance teams should expect post-approval safety obligations to follow if any of the three products is cleared, as is standard after a marketing authorisation.

Company's press release (SEC filing): BridgeBio Pharma, Inc. ↗

Article written by VigiEye from the official source (BridgeBio Pharma, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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