BridgeBio reports Q3 2026 results, three PDUFA dates ahead and new Phase 3 study starts

BridgeBio Pharma reported financial results for the third quarter ended September 30, 2026, on October 29, 2026, alongside a set of pipeline updates across its four late-stage programs.

The company dosed the first participant in ASCEND-ATTR, a Phase 3b/4 study designed to determine whether acoramidis is associated with sustained improvement in cardiac structure, function, and amyloid burden, as measured by cardiac MRI and echocardiography over 36 months.¹ Separately, the first participant was dosed in RECLAIM-HP, the registrational Phase 3 study of encaleret in chronic hypoparathyroidism, with topline results anticipated in early 2028.¹ That indication affects approximately 200,000 patients in the U.S. and EU and represents a substantial expansion of the encaleret opportunity beyond ADH1.¹

On regulatory timing, BridgeBio has three PDUFA dates in the coming months: the FDA accepted the NDA for BBP-418 on May 27, 2026, with Priority Review and a PDUFA date of November 27, 2026¹; oral infigratinib for achondroplasia has a PDUFA date of February 4, 2027, with Priority Review¹; and encaleret for ADH1 has a PDUFA date of May 8, 2027, with Priority Review.¹ For BBP-418, BridgeBio intends to submit an MAA to the EMA in the first half of 2028, based on the final Month 36 analysis of the Phase 3 FORTIFY study, with topline results expected late 2027/early 2028.¹

On cash, the company said total third quarter revenues were $353.2 million, and cash, cash equivalents and marketable securities were $1.5 billion as of September 30, 2026, which the company said fully funds all three launches and expansion indications.¹ Loss from operations was $11.6 million, driven by increased revenue and a one-time $75.0 million BEYONTTRA sales milestone from Bayer.¹