BridgeBio reports Q2 2026 results as all three pipeline NDAs reach FDA review

BridgeBio Pharma reported second quarter 2026 results on August 10, 2026, highlighting progress across its three late-stage pipeline programs. On May 27, 2026, the FDA accepted the company's New Drug Application for BBP-418 and granted Priority Review, setting a PDUFA target action date of November 27, 2026, with no advisory committee meeting currently planned.¹

The FDA also re-considered its review designation for the encaleret NDA in ADH1 and granted Priority Review, with a PDUFA target action date of May 8, 2027.¹ BridgeBio also submitted a Marketing Authorization Application to the EMA for encaleret in ADH1.¹ Separately, the company submitted an NDA to the FDA for oral infigratinib in achondroplasia and is on track to submit an MAA to the EMA in the fourth quarter of 2026, anticipating a U.S. launch in mid-2027 and an EU approval in the second half of 2027.¹

On the clinical side, the Phase 3 RECLAIM-HP study of encaleret in chronic hypoparathyroidism has activated its first investigational sites and begun screening¹, while the pediatric CALIBRATE-PEDS study completed enrollment in its first of four cohorts, adolescents aged 12 to 17.¹ The company is also enrolling an observational run-in study for a planned Phase 3 trial in hypochondroplasia, with a Phase 2 program update expected in the second half of 2026.¹

On finances, cash, cash equivalents and marketable securities totaled $720.2 million as of June 30, 2026, up from $587.5 million at year-end 2025.¹ On July 1, 2026, BridgeBio closed $1 billion in preferred equity led by Sixth Street with participation from HealthCare Royalty, an affiliate of KKR, which the company said enables it to fund three potential upcoming launches while continuing to invest in pipeline expansion.¹