BBIO BridgeBio

BridgeBio BBP-418 PDUFA set for Nov 27, 2026 (Priority Review)

FDA accepted the NDA for BBP-418 in LGMD2I/R9 and assigned a PDUFA target action date of November 27, 2026 with Priority Review. No advisory committee meeting is planned. The company is preparing for a potential first-in-class launch.

BridgeBio (BBIO) NDA for Oral Infigratinib in Achondroplasia Accepted with Priority Review, PDUFA Feb 4 2027

FDA accepted the NDA for oral infigratinib for children with achondroplasia and granted Priority Review with a PDUFA target action date of February 4, 2027. The filing is supported by positive PROPEL 3 Phase 3 data showing statistically significant improvements in annualized height velocity, height Z-score, body proportionality, and arm span. BridgeBio plans to submit an MAA to EMA in Q4 2026 and is prepared for U.S. launch upon approval.

BridgeBio launches nationwide ATTR-CM education campaign with community partners ahead of World Amyloidosis Day

BridgeBio announced a multi-partner educational initiative including a YouTube premiere on October 6, 2026 and community programming through World Amyloidosis Day on October 26, 2026 to raise awareness of ATTR-CM, particularly in Black communities at higher genetic risk.

BridgeBio commits $300K to Speak Foundation LGMD Centers of Excellence

BridgeBio partners with The Speak Foundation to fund expansion of patient-led LGMD Centers of Excellence. The program aims to improve specialized care coordination, research readiness, and access to emerging treatments for limb-girdle muscular dystrophy patients. BridgeBio is developing BBP-418 (ribitol) for LGMDR9.

acoramidis · NCT07805356 registry update

status: NOT_YET_RECRUITING → RECRUITING; countries: {'total_sites': 0, 'us_sites': 0} → {'total_sites': 5, 'us_sites': 4}

BridgeBio enters voluntary U.S. government agreement on Attruby access

BridgeBio signed a voluntary agreement with the U.S. government to expand Medicaid access to Attruby via the GENEROUS Model. The deal does not impose future pricing mandates and leaves the ForgingBridges copay program unchanged. The agreement is intended to improve affordability for rare-disease patients without altering the regulatory path for acoramidis or the three other assets under FDA review.

BridgeBio sets first PDUFA date for BBP-418 (LGMD2I/R9) on Nov 27, 2026

FDA accepted BBP-418 NDA with Priority Review and set PDUFA target action date of November 27, 2026; encaleret NDA also accepted with Priority Review and PDUFA May 8, 2027; oral infigratinib NDA submitted with U.S. launch expected mid-2027. No advisory committees planned for either accepted application.

BridgeBio: FDA accepts NDA for encaleret in ADH1; PDUFA May 8, 2027

FDA accepted the NDA for encaleret in ADH1 and set a PDUFA target action date of May 8, 2027. The agency indicated it does not plan an advisory committee meeting. BridgeBio states it is prepared to launch upon approval.

BridgeBio: FDA accepts NDA for encaleret in ADH1; PDUFA May 8, 2027

FDA has accepted the NDA for encaleret in ADH1 and set a PDUFA target action date of May 8, 2027. The agency is not planning an advisory committee meeting. BridgeBio is prepared to launch upon approval.

BridgeBio to present PROPEL 3 Phase 3 infigratinib data at ICCBH 2026

BridgeBio announced it will present primary results from the Phase 3 PROPEL 3 trial of oral infigratinib in children with achondroplasia as a late-breaking oral presentation at ICCBH 2026. The presentation is scheduled for June 28, 2026 at 3:45 pm EDT. Additional quality-of-life and observational data will also be presented at the same meeting.

BridgeBio: FDA Accepts NDA for BBP-418 in LGMD2I/R9 with Priority Review

FDA accepted the NDA for BBP-418 and granted Priority Review, setting a PDUFA target action date of November 27, 2026. The agency indicated it is not planning an advisory committee meeting. If approved, BBP-418 would be the first therapy for LGMD2I/R9 and the first for any form of LGMD.

BridgeBio submits NDA for encaleret in ADH1

BridgeBio has submitted an NDA to the FDA for encaleret as a potential first-in-class treatment for ADH1. The submission is supported by positive Phase 3 CALIBRATE results showing statistically significant normalization of calcium homeostasis. The company anticipates a U.S. launch in early 2027 and plans an MAA submission to the EMA in H2 2026.

BridgeBio submits first NDA for BBP-418 in LGMD2I/R9

BridgeBio submitted its first of three planned NDAs to the FDA for oral BBP-418 in LGMD2I/R9. The filing may be eligible for priority review given Fast Track Designation and unmet need. Two additional NDAs (encaleret in ADH1 and oral infigratinib in achondroplasia) are still expected in 1H 2026 and Q3 2026, respectively.

BridgeBio submits NDA for BBP-418 in LGMD2I/R9

BridgeBio has submitted its NDA to the FDA for oral BBP-418 in LGMD2I/R9. The submission includes interim Phase 3 FORTIFY data showing statistically significant improvements in ambulation and pulmonary function. The company anticipates U.S. approval and launch in late 2026/early 2027, potentially making BBP-418 the first approved therapy for any form of LGMD.

BridgeBio reports positive Phase 3 topline results for encaleret in ADH1

The CALIBRATE Phase 3 study met all primary and key secondary endpoints, showing 76% of patients on encaleret achieved both serum and urine calcium targets versus 4% on conventional therapy. NDA submission is now planned for the first half of 2026 to support full approval.