BridgeBio Pharma, Inc.
0 products tracked · names used in filings: BridgeBio Pharma, Inc.
Upcoming milestones
Encaleret: PDUFA target action date (autosomal dominant hypocalcemia type 1 (ADH1))
BridgeBio Pharma, Inc. (BBIO); encaleret; status: set; "…achondroplasia has a February 4, 2027 PDUFA date, with Priority Review. The MAA is now under EMA review with potential EU approval in the second half of 2027. Launch preparation is well advanced, with the U.S. field team fully staffed. In hypochondroplasia, the Phase 2/3 ACCEL study is expanding to higher doses to…"; filed 2026-10-29 · source
Oral infigratinib: PDUFA target action date (achondroplasia)
BridgeBio Pharma, Inc. (BBIO); infigratinib; NDA; status: set; "Launch preparation is well advanced, with 70% of patients concentrated at MDA Care Centers, over 70% of which the field team has reached with a 90% target by PDUFA. Based on interactions with EU national health authorities, the Company intends to submit an MAA to the EMA in the first half of 2028 - Oral…"; filed 2026-10-29 · source
BBP-418: PDUFA target action date (limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9))
BridgeBio Pharma, Inc. (BBIO); NDA; status: set; "The first participant was dosed in ASCEND-ATTR, the Phase 3b/4 study to prospectively test disease reversal with Attruby - BBP-418 for LGMD2I/R9 has a November 27, 2026 PDUFA date, with Priority Review."; filed 2026-10-29 · source
Recent milestones
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Products
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.