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.

Key facts

Filed: Oct 13, 2026, 10:01 AM
Event: PDUFA date extended
Direction: Negative
Company: BBIOBridgeBio
Asset: acoramidis
Source: SEC 8-K
Confidence: Sourced
Calendar: FDA decision (PDUFA) · Nov 27, 2026
p: <0.0001
AHV: +2.10 cm/yr
arm span z: +0.37 SD
height z score: p<0.0001
proportionality: -0.05

Source excerpt

EX-99.1 5 ef20083591_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 BridgeBio Announces FDA Acceptance and Priority Review of NDA for Oral Infigratinib for Children with Achondroplasia - Accepted for Priority Review with a PDUFA target action date of February 4, 2027; being granted Priority Review by the FDA underscores the significant unmet need for an oral targeted therapeutic option for children with achondroplasia - If approved, oral infigratinib would be the first and only approved oral therapy and a potential best-in-class treatment option for children with achondroplasia - PROPEL 3 met its primary endpoint and key secondary endpoints, delivering the strongest efficacy package reported to date in achondroplasia: the largest AHV treatment effect of any Phase 3 study (+2.10 cm/yr; p<0.0001), and the first and only statistically significant improvement in both body proportionality and arm span in an achondroplasia Phase 3 trial (Proportionality: mean difference of -0.05 in ages 3–8, p<0.05; arm span z-score: +0.37 SD, p<0.0001) -Treatment with oral infigratinib for 52 weeks in PROPEL 3 also resulted in favorable trends against placebo in clinically meaningful exploratory endpoints including sleep apnea and otitis media events - BridgeBio anticipates U.S. launch of oral infigratinib upon approval PALO ALTO, Calif., Oct. 06, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage, multi-product biopharmaceutical compan

SEC 8-K