Common stock
- Symbol
- BBIO
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 8.01, 9.01 · 8-K
BridgeBio Pharma, Inc.
BBIONASDAQEQUITYCurrent
Other Events
Item 8.01. Other Events. On October 6, 2026, BridgeBio Pharma, Inc. issued a press release titled “BridgeBio Announces FDA Acceptance and Priority Review of NDA for Oral Infigratinib for Children with Achondroplasia.” A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Company context
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.
Current securities
Registered securities in this filing
BridgeBio Pharma, Inc · 8-K · Filed 2026-10-13
Disclosure sections
Item 8.01Item 8.01 - Other Events
Item 8.01.
Other Events.
On October 6, 2026, BridgeBio Pharma, Inc. issued a press release titled “BridgeBio Announces FDA Acceptance and Priority Review of NDA for Oral Infigratinib for Children with Achondroplasia.” A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Filed exhibits (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 event…
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