BridgeBio Announces Infigratinib Is the First Ever Investigational Therapeutic Option for Achondroplasia to Be Awarded Breakthrough Therapy Designation by the FDA
BridgeBio Pharma, Inc. (BBIO)
Last bridgebio pharma, inc. earnings: 3/2 08:29 am
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Source: GlobeNewswire
- Breakthrough Therapy Designation was granted based on preliminary clinical evidence from the PROPEL 2 clinical trial, meeting the FDA’s requirement of potentially demonstrating substantial improvement in efficacy over available therapies on clinically significant endpoint(s) - BridgeBio will leverage the benefits of Breakthrough Therapy Designation to expedite the development and regulatory review of infigratinib in the United States and if approved, infigratinib could be the first-in-class oral therapeutic option for children living with achondroplasia - In Cohort 5 of PROPEL 2 (0.25 mg/kg/day), oral treatment with infigratinib resulted in a statistically significant and sustained increase in annualized height velocity (AHV), with a mean change from baseline of +2.51cm/yr at Month 12, and +2.50 cm/yr at Month 18 (p=0.0015) and statistically significant improvement in body proportionality at Month 18 (p-value of 0.001) PALO ALTO, Calif., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Bridg
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News
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- The Consensus EPS Estimates For BridgeBio Pharma, Inc. (NASDAQ:BBIO) Just Fell Dramatically [Yahoo! Finance]Yahoo! Finance
- Open-Label Extension Data Confirms Sustained Benefit of Acoramidis on Cardiovascular Outcomes, Including Statistically Significant Reduction in ACM Within 36 Months [Yahoo! Finance]Yahoo! Finance
- Open-Label Extension Data Confirms Sustained Benefit of Acoramidis on Cardiovascular Outcomes, Including Statistically Significant Reduction in ACM Within 36 MonthsGlobeNewswire
- BridgeBio Pharma Announces Publication in the New England Journal of Medicine of Phase 2 PROPEL 2 Study of Infigratinib for Children Living with Achondroplasia [Yahoo! Finance]Yahoo! Finance
BBIO
Earnings
- 11/12/24 - Beat
BBIO
Sec Filings
- 11/20/24 - Form 4
- 11/20/24 - Form 4
- 11/19/24 - Form 4
- BBIO's page on the SEC website