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
- BridgeBio Shares Recurrent Event Analysis of ATTRibute-CM, Demonstrating a 42% Reduction by Acoramidis on the Composite Endpoint of All-Cause Mortality and Recurrent Cardiovascular-related Hospitalization Events [Yahoo! Finance]Yahoo! Finance
- BridgeBio Shares Recurrent Event Analysis of ATTRibute-CM, Demonstrating a 42% Reduction by Acoramidis on the Composite Endpoint of All-Cause Mortality and Recurrent Cardiovascular-related Hospitalization EventsGlobeNewswire
- BridgeBio Pharma, Inc. (NASDAQ: BBIO) had its "overweight" rating re-affirmed by analysts at Cantor Fitzgerald. They now have a $70.00 price target on the stock.MarketBeat
- BridgeBio Pharma, Inc. (NASDAQ: BBIO) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $43.00 price target on the stock.MarketBeat
- BridgeBio Pharma, Inc. (NASDAQ: BBIO) had its "buy" rating re-affirmed by analysts at Bank of America Co.. They now have a $42.00 price target on the stock.MarketBeat
BBIO
Earnings
- 8/1/24 - Beat
BBIO
Sec Filings
- 9/17/24 - Form 4
- 9/17/24 - Form SC
- 9/13/24 - Form 144
- BBIO's page on the SEC website