Why Are Bellerophon Shares Jumping Today?

Loading...
Loading...
  • The FDA has accepted Bellerophon Therapeutics Inc's BLPH proposal to reduce the study size for its ongoing registrational REBUILD Phase 3 trial of INOpulse for the treatment of fibrotic Interstitial Lung Disease (fILD). 
  • The new study size of 140 subjects does not impact the trial's principal objective or endpoints. It maintains a power of >90% (p-value < 0.01) for the primary endpoint of Moderate to Vigorous Physical Activity (MVPA) based on the effect size observed in Phase 2.
  • Following the evaluation of baseline MVPA characteristics and review of safety data of the randomized subjects in the ongoing Phase 3 REBUILD study, the trial's independent Data Monitoring Committee (DMC) supported reducing the target study size from 300 to 140 subjects.
  • "With over 100 subjects randomized to date, we expect to complete enrollment in the first quarter of 2023 and anticipate the availability of pivotal top-line data in the third quarter of 2023," said Naseem Amin, Chairman of Bellerophon.
  • Price Action: BLPH shares are up 28.39% at $1.24 on the last check Tuesday.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechNewsPenny StocksHealth CareFDAMoversTrading IdeasGeneralBriefswhy it's moving
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...