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Why Are Bellerophon Shares Jumping Today?

Why Are Bellerophon Shares Jumping Today?

為什麼Bellerophon的股價今天會上漲？
Benzinga Real-time News ·  2022/09/27 12:08
  • The FDA has accepted Bellerophon Therapeutics Inc's (NASDAQ: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.
  • FDA已經接受了貝勒羅芬治療公司納斯達克(Sequoia Capital：BLPH)提議縮減其正在進行的INOPulse治療纖維化間質性肺疾病(FID)註冊重建第三階段試驗的研究規模。
  • 140名受試者的新研究規模不會影響試驗的主要目標或終點。它的功率保持在90%以上(p值
  • 在正在進行的第三階段重建研究中評估了基線MVPA特徵並審查了隨機受試者的安全數據後，試驗的獨立數據監測委員會(DMC)支持將目標研究規模從300人減少到140人。
  • Bellerophon董事長納西姆·阿明表示：“到目前為止，有100多名受試者被隨機分配，我們預計將在2023年第一季度完成登記，並預計在2023年第三季度提供關鍵的頂級數據。”
  • 價格行動：BLPH股價週二尾盤上漲28.39%，至1.24美元。
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