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Why Are Bellerophon Shares Jumping Today?

Why Are Bellerophon Shares Jumping Today?

为什么Bellerophon的股价今天会上涨？
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已经接受了贝勒罗芬治疗公司纳斯达克(Sequoia Capital：BLPH)提议缩减其正在进行的INOPulse治疗纤维化间质性肺疾病(FID)注册重建第三阶段试验的研究规模。
  • 140名受试者的新研究规模不会影响试验的主要目标或终点。它的功率保持在90%以上(p值
  • 在正在进行的第三阶段重建研究中评估了基线MVPA特征并审查了随机受试者的安全数据后，试验的独立数据监测委员会(DMC)支持将目标研究规模从300人减少到140人。
  • Bellerophon董事长纳西姆·阿明表示：“到目前为止，有100多名受试者被随机分配，我们预计将在2023年第一季度完成登记，并预计在2023年第三季度提供关键的顶级数据。”
  • 价格行动：BLPH股价周二尾盘上涨28.39%，至1.24美元。
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