Pliant Therapeutics (PLRX, Financials) shares tumbled 58.8% to $3.21 as of 12:40 p.m. ET on Monday, following a 34.8% decline on Friday, after the company announced a voluntary pause in enrollment and dosing for its BEACON-IPF Phase 2b trial.
The independent Data Safety Monitoring Board of the trial is cited as the reason for the choice.
The suspension, according to the business, will provide time for data assessment and DSMB justification understanding. The study will remain blinded in order to maintain its integrity; patients already enrolled in it will stay in the experiment. Pliant is now alerting worldwide regulatory authorities and has alerted clinical trial investigators.
Targeting ?v?6 and ?v?1 integrins, proteins linked in fibrosis, Bexotegrast is an oral small-molecule inhibitor being studied. The U.S. Food and Drug Administration has assigned it Fast Track and Orphan Drug designations; the European Medicines Agency has assigned it Orphan Drug status. The BEACON-IPF study is assessing the medication as a possible therapy for the progressive lung illness known as idiopathic pulmonary fibrosis, for which there are few therapeutic choices.
Pliant said it is still dedicated to working with authorities and the DSMB to decide the best course ahead, but it did not provide a restarting enrollment timetable. As additional data becomes available, the business said it would provide updates.
This article first appeared on GuruFocus.免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。