4TEEN4 Receives FDA Fast Track Designation for Invobenitug in Cardiogenic Shock

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โดย GlobeNewswire·Read original
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4TEEN4 Pharmaceuticals GmbH announced that the U.S. Food and Drug Administration has granted Fast Track Designation to invobenitug for the treatment of cardiogenic shock. Invobenitug is the company's lead investigational monoclonal antibody targeting circulating dipeptidyl peptidase 3, and it is currently being evaluated in the PROCARD 2a Phase 1b/2a trial in patients with cardiogenic shock and elevated cDPP3 concentrations. The designation recognizes the significant unmet medical need in cardiogenic shock, a condition with mortality rates exceeding 50% and no approved therapies targeting the underlying biology. Fast Track status facilitates development and expedites regulatory review, providing opportunities for more frequent FDA interactions and potential eligibility for Rolling Review, Accelerated Approval, and Priority Review.

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FDA Fast Track Designation for invobenitug in cardiogenic shock, a condition with high unmet need, expedites development and review.

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