ALPN - Partial clinical hold placed on Alpine Immune's davoceticept for malignancies

The FDA has placed a partial clinical hold on a phase 2 trial of Alpine Immune Sciences' (NASDAQ:ALPN) davoceticept for advanced malignancies following a patient death. The company said the participant had received a single dose each of davoceticept and Keytruda (pembrolizumab). The cause of death was related to cardiogenic shock, which treating physicians said was likely related to immune-mediated myocarditis or infection. Patients already enrolled in the trial can continue to receive medications, but no new patients will be enrolled. Also, the partial clinical hold doesn't impact davoceticept as a monotherapy. In December, Alpine (ALPN) teamed up with Horizon Therapeutics (NASDAQ:HZNP) for the development and commercialization of up to four preclinical candidates.

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Partial clinical hold placed on Alpine Immune's davoceticept for malignancies