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Daily Roundup | Replimune RP1 on the Brink: FDA Calls Melanoma Data Uninterpretable
Published 1 month, 3 weeks ago
Description
FDA reviewers say Replimune's IGNYTE overall survival analysis is "not interpretable" days before Thursday's advisory committee — shares fell more than 32% to $5.78. We break down what it means for RP1, Opdivo combination therapy, and accelerated approval in advanced melanoma, plus Gossamer Bio reacquiring worldwide seralutinib rights from Chiesi ahead of a September NDA filing in pulmonary arterial hypertension, the FDA's parallel challenge to Capricor's Duchenne data, and IQVIA's second quarter earnings.
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