In wake of a trial disaster, Seattle Genetics files sBLA; Egalet takes a dive on a CRL
→ One day after scrapping a Phase III study, Seattle Genetics filed an sBLA for Adcetris to treat patients with cutaneous T-cell lymphoma. The sBLA is based on positive results from a Phase III study published this month in The Lancet.
→ Shares of Egalet dropped 20% on the news that it received a complete response letter from the FDA requesting information about its prior approval supplement of Oxaydo tablets. The drug was designed to reduce the risk of abuse but there is currently no evidence that the formulation has less abuse potential than immediate-release oxycodone.
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