The FDA's Oncologic Drugs Advisory Committee will convene Tuesday to discuss the drug, belantamab mafodotin. Despite the drug's first-in-class potential, the briefing document for the meeting raised concerns about eye toxicity and questions about its risk-benefit profile.
A company spokesperson said the company was working to address the agency's concerns about the drug, quizartinib, for FLT3-mutated acute myeloid leukemia.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Shares of the company were down more than 12 percent in premarket trading on the Nasdaq Wednesday. They had already fallen 46 percent Friday after the release of AdCom briefing documents.