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Fly News Breaks for September 10, 2019
ITCI
Sep 10, 2019 | 10:38 EDT
JPMorgan analyst Jessica Fye said she is surprised that shares of Intra-Cellular are lower following the announcement that the FDA does not plan to schedule an Advisory Committee meeting to discuss lumateperone for schizophrenia. She thinks the base-case interpretation of the ad com update is positive, as it potentially is a sign of the FDA's comfort with lumateperone's risk/benefit and suggests the agency is comfortable evaluating the drug without outside feedback. The analyst, who added that management characterized their FDA dialogue as "very constructive" and said that they feel positive about the ad com update, is incrementally positive on the likelihood of approval following the update and keeps an Overweight rating on Intra-Cellular shares.
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