May 10 Company Quick Takes: Red flags for Daiichi ahead of ODAC; plus JHL/Genentech, J&J, Gilead

FDA reviewers raise concerns about Daiichi’s quizartinib, pexidartinib
Despite both pexidartinib and quizartinib meeting the primary endpoints in their pivotal trials, FDA reviewers raised concerns about each agent from Daiichi Sankyo Co. Ltd. (Tokyo:4568) in briefing documents posted ahead of a May 14 meeting of FDA’s Oncologic Drugs Advisory Committee. For pexidartinib, which is under review to treat tenosynovial giant cell tumor, the reviewers highlighted the amount of missing data and increased hepatotoxicity. For quizartinib, which is under review to treat relapsed or refractory FLT3-positive acute myelogenous leukemia (AML), the documents described the molecule’s efficacy as “marginal.”

JHL, Genentech fail to settle in trade secret case
Genentech Inc. did not settle its civil suit against JHL Biotech Inc. (Zhubei, Taiwan) on Thursday. The Roche (SIX:ROG; OTCQX:RHHBY) unit is seeking damages and an injunction in the U.S. District Court for the Northern District of California after three former Genentech employees and an associate were indicted in October for stealing trade secrets for JHL in a criminal case; a federal judge ordered a partial injunction against the Taiwanese company in March (see "Judge Grants Genentech Some Relief as JHL Trade Secret Case Moves Forward")...