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Shares of
CTI BioPharma CorpCTIC were trading lower by around 45 percent early Monday morning after the company
disclosed that it has received a written communication from the U.S. Food and Drug Administration (FDA).
According to CTI BioPharma, the FDA said in its letter that it has placed a partial clinical hold on the clinical studies being conducted by BioPharma under its Investigational New Drug (IND) application for pacritinib.
The partial clinical hold requires that clinical investigators may not enroll new patients or start pacritinib as initial or crossover treatment, and patients not deriving benefit after 30 weeks of pacritinib treatment should stop using pacritinib.
The FDA is also requiring CTI BioPharma to make certain modifications of protocols, including modifying all protocols for randomized trials to disallow crossover to pacritinib, provide certain notifications, revise relevant statements in the related investigator's brochure and informed consent documents.
CTI BioPharma said in its press release that it will work with the FDA and expects to submit the necessary modification. Upon submission of a revised strategy, the FDA would notify the company if it can continue the clinical studies under the IND designation.© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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