Shares of Beam Therapeutics Inc. slipped more than 10% in premarket trading on Monday after the biotechnology company said the U.S. Food and Drug Administration placed its investigational new drug application for its BEAM-201 program on clinical hold.
The Cambridge, Mass., company said the FDA informed it of the hold via e-mail on Friday, adding that the agency indicated it will provide an official letter within 30 days.
According to the FDA's website, subjects can't be given an investigational drug when a proposed study is placed on clinical hold. The agency lists several potential reasons for putting an IND on hold, including the possibility that human subjects "would be exposed to an unreasonable and significant risk of illness or injury," or that the application doesn't contain enough information to assess the risks to subjects of the proposed studies.
Beam, which submitted its application to study BEAM-201 for the treatment of relapsed/refractory T-cell acute lymphoblastic leukemia/T cell lymphoblastic lymphoma in late June, said it will provide further updates pending talks with the FDA.
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