Newron reviews FDA clinical hold feedback for ENIGMA-TRS
Newron said it received an anticipated FDA written communication placing ENIGMA-TRS on clinical hold at U.S. study centers and is reviewing feedback while preparing a response. The company expects ENIGMA-TRS 1 enrollment completion by mid-October and topline 12-week data in Q1.
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11:07:33 AM UTC
SquawkNews
Newron received FDA written feedback on the U.S. clinical hold for ENIGMA-TRS 2 and will respond after review. ENIGMA-TRS 1 enrollment is expected mid-October, with 12-week topline data in Q1 2027; ENIGMA-TRS 2 enrollment continues outside the U.S.Material DetailsContext by AI AnalystThis is a regu…