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Investing.com -- CervoMed Inc. (NASDAQ:CRVO) stock rose 2.6% in Tuesday’s premarket trading after the company announced it received positive feedback from the U.S. Food and Drug Administration (FDA) on its proposed Phase 3 clinical trial design for neflamapimod in treating dementia with Lewy bodies (DLB).
The clinical-stage biotechnology company said the FDA aligned with key aspects of its planned trial, which will evaluate neflamapimod as a potential first-in-class treatment for DLB, a condition that currently has no approved therapies in the United States or European Union.
CervoMed plans to initiate a single, global, randomized, double-blind, placebo-controlled Phase 3 clinical trial in approximately 300 DLB patients in the second half of 2026. The trial will exclude patients with evidence of Alzheimer’s disease co-pathology and use the Clinical Dementia Rating-Sum of Boxes (CDR-SB) as its primary endpoint - the same measure used in the company’s recently completed Phase 2b trial.
"We are very pleased to have achieved alignment with the FDA on key aspects of our Phase 3 design for neflamapimod in DLB, including our selected endpoints and patient enrichment strategy," said Dr. John Alam, Chief Executive Officer of CervoMed.
The company noted that the planned Phase 3 trial will be the first ever targeting cognitive and functional decline in DLB patients. Participants will receive either oral neflamapimod or placebo for 32 weeks, followed by a neflamapimod-only extension for 48 weeks.
CervoMed expects feedback from other global regulators in the coming months and plans to announce additional details regarding the Phase 3 trial design in early 2026.
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