CervoMed Announces Alignment with FDA on Registration Path for Neflamapimod in Dementia with Lewy Bodies
CervoMed Inc. (CRVO)
Company Research
Source: GlobeNewswire
FDA feedback enables CervoMed to proceed with proposed endpoints, patient enrichment strategy, and other key aspects of Phase 3 trial design to support potential New Drug Application CervoMed is advancing preparations for global pivotal trial initiation in the second half of 2026 BOSTON, Nov. 04, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO) (CervoMed or the Company), a clinical-stage biotechnology company developing treatments for age-related brain disorders, today announced it has received written feedback from the U.S. Food and Drug Administration (FDA) aligning on key aspects of CervoMed’s proposed Phase 3 clinical trial of neflamapimod, an oral, small molecule, drug candidate targeting critical disease processes underlying degenerative disorders of the brain, for the treatment of dementia with Lewy bodies (DLB) to support a potential New Drug Application (NDA) submission. There are currently no approved therapies for DLB in the United States or European Union. Phase
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News
- CervoMed Announces Late-Breaking Data at the 18th CTAD Conference Demonstrating Neflamapimod Significantly Slows Clinical Progression in Dementia with Lewy BodiesGlobeNewswire
- CervoMed (NASDAQ:CRVO) had its "buy" rating reaffirmed by analysts at D. Boral Capital. They now have a $31.00 price target on the stock.MarketBeat
- CervoMed Presents New Plasma Biomarker Data That Indicates Neflamapimod Broadly Improves Neuroinflammation and Neurodegeneration in Dementia with Lewy Bodies (DLB)GlobeNewswire
- CervoMed to Share New Data on Neflamapimod as a Treatment for Dementia with Lewy Bodies at the 18th Clinical Trials on Alzheimer's Disease (CTAD) ConferenceGlobeNewswire
- CervoMed (NASDAQ:CRVO) had its "buy" rating reaffirmed by analysts at D. Boral Capital. They now have a $31.00 price target on the stock.MarketBeat
CRVO
Earnings
- 11/7/25 - Miss
CRVO
Sec Filings
- 12/5/25 - Form 4
- 12/5/25 - Form 3
- 12/5/25 - Form 8-K
- CRVO's page on the SEC website