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CervoMed Gains FDA Alignment for Phase 3 Trial

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CervoMed Gains FDA Alignment for Phase 3 Trial

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CervoMed ( (CRVO) ) has shared an announcement.

On November 4, 2025, CervoMed Inc. announced it received alignment from the U.S. FDA on key aspects of its proposed Phase 3 clinical trial for neflamapimod, aimed at treating dementia with Lewy bodies (DLB). The feedback allows CervoMed to proceed with its trial design, which includes a global, randomized, double-blind study involving approximately 300 patients, with the trial set to begin in the second half of 2026. This development marks a significant milestone for CervoMed, reinforcing its scientific approach and providing a regulatory pathway toward potential approval. The trial is designed to exclude patients with Alzheimer’s disease co-pathology and will focus on cognitive and functional decline, with the aim of establishing neflamapimod as a first-in-class treatment for DLB, a condition currently lacking approved therapies.

The most recent analyst rating on (CRVO) stock is a Buy with a $20.00 price target. To see the full list of analyst forecasts on CervoMed stock, see the CRVO Stock Forecast page.

Spark’s Take on CRVO Stock

According to Spark, TipRanks’ AI Analyst, CRVO is a Neutral.

CervoMed’s primary challenges stem from its lack of revenue and persistent financial losses, which heavily weigh down its stock score. However, positive technical indicators and recent promising clinical trial results provide a speculative upside, balancing some of the financial concerns. Valuation remains a challenge due to negative earnings, but the potential for future success in clinical trials offers hope for long-term growth.

To see Spark’s full report on CRVO stock, click here.

More about CervoMed

CervoMed is a clinical-stage biotechnology company focused on developing treatments for age-related brain disorders. Its lead drug candidate, neflamapimod, is an oral, small molecule targeting neuroinflammation and neurodegeneration, with ongoing development for dementia with Lewy bodies (DLB), recovery after ischemic stroke, and frontotemporal dementia.

Average Trading Volume: 110,994

Technical Sentiment Signal: Strong Sell

Current Market Cap: $64.95M

For detailed information about CRVO stock, go to TipRanks’ Stock Analysis page.

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