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CervoMed (CRVO)

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Earnings summaries and quarterly performance for CervoMed.

Research analysts covering CervoMed.

Recent press releases and 8-K filings for CRVO.

CervoMed Announces FDA Alignment on Phase 3 Trial for Neflamapimod in DLB
CRVO
New Projects/Investments
Product Launch
  • CervoMed Inc. has received FDA alignment on key aspects of its proposed Phase 3 clinical trial design for neflamapimod in Dementia with Lewy Bodies (DLB), which supports a potential New Drug Application (NDA) submission.
  • The company plans to initiate a single, global, randomized, double-blind, placebo-controlled Phase 3 clinical trial in approximately 300 patients with DLB in the second half of 2026.
  • The primary endpoint for the planned Phase 3 trial will be the worsening of global cognition and function as measured by the Clinical Dementia Rating-Sum of Boxes (CDR-SB).
  • The trial design includes a patient enrichment strategy to exclude those with historical evidence of Alzheimer's disease co-pathology.
  • There are currently no approved therapies for DLB in the United States or European Union.
Nov 4, 2025, 12:08 PM
ServoMed Inc. Provides Update on Neflumab for Dementia with Lewy Bodies
CRVO
New Projects/Investments
Product Launch
  • ServoMed Inc. (CRVO) is a clinical-stage company focused on developing Neflumab, an investigational orally administered small molecule brain penetrant, for neurological diseases.
  • Neflumab's lead indication is Dementia with Lewy Bodies (DLB), a chronic neurodegenerative disease that currently has no approved therapies and represents a large market opportunity, with an estimated 150,000-280,000 patients in the US.
  • Phase 2b clinical data for Neflumab in pure DLB patients demonstrated a 52% reduction in the mean change in CDR Sum of Boxes (CDR SB), which increased to 82% in the enriched population, and showed a 67-75% reduced risk of disease progression.
  • The company is preparing to initiate a 24-week, 300-patient Phase 3 trial for Neflumab in pure DLB in 2026, following ongoing discussions with the FDA regarding the trial design.
  • Neflumab has exhibited a favorable safety profile across all studies to date, with no discontinuations due to severe adverse events.
Oct 22, 2025, 3:25 PM
CervoMed provides update on neflamapimod Phase 3 plans for Dementia with Lewy Bodies
CRVO
New Projects/Investments
Product Launch
Guidance Update
  • CervoMed Inc. (CRVO) is a clinical-stage company focused on neurological diseases, with its lead product, neflamapimod, preparing to enter Phase 3 trials for dementia with Lewy bodies (DLB).
  • Phase 2 clinical data for neflamapimod demonstrated significant improvements in DLB patients, including a 52% to 82% reduction in the mean change in CDR-Sum of Boxes (CDR-SB) scale and a 67% to 75% reduced risk of progression in pure DLB patients with the effective drug formulation.
  • The company plans to initiate its Phase 3 pivotal studies in Q3 2026, which will be a 24-week placebo-controlled randomized study involving approximately 300 pure DLB patients.
  • DLB represents a large, untapped market opportunity with no currently approved therapies, and neflamapimod has received Fast-Track designation from the FDA.
  • Beyond DLB, CervoMed's pipeline also includes neflamapimod in Phase 2 trials for recovery after stroke and frontotemporal dementia (the latter having orphan drug designation).
Oct 22, 2025, 3:25 PM
CervoMed Inc. Prepares for Phase 3 Trial of Neflamapimod in DLB
CRVO
New Projects/Investments
Product Launch
  • CervoMed Inc. (CRVO) is a clinical-stage company focused on neurological diseases of aging, with its lead product, neflamapimod, targeting Dementia with Lewy Bodies (DLB).
  • The company is preparing to initiate Phase 3 pivotal studies for neflamapimod in pure DLB, with discussions ongoing with the FDA regarding trial design, including a 24-week placebo-controlled study with approximately 300 patients, aiming for a Q3 2026 start.
  • Phase 2 clinical data demonstrated significant improvement in the CDR-Sum of Boxes scale, showing a 52% reduction in the mean change for all participants on the effective drug batch, increasing to an 82% reduction in the enriched pure DLB population, and a 67%-75% reduction in the risk of disease progression.
  • DLB represents a large, untapped market opportunity with no currently approved therapies, and neflamapimod has a favorable safety profile across all studies to date.
Oct 22, 2025, 3:25 PM
CervoMed Provides Update on Neflamapimod Development for Dementia with Lewy Bodies
CRVO
New Projects/Investments
  • CervoMed Inc. is a clinical-stage company focused on neurological diseases of aging, with its lead product, neflamapimod, preparing to enter Phase 3 trials for dementia with Lewy bodies (DLB).
  • The company has reported positive Phase 2 clinical data for neflamapimod in pure DLB patients, demonstrating significant improvements in the CDR-Sum of Boxes scale and a 67% to 75% reduction in the risk of disease progression for patients on the active drug (Batch B) compared to placebo.
  • DLB represents a large and untapped commercial market with no currently approved therapies, affecting an estimated 150,000 to 180,000 patients in the US.
  • CervoMed is in discussions with the FDA regarding the design of its Phase 3 trial, which is expected to be a 24-week placebo-controlled randomized study involving approximately 300 patients and is anticipated to start in Q3 2026.
  • Beyond DLB, CervoMed also has neflamapimod in Phase 2 clinical trials for recovery after stroke and frontotemporal dementia (primary progressive aphasia).
Oct 22, 2025, 3:25 PM
CervoMed Announces Positive New Data from Phase 2b Trial for Neflamapimod in DLB
CRVO
New Projects/Investments
Guidance Update
  • CervoMed Inc. announced new data from its Phase 2b RewinD-LB trial, demonstrating neflamapimod's potential as a treatment for dementia with Lewy bodies (DLB).
  • The data showed significant improvement in the primary outcome measure, Clinical Dementia Rating Sum of Boxes (CDR-SB), in participants with a low likelihood of Alzheimer's disease co-pathology.
  • Neflamapimod also led to a significant reduction in plasma glial fibrillary acidic protein (GFAP), a neurodegeneration biomarker, which correlated with improved CDR-SB scores.
  • The company anticipates U.S. Food and Drug Administration (FDA) feedback on its Phase 3 trial design in the fourth quarter of 2025.
Oct 8, 2025, 8:33 PM