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CervoMed Inc. (NASDAQ: CRVO) is a clinical-stage biotechnology company dedicated to developing innovative treatments for age-related neurological disorders. The company’s main product candidate is neflamapimod, an orally administered small molecule that penetrates the brain to inhibit p38MAP kinase alpha (p38α). This investigational drug is being developed to address synaptic dysfunction, a reversible aspect of neurodegenerative diseases such as dementia with Lewy bodies (DLB).
Recent achievements for CervoMed include the completion of patient enrollment in the RewinD-LB Phase 2b study, which is a critical step in evaluating neflamapimod's efficacy in treating DLB. This milestone reflects the company’s operational capability and the high engagement levels across clinical sites. CervoMed's financial health is robust, supported by a $21 million grant from the National Institutes of Health's National Institute on Aging (NIA) and a $50 million financing deal, which is expected to provide a financial runway through the end of 2025.
In terms of research and development, the company has shown significant progress. Neflamapimod has demonstrated the potential to modulate cholinergic dysfunction and degeneration in preclinical and clinical studies, thereby improving cognitive and motor tasks. The ongoing RewinD-LB trial aims to provide a clear path to market for neflamapimod by the end of 2024.
CervoMed also boasts a series of strategic updates, including the successful listing on NASDAQ and strengthening its leadership team. The company's leadership includes industry veterans like Joshua Boger, Ph.D., who serves as non-executive Chair of the Board, and John Alam, MD, the Chief Executive Officer. The company continues to publish data that reinforces neflamapimod's potential as a highly differentiated, first-to-market treatment option for patients with DLB.
CervoMed’s commitment to advancing neurological health is evident through its collaborations with academic researchers and participation in prominent scientific forums. Notably, the company’s ongoing efforts include exploring additional therapeutic applications for neflamapimod in other cholinergic dysfunction-driven neurological disorders.
With its strong financial foundation and promising clinical pipeline, CervoMed Inc. is well-positioned to make significant strides in the treatment of age-related neurological disorders, ultimately aiming to improve the quality of life for patients globally.
CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders, has granted equity awards to two new employees. The company awarded options to purchase a total of 14,753 shares of common stock, with an exercise price of $11.91 per share, matching the closing price on December 6, 2024. These options will vest over three years in 36 equal monthly installments, contingent on continued employment. The grants were approved by the Compensation Committee as inducement awards under Nasdaq Listing Rule 5635(c)(4).
CervoMed (NASDAQ: CRVO) announced disappointing topline data from its RewinD-LB Phase 2b clinical trial evaluating neflamapimod for treating dementia with Lewy bodies (DLB). The trial failed to meet statistical significance for its primary endpoint (CDR-SB) and key secondary endpoints. Target plasma drug concentrations were not achieved during the trial's double-blind phase, potentially affecting the results.
While the drug showed favorable safety and tolerability with no new safety concerns, CervoMed is pausing preparations for the planned Phase 3 trial until completing a thorough analysis. The company expects the full double-blind phase data in January 2025 and open-label extension data in late Q2 2025.
CervoMed (NASDAQ: CRVO) announced that its oral drug neflamapimod received Orphan Drug Designation from the FDA for treating frontotemporal dementia (FTD). The designation applies to therapies for rare diseases affecting fewer than 200,000 people in the US and provides benefits including tax credits, development assistance, and seven years of marketing exclusivity. The company is preparing for a Phase 3 trial in dementia with Lewy bodies (DLB) in mid-2025 and expects topline data from the RewinD-LB Phase 2b trial in December 2024.
CervoMed (NASDAQ: CRVO) announced two key senior leadership appointments to advance the development of neflamapimod. Dr. Claudia Ordonez joined as Senior Vice President, Medical Science, bringing expertise from previous roles at Vertex and Biogen. Dr. Mark De Rosch was appointed Senior Vice President, Regulatory and Government Affairs and Program Management, contributing over 30 years of experience in regulatory and CMC functions. The company expects topline data from the RewinD-LB study in December 2024 and plans Phase 3 initiation in mid-2025 for dementia with Lewy Bodies treatment. The company also granted stock options to three new employees, including 32,000 shares to Dr. De Rosch at $12.53 per share.
CervoMed Inc. (NASDAQ: CRVO) reported Q3 2024 financial results and corporate updates. The company completed the last patient visit in its RewinD-LB Phase 2b trial for neflamapimod in early-stage dementia with Lewy bodies, with topline data expected in December 2024. Financial highlights include cash position of $46.7 million as of September 30, 2024, grant revenue of $1.9 million, R&D expenses of $5.1 million, and a net loss of $4.8 million. The company expects current funding to support operations through 2025.
CervoMed (NASDAQ: CRVO) has been awarded the Prix Galien USA 2024 prize in the Best Startup category, selected from 43 nominees. The award recognizes the company's progress in developing the first treatment for Dementia with Lewy bodies (DLB), a condition affecting over 1.4 million patients in the U.S. and EU. The company is approaching topline results for their RewinD-LB Phase 2b clinical trial of neflamapimod in December. The Prix Galien USA, established in 2007, is considered America's preeminent prize for scientific advances in life sciences.
CervoMed (NASDAQ: CRVO), a clinical stage company developing treatments for age-related neurologic disorders, has announced its participation in two upcoming investor conferences in November 2024. The company will present at the Sidoti Virtual Micro Cap Conference on November 14 at 2:30 PM ET and the Stifel 2024 Healthcare Conference on November 19 at 3:00 PM ET. Both presentations will be available via webcast and accessible through CervoMed's website investor section.
CervoMed presented key findings at the CTAD Conference regarding neflamapimod's potential in treating dementia with Lewy bodies (DLB). The presentations highlighted significant reduction in plasma GFAP levels (p=0.015 vs placebo) in Phase 2a trials, indicating reduced neurodegenerative disease activity. The ongoing RewinD-LB Phase 2b study successfully enrolled DLB patients without tau pathology, optimizing the potential treatment effect. The study's sample size of 80 patients per arm provides nearly 100% statistical power for meeting its primary endpoint. Topline results are expected in December.
CervoMed (NASDAQ: CRVO) announced it will present detailed safety and efficacy results from its RewinD-LB Phase 2b clinical trial of neflamapimod in dementia with Lewy bodies (DLB) at the International Lewy Body Dementia Conference in January 2025. The company expects to release topline data from the study in December 2024. The presentation will take place during the Therapeutics in DLB session on January 31, 2025.
CEO John Alam expressed confidence in the trial design's ability to detect statistically significant and clinically meaningful differences between neflamapimod and placebo, noting there are currently no approved therapies for DLB.
CervoMed Inc. (NASDAQ: CRVO) has announced the Last Patient Last Visit in its Phase 2b RewinD-LB clinical trial evaluating neflamapimod for early-stage dementia with Lewy bodies (DLB). The company is on track to report topline efficacy and safety data in December 2024. Key highlights include:
- 96% of enrolled patients completed the 16-week double-blind placebo-controlled portion
- 98% of those patients continued into the open label extension
- The Data Safety Monitoring Board concluded the study may proceed without modification
- CervoMed will present late-breaking oral presentations at the upcoming Clinical Trials on Alzheimer's Disease (CTAD) conference
The company believes neflamapimod has the potential to restore function and improve cognitive and motor functions in DLB patients, addressing a significant unmet need in this population.
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