CRVO

Continued progress towards initiating planned Phase 3 trial evaluating neflamapimod in patients with dementia with Lewy bodies in second half of 2026, subject to financing Presented new analyses at AAN 2026 highlighting first-ever MRI data demonstrating evidence of reversible disease progression in the basal forebrain with neflamapimod treatment Presented new analyses at AD/PD™ 2026 demonstrating that patients with lower plasma pTau181 levels, a biomarker indicating an earlier stage of disease and a low likelihood of having Alzheimer’s disease co-pathology, experienced greater clinical benefit from neflamapimod BOSTON, May 18, 2026 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical-stage biotechnology company developing treatments for age-related brain disorders (CervoMed or the Company), today reported financial results for the first quarter ended March 31, 2026, and provided corporate updates. John Alam, MD, Chief Executive Officer of CervoMed, stated: “CervoMed has built a robust and compelling neflamapimod dataset in patients with dementia with Lewy bodies (DLB) comprised of positive Phase 2b clinical data, including first-ever magnetic resonance imaging (MRI) data showing evidence of increase in size and enhancement of function in the basal forebrain, key accompanying biomarker and PK/PD data, and a new formulation and manufacturing process. Collectively, this work has led to alignment with the United States (US) Food and Drug Administration (FDA) and global regulatory authorities on a final design for our planned Phase 3 trial in patients with DLB. We are extremely proud of the recent progress we have made, and are encouraged by the positive feedback received from various stakeholders around the potential of neflamapimod as a disease-modifying treatment for DLB.” First Quarter 2026 and Recent Program Highlights Dementia with Lewy Bodies Aligned with global regulatory authorities and finalized design for the Company’s planned Phase 3 trial in patients with DLB, which is subject to available financing. CervoMed selected 50mg three times per day of a stable crystal form of neflamapimod produced using a new, controlled manufacturing process as the dose and dosing regimen that will be used for the Company’s planned Phase 3 trial in patients with DLB. At AAN 2026, CervoMed presented first-ever placebo-controlled MRI analyses which provided evidence...

CervoMed Inc. (NASDAQ:CRVO) earns a place on our top 10 stocks under $5 that could triple. On March 17, 2026, CervoMed Inc. (NASDAQ:CRVO) announced results for the fourth quarter and full year 2025. The company highlighted advancements in its neflamapimod program for dementia with Lewy bodies (DLB). CervoMed Inc. (NASDAQ:CRVO) further reported favorable Phase 2b RewinD-LB data at CTAD 2025 while achieving an agreement with the FDA and international authorities on the design of a Phase 3 trial. This trial is expected to commence in the latter part of 2026. With the start of the EXPERTS-ALS investigation and topline findings from Phase 2a trials in ischemic stroke recovery and primary progressive aphasia, the upcoming calendar remains catalyst-heavy. In terms of finances, CervoMed Inc. (NASDAQ:CRVO) reported $20.9 million in cash as of December 31, 2025, indicating a runway of roughly six months, with R&D expenses of $21.8 million and a net loss of $27.0 million for the year. A day later, Boobalan Pachaiyappan of Roth Capital reduced the price target on CervoMed Inc. (NASDAQ:CRVO) from $19 to $11 while keeping a “Buy” rating. The analyst noted that results were largely in line with expectations, but the company may need to raise capital on less favorable terms. CervoMed Inc. (NASDAQ:CRVO) is a clinical-stage biotechnology firm specializing in CNS-targeted therapeutics, namely, neflamapimod, aimed at neurodegenerative conditions such as dementia with Lewy bodies, stroke rehabilitation, and several other cerebral disorders. While we acknowledge the potential of CRVO as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and 15 Stocks That Will Make You Rich in 10 Years Disclosure: None. Follow Insider Monkey on Google News.

Reported positive Phase 2b RewinD-LB clinical data at CTAD 2025; additional analyses to be presented at AD/PD 2026 Obtained alignment with FDA and global regulators for planned Phase 3 trial design in patients with DLB and selected Phase 3 formulation, dose and dosing regimen Multiple potential catalysts anticipated in the second half of 2026, including initiation of the planned Phase 3 trial, topline data from Phase 2a ischemic stroke recovery trial, initial topline data from Phase 2a primary progressive aphasia trial, and initiation of EXPERTS-ALS trial in Amyotrophic Lateral Sclerosis BOSTON, March 17, 2026 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical-stage biotechnology company developing treatments for age-related brain disorders (CervoMed or the Company), today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided corporate updates. “CervoMed made significant strides in 2025 and early 2026 with its lead neflamapimod program in dementia with Lewy bodies (DLB). We reported positive and supportive Phase 2b RewinD-LB data at the 18th Clinical Trials on Alzheimer's Disease (CTAD) Conference, obtained alignment with the U.S. Food and Drug Administration (FDA) and other global regulators on the design of our planned Phase 3 trial design in patients with DLB, and selected the neflamapimod formulation, dose and dosing regimen that will be used in the planned Phase 3 trial,” said John Alam, MD, Chief Executive Officer of CervoMed. “We are now looking ahead to a catalyst-driven 2026, including initiation of the planned Phase 3 trial evaluating neflamapimod in DLB in the second half of 2026, subject to available financing. In addition, we expect to report initial topline Phase 2a results from our other programs evaluating neflamapimod in both ischemic stroke recovery (RAS) and the non-fluent variant primary progressive aphasia (nfvPPA), along with initiation of the EXPERTS-ALS trial in amyotrophic lateral sclerosis (ALS), all during the second half of 2026 as well.” Fourth Quarter 2025 and Recent Program Highlights Dementia with Lewy Bodies CervoMed selected 50mg three times per day (TID) of a stable crystal form of neflamapimod produced using a new, controlled manufacturing process as the dose and dosing regimen that will be used for the Company’s planned Phase 3 trial in patients with DLB. CervoMed...

Pharming Group PHAR is slated to report fourth-quarter 2025 results on March 12, 2026, before the opening bell. We expect investors to focus on the sales performances of PHAR’s marketed drugs and other pipeline updates when it reports fourth-quarter 2025 results. The Zacks Consensus Estimate for quarterly revenues in the to-be-reported quarter is pegged at $104.8 million. The consensus mark for Pharming Group’s earnings per share is pinned at 15 cents. Let us see how things are likely to have shaped up for PHAR in the soon-to-be-reported quarter. Pharming Group’s total revenues only comprise its product sales. It derives the bulk of its revenues from the sale of Ruconest (conestat alfa), its flagship therapy for treating hereditary angioedema (HAE), which is approved in the United States, the EU and the U.K. Since its launch, Ruconest has become the company’s primary growth engine, driven by a growing patient and prescriber base, which is expected to have boosted fourth-quarter sales as well. In the third-quarter earnings release, Pharming Group announced that it would withdraw Ruconest from all non-U.S. markets, which generated $1.1 million (1.3% of quarterly revenues) and were not financially sustainable. The company will focus on ensuring patient continuity of care while redirecting resources to higher-growth pipeline opportunities. Investors are likely to seek greater clarity on this matter during the fourth-quarter earnings call. Pharming Group’s second marketed product, Joenja (leniolisib), was in-licensed from Novartis and is approved for treating patients (aged 12 years and older), with activated phosphoinositide 3-kinase delta syndrome (APDS) in the United States, the EU and the U.K. Joenja sales are also expected to have grown year over year in the fourth quarter, primarily driven by an increase in U.S. and U.K. patients on paid therapy. Please note that both marketed drugs have also posted sequential growth in all three quarters of 2025. This trend is expected to have continued in the fourth quarter as well. Pharming Group shares have gained 11.5% in the past six months compared with the industry’s 22% growth. Image Source: Zacks Investment Research Investors will also likely be interested in updates regarding PHAR’s mid to late-stage pipeline candidates on the fourth-quarter earnings call. The FDA recently rejected the company’s regulatory applic...

Aligned with U.S Food and Drug Administration (FDA) on design of planned Phase 3 clinical trial of neflamapimod in patients with dementia with Lewy bodies (DLB) Reported 32-week data from Phase 2b RewinD-LB trial showing neflamapimod treatment in patients with DLB had a durable beneficial effect on clinical progression and resulted in substantial reductions in plasma levels of a well-established biomarker of neurodegeneration Meeting with global regulators in coming months and preparing for global pivotal trial initiation in second half of 2026 Initial biomarker data from Phase 2a trial in a sub-type of frontotemporal dementia (FTD) and topline results from Phase 2a trial in recovery after stroke expected in 2026 BOSTON, Nov. 10, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related brain disorders (CervoMed or the Company), today reported its financial results for the third quarter ended September 30, 2025, and provided corporate updates. “In the past nine months, CervoMed has made remarkable strides, culminating in our recent alignment with the FDA on key aspects of the design of our planned Phase 3 clinical trial in DLB” said John Alam, M.D., Chief Executive Officer of CervoMed. “Our 32-week treatment data from the RewinD‑LB trial announced during the third quarter and in early October demonstrated a sustained beneficial effect on clinical progression and a substantial effect on an established biomarker of neurodegenerative disease activity. The combination of the results observed in our Phase 2a and 2b trials and our recent alignment with the FDA fuels our optimism and reinforces our commitment to developing a much-needed therapy for patients, caregivers, and families facing DLB. We believe neflamapimod has the potential to transform the treatment landscape for DLB by treating the cognitive and functional decline that defines this devastating disease and that these recent milestones have brought us closer to delivering the first approved therapy for patients with DLB in the United States.” Recent Highlights and Anticipated Milestones In November 2025, CervoMed announced alignment with the FDA on a registration path for neflamapimod in DLB. The FDA’s feedback will enable CervoMed to proceed with the proposed endpoints, patient enrichment strategy, and other key aspects of the Compa...

Reported 32-week data from Phase 2b RewinD-LB Trial Extension phase showing neflamapimod treatment resulted in a substantial reduction in clinically significant worsening compared to control arm over 32 weeks, which improved further among patients who have minimal evidence of Alzheimer’s disease (AD) co-pathology (ptau181 < 2.2 pg/mL at screening) At week 32 of the Extension phase, patients treated with neflamapimod demonstrated a significant reduction from baseline in plasma levels of glial fibrillary acidic protein (GFAP) Plan to engage with U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025 to align on trial design for the Phase 3 program in Dementia with Lewy Bodies (DLB) BOSTON, Aug. 11, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders (CervoMed or the Company), today reported its financial results and corporate updates for the second quarter ended June 30, 2025. “With the reporting of both 16- and 32-week Extension phase data from the Phase 2b RewinD-LB trial, we have solidified the evidence for slowing clinical progression in DLB associated with neflamapimod treatment. This proof-of-concept, combined with the notable reductions seen in plasma levels of GFAP, an important blood-based biomarker of the underlying neurodegenerative process in DLB, provide us with valuable results and a deeper understanding that further increases our confidence in Phase 3 success and neflamapimod’s potential to make a meaningful difference for patients if approved. We are actively preparing for discussions with the FDA, which we expect to take place in the fourth quarter of 2025, to align on the design of our planned Phase 3 trial,” said John Alam, MD, Chief Executive Officer of CervoMed. Recent Highlights and Anticipated Milestones In July 2025, the Company presented 32-week results from the open-label Extension phase of the Phase 2b RewinD-LB trial at the Alzheimer’s Association International Conference in Toronto, Canada. Based on the primary endpoint of Clinical Dementia Rating Sum of Boxes (CDR-SB), patients treated with neflamapimod showed 54% risk reduction in clinically significant worsening compared to control at Week 32 of treatment (p=0.0037). This risk reduction improved to 64% (p=0.0001) among patients who have minimal evidence of AD co-patho...

Explore CervoMed's Fair Values from the Community and select yours Revenue: US$1.76m (down 47% from 2Q 2024). Net loss: US$6.26m (loss widened by 170% from 2Q 2024). US$0.70 loss per share (further deteriorated from US$0.27 loss in 2Q 2024). This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue exceeded analyst estimates by 22%. Earnings per share (EPS) missed analyst estimates by 19%. Looking ahead, revenue is forecast to grow 11% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are up 12% from a week ago. You should always think about risks. Case in point, we've spotted 5 warning signs for CervoMed you should be aware of, and 2 of them don't sit too well with us. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Revenue: US$1.92m (down 18% from 1Q 2024). Net loss: US$4.89m (loss widened by 95% from 1Q 2024). US$0.56 loss per share (further deteriorated from US$0.41 loss in 1Q 2024). Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue exceeded analyst estimates by 13%. Earnings per share (EPS) also surpassed analyst estimates by 9.0%. Looking ahead, revenue is forecast to grow 8.0% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 7.2% from a week ago. It's necessary to consider the ever-present spectre of investment risk. We've identified 4 warning signs with CervoMed (at least 2 which make us uncomfortable), and understanding these should be part of your investment process. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Reported positive 16-week results from the extension phase of the Phase 2b RewinD-LB trial, demonstrating proof-of-concept for neflamapimod as a potential treatment for dementia with Lewy bodies (DLB) Plan to initiate Phase 3 trial of neflamapimod in DLB in mid-2026 following meeting with regulatory authorities Initiating separate Phase 2a trials to evaluate neflamapimod in patients with primary progressive aphasia and patients in the recovery phase after ischemic stroke BOSTON, May 12, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders (CervoMed or the Company), today reported its financial results for the first quarter ended March 31, 2025. “The first quarter of 2025 represented a tidal shift for CervoMed. We believe the evidence of slowed clinical progression demonstrated in the 16-week results from the extension phase of our RewinD-LB trial affirm our initial hypothesis of drug benefit, and explain the results from the initial phase of the trial reported in December 2024. More importantly, we believe the 16-week data demonstrate proof-of-concept for neflamapimod as a potential treatment for DLB, underscoring neflamapimod’s first-to-market potential for this devastating disease. We anticipate 32-week results from the extension phase in the second half of 2025 and are actively preparing for discussions with the U.S. Food and Drug Administration (FDA) regarding the design of our Phase 3 trial, which we plan to initiate in mid-2026,” said John Alam, MD, Chief Executive Officer of CervoMed. “In parallel, in the near future we will be initiating a Phase 2 trial evaluating neflamapimod in patients with primary progressive aphasia (PPA), and recently initiated a Phase 2 trial in patients recovering from ischemic stroke—important steps that we believe complement our lead DLB program, build on the compelling data seen so far, and expand our exploration of neflamapimod’s full therapeutic potential. I want to express my deep gratitude to our dedicated scientific team, as well as to the patients and caregivers participating in our clinical programs.” Recent Highlights and Anticipated Milestones In March 2025, CervoMed reported positive 16-week results from the extension phase of the RewinD-LB trial in which patients who were administered a more recently manufactured bat...

During the first 16 weeks of the Extension phase of the RewinD-LB clinical study neflamapimod slowed clinical progression compared to controls, as assessed by Clinical Dementia Rating Sum of Boxes (CDR-SB) and Clinical Global Impression of Change (CGIC) Neflamapimod was associated with a reduced incidence of falls in the Extension phase of the study and new data to be presented at AD/PD™ 2025 demonstrates improvements on endpoints measuring cognitive fluctuations and working memory The results demonstrate proof-of-concept for neflamapimod as a treatment for dementia with Lewy bodies (DLB) BOSTON, April 02, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders (CervoMed or the Company), today announced that investigators plan to present results, including new results, from the Extension phase of the Phase 2b RewinD-LB study that show neflamapimod demonstrated a clinically meaningful effect on slowing clinical progression in patients with DLB in an oral presentation during the 19th International Conference on Alzheimer’s and Parkinson’s Disease and Related Neurologic Disorders (AP/PD™) on Saturday, April 5, 2025. “The RewinD-LB Extension phase results for neflamapimod are highly encouraging. We are seeing a clear and meaningful effect on clinical worsening over time in patients with DLB, as assessed by CDR-SB and CGIC, which is further supported by positive data across several additional clinical endpoints,” stated Stephen Gomperts, MD, PhD, Associate Professor of Neurology at Harvard Medical School, Director, Lewy Body Dementia Unit at the Massachusetts General Hospital and site Principal Investigator for the RewinD-LB study. “Importantly, these results validate and replicate prior clinical trial results and are consistent with the scientific hypothesis that neflamapimod can provide clinical benefit by arresting the loss of cholinergic neuron function in the basal forebrain.” “The presentation of the Extension phase data at AD/PD™ 2025 is an opportunity to share our findings and engage deeply with the DLB medical community as we plan for pivotal development and work to bring neflamapimod to patients as rapidly as possible,” said John Alam, MD, Co-Principal Investigator of the RewinD-LB study and CEO of CervoMed. “The positive findings across the primary outcome mea...

Revenue: US$9.74m (up 36% from FY 2023). Net loss: US$16.3m (loss widened by US$14.1m from FY 2023). US$2.02 loss per share (further deteriorated from US$0.82 loss in FY 2023). All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue exceeded analyst estimates by 4.3%. Earnings per share (EPS) missed analyst estimates by 9.0%. Looking ahead, revenue is expected to decline by 1.9% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 20%. Performance of the American Biotechs industry. The company's shares are up 308% from a week ago. We don't want to rain on the parade too much, but we did also find 5 warning signs for CervoMed (3 don't sit too well with us!) that you need to be mindful of. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

-Reported positive 16-week results from the extension phase of the Phase 2b RewinD-LB trial of neflamapimod in dementia with Lewy bodies (DLB), including improvement on the trial’s primary outcome measure- -Plan to initiate Phase 3 trial in mid-2026 following meeting with regulatory authorities- -Awarded 2024 Prix Galien USA Award as “Best Startup” by the Galien Foundation- BOSTON, March 17, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders (CervoMed or the Company), today reported its financial results for the fourth quarter and full year ended December 31, 2024. “Following the highly encouraging 16-week extension results from our Phase 2b RewinD-LB trial, we believe we have established proof-of-concept for neflamapimod as a potential treatment for DLB. Our team is now focused on reporting the results from the 32-week extension phase in the second half of 2025 and discussing next steps on Phase 3 trial design with regulatory authorities,” said John Alam, MD, Chief Executive Officer of CervoMed. Recent Highlights and Anticipated Milestones The 16-week results from the extension phase of the Phase 2b RewinD-LB trial have been accepted as an oral presentation at the 19th International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurologic Disorders (AD/PD™) in Vienna, Austria, April 1-5, 2025. In March 2025, CervoMed reported positive 16-week results from the extension phase of the RewinD-LB trial in which patients who were administered a new batch of neflamapimod capsules had higher plasma drug concentration levels and demonstrated improvements on the primary outcome measure, Clinical Dementia Rating Sum of Boxes (p<0.001 v. old capsules; p=0.003 v. placebo), and a key secondary endpoint. The full details on these results can be found here. The Company expects to report 32-week results from the extension phase of the RewinD-LB trial in the second half of 2025. Initial safety, biomarker and pharmacokinetic data from an ongoing trial in patients with mild-to-moderate DLB being treated with a twice daily regimen (80mg BID) of neflamapimod is expected to be available in the fourth quarter of 2025. In January 2025, the Company presented at the 8th International Lewy Body Dementia Conference (ILBDC) in Amsterdam, the Netherlands. During 2025, Cervo...