BMEA

Successfully completed chronic toxicology studies for icovamenib, providing the nonclinical support for advancing to chronic clinical dosing, beyond the 12-week clinical dosing that has been used to date Topline data reported from the Phase II COVALENT-112 clinical trial of icovamenib in type 1 diabetes (“T1D”), supporting proposed mechanism of action First patients dosed in the Phase II COVALENT-211 and COVALENT-212 clinical trials of icovamenib in type 2 diabetes (“T2D”); both trials are on track with topline 26-week data expected in the fourth quarter of 2026 The Phase I GLP-131 (BMF-650) obesity clinical trial is on track; initial 28-day weight reduction data expected in the second quarter of 2026 Cash runway projected into the first quarter of 2027 SAN CARLOS, Calif., May 11, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today reported its financial results for the first quarter ended March 31, 2026, and provided a business update. “Across our portfolio, we continue to execute with focus and discipline, with all of our key clinical programs progressing on track toward important upcoming milestones, while maintaining a disciplined approach to managing our cash burn,” said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. “The recent 52-week data from the Phase II COVALENT-112 clinical trial in type 1 diabetes further support targeting menin as a novel approach across both type 1 and type 2 diabetes, which offers a paradigm shift and differs materially from existing therapeutic approaches. We are building on these findings with plans to initiate an investigator-sponsored Phase II clinical trial in collaboration with leading academic institutions specializing in T1D. We believe this collaboration, alongside the continued advancement of our type 2 diabetes and obesity programs, positions Biomea to deliver meaningful data across multiple indications in 2026.” Recent Corporate Highlights: Icovamenib Potential First-in-Class Oral Small Molecule Product Candidate Targeting Menin for Diabetes Chronic toxicology studies in two species were successfully completed for icovamenib, providing nonclinical support for chronic clinical dosing beyond the 12-week duration used to date; findings demonstrated a favorable safety...

A 52% increase from baseline in mean C-peptide AUC at Week 12 in patients diagnosed within 0–3 years (n=5) receiving icovamenib 200 mg, with a clear dose response observed vs 100 mg (n=6) Persistence observed through Week 52, with mean C-peptide AUC largely preserved in 200 mg group (~7% decline from baseline) following only 12 weeks of dosing Preservation of C-peptide also observed in patients diagnosed between 3-15 years (n=9) Icovamenib was generally well tolerated across all dosing arms and demonstrated a favorable safety and tolerability profile through Week 52 Comprehensive dataset to be presented at the American Diabetes Association’s (ADA) Scientific Sessions (abstract is preliminary until time of presentation; full release on June 5th at 6:30 pm CST) Company to host a conference call to discuss results on Tuesday, April 28 at 8:30 am ET SAN CARLOS, Calif., April 27, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced positive 52-week results from its Phase 2 COVALENT-112 trial evaluating the efficacy, safety, and tolerability of icovamenib in patients with type 1 diabetes (“T1D”). These data are based on a proof-of-concept study enrolling small subsets of Stage 3 T1D patients dosed with icovamenib at 100 mg and 200 mg in two cohorts (patients diagnosed within 3 years and those diagnosed within 3-15 years). “The results we presented today mark an encouraging step forward for Biomea. The magnitude and durability observed are not typically seen in type 1 diabetes, which makes these findings particularly compelling. These data further validate targeting menin as a potential approach across both type 1 and type 2 diabetes,” said Mick Hitchcock, Ph.D., Interim CEO and Board Member of Biomea Fusion. “We look forward to presenting additional data at an upcoming scientific meeting and advancing our type 1 diabetes program in collaboration with leading clinical centers in the United States” The COVALENT-112 trial demonstrated encouraging results in patients with T1D. In patients diagnosed within 0-3 years, treatment with icovamenib 200 mg once daily for 12 weeks resulted in a 52% increase in mean C-peptide area under the curve (AUC) at Week 12 (p < 0.001; n=5), representing a magnitude of improvement that is not commonly reported in published...

Biomea Fusion, Inc. (NASDAQ:BMEA) earns a place on our list of the top 10 stocks under $5 that could triple. As of March 19, 2026, almost 88% of covering analysts keep bullish ratings on the stock. With a consensus price target of $6.00, indicating a potential upside of 415.02%, analyst sentiment remains positive toward Biomea Fusion, Inc. (NASDAQ:BMEA). On March 14, 2026, Biomea Fusion, Inc. (NASDAQ:BMEA) reported positive 52-week follow-up findings from its Phase II COVALENT-111 study of icovamenib in type 2 diabetes at the ATTD conference in Barcelona. This clinical progress serves as the foundation for analyst optimism. Of the 267 patients assessed in the randomized, placebo-controlled trial, 163 completed at least 80% of their dosage before a clinical hold. The findings showed statistically significant declines in HbA1c, with severe insulin-deficient individuals experiencing reductions of up to 1.50% at Week 52. Efficacy was further supported by improvements in beta-cell activity and long-lasting glucose control nine months after therapy. There were no significant side effects or treatment-related discontinuations, and the therapy was well tolerated. Biomea Fusion, Inc. (NASDAQ:BMEA) formulates covalent small-molecule therapeutics aimed at treating cancers and metabolic disorders, with its primary candidate, icovamenib, targeting diabetes and BMF-219 addressing oncogenic signaling in genetically characterized tumors. While we acknowledge the potential of BMEA 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.

Initiated two Phase II trials COVALENT-211 and COVALENT-212 (icovamenib in type 2 diabetes) with 26-week primary endpoint data anticipated in the fourth quarter of 2026 Completed 52-week follow-up from Phase II trial COVALENT-112 (icovamenib in type 1 diabetes) with data expected in the second quarter of 2026 Initiated Phase I trial enrollment of GLP-131 (BMF-650 in obesity) with initial 28-day weight reduction data expected in the second quarter of 2026 Projected cash runway into the first quarter of 2027 SAN CARLOS, Calif., March 24, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today reported its financial results for the full year ended December 31, 2025, and provided a business update. “The past year was a year of execution for Biomea as we advanced from validating the menin pathway in primarily preclinical experiments to now generating durable, clinical data in patients with type 2 diabetes with our lead asset, icovamenib,” said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. “We reported persistent 52-week clinical activity with icovamenib following a short 12-week treatment course. Following these initial findings, we initiated two Phase II studies in type 2 diabetes from which we expect to have primary end point data before year end. We also advanced our own next-generation oral GLP-1 receptor agonist, BMF-650, into a Phase I study which we expect will read out in the second quarter. We are excited about the current momentum as we believe Biomea is well positioned to execute on key value-creating milestones with multiple data readouts from our four clinical studies, while predicting a cash runway into the first quarter of 2027.” Recent Corporate Highlights: Icovamenib Potential First-in-Class Oral Small Molecule Product Candidate Targeting Menin for Diabetes The Company presented 52-week follow-up data from the Phase II COVALENT-111 study in patients with type 2 diabetes not achieving glycemic targets despite standard of care therapy. The data demonstrated durable and clinically meaningful reductions in HbA1c that persisted nine months after completion of a 12-week treatment course. In patients with severe insulin-deficient type 2 diabetes receiving one or more antihyperglycemic agents at baseline, ic...

Durable Glycemic and C-Peptide Improvements with Icovamenib in Insulin-Deficient Type 2 Diabetes SAN CARLOS, Calif., Dec. 05, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced that it presented COVALENT-111 study results at the 23rd WCIRDC which took place December 3-6, 2025 in Los Angeles, California. The data showed durable glycemic and c-peptide improvements with icovamenib, a menin inhibitor targeting beta-cell restoration in insulin deficient type 2 diabetes. “I am very pleased that our data was selected for an oral presentation at the WCIRDC meeting this year. Over the past 24 months, our clinical studies have shown that selective inhibition of menin can meaningfully influence the clinical response of patients with insulin deficient diabetes. The results we presented at this meeting highlight the lasting and continuous benefits observed in in our study, with durable glycemic and C-peptide improvements 9 months after the last dose,” said Mick Hitchcock, Ph.D., Interim CEO and Board Member of Biomea Fusion. “Targeting menin offers promise for people living with diabetes, with the potential to support the natural insulin producing capacity of the pancreatic beta cells. Icovamenib, as a selective menin inhibitor, represents a first in class approach in this area of research.” Key Highlights from WCIRDC showing HbA1c and C-peptide responses at week 52 – 9 months post the last dose: Icovamenib demonstrated durable and continuous treatment effect in severe insulin-deficient type 2 diabetes (T2D) Higher HbA1c reduction was associated with higher icovamenib exposure Icovamenib improved long-term insulin secretion in severe insulin-deficient T2D Treatment effect in GLP-1 “failures” continued to improve with durable and clinically significant improvements in HbA1c Icovamenib was generally well-tolerated, with no adverse-event related discontinuations and no related serious adverse events The abstract will be published in the peer-reviewed Metabolism: Experimental and Clinical. The presentation will be available on Biomea Fusion's Investor Relations Page under the Events. Please find a link here to our website where the poster will be available. COVALENT-111 Study Design COVALENT-111 is a double-blind, randomized, placebo-controlled trial that e...

Advances diabetes and obesity programs with icovamenib demonstrating durable 52-Week Phase II data and with BMF-650, Biomea’s next-generation, oral small molecule glucagon-like peptide-1 (“GLP-1”) receptor agonist (“RA”), dosing its first patient in a Phase I clinical trial Presented preclinical activity of icovamenib in combination with semaglutide in type 2 diabetes (“T2D”) animal model at EASD Annual Meeting, demonstrating enhanced glycemic control and body weight reduction with preservation of lean mass Raised approximately $68 million in gross proceeds through two public offerings, extending projected cash runway into the first quarter of 2027 SAN CARLOS, Calif., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today reported its financial results for the third quarter ended September 30, 2025, and provided a business update. "Since I joined the company we have reduced our expenses and focused the team on our core assets, advancing them to the next clinical milestones. During the third quarter we streamlined the operations, bringing the workforce down to approximately 40 employees. In addition, we released promising Phase II icovamenib data, which then provided the necessary tailwind to gain funding into 2027,” said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. “Icovamenib demonstrated continued reduction in HbA1c, nine months-post dosing in both of our identified target populations while maintaining a safety profile similar to placebo. These findings support our thesis that menin inhibition can potentially address the underlying cause of diabetes. Icovamenib is now moving rapidly into two Phase II studies enrolling each of these patient subtypes. With BMF-650, we also made great progress and have now dosed our first patient in a Phase I study.” Third Quarter Highlights: Icovamenib (Oral Small Molecule Menin Inhibitor for T2D and Type 1 Diabetes (“T1D”)) Reported positive 52-week follow-up results from the Company’s Phase II COVALENT-111 study of icovamenib in T2D. The study demonstrated durable and clinically meaningful HbA1c reductions nine months after completion of dosing. In patients with severe insulin-deficient diabetes receiving one or more antihyperglycemic agents at baseline, icovamenib...

Icovamenib showed a sustained treatment benefit at Week 52 (9 months past the end of treatment) in the severe insulin-deficient diabetes patient population taking one or more antihyperglycemic medications at baseline, with a 1.8% placebo adjusted mean reduction in HbA1c (Arm B) Type 2 diabetes patients on a GLP-1-based therapy failing to achieve their target HbA1c also showed a clinically meaningful response from only 12 weeks of icovamenib treatment with a mean placebo adjusted HbA1c reduction of 1.8% (Arms A, B, and C combined) at Week 52 Icovamenib was generally well tolerated across all dosing arms and demonstrated a favorable safety and tolerability profile through Week 52 Phase II trials in severe insulin-deficient diabetes patients and diabetes patients not achieving glycemic target with a GLP-1-based therapy are expected to begin in the fourth quarter of 2025 Company to host a conference call to discuss results on Tuesday, October 7 at 8:30 am ET SAN CARLOS, Calif., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced positive 52-week results from its Phase II COVALENT-111 study evaluating the efficacy, safety, and tolerability of icovamenib in patients with type 2 diabetes (T2D). “We are encouraged by the durability of icovamenib’s effect observed nine months post-dosing at Week 52,” said Mick Hitchcock, Ph.D., Interim CEO and Board Member of Biomea Fusion. “We believe that we now have in hand initial evidence of durable efficacy, additional favorable safety data, a clear understanding of an effective dose, and most importantly, the target patient populations. Icovamenib demonstrates potential to transform the diabetes treatment landscape by effectively addressing the underlying biology.” COVALENT-111 Study Design COVALENT-111 is a double-blind, randomized, placebo-controlled trial that enrolled adult patients diagnosed with T2D within the last 7 years. Eligible participants had HbA1c levels between 7.0% and 10.5%, and a body mass index (BMI) between 25 and 40 kg/m². At baseline, all participants were treated with lifestyle management, including diet and exercise, with or without antidiabetic medications and had inadequate glycemic control despite treatment with up to three antidiabetic medications. The study evaluated icova...

Three presentations at ADA 2025 highlighted the therapeutic potential of icovamenib across multiple aspects of metabolic health: In patients with type 2 diabetes (T2D) not achieving glycemic targets, icovamenib demonstrated durable HbA1c reduction and improved beta-cell function subsequent to the dosing period In a rodent model of T2D, icovamenib in combination with low-dose semaglutide, promoted enhanced glycemic control and weight loss with complete lean mass preservation Icovamenib promoted healthy myotube morphology and reduced drug-induced atrophy in ex-vivo human myotube cultures Next-generation oral GLP-1 receptor agonist (RA) candidate, BMF-650, demonstrated robust, dose-dependent weight loss and appetite suppression in obese non-human primates; planned Investigational New Drug (IND) submission remains on track for the second half of 2025 Raised approximately $42.8 million in gross proceeds through a public offering, extending projected cash runway into the second half of 2026 Reduced the workforce and quarterly expenses to support the advancement of the ongoing core programs SAN CARLOS, Calif., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today reported its financial results for the second quarter ended June 30, 2025, and provided a business update. “In the second quarter, we presented clinical and preclinical results with icovamenib that support its unique role as a novel, potentially first-in-class investigational agent for the treatment of type 2 diabetes as well as in obesity, while further strengthening our BMF-650 program with robust data in non-human primates,” said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. “At ADA 2025, we showed in preclinical models that our menin inhibitor, icovamenib, in combination with low-dose semaglutide not only drove superior glycemic control but also considerably boosted weight reduction, while fully preserving lean mass and outperforming semaglutide alone. Furthermore, icovamenib promoted myotube health and reduced drug-induced atrophy in a human cell model, highlighting its potential to support muscle health. We look forward to engaging with FDA and further evaluating icovamenib in this patient setting. Our next-generation investigational GLP-1 RA,...

Biomea Fusion (BMEA) said Wednesday that preclinical data for its investigational weight loss drug,

Company Announces Strategic Realignment to Focus on Core Programs and Extend Cash Runway Icovamenib progressing toward the next phase of clinical development in insulin deficient type 2 diabetes patients and patients that are currently uncontrolled on a GLP-1 based therapy Biomea's next generation oral GLP-1 receptor agonist (BMF-650) filing for IND All other clinical and preclinical activities are either being partnered or closed REDWOOD CITY, Calif., May 05, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today reported its financial results for the first quarter ended March 31, 2025, and provided a business update. “In the first quarter of 2025, we executed a focused realignment of our operations to concentrate resources on our highest-value opportunities and extend our cash runway and position Biomea for long-term success,” said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. “With icovamenib advancing in insulin-deficient type 2 diabetes patients and BMF-650 on track for IND submission, we are strategically positioned to deliver meaningful clinical data and drive value across our metabolic pipeline. These actions reflect our commitment to capital efficiency and developing the core therapies that we believe will have the potential to transform the lives of patients with diabetes and obesity.” Strategic Realignment Highlights Prioritizing Core Programs: Biomea will focus development efforts and investments on icovamenib, a novel oral menin inhibitor for diabetes, and BMF-650, a next-generation oral GLP-1 receptor agonist. Operational Streamlining: The Company has implemented a cost-reduction initiative, including a workforce reduction of approximately 35%, to reduce the overall operating expenses and extend its cash runway into the fourth quarter of 2025. As part of this initiative, Biomea is consolidating its workforce at the current research facility known as the Biomea Innovation Lab Center located in San Carlos, CA as of May 31, eliminating the cost of maintaining two separate facilities. Key Anticipated 2025 Milestones: Icovamenib (Oral Small Molecule Menin Inhibitor for Type 2 and Type 1 Diabetes) 52-week data from the Phase II COVALENT-111 study in type 2 diabetes expected in the second half of 2025. T...

Mick Hitchcock, Ph.D., appointed Interim Chief Executive Officer Biomea preparing icovamenib for late-stage clinical development Multiple milestones anticipated in 2025 including: FDA meeting anticipated in first half 2025 to discuss icovamenib late-stage development in severe insulin deficient patients COVALENT-111 (T2D) 52-week data anticipated in second half 2025 COVALENT-112 (T1D) open label data anticipated in second half 2025 BMF-650 IND application submission planned in second half 2025 REDWOOD CITY, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, reported fourth quarter and full year 2024 financial results and corporate highlights. “2024 was a transformative year for Biomea, marked by the advancement of icovamenib into late-stage development and compelling clinical data that reinforced our confidence in its potential to reshape diabetes treatment, particularly for patients with severe insulin deficiency,” said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. “As we move into this next phase, the Board made a strategic decision to align leadership with the company’s evolution, and I’m honored to step in and contribute decades of experience in late-stage development, regulatory strategy, and commercialization to help guide Biomea forward. This transition reflects the continued confidence in our menin inhibitor program and the strength of our covalent small molecule platform. We remain fully committed to advancing icovamenib and delivering on our mission to transform diabetes treatment through this disease-modifying therapy. With key data readouts and regulatory milestones ahead, 2025 is set to be a pivotal year for the company.” In March 2025, the Company announced a leadership transition, appointing Board member Mick Hitchcock, Ph.D., as Interim Chief Executive Officer, succeeding Thomas Butler. In January 2025, we announced plans to position Biomea as a dedicated diabetes and obesity medicines company. Building on our most recent clinical trial results, our strategic focus for icovamenib is now exclusively centered on metabolic disorders. As a result, we are terminating all ongoing oncology trials involving icovamenib and will conclude the BMF-500 study in patients with relapse...