| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
Phase 2 data readout example | Phase 2 | — | Subscribe to access the data. | Small Molecules | Endocrine System | ||
Phase 2 data readout example | Phase 2 | — | Subscribe to access the data. | Small Molecules | Endocrine System | ||
Phase 2 data readout example | Phase 2 | — | Subscribe to access the data. | Small Molecules | Endocrine System |
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Biomea Fusion, Inc.$1.32
-0.04 (-3.01%)
C 47Pipeline Score Fair Value Pharma · Clinical
Market Cap
102.67 M
EPS
-0.89
P/E Ratio
-
Value Trade
1.74 M
SEC Financials
Q1 2026Dilution Risk
40%R&D Expenses
9.12 M
Operating CF
-11.67 M
Total Assets
46.38 M
Total Liabilities
27.67 M
Equity
18.72 M
D/E Ratio
12,345
0 %
Week
-26.8 %
1 Month
9.23 %
3 Month
44.9 %
6 Month
-91.89 %
5 Year
-92.9 %
All Time
Cash Data
Cash Position
44.69 M
Monthly Burn
3.89 M
Runway
9.7 mo
Burn Trend
SEC Filing
May 11, 2026
Overview
Volume
1.41 M
52 Week Range
0.87 - 3.08
% held by Insiders
6.76 %
% held by Institutions
39.57 %
Enterprise Value
58.84 M
Total Shares
72.31 M
Short %
21.25 %
Float Shares
65.08 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for Biomea Fusion, Inc.
381Total events
5Upcoming
69Tier-1 (high impact)
2021 – 2027Coverage
Upcoming catalysts 5
Event history 376
Q3 2026
◆Enrollment UpdateicovamenibTrial
Enrollment to begin in Q3 2026 for icovamenib + semaglutide arm
obesitysource ↗
Q3 2026
◆Topline ReadoutBMF-650Clinical Data
Initial 28-day clinical weight reduction data from Phase I GLP-131 study
obesitysource ↗
Q3 2026
◆Trial InitiationicovamenibTrial
Planned Phase 2 trial in T1D patients diagnosed within past 3 years to be initiated
type 1 diabetessource ↗
Jun 7, 2026
◆Late-BreakericovamenibPresentation
Icovamenib, a Menin Inhibitor, Improves Endogenous Insulin Secretion in Type 1 Diabetes: Results from the COVALENT-112 Study
type 1 diabetessource ↗
Jun 7, 2026
◆Poster PresentationicovamenibPresentation
Late-breaking preclinical poster at ADA Scientific Sessions: Menin Inhibitor Icovamenib Activates Mechanisms That Support Metabolic Health (poster #2871-LB)
metabolic healthsource ↗
Jun 5, 2026
◆AbstracticovamenibPresentation
Embargo lift and publication of abstracts on Diabetes journal website and Biomea website
diabetessource ↗
Jun 5, 2026
◆Oral PresentationicovamenibPresentation
Comprehensive dataset to be presented at ADA Scientific Sessions
type 1 diabetessource ↗
Jun 5, 2026
●Enrollment UpdateBMF-650Trial
Expansion of Phase I BMF-650 study to evaluate rapid one-step titration
obesitysource ↗
Jun 3, 2026
▲Partnership / LicenseCorporate
Research collaboration with University of Leicester to evaluate icovamenib in combination with semaglutide in obesity
Jun 3, 2026
▲Trial InitiationicovamenibTrial
Activation of experimental arm evaluating icovamenib + semaglutide in OPAL study
obesitysource ↗
Jun 2026
◆Oral PresentationicovamenibPresentation
Comprehensive dataset to be presented at ADA Scientific Sessions
type 1 diabetessource ↗
May 12, 2026
◆Oral PresentationPresentation
Management to participate in upcoming investor conferences with fireside chats
Drug Pipeline Intelligence
C47
Pipeline Score $115M
Pipeline ValueFair Value
Valuation Signal4
Drugs Scored1.1x
rNPV / MCap Top 71%
Micro Cap (rank 265 of 911)
Percentile RankBiomea Fusion, Inc. carries a moderate pipeline score (47/100), with $2.7B risk-adjusted pipeline value, led by BMF-219 in Type 2 Diabetes Mellitus (Phase 1), across $131B in total addressable markets.
Showing 1 of 1 assets
| Drug | Indication | Phase | NCT ID | PTRS | rNPV | Status | Enrollment | Velocity | Design | Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BMF-219 Small molecule | Type 2 Diabetes Mellitus | Phase 1 | NCT05731544 | 14% | $2.1B | COMPLETED | 443 | - | - | Jul 8, 2025 | - | Nov 10, 2025 |
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
icovamenib | type 1 diabetes | Phase 2 | 2026-05-11 | Topline data from the Phase II COVALENT-112 clinical trial evaluating icovamenib in T1D patients were reported from the 52-week. Read More | Biomea Fusion Reports First Quarter 2026 Financial Results and Corporate Highlights Read More | |
icovamenib | type 1 diabetes | Phase 2 | 2026-05-11 | Topline data from the Phase II COVALENT-112 clinical trial evaluating icovamenib in T1D patients were reported from the 52-week. Read More | Biomea Fusion Reports First Quarter 2026 Financial Results and Corporate Highlights Read More | |
icovamenib | type 1 diabetes | Phase 2 | 2026-05-11 | Topline data from the Phase II COVALENT-112 clinical trial evaluating icovamenib in T1D patients were reported from the 52-week. Read More | Biomea Fusion Reports First Quarter 2026 Financial Results and Corporate Highlights Read More |
Inside Trades
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in BMEA
| HedgeFund Name ( 3 ) | % of Portfolio | Current MV - | Shares Owned - | Activity Avg Price $0 |
|---|---|---|---|---|
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K |
BMEA Institutional Ownership Trends
Current Insider %
5.20%
—+0.00%
Current Institutional %
62.40%
—+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
| 2026-07-17 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2026-07-17 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2026-07-17 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
BMEA▼ -7.3%on this news
Biomea Fusion Presents New Clinical and Translational Data for Icovamenib at the American Diabetes Association (“ADA”) 86th Scientific Sessions and Announces Expansion of Ongoing Phase I BMF-650 Study
Biomea Fusion presented promising new clinical and translational data for icovamenib at the ADA 86th Scientific Sessions. The data highlights potential benefits in muscle preservation, fat reduction, and improvements in glycemic control among type 1 and type 2 diabetes patients. Additionally, Biomea announced the expansion of its Phase I BMF-650 study to optimize dosing and enhance weight loss potential. Overall, the findings support icovamenib's broader therapeutic utility in obesity and diabetes management.
Read more →BMEA▼ -5.1%on this news· ran to -16% by day 3shared move
Biomea Fusion Announces Research Collaboration with University of Leicester to Evaluate Icovamenib in Combination with Semaglutide in Obesity
Biomea Fusion has announced a collaboration with the University of Leicester to evaluate the effects of icovamenib in combination with semaglutide on obesity. This study, part of the OPAL platform trial, aims to assess improvements in physical function and metabolic outcomes. The trial will begin enrollment in Q3 2026, focusing on individuals who are overweight or obese without type 2 diabetes.
Read more →BMEA▼ -6.3%on this news· ran to -21% by day 3
Biomea Fusion to Participate at Upcoming Investor Conferences - May 12, 2026
Biomea Fusion, Inc. announced its participation in upcoming investor conferences, highlighting its focus on developing therapies for diabetes and obesity. The company aims to address metabolic disorders affecting a large portion of the global population. Webcasts of the events will be available for those unable to attend live.
Read more →BMEABiomea Fusion Reports First Quarter 2026 Financial Results and Corporate Highlights
Biomea Fusion reported its first quarter 2026 financial results, highlighting progress in its clinical trials for icovamenib in type 1 and type 2 diabetes. The company successfully completed chronic toxicology studies and initiated two Phase II trials for type 2 diabetes. Additionally, topline data from the Phase II COVALENT-112 trial showed promising results, with a cash runway projected into early 2027.
Read more →BMEABiomea Fusion Announces Poster Presentations of Icovamenib at the American Diabetes Association (ADA) 86th Scientific Sessions
Biomea Fusion announced that three abstracts on icovamenib will be presented at the ADA 86th Scientific Sessions. The presentations will showcase data on the investigational oral menin inhibitor's effects on beta cell function in type 1 and type 2 diabetes. The event will take place from June 5-8, 2026, in New Orleans.
Read more →BMEA▼ -11.6%on this news
Biomea Fusion Announces Positive 52-Week Results from Phase 2 COVALENT-112 Trial in Type 1 Diabetes Showing C-Peptide Improvement and Durability Following 12-Weeks of Icovamenib Treatment
Biomea Fusion announced positive results from its Phase 2 COVALENT-112 trial for icovamenib in type 1 diabetes, showing a significant 52% increase in mean C-peptide levels after 12 weeks. The treatment demonstrated durability, with effects largely preserved through Week 52. Icovamenib was well tolerated, and the company plans to advance further trials.
Read more →BMEA▼ -11.6%on this newsshared move
Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future business and financial performance of Biomea Fusion, Inc
Biomea Fusion, Inc. has shared forward-looking statements regarding future business and financial performance. The presentation emphasizes the uncertain nature of these predictions, which are influenced by various risks, including regulatory approvals and market dynamics. Specifically, the discussion touches on the investigational therapies for Type 1 Diabetes and the limitations associated with existing treatment options. A focus is placed on the anticipated clinical trials and the goals of restoring beta cell function, although challenges persist in achieving durable therapeutic outcomes.
Read more →BMEA▲ +15.9%on this news
Biomea Fusion Announces First Patient Dosed in Newly Initiated Phase II Programs Enrolling Type 2 Diabetes Patients Failing on Standard-of-Care Therapies
Biomea Fusion has announced the dosing of its first patient in the Phase II clinical programs, COVALENT-211 and COVALENT-212, which target type 2 diabetes patients not achieving glycemic control with standard therapies. These studies assess the investigational drug icovamenib, anticipated to deliver topline data by the end of 2026. The trials focus on patients requiring improved glucose management, demonstrating previously observed durability in response. This marks a critical advancement for Biomea as it looks to address unmet medical needs in diabetes treatment.
Read more →BMEA▲ +8%on this news· ran to +21% by day 1
Biomea Fusion Reports Full Year 2025 Financial Results and Corporate Highlights
Biomea Fusion reported its financial results for 2025, highlighting advancements in its diabetes and obesity treatments. The company achieved durable clinical data with icovamenib and initiated two Phase II studies in type 2 diabetes. Additionally, Biomea advanced its next-generation GLP-1 receptor agonist, BMF-650, into a Phase I study, with expectations for multiple data readouts in the coming year.
Read more →BMEA▼ -8.1%on this news· ran to -20% by day 3
Biomea Fusion Presents Phase II COVALENT-111 Data in Type 2 Diabetes at the 19th International Conference on Advanced Technologies & Treatments for Diabetes 2026
Biomea Fusion presented positive 52-week follow-up results from its Phase II COVALENT-111 study at the ATTD 2026 conference. The study evaluated icovamenib's efficacy, safety, and tolerability in patients with type 2 diabetes. Results showed significant reductions in HbA1c levels, particularly in severe insulin-deficient patients. The company plans to initiate further studies targeting optimal patient populations.
Read more →BMEA▲ +7.6%on this news
st 1 QUARTER 2026 Biomea Fusion Corporate Presentation 1 Legal disclaimer & forward-looking statements Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These st
Biomea Fusion, Inc. is advancing its clinical programs targeting diabetes and obesity with promising developments in their oral medications, ICOVAMENIB and BMF-650. The company is preparing for significant data readouts in 2026, including two Phase II studies relevant for Type 2 diabetes, where unmet patient needs remain high. Initial results for ICOVAMENIB show potential for beta-cell restoration, and ongoing trials for BMF-650 target weight reduction in obese patients. Biomea retains full rights to its products and is adequately funded for upcoming milestones.
Read more →BMEABiomea Fusion to Participate at Upcoming Investor Conferences
Biomea Fusion, Inc. (Nasdaq: BMEA) has announced its participation in several upcoming investor conferences including the Oppenheimer 36th Annual Healthcare Life Sciences Conference, The Citizens Life Sciences Conference, and the BMO Metabolic Health Summit. At these events, the company will present its work and engage in one-on-one meetings with investors. Biomea is involved in developing therapies for diabetes and obesity, which are significant global health challenges. The presentations will also be available via webcast for those unable to attend in person.
Read more →BMEA▲ +6.6%on this news
Legal Disclaimer & Forward-looking Statements Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future business a
Biomea Fusion provided a presentation outlining their forward-looking statements regarding the future business and potential financial performance concerning their diabetes treatment, Icovamenib. The company noted that these statements involve inherent risks and uncertainties, which could significantly impact actual outcomes. The drug is in clinical trials and aims to address type 2 diabetes through mechanisms that enhance insulin secretion. The potential benefits of Icovamenib include targeting an unaddressed pathway, although the landscape of regulatory and market risks remains complex.
Read more →BMEABiomea Fusion Enters 2026 Focused on Executing Key Icovamenib and BMF-650 Milestones
Biomea Fusion has outlined its strategic priorities for 2026, focusing on advancing its drug candidates, icovamenib and BMF-650, through clinical trials. Icovamenib is progressing towards late-stage development with promising data indicating its potential as a treatment for insulin-deficient type 2 diabetes. Concurrently, BMF-650, an oral GLP-1 receptor agonist, aims to deliver patient-friendly metabolic benefits. The company plans to present detailed milestones and strategies at the upcoming 44th Annual J.P. Morgan Healthcare Conference.
Read more →BMEABiomea Fusion to Present at the 44th Annual J.P. Morgan Healthcare Conference
Biomea Fusion, Inc. will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026. Mick Hitchcock, Ph.D., the Interim CEO, will lead the presentation, and the management team will also hold one-on-one meetings during the event. The conference runs from January 12-15, 2026, highlighting Biomea's commitment to addressing diabetes and obesity.
Read more →BMEABiomea Fusion Announces KOL Presentation and Interview on Menin and Icovamenib at WCIRDC 2025
Biomea Fusion announced a KOL interview featuring Dr. Ralph DeFronzo during the WCIRDC 2025, discussing the potential of icovamenib in diabetes treatment. The interview emphasized the preclinical and clinical findings supporting icovamenib as a promising approach for restoring beta cell function. Additionally, Dr. DeFronzo's presentation highlighted icovamenib's long-term potential as a disease-modifying therapy for diabetes. This research underlines the growing interest and need for innovative diabetes therapies to improve patient outcomes.
Read more →BMEABiomea Fusion Presents COVALENT-111 Study Results at the 23rd World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC)
Biomea Fusion presented positive results from the COVALENT-111 study at the 23rd WCIRDC, highlighting significant improvements in glycemic control and insulin secretion from icovamenib, a selective menin inhibitor. The data suggests durable effects even 9 months after the last dose, demonstrating the treatment's potential in severe insulin-deficient type 2 diabetes. The trial's findings were well-received, with no serious adverse events reported, reinforcing the safety of the therapy. The research marks a significant development in diabetes treatment, providing hope for improved management of the condition.
Read more →BMEA▼ -7.3%on this news
Biomea Fusion Announces Oral Presentation of Icovamenib at the 23rd World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC)
Biomea Fusion has announced that it will present long-term follow-up data for its investigational drug, icovamenib, at the 23rd World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. This event will take place from December 3-6, 2025, in Los Angeles, California. The presentation, which is one of only six oral presentations at the congress, highlights icovamenib's potential as a significant advancement in treating type 2 diabetes, particularly for insulin-deficient patients. The company aims to address the critical need for effective treatments in this area.
Read more →BMEA▼ -7.3%on this news
Biomea Fusion, Inc. Reports Inducement Grant under Nasdaq Listing Rule 5635(c)(4)
Biomea Fusion, Inc. announced the granting of stock options to a new employee as part of its 2023 Inducement Equity Plan. This grant, made under Nasdaq Listing Rule 5635(c)(4), involves 7,500 shares that will vest over a four-year period. Biomea, focused on diabetes and obesity treatments, aims to develop transformative oral medications targeting these significant health challenges. This initiative indicates the company's commitment to growth and attracting talent in the biopharma sector.
Read more →BMEABiomea Fusion to Participate at Jefferies London Healthcare Conference
Biomea Fusion, Inc. will participate in a fireside chat at the Jefferies London Healthcare Conference on November 17, 2025. The company will also hold one-on-one meetings with investors on November 17-18, 2025. Biomea is focused on developing oral therapies for diabetes and obesity, addressing significant global health challenges.
Read more →BMEA▲ +6.3%on this newsshared move
Biomea Fusion Showcases Preclinical Advances for BMF-650 and Icovamenib with Low Dose Semaglutide at ObesityWeek® 2025
Biomea Fusion presented preclinical data for BMF-650 and icovamenib at ObesityWeek 2025. BMF-650 is an oral GLP-1 receptor agonist showing efficacy in weight loss and glycemic control. The combination of icovamenib with low-dose semaglutide demonstrated superior weight loss effects in ZDF rats. Clinical evaluations for icovamenib are set to begin in early 2026.
Read more →BMEA▲ +6.3%on this newsshared move
Biomea Fusion Reports Third Quarter 2025 Financial Results and Corporate Highlights
Biomea Fusion reported its third quarter 2025 financial results, highlighting significant advancements in its clinical programs. The company announced promising Phase II data for icovamenib, demonstrating effective HbA1c reduction in target populations. Additionally, Biomea successfully completed a public offering, raising approximately $25 million to support its operations and clinical trials.
Read more →BMEABiomea Fusion to Present Poster Presentations at ObesityWeek®2025
Biomea Fusion, Inc. will present poster presentations at ObesityWeek® 2025 in Atlanta, Georgia, from November 4-7, 2025. The presentations will focus on preclinical data for BMF-650, a next-generation oral GLP-1 receptor agonist, and combination data for icovamenib with semaglutide. These findings aim to enhance treatment options for obesity and diabetes.
Read more →BMEABiomea Fusion Announces First Patient Dosed in Phase I Study of BMF-650 a Next-Generation Oral GLP-1 Receptor Agonist
Biomea Fusion has announced the dosing of the first patient in a Phase I clinical trial for BMF-650, a next-generation oral GLP-1 receptor agonist aimed at treating obesity. The drug demonstrated promising preclinical results, including significant weight loss in animal models. The trial will evaluate safety, tolerability, and preliminary efficacy, with initial data expected in the first half of 2026.
Read more →BMEA▼ -9.4%on this newsshared move
Biomea Fusion to Participate in Citi's SMID Biotech C-Suite Fireside Chat Series
Biomea Fusion, Inc. will participate in Citi's SMID Biotech C-Suite Fireside Chat Series on October 23, 2025. The event will feature a live audio webcast available on their website. Biomea specializes in developing oral therapies for diabetes and obesity, addressing critical metabolic disorders.
Read more →BMEA▼ -30.9%on this news
Biomea Fusion Announces Pricing of Public Offering of Securities
Biomea Fusion, Inc. has announced the pricing of its public offering, which includes over 11 million shares of common stock and warrants. The offering aims to raise approximately $25 million and is expected to close on October 8, 2025. Jefferies is the sole book-running manager for this offering, which is part of Biomea's strategy to fund its diabetes and obesity treatments.
Read more →BMEA▼ -30.9%on this newsshared move
Biomea Fusion Announces Positive 52-Week Results from Phase II COVALENT-111 Study in Type 2 Diabetes Demonstrating Non-Chronic Treatment with Icovamenib Benefits Two Distinct Patient Populations
Biomea Fusion has reported positive 52-week results from its Phase II COVALENT-111 study of icovamenib for type 2 diabetes. The study demonstrated significant and durable reductions in HbA1c levels among patients, particularly those with severe insulin deficiency. Icovamenib maintained a favorable safety profile throughout the study, indicating its potential as a transformative treatment option. The findings suggest icovamenib could effectively address the underlying biology of diabetes.
Read more →BMEA▲ +24.2%on this newsshared move
Biomea Fusion Announces Proposed Public Offering of Securities
Biomea Fusion, Inc. has announced a proposed underwritten public offering of its common stock and accompanying warrants, managed by Jefferies. The offering is part of Biomea's strategy to fund its clinical-stage development focused on diabetes and obesity therapies. It's important to note that the completion of this offering is subject to market conditions and there are uncertainties regarding its size and terms. Biomea has also filed a shelf registration statement with the SEC for this offering.
Read more →BMEABiomea Fusion, Inc. Reports Inducement Grant under Nasdaq Listing Rule 5635(c)(4)
Biomea Fusion, Inc. has announced the grant of non-qualified stock options to a new employee as part of their 2023 Inducement Equity Plan. The options, totaling 48,000 shares, will vest quarterly over four years, contingent on the employee's continued employment. This grant complies with Nasdaq Listing Rule 5635(c)(4) and reflects the company's commitment to expanding its workforce.
Read more →BMEABiomea Fusion Presents Data Demonstrating Enhanced Preclinical Activity of Icovamenib in Combination with Semaglutide in Type 2 Diabetes (T2D) Animal Model at the 61st EASD Annual Meeting and Provides Additional Corporate Update
Biomea Fusion presented encouraging preclinical data at the 61st EASD Annual Meeting, indicating that icovamenib, when combined with low-dose semaglutide, significantly enhances glycemic control and promotes weight loss while preserving lean mass in a Type 2 Diabetes animal model. The company highlighted remarkable results from their study, including a 60% reduction in fasting blood glucose levels. Additionally, Biomea announced the FDA clearance for its IND application for BMF-650, with a Phase I clinical trial set to begin soon. These developments underscore the potential of Biomea's therapies in addressing the needs of diabetes patients.
Read more →BMEABiomea Fusion Reports Second Quarter 2025 Financial Results and Corporate Highlights • Three presentations at ADA 2025 highlighted the therapeutic potential of icovamenib across multiple aspects of metabolic healt
Biomea Fusion reported positive second quarter 2025 financial results, highlighting the therapeutic potential of icovamenib for type 2 diabetes and BMF-650 for obesity. At ADA 2025, icovamenib showed significant improvements in glycemic control and weight loss compared to semaglutide alone. The company successfully raised $42.8 million to support its pipeline, while also reducing operational expenses. However, it faced a net loss and workforce reduction, which could pose challenges for future growth and research efforts.
Read more →BMEABiomea Fusion Appoints Julianne Averill to its Board of Directors
Biomea Fusion, Inc. has appointed Julianne Averill to its Board of Directors, effective July 22, 2025. Averill, a seasoned finance and strategy executive with over 20 years in the life sciences and digital health sectors, succeeds Bihua Chen, who has stepped down after four years. The company believes Averill's expertise will significantly contribute to advancing its diabetes and obesity care programs as it prepares for future growth.
Read more →BMEA▼ -6.6%on this news
Biomea Fusion Presents New Preclinical and Clinical Data on Icovamenib at the 85th Scientific Sessions of the American Diabetes Association (ADA)
Biomea Fusion presented promising preclinical and clinical data for icovamenib, an oral menin inhibitor, at the 85th Scientific Sessions of the ADA. In a rodent model of type 2 diabetes, icovamenib combined with semaglutide improved glycemic control and supported weight loss while preserving lean mass. The Phase II COVALENT-111 trial showed a notable mean HbA1c reduction among severely insulin-deficient patients after treatment with icovamenib. These findings underscore the potential of icovamenib in transforming diabetes care.
Read more →BMEA▼ -34.1%on this newsshared move
Biomea Fusion Reports Preclinical Data for BMF-650, a Next-Generation Oral GLP-1 Receptor Agonist Candidate, Demonstrating Robust Weight Loss and Appetite Suppression in Obese Non-Human Primates
Biomea Fusion has reported promising preclinical data for BMF-650, indicating significant weight loss and appetite suppression in obese non-human primates. The study showed a clear and dose-dependent reduction in food intake, with the monkeys losing an average of 12% to 15% of their body weight over 28 days. The company is progressing toward an Investigational New Drug (IND) application expected in the second half of 2025, with plans for a Phase I study in late 2025. These findings suggest BMF-650 could become a leading oral GLP-1 receptor agonist.
Read more →BMEA▲ +10.3%on this news· ran to -36% by day 3shared move
Corporate Update June 2025 Slide 1 Legal Disclaimer & Forward-Looking Statement Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to futu
Biomea Fusion, Inc. provided an update on its forward-looking initiatives, emphasizing its focus on innovative treatments for type 2 diabetes and obesity. The company's lead candidate, Icovamenib, aims to enhance beta cell functionality, showing promise in improving HbA1c levels and promoting weight loss. The upcoming milestones for clinical trials in 2025 are set to address critical unmet needs in these therapeutic areas, and they note an anticipated shorter duration for Phase III studies based on initial feedback from regulatory bodies. Overall, Biomea Fusion is positioning itself as a leader in developing effective and durable diabetes therapies.
Read more →BMEA▼ -9.6%on this news· ran to -27% by day 3shared move
Biomea Fusion Presents Updated Preliminary Clinical Data for Covalent FLT3 Inhibitor BMF-500 in Relapsed or Refractory Acute Leukemia at EHA 2025
Biomea Fusion has presented updated preliminary clinical data for BMF-500, a covalent FLT3 inhibitor, during the EHA 2025 Congress. The results from the COVALENT-103 trial indicate substantial clinical activity, with a majority of patients showing bone marrow blast reduction. Notably, some patients achieved significant responses, such as complete remission and morphologic leukemia-free states. The ongoing dose escalation is aimed at determining optimal dosing and further evaluating the drug's safety and efficacy in treating relapsed or refractory acute leukemia.
Read more →BMEA▼ -10.4%on this news
Biomea Fusion’s BMF-500 Selected for Poster Presentation at EHA 2025 Highlighting Phase I Data in Relapsed/Refractory Acute Leukemia
Biomea Fusion's BMF-500 has been selected for a poster presentation at the EHA 2025 Congress, showcasing preliminary Phase I data from the COVALENT-103 trial in relapsed/refractory acute leukemia. The trial indicates promising safety and clinical activity, with a significant number of patients experiencing reductions in bone marrow blasts. The company is exploring strategic partnerships to further develop BMF-500, which has shown early signs of improved overall survival compared to historical benchmarks. The ongoing trial aims to determine the optimal biologic dose and further evaluate the drug's efficacy.
Read more →BMEA▼ -8.3%on this news· ran to -23% by day 1
Biomea Fusion Reports First Quarter 2025 Financial Results and Corporate Highlights Company Announces Strategic Realignment to Focus on Core Programs and Extend Cash Runway • Icovamenib progressing toward the next
Biomea Fusion has reported its financial results for Q1 2025, highlighting a strategic realignment to focus on core diabetes and obesity programs. The company aims to extend its cash runway and enhance operational efficiency, which includes a significant workforce reduction. Key milestones for the advancement of icovamenib and BMF-650 are anticipated later in 2025. Despite recent financial losses, the company is optimistic about its future prospects with ongoing clinical developments.
Read more →BMEA▼ -6.6%on this news
Biomea Fusion, Inc. Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)
Biomea Fusion, Inc. has announced the granting of non-qualified stock options to two new employees, totaling 30,000 shares. These options will vest quarterly over four years, contingent on continued employment. This action is part of the company's compliance with Nasdaq Listing Rule 5635(c)(4), supported by its 2023 Inducement Equity Plan. Biomea Fusion is dedicated to developing therapies for diabetes and obesity through its proprietary technology.
Read more →BMEA▼ -7.4%on this newsshared move
Biomea Fusion Reports Fourth Quarter and Full Year 2024 Financial Results and Corporate Highlights • Mick Hitchcock, Ph.D., appointed Interim Chief Executive Officer • Biomea preparing icovamenib for late-s
Biomea Fusion reported its fourth quarter and full year 2024 financial results, highlighting significant advancements in the development of icovamenib for diabetes treatment. Dr. Mick Hitchcock has been appointed as the Interim CEO, reflecting a strategic focus shift towards metabolic disorders. The company anticipates key milestones in 2025, including FDA meetings and data from various clinical trials. However, Biomea also faces challenges, reporting a net loss of $138.4 million for the year and ceasing ongoing oncology trials.
Read more →BMEABiomea Fusion Announces Leadership Transition Board member Mick Hitchcock named interim CEO replacing Thomas Butler. COO and President Ramses Erdtmann continuing at Biomea in current role.
Biomea Fusion, Inc. has announced a leadership transition, appointing Board member Mick Hitchcock as interim CEO, replacing Thomas Butler. Hitchcock's experience since 2021 on the board positions him well to lead the company during this critical phase. The company is currently developing innovative therapies for diabetes, leveraging significant clinical data from icovamenib. The transition is intended to guide Biomea's late-stage development efforts and enhance regulatory engagement.
Read more →BMEABiomea Fusion Announces Leadership Transition
Biomea Fusion, Inc. has announced a leadership transition, appointing Mick Hitchcock as interim CEO following Thomas Butler's departure. Hitchcock, a board member since 2021, emphasized the company's commitment to developing a novel diabetes therapy, mentioned recent positive clinical results for icovamenib, and outlined his vision for advancing the company’s late-stage development and regulatory efforts. Biomea continues to focus on its pipeline of covalent therapies aimed at treating diabetes and metabolic diseases.
Read more →BMEABiomea Fusion to Unveil New Icovamenib Data at the 18th International Conference on Advanced Technologies & Treatments for Diabetes
Biomea Fusion, Inc. announced it will present new data on icovamenib at the ATTD 2025 conference in Amsterdam. The presentations will include preclinical data and findings from the COVALENT-111 study, emphasizing icovamenib's ability to improve beta cell function and glycemic control in Type 2 diabetes patients. This investigation supports the hypothesis that icovamenib could serve as a first-in-class, disease-modifying therapy, which addresses a critical unmet need in diabetes treatment.
Read more →BMEABiomea Fusion to Become a Diabetes & Obesity Medicines Company
Biomea Fusion has announced its strategic shift to concentrate on diabetes and obesity medications, particularly through the development of icovamenib, a small molecule that targets metabolic disorders. The company plans to advance icovamenib for late-stage clinical trials after demonstrating significant efficacy in patients with low insulin production. It aims to enhance treatment options for those inadequately controlled on existing therapies. Biomea is scheduled to present further clinical data and its 2025 plans at the upcoming J.P. Morgan Healthcare Conference.
Read more →BMEABiomea Fusion Reports New Preclinical Data on Icovamenib-Semaglutide Combination Study
Biomea Fusion has reported promising preclinical data on its investigational drug, icovamenib, when used in combination with semaglutide. The study indicated that this combination resulted in significant improvements in various metabolic parameters, including a reduction in body weight and blood glucose levels. Specifically, the therapy achieved an 11.5% decrease in body weight and a notable enhancement in insulin secretion compared to semaglutide alone. The company aims to present further data at the upcoming J.P. Morgan Conference in January 2025.
Read more →BMEA▲ +5.1%on this newsshared move
Biomea Fusion to Present at the 43rd Annual J.P. Morgan Healthcare Conference
Biomea Fusion, Inc. announced that CEO Thomas Butler will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025. The conference, scheduled from January 13 to 16, will also feature one-on-one meetings with the company's management team. Biomea is dedicated to developing oral covalent small molecules for treating diabetes, obesity, and genetically defined cancers, employing their proprietary FUSION System. The company aims to significantly improve treatment strategies and potentially cure these conditions.
Read more →BMEA▼ -20.7%on this news· ran to -34% by day 1
Biomea Fusion Announces Positive Topline Results from Ongoing Phase II COVALENT-111 Study in Patients with Type 2 Diabetes
Biomea Fusion announced positive topline results from its Phase II COVALENT-111 study evaluating icovamenib in patients with type 2 diabetes. The study demonstrated statistically significant reductions in HbA1c levels across different dosing arms, particularly showing a mean reduction of 0.5% in the optimal dosing group. The drug was well-tolerated with no serious adverse events reported, supporting its safety profile. However, a clinical hold imposed by the FDA during the study affected patient dosing and ongoing studies. Biomea plans to engage with the FDA for further development based on these promising results.
Read more →BMEABiomea Fusion to Host Conference Call to Announce Topline Results from Phase II COVALENT-111 Study in Patients with Type 2 Diabetes (T2D)
Biomea Fusion, Inc. has announced plans to host a conference call on December 17, 2024, to present topline results from its Phase II COVALENT-111 study of icovamenib in patients with type 2 diabetes. The company focuses on developing oral covalent small molecules aimed at treating diabetes, obesity, and certain cancers, highlighting the advantages of their synthetic compounds. The event is expected to provide insights into the efficacy and potential benefits of their treatment approach.
Read more →BMEA▼ -5.5%on this news· ran to -24% by day 3shared move
Biomea Fusion Announces Oral and Poster Presentations of Icovamenib at the 22nd World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC)
Biomea Fusion has announced that icovamenib will be showcased through one oral and one poster presentation at the 22nd World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease in December 2024. Preclinical studies indicate that icovamenib enhances beta cell function and increases responsiveness to GLP-1-based therapies, which could lead to lower dosing requirements and fewer side effects. The findings suggest a potential for icovamenib to improve the effectiveness of diabetes management. This investigational compound could significantly influence treatment approaches for diabetes patients if further clinical studies confirm its benefits.
Read more →BMEA▼ -5.1%on this newsshared move
Biomea Fusion Announces Preliminary Data from Ongoing COVALENT-103 Study of Investigational Covalent FLT3 Inhibitor BMF-500 in Relapsed or Refractory Acute Leukemia
Biomea Fusion has released preliminary data from the ongoing COVALENT-103 study, showcasing the investigational covalent FLT3 inhibitor BMF-500 for treating relapsed or refractory acute leukemia. The data indicates a positive safety profile, along with evidence of clinical activity in patients with FLT3 mutations. Notably, one patient achieved a complete response after two cycles of treatment. The findings suggest that BMF-500 may offer significant benefits in a patient population with historically poor outcomes following current therapies.
Read more →BMEABiomea Fusion to Host Conference Call to Present initial Clinical Data from Phase I COVALENT-103 Study of BMF-500, a Covalent FLT3 Inhibitor, in Relapsed or Refractory Acute Leukemia
Biomea Fusion announced it will host a conference call on December 9, 2024, to present initial clinical data from the Phase I COVALENT-103 study of BMF-500, a covalent FLT3 inhibitor targeting relapsed or refractory acute leukemia. This trial is part of Biomea's broader effort to develop oral covalent small molecules for various cancers and metabolic conditions. The study aims to evaluate BMF-500's safety and efficacy, with promising preclinical data indicating its high potency and specificity against FLT3 mutations, a common target in AML.
Read more →BMEA▼ -9.4%on this newsshared move
Legal Disclaimer & Forward-Looking Statements Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future business a
Biomea Fusion, Inc. presented forward-looking statements regarding their GLP-1 RA candidate BMF-650 and its combination with icovamenib during a recent conference call. The company discussed preclinical findings that suggest potential benefits of using their candidate alongside other GLP-1 based therapies. However, they also cautioned that forward-looking statements involve risks and uncertainties that may affect future outcomes. No specific negative events or risks were highlighted in the presentation.
Read more →BMEA▼ -14.3%on this news· ran to -27% by day 3shared move
Biomea Fusion Presents Preclinical Data Showing Icovamenib (BMF-219) Enhanced Effectiveness of GLP-1-Based Therapies and Introduces BMF-650, a Next-Generation, Oral Small-Molecule GLP-1 Receptor Agonist Candidate
Biomea Fusion has presented encouraging preclinical data demonstrating that icovamenib (BMF-219) enhances the effectiveness of glucagon-like peptide-1 (GLP-1)-based therapies, potentially improving insulin secretion in diabetes patients. Additionally, the company has disclosed positive early results for BMF-650, a next-generation oral GLP-1 receptor agonist candidate. This includes improved glucose-stimulated insulin secretion and appetite suppression observed in preclinical studies. A Phase II clinical trial investigating the combination of icovamenib and GLP-1-based therapies is expected to begin in 2025.
Read more →BMEABiomea Fusion Reports Third Quarter 2024 Financial Results and Corporate Highlights • U.S. Food and Drug Administration (FDA) lifted Clinical Hold on COVALENT-111 (Type 2 Diabetes) & COVALENT-112 (Type 1 Diabetes)
Biomea Fusion has announced positive advancements in its diabetes treatment pipeline, with the FDA lifting the clinical hold on its COVALENT trials for Type 1 and Type 2 diabetes. The company is set to provide topline data for two ongoing trials in December 2024, alongside introducing a new diabetes and obesity candidate, BMF-650. Financial results revealed a significant net loss, raising concerns about cash reserves decreasing from $177.2 million to $88.3 million. Additionally, Biomea is expanding its advisory team with the formation of a Global Scientific Advisory Board consisting of leading diabetes experts.
Read more →BMEABiomea Fusion Announces Approval of “icovamenib” as International Nonproprietary Name for BMF-219
Biomea Fusion, a clinical-stage biopharmaceutical company, announced that the World Health Organization has approved 'icovamenib' as the International Nonproprietary Name for its leading product candidate BMF-219. Additionally, the name has also been adopted by the United States Adopted Name Council as the USAN. This recognition is expected to aid in the clinical development and marketing of Biomea's treatment for diabetes and related conditions. Biomea plans to use 'icovamenib' in its future communications as it progresses in its clinical trials.
Read more →BMEA▲ +5.4%on this news
Biomea Fusion to Host Conference Call and Webcast on Wednesday, October 30th at 4:30 pm ET to Announce Our Lead Clinical Candidate, BMF-650, a Next-Generation, Oral Small-Molecule GLP-1 Receptor Agonist and Preclinical Data Combining BMF-219 with a GLP-1 RA-Based Therapy
Biomea Fusion, Inc. announced it will host a conference call and webcast on October 30th to unveil its lead clinical candidate, BMF-650, an oral small-molecule GLP-1 receptor agonist. The event will also cover preclinical results of the combination therapy involving BMF-219. The company aims to address obesity and diabetes, which are major health concerns with rising prevalence globally. The announcement reflects Biomea's commitment to developing innovative treatment options, although it acknowledges inherent risks in drug development.
Read more →BMEABiomea Fusion to Present at the 1st Annual Asian Conference on Innovative Therapies for Diabetes Management (ATTD-ASIA 2024)
Biomea Fusion will present data at the ATTD-ASIA 2024 conference focused on innovative diabetes therapies. The company will feature findings from its Phase II clinical trials, COVALENT-111 and COVALENT-112, evaluating the efficacy of the oral menin inhibitor BMF-219 in patients with type 2 and type 1 diabetes, respectively. However, both trials are currently on hold due to regulatory concerns from the FDA, which may affect their progress and patient enrollment moving forward.
Read more →BMEA▼ -5.9%on this news
Biomea Announces Formation of Global Scientific Advisory Board with 22 World-Renowned Diabetes Experts
Biomea Fusion, Inc. has announced the formation of a Global Scientific Advisory Board comprised of 22 distinguished experts in diabetes. This board will guide the development of Biomea's lead candidate, BMF-219, which aims to regenerate insulin-producing beta cells. The advisory group includes prominent figures in beta cell research and diabetes therapeutics, enhancing Biomea's capabilities as it navigates the clinical development and commercialization of its novel covalent menin inhibitor. CEO Thomas Butler expressed enthusiasm for the team's collective expertise, indicating significant potential for innovation in diabetes care.
Read more →BMEA▲ +9.1%on this newsshared move
FDA Lifts Clinical Hold on BMF-219 in Type 2 and Type 1 Diabetes Trials
Biomea Fusion, Inc. announced that the FDA has lifted the clinical hold on its Phase I/II trials of BMF-219 for type 2 and type 1 diabetes. The company expressed gratitude for the FDA's swift resolution and confidence in BMF-219 as a first-in-class diabetes treatment. Previous safety concerns from earlier studies were not confirmed in the larger Phase 2b Expansion Study, enhancing confidence in the ongoing trials. Biomea is moving forward with its development plans for BMF-219 following the resumption of its studies.
Read more →BMEABiomea Fusion Reports Second Quarter 2024 Financial Results and Corporate Highlights • COVALENT-111 Phase 2b on track for Q4 2024 readout • COVALENT-112 Phase 2a on track for Q4 2024 readout • Announ
Biomea Fusion reported its second quarter 2024 financial results, highlighting that the readouts for both COVALENT-111 and COVALENT-112 are on schedule for Q4 2024. Additionally, a new program in obesity is set to be announced in Q3 2024. The company reported a significant net loss and is currently addressing a clinical hold imposed by the FDA regarding its BMF-219 trials due to safety concerns. Despite challenges, early data from COVALENT-112 shows promising clinical activity.
Read more →BMEABiomea Fusion Announces BMF-219 in Diabetes Placed on Clinical Hold
Biomea Fusion has announced that the FDA has placed a full clinical hold on its BMF-219 trials for diabetes due to concerns over possible drug-induced hepatotoxicity. Despite this setback, the company continues to collect safety and efficacy data during the hold. Biomea is committed to working closely with the FDA to resolve the issues and resume trials. Initial results indicate that BMF-219 is well-tolerated and may improve glycemic control, highlighting its potential despite the current challenges.
Read more →BMEABiomea Fusion Announces Completion of Enrollment of First 3 Arms in Phase 2 Expansion Cohorts of COVALENT-111 Study for BMF-219 in Type 2 Diabetes
Biomea Fusion announced the completion of enrollment for the first three arms of the COVALENT-111 study, involving over 260 patients with type 2 diabetes. The study aims to evaluate the efficacy and safety of BMF-219 through various dosing regimens. Initial results indicate promising durability of glycemic control with BMF-219, suggesting potential as a novel treatment approach for type 2 diabetes. Data from the expansion arms are expected to be presented in Q4 2024.
Read more →BMEABiomea Fusion Reports First Quarter 2024 Financial Results and Corporate Highlights • Reported positive data from the escalation portion of Phase 1/2 study (COVALENT-111) in type 2 diabetes patients, displaying du
Biomea Fusion has announced promising preliminary results from its ongoing Phase 1/2 studies for its drug BMF-219, demonstrating improvements in glycemic control in type 2 diabetes patients and early clinical activity in type 1 diabetes patients. The company reported a cash position of $145.3 million at the end of Q1 2024, despite a net loss of $39.1 million during the same period. Enrollment rates for both studies are increasing, and the company has several anticipated milestones for 2024.
Read more →BMEABiomea Fusion Highlights Initial Data from the First Two Type 1 Diabetes Patients Dosed with BMF-219 BMF-219 is an investigational novel covalent menin inhibitor developed to regenerate insulin-producing beta cells with
Biomea Fusion has reported initial response data from the first two type 1 diabetes patients in the COVALENT-112 study who received the investigational drug BMF-219. Both patients exhibited improved beta-cell function after just four weeks of treatment, indicating potential disease-modifying benefits. The study aims to validate these findings with larger patient groups and longer follow-ups. The ongoing Phase II trial is designed to explore the safety and efficacy of BMF-219 as a novel therapeutic approach for diabetes management.
Read more →BMEABiomea Fusion Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Highlights • In 2023, reported Phase 2 data (COVALENT-111) in type 2 diabetes patients supporting the disease-modifying poten
Biomea Fusion announced its fourth quarter and full year 2023 financial results, highlighting the encouraging Phase 2 data for BMF-219 in type 2 diabetes, which shows potential in disease modification. The company is progressing well with the expansion of COVALENT-111, aiming to gather more data on the drug's efficacy. Additionally, a new Phase 2 study for type 1 diabetes (COVALENT-112) has been initiated. With a cash position of $177.2 million, Biomea is preparing for important clinical developments anticipated in 2024.
Read more →BMEABiomea Fusion Presents Patient Cohorts in COVALENT-111 Displaying a Durable Placebo-Adjusted Mean Reduction of up to 1.4% in HbA1c While Off Therapy at Week-26, after BMF-219 s 28-Day Treatment Cycle, Supporting Improved
Biomea Fusion has presented positive data from the COVALENT-111 trial, demonstrating a mean reduction of up to 1.4% in HbA1c levels after a 28-day treatment cycle of BMF-219 in patients with type 2 diabetes. This data will be showcased at the ATTD conference in Florence, highlighting the drug's potential in managing glycemic control. The ongoing study's success may pave the way for an expansion phase and further trials, including those for type 1 diabetes. Overall, the results support Biomea's goal of improving treatments for metabolic diseases.
Read more →BMEAJP Morgan 2024 Corporate Presentation Page 1 Disclaimer Legal Disclaimer & Forward-Looking Statements Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These sta
Biomea Fusion, Inc. has provided a corporate presentation outlining its forward-looking statements regarding future business performance and potential risks. The company is focused on developing innovative therapies targeting genetically defined cancers and metabolic diseases, with several clinical trials underway. It emphasizes its experienced management team and a promising pipeline. However, the presentation also highlights the uncertainties and risks associated with these forward-looking statements, including the potential for delays in clinical trial outcomes and external economic factors.
Read more →BMEABiomea Fusion Highlights Recent Updates and Anticipated 2024 Corporate Milestones at 42nd Annual J.P. Morgan Healthcare Conference
Biomea Fusion Inc. is highlighting its recent clinical advancements and corporate milestones at the 42nd Annual J.P. Morgan Healthcare Conference. Progress includes the expansion of its Phase II COVALENT-111 study for type 2 diabetes and the initiation of COVALENT-112 for type 1 diabetes, with data readouts expected in 2024. The company is moving forward with its research on BMF-219 and BMF-500, focusing on genetically-defined cancers and metabolic diseases. Biomea anticipates significant data presentations and milestones throughout the year.
Read more →BMEA▲ +8.4%on this newsshared move
Biomea Fusion Announces Dosing of First Type 1 Diabetes Patient in Phase II Study (COVALENT-112) with BMF-219
Biomea Fusion has announced the dosing of the first patient in its Phase II clinical trial (COVALENT-112) for BMF-219, a novel treatment for type 1 diabetes. This study seeks to assess the safety and efficacy of the drug in restoring beta cell function among adult patients who have been diagnosed for up to 15 years. With expectations to reveal data in 2024, the trial involves both a double-blind and open-label component to thoroughly evaluate the drug's potential benefits and risks.
Read more →BMEABiomea Fusion to Present at the 42nd Annual J.P. Morgan Healthcare Conference
Biomea Fusion, Inc. has announced that its CEO Thomas Butler will present at the 42nd Annual J.P. Morgan Healthcare Conference on January 9, 2024. The company, which specializes in developing covalent small molecules for genetically defined cancers and metabolic diseases, will also hold 1x1 meetings during the conference. A live webcast of the presentation will be available on their website, highlighting their innovative drug development techniques and proprietary technology.
Read more →BMEA▼ -30.3%on this news
Biomea Fusion Presents Achievement of Minimal Residual Disease Negativity (MRD-neg) in First Complete Responder from Ongoing Phase I Study (COVALENT-101) of BMF-219 in Patients with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) at the 2023 ASH Annual Meeting
Biomea Fusion presented promising clinical data for BMF-219, a covalent menin inhibitor, at the 2023 ASH Annual Meeting. The Phase I COVALENT-101 study indicated a 29% complete response rate among evaluable patients with relapsed or refractory acute myeloid leukemia (AML). BMF-219 was generally well tolerated, with no significant toxicities reported. Continued trials will focus on optimizing dosing and targeting patients with menin-sensitive mutations to enhance therapeutic outcomes.
Read more →BMEA▼ -30.3%on this newsshared move
Biomea Fusion Announces Near Doubling the Percentage of Patients with Durable HbA1c Reduction in the 200 mg Dose Cohorts
Biomea Fusion has announced encouraging results from its Phase II clinical study of BMF-219, where 40% of patients in the 200 mg dosing cohort achieved a durable reduction in HbA1c of 1% or more by week 26. This marks a significant improvement compared to the 20% reduction observed in the 100 mg cohort. The company plans to present detailed long-term follow-up data at the upcoming ATTD conference in March 2024, indicating ongoing progress in diabetes treatment. The study has reported no serious adverse events, highlighting BMF-219's safety profile.
Read more →BMEA▲ +12.4%on this newsshared move
Biomea Fusion Presents Long-Term Follow-Up Data Showing Improved Glycemic Control after 22 Weeks Off Treatment in Ongoing Phase II Study (COVALENT-111) of BMF-219 in Adults with Type 2 Diabetes in a Poster Presentation at the World Congress Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC)
Biomea Fusion presented promising long-term follow-up data from the Phase II COVALENT-111 study of BMF-219 for adults with type 2 diabetes. The data indicated a significant placebo-adjusted reduction in HbA1c levels at 26 weeks following treatment cessation, suggesting improved glycemic control. Additionally, BMF-219 was well tolerated, with no severe adverse events reported. The research also highlighted the potential role of menin inhibitor BMF-219 in enhancing beta cell function and insulin production.
Read more →BMEA▼ -18.5%on this newsshared move
Biomea Fusion to Present Long-Term Follow-Up Data from Ongoing Phase II Study (COVALENT-111) of BMF-219 in Adults with Type 2 Diabetes and Results from Ex-Vivo Human Islet Experiments at the World Congress Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC)
Biomea Fusion is set to present data from its ongoing Phase II study of BMF-219, a novel menin inhibitor for Type 2 diabetes, at the WCIRDC. The study highlights promising results, including significant reductions in HbA1C levels among participants and favorable safety profiles. The ongoing research aims to explore BMF-219's effect on beta cell regeneration, addressing a fundamental challenge in diabetes treatment. Preliminary findings suggest potential disease-modifying benefits of BMF-219, with presentations scheduled for December 7-8, 2023.
Read more →BMEABiomea Fusion Announces Health Canada Clearance of Clinical Trial Application (CTA) for BMF-219 in Type 1 Diabetes
Biomea Fusion has received clearance from Health Canada to initiate a Phase II clinical trial for BMF-219, an investigational covalent menin inhibitor aimed at treating type 1 diabetes. This trial, named COVALENT-112, will evaluate the safety and efficacy of BMF-219 in adults diagnosed with type 1 diabetes, assessing two different dosages over a 12-week period. The trial will also include an open label portion for participants with a longer duration of the disease. This advancement follows FDA clearance for the same trial in October 2023, showcasing the drug's potential in restoring insulin-producing beta cells.
Read more →BMEABiomea Fusion Announces Acceptance of Three Abstracts for its Novel Menin Inhibitor Highlighting Durable Glycemic Control in Diabetes Patients at the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in 2024
Biomea Fusion, Inc. announced the acceptance of three abstracts for presentation at the 2024 International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Florence, Italy. The abstracts detail new clinical data from the COVALENT-111 trial, which evaluates the company’s BMF-219 menin inhibitor as a treatment for type 2 diabetes. This novel approach aims to improve glycemic control and regenerate beta cells, addressing a significant need in diabetes management. Further information will be disclosed according to ATTD policies.
Read more →BMEABiomea Fusion Abstract “BMF-219: A Novel Therapeutic Agent to Reestablish Functional Beta Cells and Provide Long-term Glycemic Control" Selected as One of Six Oral Presentations at 21st World Congress Insulin Resistance, Diabetes & Cardiovascular Disease
Biomea Fusion, Inc. (BMEA) announced that its abstract on BMF-219, a novel therapeutic agent aimed at restoring functional beta cells for long-term glycemic control, has been selected for an oral presentation at the 21st World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC) on December 8, 2023. The company will also present topline data from the COVALENT-111 clinical trial, which focuses on multiple dosing cohorts of BMF-219 in patients with type 2 diabetes. This meeting signifies a crucial opportunity to showcase Biomea's advancement in diabetes care and its potential therapeutic benefits.
Read more →BMEABiomea Fusion to Present New Data from Ongoing Phase II Study (COVALENT-111) of BMF-219 in Patients with Type 2 Diabetes at the World Congress Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC)
Biomea Fusion, a clinical-stage biopharmaceutical company, is set to present new data from its Phase II COVALENT-111 study of BMF-219 for type 2 diabetes at the upcoming WCIRDC meeting in Los Angeles. The study aims to evaluate the safety and efficacy of BMF-219, a novel therapeutic agent that targets the regeneration of functional beta cells. Topline data from the escalation portion of the study is anticipated to be released before the end of the year. This presentation highlights Biomea's commitment to addressing crucial metabolic health issues through innovative developments.
Read more →BMEABiomea Fusion Announces Two Poster Presentations at Upcoming ASH Annual Meeting 2023
Biomea Fusion has announced that abstracts for its investigational drugs BMF-219 and BMF-500 have been accepted for presentation at the upcoming ASH Annual Meeting 2023. BMF-219 is a covalent menin inhibitor currently in a Phase 1 clinical study for liquid and solid tumors, while BMF-500 is a covalent FLT3 inhibitor also in a Phase 1 study for acute leukemias. The presentations will take place in San Diego from December 9-12, 2023, highlighting the ongoing advancements in the company's clinical trials.
Read more →BMEABiomea Fusion Reports Third Quarter 2023 Financial Results and Corporate Highlights • Demonstrated durable HbA1c lowering in the escalation portion of ongoing Phase II study in type 2 diabetes (COVALENT-111), with
Biomea Fusion reported its third-quarter 2023 financial results, highlighting the successful lowering of HbA1c levels in type 2 diabetes patients through the COVALENT-111 study. The company is actively enrolling patients in both type 1 and type 2 diabetes trials, with the potential to initiate treatments earlier than expected. Furthermore, initial results from the ongoing Phase I trial of BMF-219 for treating relapsed/refractory AML patients demonstrated encouraging efficacy. Despite these advancements, Biomea reported increased net losses and elevated research and development costs during the quarter.
Read more →BMEA▲ +6.7%on this news
Biomea Fusion Announces First Patient Dosed with Covalent FLT3 Inhibitor BMF-500 in Relapsed or Refractory Acute Leukemia in Phase I Clinical Trial (COVALENT-103)
Biomea Fusion has announced the dosing of the first patient in its Phase I clinical trial (COVALENT-103) for BMF-500, a new covalent FLT3 inhibitor aimed at treating adults with relapsed or refractory acute leukemia. The trial will assess the safety and efficacy of BMF-500, which shows strong potential in targeting various FLT3 mutations based on preclinical studies. This marks a significant advancement in Biomea's efforts to provide effective therapies for genetically defined cancers. The company aims to explore further combination therapies involving BMF-500 and other treatments.
Read more →BMEABiomea Fusion Announces FDA Clearance of Investigational New Drug (IND) Application for BMF-219 in Type 1 Diabetes
Biomea Fusion has received FDA clearance for its investigational new drug application for BMF-219, allowing the initiation of the COVALENT-112 Phase II clinical trial in adults with type 1 diabetes. The study aims to evaluate the safety and efficacy of BMF-219, a covalent menin inhibitor, which may help restore insulin-producing beta cell function. This multi-arm trial will involve approximately 150 patients and focus on assessing the effects of two oral doses of BMF-219 versus placebo. Biomea's previous research indicates significant potential in addressing the underlying causes of diabetes, marking a positive advancement for possible new treatments.
Read more →BMEABiomea Fusion Announces FDA and Health Canada Clearance of the Expansion Cohorts of the Ongoing COVALENT-111 Phase II Study
Biomea Fusion has received FDA and Health Canada clearance for the expansion phase of its ongoing COVALENT-111 Phase II study, which will investigate the effects of BMF-219 on type 2 diabetes patients. The study will enroll approximately 300 patients across three cohorts, with a fourth cohort to follow. Early data from the escalation portion shows that a substantial percentage of patients experienced HbA1c reductions, indicating potential effectiveness of BMF-219. Topline results are expected later in 2023, suggesting an optimistic outlook on this innovative treatment approach.
Read more →BMEABiomea Fusion Reports Second Quarter 2023 Financial Results and Corporate Highlights • Reported additional positive clinical data at ADA 83 rd Scientific Sessions from the first two cohorts of patients with type 2
Biomea Fusion reported positive second quarter 2023 financial results, highlighting additional clinical data from the ongoing Phase I/II study of BMF-219 for type 2 diabetes and initial responses in relapsed/refractory AML patients. The data showed substantial improvements in HbA1c and suggested BMF-219 might serve as a disease-modifying therapy. BMF-219's promising safety profile was noted, with no serious adverse effects reported. Biomea continues to advance its pipeline, including another product candidate, BMF-500, toward clinical evaluation.
Read more →BMEA▼ -14.6%on this news
BMF-219 Induces Complete Responses in Target Acute Myeloid Leukemia (AML) Patient Population Initial topline data from COVALENT-101 trial revealed 2 complete responses (CRs) out of 5 relapsed/refractory AML patients carr
Biomea Fusion announced preliminary topline data from the Phase I COVALENT-101 trial, reporting two complete responses in relapsed/refractory AML patients treated with BMF-219. This covalent menin inhibitor has shown promising early results, demonstrating its role in targeting genetically defined mutations in AML. No significant safety concerns were reported during the trial, supporting the potential for further dose escalation and optimization. The company anticipates presenting additional data at a scientific conference in the near future.
Read more →BMEA▼ -20.4%on this news
Biomea Fusion Presents Positive Clinical Data from the Initial Cohorts of the Ongoing Phase II Study (COVALENT-111) of BMF-219 in Patients with Type 2 Diabetes Mellitus at the American Diabetes Association (ADA) 83rd Scientific Sessions; 100 mg Cohort 3 Demonstrated a 90% Response Rate and 70% Maintained or Improved Time in (Normal Glucose) Range, While Off-Treatment
Biomea Fusion presented promising clinical data for its investigational drug BMF-219 at the ADA 83rd Scientific Sessions. The Phase II study COVALENT-111 showed that 90% of patients in Cohort 3 achieved a response, with 70% maintaining or improving their glucose levels even after treatment cessation. The drug demonstrated a continual reduction in HbA1c levels, with 60% of patients achieving target levels by Week 12. This suggests BMF-219's potential as a disease-modifying treatment for type 2 diabetes, though additional validation is needed in larger cohorts.
Read more →BMEABiomea Fusion to Present Late Breaking Data from Ongoing Phase II Trial, COVALENT-111, Evaluating BMF-219 in Patients with Type 2 Diabetes at ADA 2023
Biomea Fusion, Inc. is set to present new clinical data from its ongoing Phase II COVALENT-111 trial at the 2023 American Diabetes Association's Scientific Sessions. The trial evaluates BMF-219, a novel covalent menin inhibitor, aimed at restoring healthy insulin-producing beta cells for type 2 diabetes patients. The poster presentation will take place from June 23-26 in San Diego, complemented by a KOL investor event on June 24. Initial topline results from prior cohorts indicate potential benefits of BMF-219 in glycemic control.
Read more →BMEA▼ -8.5%on this news
Biomea Fusion Reports First Quarter 2023 Financial Results and Corporate Highlights • Reported initial positive clinical data from first two cohorts of Phase II of ongoing Phase I/II study (COVALENT-111) of BMF-21
Biomea Fusion has reported its first quarter 2023 financial results, emphasizing initial positive data from its ongoing Phase II trials of BMF-219 for Type 2 diabetes. The company is also progressing with its portfolio, including enrollment in multiple studies targeting various liquid and solid tumors. Additionally, Biomea successfully closed a public offering, enhancing its financial position with approximately $250 million available for development. Key milestones include upcoming clinical data presentations at significant scientific meetings.
Read more →BMEA▲ +7.6%on this newsshared move
Biomea Fusion Announces FDA Clearance of Investigational New Drug (IND) Application for Covalent FLT3 Inhibitor BMF-500 in Relapsed or Refractory Acute Leukemia BMF-500, a novel 3 rd generation covalent inhibitor of fms-
Biomea Fusion has announced that the FDA has cleared its Investigational New Drug (IND) application for BMF-500, a covalent FLT3 inhibitor aimed at treating relapsed or refractory acute leukemia. This approval paves the way for a Phase I trial (COVALENT-103), marking a significant advancement in Biomea's development of innovative covalent small molecules. Preclinical studies have demonstrated BMF-500’s high potency and selectivity, positioning it as a potentially effective treatment for patients with FLT3 mutations. The company plans to explore both single-agent and combination therapies to improve patient outcomes.
Read more →BMEA▲ +5.8%on this news
Biomea Fusion to Present Late Breaking Data from Ongoing Phase II Trial, COVALENT-111, Evaluating BMF-219 in Patients with Type 2 Diabetes, at the ADA 83rd Scientific Sessions 2023 in June
Biomea Fusion, Inc. announced that it will present new clinical data from the COVALENT-111 trial evaluating BMF-219 for type 2 diabetes at the ADA 83rd Scientific Sessions in June 2023. The presentation will include findings from the trial's Phase II portion, which focuses on patients with uncontrolled type 2 diabetes. Additionally, the company will host an investor and Key Opinion Leader (KOL) event during the sessions. The ongoing trial aims to determine the efficacy of BMF-219 in regenerating insulin-producing beta cells, potentially offering a new treatment approach for managing type 2 diabetes.
Read more →BMEABiomea Fusion To Present Two Preclinical Posters at the 114th AACR Annual Meeting
Biomea Fusion announced the presentation of two preclinical posters at the 114th AACR Annual Meeting, highlighting promising data for its investigational drugs BMF-219 and BMF-500. The studies demonstrate BMF-219's superior potency in inhibiting growth in CLL samples compared to existing treatments and suggest that combining it with BMF-500 could enhance effectiveness in AML models. The data collected supports the potential clinical use of these covalent inhibitors in therapeutics for genetically defined cancers.
Read more →BMEABiomea Fusion Announces Closing of Upsized Public Offering and Full Exercise of the Underwriters’ Option to Purchase Additional Shares
Biomea Fusion, Inc. announced the successful closing of its upsized public offering, comprising 5,750,000 shares at $30.00 each, generating approximately $172.5 million in gross proceeds. The funds are designated for advancing clinical development of its lead drug, BMF-219, along with improvements in production and exploration of additional diabetic patient populations. The company works to discover novel treatments for genetically defined cancers and metabolic diseases using its proprietary FUSION System.
Read more →BMEABiomea Fusion Announces Pricing of Upsized Public Offering of Common Stock
Biomea Fusion, Inc. has announced the pricing of an upsized public offering of 5 million shares of common stock, priced at $30.00 each. This offering is expected to generate gross proceeds of $150 million before expenses and is set to close on April 3, 2023, pending customary conditions. Biomea aims to utilize the funds to further its pipeline of novel covalent small molecules for treating genetically defined cancers and metabolic diseases.
Read more →BMEA▲ +5.3%on this newsshared move
Biomea Fusion Announces Proposed Public Offering of Common Stock
Biomea Fusion, Inc. has announced a proposed public offering of common stock worth $125 million, with an additional $18.75 million possible through an underwriter option. The offering is currently set under market conditions and is supported by financial partners including J.P. Morgan and Citigroup. As a clinical-stage biopharmaceutical company, Biomea aims to enhance treatment options for genetically defined cancers and metabolic diseases using novel covalent small molecules. The announcement includes forward-looking statements that highlight various risks associated with the offering's completion.
Read more →BMEA▲ +99%on this news· ran to +110% by day 1shared move
Biomea Fusion Announces Positive Data from Initial Cohorts of Ongoing Phase II Study (COVALENT-111) of BMF-219 in Patients with Type 2 Diabetes; 100 mg Cohort 3 Demonstrated an 89% Response Rate and 1% Median Reduction i
Biomea Fusion has announced positive initial data from its ongoing Phase II study of BMF-219 in patients with Type 2 Diabetes (COVALENT-111). The study indicates an 89% response rate among participants in the 100 mg cohort, along with a median HbA1c reduction of 1% observed at Day 28. The treatment aims to regenerate insulin-producing beta cells and exhibits potential as a disease-modifying therapy. The study is ongoing, with further evaluation planned for efficacy and tolerability across multiple dose levels.
Read more →BMEA▲ +99%on this news· ran to +110% by day 1shared move
Biomea Fusion Reports Fourth Quarter and Full Year 2022 Financial Results and Corporate Highlights • Expanded clinical development footprint of BMF-219, the company's lead investigational, orally administered, cov
Biomea Fusion has reported its fourth quarter and full year 2022 financial results, highlighting significant advancements in its clinical programs. The company expanded the development of its lead candidate, BMF-219, across eight tumor types and type 2 diabetes, with promising results emerging from ongoing trials. Despite a larger net loss compared to the previous year and a reduced cash position, Biomea remains optimistic about upcoming data readouts and the potential of its therapies in treating genetically defined cancers and metabolic diseases.
Read more →BMEA▲ +5.3%on this news· ran to +105% by day 3shared move
Biomea Fusion to Host Conference Call and Webcast to Discuss Initial Phase II Clinical Data for BMF-219 in Subjects with Type 2 Diabetes on March 28th, 2023 at 8:30 a.m. ET
Biomea Fusion, Inc. announced it will hold a conference call and webcast on March 28th, 2023, to discuss initial clinical data from the Phase II trial of BMF-219 for Type 2 Diabetes. The ongoing Phase II portion of the COVALENT-111 study comprises multiple ascending dose cohorts of patients uncontrolled by existing therapies. BMF-219 targets the regeneration of beta cells in the pancreas, potentially providing long-term glycemic control. This development aims to address the increasing prevalence of Type 2 Diabetes in the United States.
Read more →BMEA▼ -8.1%on this news
Biomea Fusion To Participate In Upcoming Investor Events
Biomea Fusion, Inc. (BMEA) has announced its participation in several upcoming investor events, including virtual fireside chats and meetings during major healthcare conferences. The company focuses on developing covalent small molecules to treat genetically defined cancers and metabolic diseases. Such engagements aim to enhance investor relations and showcase Biomea's innovative therapeutic approaches. The company emphasizes its proprietary FUSION™ System in advancing its drug development pipeline while acknowledging certain forward-looking risks. Archived replays of the events will be available on Biomea's investor page.
Read more →BMEA▲ +11.7%on this news· ran to +32% by day 3
Biomea Fusion Doses First Patient in Phase I/Ib Clinical Trial (COVALENT-102) of BMF-219 in KRAS Mutant Solid Tumors
Biomea Fusion has initiated a Phase I/Ib clinical trial, COVALENT-102, for BMF-219, the first menin inhibitor targeting KRAS-mutated solid tumors. The drug aims to treat patients with non-small cell lung cancer, colorectal cancer, and pancreatic cancer, showing promising sensitivity in preclinical studies. The trial will evaluate the safety, tolerability, and optimal dosing of BMF-219 in these patient populations. BMF-219 stands out for its potential to overcome resistance mechanisms seen with existing KRAS-targeted therapies.
Read more →BMEABiomea Fusion to Present at 41 st Annual J.P. Morgan Healthcare Conference and Highlight 2023 Corporate Milestones
Biomea Fusion, Inc. announced that its CEO, Thomas Butler, will present key corporate milestones at the upcoming J.P. Morgan Healthcare Conference. The company, focused on developing novel covalent small molecules for treating genetically defined cancers and metabolic diseases, enters 2023 with significant progress, including three ongoing clinical trials studying BMF-219 across cancer and diabetes indications. Additionally, Biomea anticipates advancing BMF-500 into clinical trials pending FDA clearance of an IND. The company aims to maintain momentum with patient-centric execution throughout the year.
Read more →BMEABiomea Fusion to Present at 41st Annual J.P. Morgan Healthcare Conference and Highlight 2023 Corporate Milestones
Biomea Fusion, Inc. is scheduled to present at the 41st Annual J.P. Morgan Healthcare Conference, showcasing its 2023 corporate milestones. The company highlighted strong progress in its clinical trials, including BMF-219 for various cancers and Type 2 diabetes. Biomea plans to further advance its clinical studies, with initial data from multiple trials expected in the first half of 2023, demonstrating its potential in treating genetically defined diseases.
Read more →BMEA▼ -9.7%on this news· ran to -20% by day 3shared move
Biomea Fusion Announces Dosing of First Patient with Type 2 Diabetes in the United States in Ongoing Phase I/II (COVALENT-111) Study of BMF-219
Biomea Fusion has announced the dosing of the first patient with type 2 diabetes in the Phase II portion of its COVALENT-111 study in the U.S. This clinical trial is investigating BMF-219, an orally available menin inhibitor, which aims to improve beta cell function and potentially address the underlying causes of diabetes. Initial data from this phase of the trial is anticipated in the first half of 2023, highlighting the company's progress in diabetes treatment innovation.
Read more →BMEABiomea Fusion Announces FDA Clearance of Investigational New Drug (IND) Application for Covalent Menin Inhibitor BMF-219 in Type 2 Diabetes COVALENT-111, a Phase I/II clinical trial in patients with type 2 diabetes, alre
Biomea Fusion Announces FDA Clearance of Investigational New Drug (IND) Application for Covalent Menin Inhibitor BMF-219 in Type 2 Diabetes REDWOOD CITY, Calif., December 14, 2022 (GLOBE NEWSWIRE) Biomea Fusion, Inc. ( Biomea ) (Nasdaq: BMEA), a clinical-stage biopharmaceutica
Read more →BMEABiomea Fusion Presents at the 2022 ASH Annual Meeting Preclinical Data on BMF-500 Supporting its Potential as the Most Potent and Selective FLT3 Inhibitor to Date BMF-500, an investigational third generation covalent FLT
Biomea Fusion Presents at the 2022 ASH Annual Meeting Preclinical Data on BMF-500 Supporting its Potential as the Most Potent and Selective FLT3 Inhibitor to Date REDWOOD CITY, Calif., December 12, 2022 (GLOBE NEWSWIRE) Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biop
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Biomea Fusion to Participate in Piper Sandler 34th Annual Healthcare Conference
REDWOOD CITY, Calif., Nov. 11, 2022 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”)(Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defi
Read more →BMEA▼ -10.2%on this news· ran to -25% by day 3
Biomea Fusion Reports Third Quarter 2022 Financial Results and Business Highlights • Continued to establish Biomea Fusion as the next-generation leader in covalent medicines • Expanded clinical development
Biomea Fusion Reports Third Quarter 2022 Financial Results and Business Highlights -Continued to establish Biomea Fusion as the next-generation leader in covalent medicines -Expanded clinical development footprint of BMF-219, the company's lead investigational, orally administe
Read more →BMEABiomea Fusion to Present Preclinical Data for BMF-500, an Investigational Oral Covalent FLT3 Inhibitor, at the 64th American Society of Hematology (ASH) Annual Meeting
BMF-500, an investigational third generation covalent FLT3 inhibitor, has demonstrated preclinically that it may be the most potent and selective inhibitor of FLT3 evaluated to date: Greater Cytotoxicity: In acute myeloid leukemia (AML) cell lines, three-hour treatment with BMF-5
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Biomea Fusion Announces Dosing of First Patient with Type 2 Diabetes and Completion of Phase I Healthy Volunteer Portion of Phase I/II (COVALENT-111) Study of BMF-219 BMF-219 is the first menin inhibitor to reach the cli
Biomea Fusion Announces Dosing of First Patient with Type 2 Diabetes and Completion of Phase I Healthy Volunteer Portion of Phase I/II (COVALENT-111) Study of BMF-219 REDWOOD CITY, Calif., October 31, 2022 (GLOBE NEWSWIRE) Biomea Fusion, Inc. ( Biomea ) (Nasdaq: BMEA), a clinica
Read more →BMEABiomea Fusion Announces First Patient Dosed with Chronic Lymphocytic Leukemia (CLL) in COVALENT-101 Trial
COVALENT-101 now includes patients with relapsed/refractory (R/R) CLL BMF-219 is the first menin inhibitor in the clinic for CLL Preclinical data presented at ASCO 2022 demonstrated the potency of BMF-219, a covalent menin inhibitor, across varying cytogenetic risk profiles and
Read more →BMEABMF-219 Enters the Clinic for KRAS Solid Tumors Biomea Fusion announces FDA clearance of Investigational New Drug (IND) application for covalent menin inhibitor BMF-219 in KRAS solid tumors. Biomea Fusion will now initia
BMF-219 Enters the Clinic for KRAS Solid Tumors REDWOOD CITY, Calif., October 14th, 2022 (GLOBE NEWSWIRE) Biomea Fusion, Inc. ( Biomea ) (Nasdaq: BMEA), a biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with genet
Read more →BMEABiomea Fusion Presents New Translational Data at the European Association for the Study of Diabetes (EASD) 2022 in Animal Models and Ex-vivo Human Donor Islets Further Supporting BMF-219 s Potential as an Oral, Long-Acti
These risks concerning Biomea Fusion s business and operations are described in additional detail in its periodic filings with the U.S. Securities and Exchange Commission (the SEC ), including its most recent periodic report filed with the SEC and subsequent filings thereafter. B
Read more →BMEABiomea Fusion Presents New Preclinical Data at the European Association for the Study of Diabetes (EASD) Annual Meeting Describing BMF-219 s Potential as a Novel, Oral, Long-Acting Treatment for Type 2 Diabetes
Biomea Fusion Presents New Preclinical Data at the European Association for the Study of Diabetes (EASD) Annual Meeting Describing BMF-219 s Potential as a Novel, Oral, Long-Acting Treatment for Type 2 Diabetes September 20, 2022, at REDWOOD CITY, California, September 20, 2022
Read more →BMEABiomea Fusion Presents Additional Preclinical Data Demonstrating Anti- Tumor Activity and Mechanistic Evidence for BMF-219 in Diffuse Large B-Cell Lymphoma and Multiple Myeloma Models at International Myeloma Society Ann
Biomea Fusion Presents Additional Preclinical Data Demonstrating Anti- Tumor Activity and Mechanistic Evidence for BMF-219 in Diffuse Large B-Cell Lymphoma and Multiple Myeloma Models at International Myeloma Society Annual Meeting REDWOOD CITY, Calif., Aug. 26, 2022 (GLOBE NEWS
Read more →BMEABiomea Fusion Reports Second Quarter 2022 Financial Results and Business Highlights • Continued to make significant progress advancing BMF-219, the company's lead investigational orally administered covalent menin
Biomea Fusion Reports Second Quarter 2022 Financial Results and Business Highlights -Continued to make significant progress advancing BMF-219, the company's lead investigational orally administered covalent menin inhibitor, in multiple oncology indications oCOVALENT-101 (Phase
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Biomea Fusion Selected for Two Oral Presentations at the European Association for the Study of Diabetes Annual Meeting Describing BMF-219’s Potential as a Novel, Oral, Long-Acting, Acute Treatment for Type 2 Diabetes
Biomea to present two oral abstracts across multiple animal models highlighting the ability of BMF-219, a covalent menin inhibitor, to significantly lower HbA1C (approximately two-fold greater reduction than active control, liraglutide) and to increase beta cell function. BMF-21
Read more →BMEA▲ +14%on this news· ran to +34% by day 3
Biomea Fusion Announces First Patient Dosed in Multiple Myeloma Cohort of COVALENT-101 Trial
BMF-219, a covalent menin inhibitor, is the first menin inhibitor administered to patients with relapsed/refractory (R/R) multiple myeloma (MM) Patients with R/R MM and R/R diffuse large B-cell lymphoma (DLBCL) are eligible for enrollment in COVALENT-101 Enrollment continuing f
Read more →BMEAPreclinical Activity of irreversible menin inhibitor, BMF-219, in Chronic Lymphocytic LeukemiaPriyanka Somanath, PhD1, Daniel Lu, MS 1 Brian Law, BS 1, Lekha Kumar, MS1, Tenley Archer, PhD, Tripta Rughwani, MS, Taisei Ki
Preclinical Activity of irreversible menin inhibitor, BMF-219, in Chronic Lymphocytic LeukemiaPriyanka Somanath, PhD1, Daniel Lu, MS 1 Brian Law, BS 1, Lekha Kumar, MS1, Tenley Archer, PhD, Tripta Rughwani, MS, Taisei Kinoshita, PhD1, Mini Balakrishnan, PhD1 and Thomas Butler, M
Read more →BMEABiomea Fusion Presents Novel Preclinical Data at ADA 2022 Suggesting BMF-219’s Potential as an Oral, Long-Acting Treatment for Type 2 Diabetes
Menin acts as a ‘brake’ on beta cell regeneration; inhibiting menin function with BMF-219 may increase beta cell production and function, thereby increasing insulin levels and controlling high glucose levels BMF-219, a covalent menin inhibitor, showed strong, prolonged glycemic
Read more →BMEA▲ +7.6%on this news· ran to +57% by day 3shared move
Biomea Fusion to Participate in Jefferies Healthcare Conference
REDWOOD CITY, Calif., June 02, 2022 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancer
Read more →BMEA▼ -18.9%on this newsshared move
Biomea Fusion to Present New Preclinical Data on BMF-219 in Two Diabetic Animal Models at ADA 2022
Company to host virtual investor R&D event on Monday, June 6, 2022 at 4:05 PM EDT featuring covalent menin inhibitor, BMF-219, as a potential novel treatment for type 2 diabetes REDWOOD CITY, Calif., June 01, 2022 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (Nasdaq: BMEA), a clinica
Read more →BMEABiomea Fusion to Present New Preclinical Data Showing BMF-219’s Strong Activity in Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) Tumor Models at ASCO 2022
BMF-219 is the first investigational menin inhibitor in clinical development to show potential as a therapeutic agent for CLL BMF-219, a covalent menin inhibitor, demonstrated potency across ex vivo CLL tumor models with varying cytogenetic risk profiles and Rai stages, indicati
Read more →BMEA▲ +8.5%on this news
Biomea Fusion to Attend H.C. Wainwright Global Investment Conference
REDWOOD CITY, Calif., May 20, 2022 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers
Read more →BMEA▲ +16.2%on this newsshared move
Biomea Fusion Announces IND Candidate Selection: BMF-500, a Potential Best-in-Class Oral Covalent Inhibitor of FLT3
BMF-500, an investigational third-generation covalent inhibitor of FLT3, demonstrated picomolar IC50 values across key FLT3 isoforms, potentially making it the most potent inhibitor of its class Highly selective for FLT3, BMF-500 was observed to avoid other type III receptor tyr
Read more →BMEABiomea Fusion Reports First Quarter 2022 Financial Results and Business Highlights • COVALENT-101 study continues to enroll relapsed/refractory (R/R) acute myeloid leukemia (AML) and acute lymphocytic leukemia (AL
Biomea Fusion Reports First Quarter 2022 Financial Results and Business Highlights -COVALENT-101 study continues to enroll relapsed/refractory (R/R) acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL) patients and has included R/R diffuse large B-cell lymphoma (DLB
Read more →BMEABiomea Fusion to Participate in Bank of America Securities 2022 Healthcare Conference
REDWOOD CITY, Calif., May 09, 2022 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers
Read more →BMEABiomea Fusion Announces Acceptance of Multiple Abstracts at the 2022 ASCO Annual Meeting
Biomea to present preclinical data in chronic lymphocytic leukemia (CLL) and Trial In Progress (TIP) information for its ongoing COVALENT-101 Phase I trial REDWOOD CITY, Calif., April 27, 2022 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceut
Read more →BMEA▼ -12%on this newsshared move
FIRST AMENDMENT TO CHANGE IN CONTROL AND SEVERANCE AGREEMENT This First Amendment to Change in Control and Severance Agreement (this Amendment ) is executed as of [ ], 2022, by and between Biomea Fusion, Inc., a Delaware
CHANGE IN CONTROL AND SEVERANCE AGREEMENT This First Amendment to Change in Control and Severance Agreement (this Amendment ) is executed as of [ ], 2022, by and between Biomea Fusion, Inc., a Delaware corporation (the Company ), and [ ] (the Executive ). Company and Executive
Read more →BMEABiomea Fusion Reports Preclinical Data on BMF-219 and Trial in Progress Presentations at AACR 2022 Annual Meeting
Biomea Fusion Reports Preclinical Data on BMF-219 and Trial in Progress Presentations at AACR 2022 Annual Meeting REDWOOD CITY, Calif., April 08, 2022 (GLOBE NEWSWIRE) Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and d
Read more →BMEABiomea Fusion Announces Acceptance of Late Breaking Presentation of Lead Menin Inhibitor BMF-219 in Diabetes at ADA 82nd Scientific Sessions 2022
Biomea to present additional preclinical data from an in vivo study of BMF-219 in type 2 diabetes REDWOOD CITY, Calif., April 06, 2022 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of
Read more →BMEA▼ -9.3%on this news
Biomea Fusion to Present at Oppenheimer’s 32nd Annual Virtual Healthcare Conference
REDWOOD CITY, Calif., March 15, 2022 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible covalent small molecules to treat and improve the lives of patients with geneti
Read more →BMEABiomea Fusion Announces Presentation of Lead Menin Inhibitor BMF-219 in Diabetes at ADA 82nd Scientific Sessions 2022
Biomea to present preclinical data from multiple in vivo studies Biomea plans to initiate a Phase I/II clinical trial of BMF-219 in diabetes in the second half of 2022, subject to submission and clearance of an investigational new drug (IND) application REDWOOD CITY, Calif., Ma
Read more →BMEABiomea Fusion Announces Upcoming Presentations of Preclinical Data in Diffuse Large B-Cell Lymphoma, Multiple Myeloma, and Several KRAS Mutant Solid Tumors for BMF-219 at AACR Annual Meeting 2022
Irreversible covalent menin inhibitor, BMF-219, exhibited high potency and complete growth inhibition in high-grade B-cell lymphoma and multiple myeloma (MM) preclinical patient derived ex vivo models BMF-219 demonstrated high potency in various KRAS-mutant cell lines, as well a
Read more →BMEA▼ -6.8%on this news
Biomea Fusion Reports Fourth Quarter and Full Year 2021 Financial Results and Corporate Highlights Phase I trial of BMF-219, an irreversible covalent menin inhibitor, is currently underway Plan to initiate trials of BMF-
Biomea Fusion Reports Fourth Quarter and Full Year 2021 Financial Results and Corporate Highlights REDWOOD CITY, Calif., February 28th, 2022 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery a
Read more →BMEA▼ -8.4%on this news
Biomea Fusion Announces Appointment of Steve Morris, M.D. as Chief Medical Officer
Renowned physician-scientist’s groundbreaking work led to the discovery and characterization of multiple oncogenes, including anaplastic lymphoma kinase (ALK) Dr. Morris will lead clinical development of BMF-219, an irreversible covalent menin inhibitor currently in a Phase I cl
Read more →BMEABiomea Fusion Announces First Patient Dosed
BMF-219 is the first irreversible covalent menin inhibitor to enter the clinic Phase I trial is enrolling patients with relapsed/refractory acute leukemias, including those with MLL1/KMT2A gene rearrangements or NPM1 mutations Phase I trial is expected to include up to 20 clini
Read more →BMEA▲ +5.3%on this news
Corporate Presentation January 2022 1 Disclaimer and Forward-Looking Statement Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to futur
Disclaimer and Forward-Looking Statement Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future business and financial performance of Biomea Fusion, Inc. (the "Company")
Read more →BMEABiomea Fusion Announces Participation at the H.C. Wainwright 2022 BioConnect Conference
REDWOOD CITY, Calif., Jan. 11, 2022 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and improve the lives of patients with genet
Read more →BMEABiomea Fusion Announces 2022 Clinical Development Plan to Initiate Studies in up to Seven Different Tumor Types and in Diabetes for BMF-219
REDWOOD CITY, Calif., Jan. 10, 2022 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and improve the lives of patients with genet
Read more →BMEA▲ +5.6%on this newsshared move
Biomea Fusion Releases Pre-Clinical Data with BMF-219 in Diabetes
REDWOOD CITY, Calif., Jan. 06, 2022 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of irreversible small molecules to treat and improve the lives of patients with genetically
Read more →BMEABiomea Fusion Moves into New Headquarters and Expands R&D Facility
REDWOOD CITY, Calif., Jan. 04, 2022 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and improve the lives of patients with genet
Read more →BMEABiomea Fusion to Present at the 40th Annual J.P. Morgan Healthcare Conference
REDWOOD CITY, Calif., Dec. 21, 2021 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and improve the lives of patients with genet
Read more →BMEA▼ -9.6%on this news
Biomea Fusion to be added to NASDAQ Biotechnology Index
REDWOOD CITY, Calif., Dec. 14, 2021 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and improve the lives of patients with genet
Read more →BMEABiomea fusion tm Corporate Presentation November 2021 Disclaimer and Forward-Looking Statement Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements
Biomea fusion tm Corporate Presentation November 2021 Disclaimer and Forward-Looking Statement Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future financial performan
Read more →BMEABiomea Fusion to Participate in Two Upcoming Investor Conferences
REDWOOD CITY, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and improve the lives of patients with genet
Read more →BMEABiomea Fusion Publishes Abstract on BMF-219 at ASH Annual Meeting
BMF-219 displays global disruption of menin, highlighting ‘219’s novel mechanism of action Molecule elicits broad impact on the complexes surrounding menin, resulting in strong modulation of MYC expression, highlighting potential in multiple cancer types BMF-219 demonstrated po
Read more →BMEA▲ +8.1%on this newsshared move
Biomea Fusion Reports Third Quarter 2021 Financial Results and Business Highlights Announced FDA clearance of Investigational New Drug Application (IND) for BMF-219, the company's first development candidate from the FUS
Biomea Fusion Reports Third Quarter 2021 Financial Results and Business Highlights REDWOOD CITY, Calif., Nov. 03, 2021 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of nove
Read more →BMEA▲ +17.3%on this news
Biomea Fusion Announces FDA Clearance of Investigational New Drug Application for Irreversible Menin Inhibitor BMF-219 Biomea Fusion to transform to a Clinical Stage Company with First in Human (FIH) Clinical Trial BMF-2
Biomea Fusion Announces FDA Clearance of Investigational New Drug Application for Irreversible Menin Inhibitor BMF-219 REDWOOD CITY, Calif., Sept. 16, 2021 (GLOBE NEWSWIRE) Biomea Fusion, Inc. ( Biomea ) (Nasdaq: BMEA), a biopharmaceutical company focused on the discovery and
Read more →BMEABiomea Fusion Reports Second Quarter 2021 Financial Results and Business Highlights Completed investigational new drug ("IND") enabling studies for lead program, BMF-219, an irreversibly binding menin inhibitor. On track
Biomea Fusion Reports Second Quarter 2021 Financial Results and Business Highlights REDWOOD CITY, Calif., August 11, 2021 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a preclinical-stage biopharmaceutical company focused on the discovery and development of
Read more →BMEACorporate Presentation July 2021 Disclaimer and Forward-Looking Statement Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future eve
Presentation July 2021 Disclaimer and Forward-Looking Statement Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future financial performance of Biomea Fusion, Inc. (the
Read more →BMEABIOMEA Fusion Strengthens its Executive Team with Appointment of Franco Valle as Chief Financial Officer
REDWOOD CITY, Calif., June 28, 2021 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a preclinical-stage biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers, announ
Read more →BMEABiomea Fusion Reports First Quarter 2021 Financial Results and Business Highlights -- Received $167 million in aggregate gross proceeds in April from initial public offering -- - Advancing lead oncology program BMF-219,
Biomea Fusion Reports First Quarter 2021 Financial Results and Business Highlights -- Received $167 million in aggregate gross proceeds in April from initial public offering -- - Advancing lead oncology program BMF-219, a small molecule irreversible menin inhibitor, toward IND
Read more →BMEABiomea Announces Closing of Initial Public Offering Redwood City, California
Biomea Announces Closing of Initial Public Offering Redwood City, California, April 20, 2021 Biomea Fusion, Inc. ( Biomea ) (Nasdaq: BMEA), a preclinical-stage biopharmaceutical company focused on the discovery, development and commercialization of irreversible small molecules
Read more →BMEABiomea Announces Pricing of Initial Public Offering
REDWOOD CITY, Calif., April 15, 2021 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a preclinical-stage biopharmaceutical company focused on the discovery, development and commercialization of irreversible small molecules to treat patients with genetically def
Read more →Competitive Position
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