Biomea Fusion Announces BMF-219 in Diabetes Placed on Clinical Hold

Biomea Fusion Announces BMF-219 in Diabetes Placed on Clinical Hold

 

Biomea Fusion, Inc. ("Biomea" or the "Company") (Nasdaq: BMEA), announced that the Company has received notice from the U.S. Food and Drug Administration (FDA) that a full clinical hold has been placed on Biomea's ongoing Phase III clinical trials of the Company's investigational covalent menin inhibitor BMF-219 in type 2 and type 1 diabetes (COVALENT-111 and COVALENT-112), respectively. The Company will continue ongoing safety and efficacy data collection during the hold.

 

"We respect the FDA's decision and agree that patient safety is paramount and our top priority. We are fully collaborating and working diligently with the FDA to put a plan in place as quickly as possible to ensure patient safety and look forward to resuming the studies once we have authorization from the FDA. The results to date have supported that BMF-219 is generally well-tolerated and can restore glucose-controlled insulin production and improve glycemic control. Based on the totality of the safety and efficacy data for BMF-219 in diabetes to date, we remain committed to advancing BMF-219 with its potentially transformative profile," stated Thomas Butler, Biomea Fusion's Chief Executive Officer and Chairman of the Board.

 

The FDA cited deficiencies based on the level of possible drug-induced hepatotoxicity observed in the completed Dose Escalation Phase of COVALENT-111. During the Dose Escalation studies, higher doses (up to 400 mg), various food intake regimens, medical history and concomitant medications may have contributed to observed liver enzyme elevations. As previously reported, the majority of adverse events (AEs) have been mild to moderate in nature and no serious adverse reactions (SARs) have been reported to date with BMF-219 in COVALENT-111 and COVALENT-112.

 

  About COVALENT-111  

 

COVALENT-111 is a multi-site, randomized, double-blind, placebo-controlled Phase I/II study. In the completed Phase I portion of the trial, healthy patients were enrolled in single ascending dose cohorts to evaluate safety at the prospective dosing levels for type 2 diabetic patients. Phase II consists of multiple ascending dose cohorts and includes adult patients with type 2 diabetes uncontrolled by standard of care medicines. Once the Escalation Phase of COVALENT-111 was completed, the study advanced into an Expansion Phase consisting of multiple cohorts dosing type 2 diabetes patients for longer dose durations. Additional information about this Phase I/II clinical trial of BMF-219 in type 2 diabetes can be found at ClinicalTrials.gov using the identifier NCT05731544.

 

  About COVALENT-112  

 

COVALENT-112 is a multi-site, randomized, double-blind, placebo-controlled Phase II study in adults with stage 3 type 1 diabetes. This stage describes the period following clinical diagnosis of type 1 diabetes when symptoms are present due to significant beta cell loss. COVALENT-112 will be a multi-arm trial comparing two different doses of BMF-219 to placebo (1:1:1) to evaluate the efficacy, safety, and durability of BMF-219 in adults with type 1 diabetes. Approximately 150 patients will be enrolled in the trial and will receive either BMF-219 or placebo over 12 weeks, followed by a 40-week off treatment period.

 

This trial also includes an open-label portion for adults with type 1 diabetes up to 15 years since diagnosis. The open-label portion (n=40) is examining the efficacy, safety, and durability of BMF-219 at two oral dose levels, 100 mg and 200 mg over 12-week treatment followed by a 40-week off treatment period.

 

Additional information about the Phase II clinical trial of BMF-219 in type 1 diabetes can be found at ClinicalTrials.gov using the identifier NCT06152042.

 

  About Biomea Fusion  
Biomea Fusion is a clinical stage biopharmaceutical company focused on the discovery and development of oral covalent small molecules to treat patients with metabolic diseases and genetically defined cancers. A covalent small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional non-covalent drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response.

 

We are utilizing our proprietary FUSION™ System to discover, design and develop a pipeline of next-generation covalent-binding small molecule medicines designed to maximize clinical benefit for patients. We aim to have an outsized impact on the treatment of disease for the patients we serve. We aim to cure.

 

Visit us at biomeafusion.com and follow us on LinkedIn , Twitter and Facebook .

 

  Forward-Looking Statements  

 

Statements we make in this press release may include statements which are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact, including statements regarding the clinical and therapeutic potential of our product candidates and development programs, including BMF-219, the potential of BMF-219 as a treatment for type 2 and type 1 diabetes, our research, development and regulatory plans, the progress of our ongoing and planned clinical trials, including COVALENT-111 and COVALENT 112, our plans to address the matters raised in the FDA's clinical hold letter, our ability to resolve the clinical hold on a timely basis, or at all, the availability of data from our clinical trials and the timing of such events, may be deemed to be forward-looking statements. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions.

 

Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including the risk that we may encounter delays in preclinical or clinical development, patient enrollment and in the initiation, conduct and completion of our ongoing and planned clinical trials and other research and development activities. 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. Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

 
Contact: Investor Relations Chunyi Zhao, PhD Associate Director of Investor Relations & Corporate Development czhao@biomeafusion.com Media Relations Neera Chaudhary nchaudhary@biomeafusion.com 
 

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Biomea Fusion, Inc. Reports Inducement Grant under Nasdaq Listing Rule 5635

Biomea Fusion, Inc. Reports Inducement Grant under Nasdaq Listing Rule 5635

 

Biomea Fusion, Inc. (Nasdaq: BMEA) ("Biomea" or the "Company"), a clinical stage biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases, today announced that on June 1, 2024, the compensation committee of Biomea's board of directors granted one new employee non-qualified stock options to purchase an aggregate of 25,000 shares of the Company's common stock. The shares underlying the employee's stock options will vest 116 on a quarterly basis over four years, subject to the employee's continued employment with the Company on such vesting dates.

 

The above-described award was made pursuant to the terms of Biomea's 2023 Inducement Equity Plan (the "Plan") and was granted as an inducement material to the employee entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The Plan was adopted by Biomea's board of directors on November 17, 2023.

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Biomea 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 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, Inc. ("Biomea") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, today announced the completion of enrollment of the first three dose expansion arms of COVALENT-111, with a total of over 260 type 2 diabetes patients enrolled.

 

The COVALENT-111 study is a multi-site, randomized, double-blind, placebo-controlled Phase I/II study. Phase II consists of multiple dose escalation and dose expansion cohorts including adult patients with type 2 diabetes uncontrolled by standard of care medicines. The dose escalation phase is evaluating BMF-219 dosed over 4 weeks with 22 weeks follow-up off treatment. The first three arms (A, B, C) of the expansion phase are evaluating BMF-219 dosed over 8 and 12 weeks at 100 mg and 200 mg with up to 40 weeks of follow-up off treatment.

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Biomea Fusion Reports First Quarter 2024 Financial Results and Corporate Highlights

Biomea 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 durable improved glycemic control while off therapy for 22 weeks, supporting the disease-modifying potential of BMF-219 to address a root cause of diabetes: a loss of healthy, insulin-producing beta cells
  •  
  • Announced initial clinical data from our Phase 2 study (COVALENT-112) in type 1 diabetes from the first two type 1 diabetes patients dosed with BMF-219 and demonstrated early signs of clinical activity with improved measures of beta-cell function after initial treatment with BMF-219
  •  
  • We expect a reduction in operating expenses in the second half of the year due to the near completion of enrollment of the first three arms of our type 2 diabetes study and near completion of enrollment of the open label portion of our type 1 diabetes study. Cash position of $145.3 million at the end of the first quarter of 2024
  •  

Biomea Fusion, Inc. ("Biomea" or "the Company") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, reported first quarter 2024 financial results and corporate highlights.

 

"Over the last two months we have seen a significant increase in the rate of enrollment for the expansion phase cohorts of our Phase 1/2 study, COVALENT-111, investigating BMF-219 in patients with type 2 diabetes. There is currently a waitlist for the fourth cohort which we expect will open for enrollment in the second half of this year.  We have also seen a significant increase in the rate of enrollment of our Phase 2 study, COVALENT-112, in patients with type 1 diabetes following the press release which provided an early look at the first two patients dosed with BMF-219. Here we highlighted the first two patients dosed with BMF-219 demonstrated an increase in C-peptide Index (Amount of C-peptide secreted per unit of glucose) during the early stages of treatment. This is truly an exciting and validating update on our progress in type 1 diabetes. Patients with type 2 diabetes have lost about 50% of their pool of beta cells while patients with type 1 diabetes have lost at least 90% of their beta-cell pool at diagnosis and are therefore not able to produce sufficient insulin to address the glucose levels in their blood. Currently approved treatments for diabetes are mostly chronic treatments helping patients to reduce the blood glucose while the mass and function of the beta cells continues to decline. We have now demonstrated in multiple preclinical experiments that BMF-219 has the potential to address diabetes at the root cause level by improving the function and mass of beta cells. The data we reported from the escalation portion of our clinical study COVALENT-111 in the first quarter of 2024 demonstrated for the first time how an agent can achieve durable glycemic control while patients are off therapy, supporting the disease-modifying potential of BMF-219 to address a root cause of diabetes," stated Thomas Butler, Biomea Fusion's Chief Executive Officer and Chairman of the Board. "In 2024, we expect to continue to advance our clinical programs with BMF-219 in diabetes and plan to report multiple data readouts throughout the remainder of the year, including topline Week 26 data of over 200 patients from our Phase 1/2 study, COVALENT-111, in type 2 diabetes, and topline Week 26 data from approximately 40 patients enrolled in the open label portion of our Phase 2 study, COVALENT-112, in type 1 diabetes patients. Our goal is to deliver a short-term, non-chronic treatment that will reconstitute insulin-producing beta cells, allowing the patients' own bodies to normalize blood sugar levels."

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Biomea Fusion, Inc. Reports Inducement Grants under Nasdaq Listing Rule 5635

Biomea Fusion, Inc. Reports Inducement Grants under Nasdaq Listing Rule 5635

 

Biomea Fusion, Inc. (Nasdaq: BMEA) ("Biomea" or the "Company"), a clinical stage biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases, today announced that on May 1, 2024, the compensation committee of Biomea's board of directors granted 8 new employees non-qualified stock options to purchase an aggregate of 80,250 shares of the Company's common stock. The shares underlying each employee's stock options will vest 116 on a quarterly basis over four years, in each case subject to each such employee's continued employment with the Company on such vesting dates. All of the above-described awards were made under Biomea's 2023 Inducement Equity Plan (the "Plan").

 

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Canadian Investment Regulatory Organization Trade Resumption - PRIZ

Canadian Investment Regulatory Organization Trade Resumption - PRIZ

 
 

Trading resumes in:

 

Company:  Prismo Metals Inc.  

 

 

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Prismo Metals Announces Closing of Upsized Private Placement Silver King Exploration to Begin in July

Prismo Metals Announces Closing of Upsized Private Placement Silver King Exploration to Begin in July

 

(TheNewswire)

 
       
  Prismo Metals Inc. 
                
 

Vancouver, British Columbia, July 18, 2025 TheNewswire - Prismo Metals Inc. (" Prismo " or the " Company ") (CSE: PRIZ,OTC:PMOMF) (OTCQB: PMOMF) is pleased to announce that further to its news release dated July 3, 2025, the Company has upsized and closed its previously announced non-brokered private placement of units of the Company (" Units ") at an issue price of $0.05 per Unit  (the "Private Placement" ). Due to strong investor demand, the Private Placement was increased from 5,000,000 Units to the issuance of 11,500,000 Units for gross proceeds of $575,000.

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Finlay Minerals Announces Increased Budget for PIL and ATTY Projects

Finlay Minerals Announces Increased Budget for PIL and ATTY Projects

 
 

Finlay Minerals Ltd . (TSXV: FYL,OTC:FYMNF) (OTCQB: FYMNF), the "Company", is pleased to announce that the approved budget under the Earn-In Agreements with Freeport-McMoRan Mineral Properties Canada Inc. ("Freeport") 1 for both the PIL and ATTY Projects, has been increased to a total of $3.6 million .

 
 

  Finlay Minerals Ltd. logo (CNW Group/Finlay Minerals Ltd.) 

 

Both projects are situated in the highly prospective Toodoggone District of British Columbia , which continues to develop as an important copper-gold (Cu-Au) district with significant potential for further discoveries.

 

Initially, the 2025 budget was set at a minimum of $750,000 for the PIL property and $500,000 for the ATTY property. However, these amounts have now been revised to up to $2.6 million for the PIL project and up to $1.0 million for the ATTY project. Both programs are fully funded under the Earn-In Agreements with Freeport . According to these agreements, Freeport may earn an 80% interest in each property by investing a total of $35 million in exploration expenditures and making cash payments totaling $4.1 million over/up to six years.   2 Until the Finlay-Freeport Earn-In Agreements complete, Finlay owns 100% of both properties.

 

The PIL   Property lies in the heart of the Toodoggone region and features several porphyry copper-gold (Cu-Au) targets, along with associated epithermal gold-silver (Au-Ag) mineralization.  To date, 18 porphyry Cu ± Mo ± Au and porphyry-related low- and high-sulphidation epithermal Au-Ag occurrences have been outlined on the PIL Property. The PIL property is adjacent to Amarc Resources and Freeport-McMoRan's JOY Project, as well as TDG Gold Corp.'s Shasta/Baker and Sofia Properties. It is also situated 25 kilometres ("km") northwest of Centerra Gold's former Kemess South Mine and 15 km east of Thesis Gold's Lawyers Project.

 

The ATTY Property covers 3,875 hectares of sub-alpine terrain in the southern Toodoggone region, an area known for significant porphyry copper-gold (Cu-Au) and epithermal gold-silver (Au-Ag) deposits. It is located between Centerra Gold's Kemess Project and the JOY Project, held by Amarc Resources and Freeport-McMoRan. The KEM target on the ATTY Property resembles the Kemess North Trend, which is home to the Kemess Underground and Kemess East deposits. Exploration will focus on the Wrich target, located near the copper geochemical anomaly at the SWT target on the JOY Property. This anomaly extends over 2 km and continues onto the ATTY Property for an additional 1.2 km to the southeast.

 

  The 2025 programs at the PIL and ATTY are well underway with:  

 
  • Detailed property-wide, 100 metre line-spaced airborne magnetic surveys completed on both properties;

  •  
  • Detailed geological and alteration mapping and expanded rock and soil sampling on up to 8 target areas on the PIL underway, with the ATTY expected to start by the end of July;

  •  
  • 53 line-km of induced polarization ("IP") geophysical surveys planned on the PIL and 16 line-km on the ATTY, and

  •  
  • Finlay acting as the Operator on both properties.
  •  

Finlay's President and CEO, Ilona Lindsay , states :  

 

  "We are very pleased with the substantial increase in approved funding for both the PIL and the ATTY. This additional funding will allow us to identify and prioritize as many targets as possible for drilling in 2026."  

 

  References:  

 
  1. Freeport-McMoRan (FCX) is a leading international metals company focused on copper, with major operations in the Americas and Indonesia and significant reserves of copper, gold, and molybdenum.

  2.  
  3. Finlay news releases NR 03-25 dated April 17, 2025 entitled: "  Finlay Minerals Enters into Earn-In Agreements with Freeport for its PIL & ATTY Properties " and NR 05-25 dated May 2, 2025 and entitled: "  Finlay Minerals Receives TSX Venture Exchange Approval for PIL Earn-In Agreement. "
  4.  

  Qualified Person:  

 

  Wade Barnes , P. Geo. and Vice President, Exploration for Finlay Minerals and a qualified person as defined by National Instrument 43-101, has approved the technical content of this news release.

 

  About finlay minerals ltd.  

 

Finlay is a TSXV company focused on exploration for base and precious metal deposits with five properties in northern British Columbia :

 

Finlay trades under the symbol "FYL" on the TSXV and under the symbol "FYMNF" on the OTCQB. For further information and details, please visit the Company's website at www.finlayminerals.com   .  

 

  On behalf of the Board of Directors,  

 

  Robert F. Brown ,
Executive Chairman of the Board

 

  Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.  

 

   Forward-Looking Information:    This news release includes certain "forward-looking information" and "forward-looking statements" (collectively, "forward-looking statements") within the meaning of applicable Canadian securities legislation. All statements in this news release that address events or developments that we expect to occur in the future are forward-looking statements.  Forward-looking statements are statements that are not historical facts and are generally, although not always, identified by words such as "expect", "plan", "anticipate", "project", "target", "potential", "schedule", "forecast", "budget", "estimate", "intend" or "believe" and similar expressions or their negative connotations, or that events or conditions "will", "would", "may", "could", "should" or "might" occur. All such forward-looking statements are based on the opinions and estimates of management as of the date such statements are made. Forward-looking statements in this news release include statements regarding, among others, the exploration plans for the PIL & ATTY Properties. Although Finlay believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those forward-looking statements. Factors that could cause actual results to differ materially from those in forward-looking statements include market prices, exploration successes, and continued availability of capital and financing and general economic, market or business conditions. These forward-looking statements are based on a number of assumptions including, among other things, assumptions regarding general business and economic conditions, the timing and receipt of regulatory and governmental approvals, the ability of Finlay and other parties to satisfy stock exchange and other regulatory requirements in a timely manner, the availability of financing for Finlay's proposed transactions and programs on reasonable terms, and the ability of third-party service providers to deliver services in a timely manner. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Finlay does not assume any obligation to update or revise its forward-looking statements, whether as a result of new information, future or otherwise, except as required by applicable law.  

 

SOURCE finlay minerals ltd. 

 

 

 

 Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/July2025/17/c1585.html  

 
 

 

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Juggernaut Closes $1,000,000 $0.64 Unit Private Placement Financing

Juggernaut Closes $1,000,000 $0.64 Unit Private Placement Financing

 

(TheNewswire)

 
        
  Juggernaut Exploration Ltd. 
                   
 

Vancouver, British Columbia TheNewswire - July 17, 2025 Juggernaut Exploration Ltd. (TSX-V: JUGR) (OTCQB: JUGRF) (FSE: 4JE) (the "Company" or "Juggernaut"), further to its July 3, 2025, news release the Company is pleased to announce that it has received approval from the TSX Venture Exchange to close its private placement financing (the "Financing") for aggregate gross proceeds of $1,000,000.

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