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 (NASDAQ: BMEA) reported positive 52-week Phase 2 COVALENT-112 results for icovamenib in type 1 diabetes.

Rhea-AI Summary

Biomea Fusion (NASDAQ: BMEA) reported positive 52-week Phase 2 COVALENT-112 results for icovamenib in type 1 diabetes. In patients diagnosed 0–3 years, 200 mg produced a 52% mean C-peptide AUC increase at Week 12 (p < 0.001; n=5), with durability through Week 52 (~7% decline from baseline). Dose response favored 200 mg versus 100 mg. C-peptide was generally preserved in 3–15 year patients (n=9). Icovamenib was generally well tolerated. Enrollment was interrupted by an FDA clinical hold that was later resolved; planned Part 2 placebo-controlled study was not completed.

Full dataset to be presented at ADA; company call April 28, 2026.

Positive

• C-peptide AUC +52% at Week 12 in 0–3 year cohort (200 mg)
• Durable effect: ~7% C-peptide decline at Week 52 after 12 weeks dosing
• Dose response: 200 mg showed greater activity vs 100 mg
• C-peptide generally preserved in 3–15 year cohort (n=9)
• Generally well tolerated through 52-week observation period

Negative

• Very small sample sizes (n=5 for primary 0–3 year 200 mg result)
• Enrollment halted earlier by FDA clinical hold; only ~half intended population enrolled
• Planned placebo-controlled Part 2 was not completed

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On Apr 28, the first trading day after this news, BMEA closed 11.56% below the previous close.

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Key Figures

C-peptide increase: 52% C-peptide decline: 7% P-value: p < 0.001 +5 more

C-peptide increase

52%

Mean C-peptide AUC increase at Week 12, 0–3 year T1D, 200 mg (n=5)

C-peptide decline

7%

Approximate decline from baseline at Week 52 after 12 weeks of 200 mg

P-value

p < 0.001

Week 12 C-peptide AUC change, 0–3 year T1D, 200 mg (n=5)

Dose level

200 mg

Once-daily icovamenib dose showing greater activity than 100 mg

Dose level

100 mg

Lower once-daily icovamenib dose comparator arm in COVALENT-112

Sample size

n=5

0–3 year T1D cohort receiving 200 mg icovamenib

Sample size

n=6

0–3 year T1D cohort receiving 100 mg icovamenib

Sample size

n=9

T1D patients diagnosed 3–15 years with preserved C-peptide

Previous Clinical trial Reports

5 past events · Latest: Mar 31

Same Type 5 events

1. Mar 31

   Phase II dosing start

   24h Move

   +15.9%

   First patients dosed in two Phase II icovamenib T2D studies.

2. Oct 27

   Phase I trial start

   24h Move

   -2.7%

   First patient dosed in Phase I BMF-650 obesity trial.

3. Oct 06

   Positive Phase II data

   24h Move

   -30.9%

   Positive 52-week COVALENT-111 T2D results with durable HbA1c benefit.

4. Jun 23

   Conference data update

   24h Move

   -6.6%

   New icovamenib clinical and preclinical data presented at ADA meeting.

5. Jun 18

   Preclinical obesity data

   24h Move

   -34.1%

   Preclinical BMF-650 data showing robust weight loss in obese primates.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

phase 2, c-peptide, area under the curve (AUC), menin, +4 more

8 terms

phase 2 medical

"positive 52-week results from its Phase 2 COVALENT-112 trial evaluating"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

c-peptide medical

"52% increase from baseline in mean C-peptide AUC at Week 12 in patients"

C‑peptide is a short protein fragment released at the same time the pancreas produces insulin; because it lingers in the blood longer than insulin itself, clinicians measure C‑peptide levels as a clear sign of how much natural insulin a person still makes. For investors, C‑peptide matters because it’s used as a measurable outcome in diabetes drug and device trials, in diagnostic tests, and by regulators to judge treatment benefit — results that can affect clinical success, approvals, and market value.

area under the curve (AUC) medical

"mean C-peptide area under the curve (AUC) at Week 12 (p < 0.001; n=5)"

Area under the curve (AUC) is a measurement of total drug exposure, calculated by adding up the drug concentration in the blood over time after a dose—think of it like totaling rainfall over a day to know how much water fell. Investors use AUC to judge how much of a medicine reaches the body, how long it lasts, and how it compares to alternatives, which affects dosing, safety, regulatory approval and commercial value.

menin medical

"These data further validate targeting menin as a potential approach across"

Menin is a protein produced by the MEN1 gene that helps control cell growth and keep cell division in check, acting like a brake on processes that can lead to tumors. For investors, changes in menin function or drugs that target it matter because they can be central to cancer and endocrine disease diagnostics or treatments, influencing clinical trial prospects, regulatory risk, and a biotech company’s valuation.

beta cell medical

"therapy targeting beta cell biology, with effects that appear to persist"

Beta cells are specialized cells in the pancreas that act like a thermostat or factory for blood sugar by producing and releasing insulin, the hormone that helps the body store or use glucose. Investors watch beta cells because many diabetes treatments, diagnostics and biotech therapies aim to protect, replace or modify their function; progress or setbacks in that work can strongly affect the commercial value and regulatory prospects of related drugs and technologies.

fda clinical hold regulatory

"enrollment and dosing were interrupted in May 2024 due to an FDA clinical hold"

A FDA clinical hold is an official pause ordered by the U.S. Food and Drug Administration that stops a company from starting or continuing a human clinical trial for a drug or medical device. Think of it as a regulatory stop sign raised when safety, study design, or data issues need resolving; for investors it can delay potential approval, increase costs, and materially change a company’s development timeline and valuation.

mixed-meal tolerance test (MMTT) medical

"measured during a mixed-meal tolerance test (MMTT), to evaluate endogenous"

A mixed-meal tolerance test (MMTT) is a clinical assessment that measures how a person’s body handles a standardized meal by tracking blood sugar and related hormones over several hours. For investors, MMTT results are important because they show whether a diabetes or metabolic drug actually improves real-world digestion and glucose control—data that can influence clinical success, regulatory approval, and a company’s stock value, much like a standardized road test shows a car’s true fuel performance.

placebo-controlled medical

"A planned placebo-controlled Part 2 of the study was not completed."

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• A 52% increase from baseline in mean C-peptide AUC at Week 12 in patients diagnosed within 0–3 years (n=5) receiving icovamenib 200 mg, with a clear dose response observed vs 100 mg (n=6)
• Persistence observed through Week 52, with mean C-peptide AUC largely preserved in 200 mg group (~7% decline from baseline) following only 12 weeks of dosing
• Preservation of C-peptide also observed in patients diagnosed between 3-15 years (n=9)
• Icovamenib was generally well tolerated across all dosing arms and demonstrated a favorable safety and tolerability profile through Week 52
• Comprehensive dataset to be presented at the American Diabetes Association’s (ADA) Scientific Sessions (abstract is preliminary until time of presentation; full release on June 5th at 6:30 pm CST)
• Company to host a conference call to discuss results on Tuesday, April 28 at 8:30 am ET
  
  

SAN CARLOS, Calif., April 27, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced positive 52-week results from its Phase 2 COVALENT-112 trial evaluating the efficacy, safety, and tolerability of icovamenib in patients with type 1 diabetes (“T1D”). These data are based on a proof-of-concept study enrolling small subsets of Stage 3 T1D patients dosed with icovamenib at 100 mg and 200 mg in two cohorts (patients diagnosed within 3 years and those diagnosed within 3-15 years).

“The results we presented today mark an encouraging step forward for Biomea. The magnitude and durability observed are not typically seen in type 1 diabetes, which makes these findings particularly compelling. These data further validate targeting menin as a potential approach across both type 1 and type 2 diabetes,” said Mick Hitchcock, Ph.D., Interim CEO and Board Member of Biomea Fusion. “We look forward to presenting additional data at an upcoming scientific meeting and advancing our type 1 diabetes program in collaboration with leading clinical centers in the United States”

The COVALENT-112 trial demonstrated encouraging results in patients with T1D. In patients diagnosed within 0-3 years, treatment with icovamenib 200 mg once daily for 12 weeks resulted in a 52% increase in mean C-peptide area under the curve (AUC) at Week 12 (p < 0.001; n=5), representing a magnitude of improvement that is not commonly reported in published studies of T1D. Importantly, the effect was durable following only 12 weeks of dosing, mean C-peptide AUC was largely preserved through Week 52, representing approximately a 7% decline from baseline. A dose response was observed, with the 200 mg dose demonstrating greater activity compared to 100 mg. Published natural history data suggest that patients with Stage 3 T1D typically experience substantial declines in C-peptide over time, underscoring the significance of preserved C-peptide following only a 12-week dosing period.

In patients with longer-standing disease (3-15 years since diagnosis), C-peptide levels were generally preserved through Week 52 (12-week treatment period + 40-week follow-up), with only a modest decline from baseline. A comprehensive dataset will be presented at the upcoming American Diabetes Association’s (ADA) Scientific Sessions in June.

Icovamenib was generally well tolerated, with no new or unexpected safety signals identified throughout the 52-week observation period. Unlike investigational approaches in T1D that rely primarily on immune suppression or cellular transplantation, icovamenib is designed as a short course, orally administered therapy targeting beta cell biology, with effects that appear to persist beyond the treatment period.

Based on these data, Biomea, in collaboration with four U.S. academic centers, is planning a Phase 2 trial in patients with T1D diagnosed within the past 3 years. The study will evaluate whether extended dosing (up to 6 or 12 months) at 200 mg further improves C-peptide and whether the addition of an immunosuppressive agent enhances clinical outcomes. This study is planned to be initiated within the second half of this year at the Barbara Davis Center for Diabetes, Joslin Diabetes Center, UT Health San Antonio Diabetes Center, and the University of Miami Diabetes Research Institute.

“Efforts to intervene against T1D have historically focused on preserving remaining insulin secretion in people just diagnosed with T1D,” said G. Alexander Fleming, MD, Founder & Executive Chairman of Kinexum and former FDA Senior Medical Officer and Division Leader for Metabolic & Endocrine Drugs, involved in the review of landmark diabetes and metabolic therapies including metformin, the first rapid acting insulin analogs, early statins, and PPAR agonists. “These icovamenib data are unique in showing increased C-peptide-reflected insulin secretion in patients with established T1D during dosing and persistence of this effect after treatment was stopped. In people with established T1D, endogenous insulin secretion progressively declines to very low levels. Any evidence of improvement in endogenous insulin secretion even among a few T1D individuals is unprecedented and of immense biologic and clinical significance. These findings warrant rigorous and longer-term evaluation.”

COVALENT-112 Study Design
COVALENT-112 (NCT06152042) was an open label Phase 2 trial evaluating icovamenib in adult patients with T1D. The study enrolled patients aged 18 to 60 years with Stage 3 T1D, including those diagnosed within 0–3 years with residual beta cell function at baseline, defined by a screening C-peptide level ≥0.2 nmol/L (Cohort 1), as well as a broader population with disease duration of 3–15 years and residual beta cell function at baseline, defined by a screening C-peptide level ≥0.08 nmol/L (Cohort 2). Participants were assigned to receive icovamenib at 100 mg or 200 mg once daily for 12 weeks, followed by a 40-week post-treatment follow-up to assess durability of effect. Study enrollment and dosing were interrupted in May 2024 due to an FDA clinical hold, which was subsequently resolved. As a result, these data reflect approximately half of the originally intended patient population. A planned placebo-controlled Part 2 of the study was not completed.

The primary endpoint was the mean change from baseline in stimulated C-peptide area under the curve (AUC), measured during a mixed-meal tolerance test (MMTT), to evaluate endogenous insulin secretion. Secondary endpoints included additional measures of beta cell function, glycemic control, insulin use, and safety.

Conference Call and Webcast Details
Webcast of Biomea’s investor update on Tuesday, April 28, 2026 at 8:30 am ET will be available to registered attendees under the Investors and Media section of the company’s website at https://investors.biomeafusion.com/news-events/events. A replay of the presentation will be archived on Biomea’s website following the event.

About Icovamenib
Icovamenib is an orally administered investigational small molecule currently in Phase 2 clinical development for the treatment of diabetes. Icovamenib targets menin, a transcriptional regulator implicated in beta cell dysfunction, and has been shown in preclinical and clinical studies to induce transient reductions in menin protein levels in pancreatic islets, thereby modulating pathways associated with insulin secretion and glycemic control. Through this mechanism, icovamenib has the potential to restore beta cell mass and function and improve endogenous insulin production. As a potential short-course therapy, icovamenib could represent a novel treatment approach for patients with diabetes, particularly those who have not achieved adequate control with standard-of-care therapies.

About Menin’s Role in Diabetes
Loss of functional beta cell mass is a core component of the natural history in both major types of diabetes, T1D (mediated by autoimmune dysfunction) and T2D (mediated by metabolic dysfunction). Beta cells are found in the pancreas and are responsible for the synthesis and secretion of insulin. Insulin is a hormone that helps the body use glucose for energy and helps control blood glucose levels. In patients with diabetes, beta cell mass and function have been observed to be diminished, leading to insufficient insulin secretion and hyperglycemia. Menin is thought to act as a brake on beta cell turnover and growth, supporting the hypothesis that inhibition of menin may enable pathways associated with beta cell regeneration and improved function. Based on these and other scientific findings, Biomea is exploring the potential for icovamenib-mediated menin inhibition as a viable therapeutic approach to treat T1D and T2D.

About Type 1 Diabetes 
Type 1 diabetes (T1D) is a chronic autoimmune disease in which the body’s immune system destroys insulin-producing beta cells in the pancreas, leading to a loss of endogenous insulin production. Approximately 9.5 million people worldwide live with T1D, with an estimated 513,000 new diagnoses each year. In the United States, about 1.8 million individuals are affected. At diagnosis, patients often have already lost a significant portion of their functional beta cell mass, and this decline typically continues over time. As a result, individuals with T1D require lifelong insulin therapy and continuous glucose monitoring to manage blood sugar levels. Despite advances in care, T1D remains associated with meaningful risks, including severe hypoglycemia and diabetic ketoacidosis (DKA), as well as long-term complications such as cardiovascular disease, kidney disease, nerve damage, and vision loss. There are currently no approved therapies that address the underlying progressive loss of beta cell function in established (Stage 3) T1D beyond insulin replacement, highlighting a significant unmet medical need for disease-modifying treatments.

About Biomea Fusion  
Biomea Fusion is a clinical-stage diabetes and obesity medicines company focused on the development of its oral small molecule therapies, icovamenib and BMF-650, for diabetes and obesity. These programs target metabolic disorders, a global health challenge affecting nearly half of all Americans and one-fifth of the world’s population. Biomea’s mission is to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions. We aim to cure!

Visit us at www.biomeafusion.com and follow us on LinkedIn, X 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 icovamenib and the potential of icovamenib as a treatment for T1D and T2D, and our expectations regarding the optimal dose and target patient population; our research, development and regulatory plans; the mechanism of action of our product candidates and development programs; the progress and initiation of our ongoing and upcoming clinical trials, including our Phase 2COVALENT-112 trial; the anticipated availability of data from our clinical trials; our planned interactions with regulators, 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 preliminary or interim results of preclinical studies or clinical trials may not be predictive of future or final results in connection with future clinical trials and 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 (“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:
Meichiel Jennifer Weiss
Sr. Director of Investor Relations and Corporate Development
ir@biomeafusion.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/65d84e8f-dc21-4794-a041-80bf6b8ede2c

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were the key COVALENT-112 results for Biomea Fusion (BMEA) announced April 27, 2026?

The direct answer: 200 mg icovamenib produced a 52% mean C-peptide AUC increase at Week 12 in 0–3 year patients. According to the company, the effect largely persisted to Week 52 with about a 7% decline from baseline and a clear dose response versus 100 mg.

How durable was the icovamenib response through Week 52 in the Phase 2 COVALENT-112 trial (BMEA)?

The direct answer: C-peptide was largely preserved through Week 52 after 12 weeks dosing. According to the company, the 200 mg group showed approximately a 7% decline from baseline at Week 52, indicating persistence of effect over the 40-week follow-up period.

Were there safety concerns reported in Biomea Fusion's COVALENT-112 results for BMEA?

The direct answer: Icovamenib was reported to be generally well tolerated with no new or unexpected safety signals. According to the company, safety and tolerability remained favorable across dosing arms during the 52-week observation period.

Why was COVALENT-112 enrollment interrupted and how did that affect BMEA's data?

The direct answer: Enrollment and dosing were interrupted in May 2024 due to an FDA clinical hold that was later resolved. According to the company, this interruption resulted in approximately half of the originally intended patient population and incomplete placebo-controlled Part 2.

What are Biomea Fusion's next clinical plans for icovamenib in type 1 diabetes (BMEA)?

The direct answer: Biomea plans a Phase 2 trial in patients diagnosed within 3 years to test extended dosing and combination approaches. According to the company, the planned study will evaluate up to 6–12 months dosing at 200 mg and potential addition of an immunosuppressive agent in four U.S. academic centers.