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BMEA Stock Up 9% as FDA Lifts Clinical Hold on 2 Diabetes Studies
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Shares of Biomea Fusion (BMEA - Free Report) gained 9.1% on Thursday after the FDA lifted the clinical hold it had earlier placed on the company’s ongoing early to mid-stage studies evaluating its lead candidate, BMF-219, for treating type 2 and type 1 diabetes (T2D and T1D). The update follows a thorough review of the clinical data on the candidate, to date.
Biomea’s BMF-219 is an investigational novel covalent menin inhibitor that has been developed using the company’s proprietary FUSION System.
Recent Regulatory Updates Related to BMEA’s Diabetes Program
In June 2024, the FDA placed a full clinical hold on Biomea’s two phase I/II studies (COVALENT-111 and COVALENT-112) evaluating BMF-219 for T2D and T1D indications, respectively.
The action was taken after the regulatory body noted issues related to potential drug-induced liver toxicity observed during the completed Dose Escalation phase of COVALENT-111. Elevated liver enzymes were possibly influenced by higher doses (up to 400 mg) of BMF-219, food intake variations, medical history and concurrent medications during the studies.
However, Biomea clarified that the drug has been generally well tolerated in clinical studies, with most adverse events reported as mild to moderate in severity. Additionally, to date, no serious adverse reactions have been identified with BMF-219 in either COVALENT-111 or COVALENT-112. Management believes that the candidate holds the potential to restore glucose-controlled insulin production and improve glycemic control in diabetes patients.
Year to date, shares of BMEA have plunged 34.1% compared with the industry’s 3.5% decline.
Image Source: Zacks Investment Research
In the latest press release, Biomea reported that the FDA’s safety review of the ongoing phase IIb expansion portion of the COVALENT-111 study of BMF-219 showed that the concerning safety signals observed in the phase IIa escalation portion of the study did not carry over. Importantly, none of the elevated lab values resulted in confirmed serious liver injury or impairment.
Having received the green light from the FDA, the company has now fully resumed its T2D and T1D studies of BMF-219.
In the fourth quarter of 2024, the company expects to report top-line 26-week data from the phase IIb portion of the COVALENT-111 study with approximately 200 patients. Top-line data readout from the phase IIa portion of the COVALENT-112 study of the candidate, with approximately 20 patients, is also expected in the fourth quarter.
Additionally, Biomea stated that it will announce a third development candidate, a potent, selective, oral small molecule GLP-1 receptor agonist, by the end of this year.
Other Programs in BMEA’s Clinical-Stage Pipeline
Apart from the diabetes indication, Biomea is also developing BMF-219 for several oncology indications. Two separate early-stage studies are currently ongoing (COVALENT-101 and COVALENT-102), which are evaluating the candidate in patients with liquid tumors and those with KRAS solid tumors, respectively.
Besides BMF-219, Biomea has another investigational candidate in its pipeline, BMF-500, which is currently being developed for the treatment of adult patients with relapsed or refractory acute leukemia in an early-stage COVALENT-103study. BMF-500 is a covalent FLT3 inhibitor, which has also been developed utilizing the FUSION System.
In the past 60 days, estimates for Krystal Biotech’s 2024 EPS have increased from $2.09 to $2.38. The consensus estimate for 2025 earnings has improved from $4.33 to $7.31. Year to date, shares of KRYS have jumped 43.8%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.33 to 28 cents. The consensus estimate for 2025 loss per share has narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 40.7%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have gained 5.7%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
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BMEA Stock Up 9% as FDA Lifts Clinical Hold on 2 Diabetes Studies
Shares of Biomea Fusion (BMEA - Free Report) gained 9.1% on Thursday after the FDA lifted the clinical hold it had earlier placed on the company’s ongoing early to mid-stage studies evaluating its lead candidate, BMF-219, for treating type 2 and type 1 diabetes (T2D and T1D). The update follows a thorough review of the clinical data on the candidate, to date.
Biomea’s BMF-219 is an investigational novel covalent menin inhibitor that has been developed using the company’s proprietary FUSION System.
Recent Regulatory Updates Related to BMEA’s Diabetes Program
In June 2024, the FDA placed a full clinical hold on Biomea’s two phase I/II studies (COVALENT-111 and COVALENT-112) evaluating BMF-219 for T2D and T1D indications, respectively.
The action was taken after the regulatory body noted issues related to potential drug-induced liver toxicity observed during the completed Dose Escalation phase of COVALENT-111. Elevated liver enzymes were possibly influenced by higher doses (up to 400 mg) of BMF-219, food intake variations, medical history and concurrent medications during the studies.
However, Biomea clarified that the drug has been generally well tolerated in clinical studies, with most adverse events reported as mild to moderate in severity. Additionally, to date, no serious adverse reactions have been identified with BMF-219 in either COVALENT-111 or COVALENT-112. Management believes that the candidate holds the potential to restore glucose-controlled insulin production and improve glycemic control in diabetes patients.
Year to date, shares of BMEA have plunged 34.1% compared with the industry’s 3.5% decline.
Image Source: Zacks Investment Research
In the latest press release, Biomea reported that the FDA’s safety review of the ongoing phase IIb expansion portion of the COVALENT-111 study of BMF-219 showed that the concerning safety signals observed in the phase IIa escalation portion of the study did not carry over. Importantly, none of the elevated lab values resulted in confirmed serious liver injury or impairment.
Having received the green light from the FDA, the company has now fully resumed its T2D and T1D studies of BMF-219.
In the fourth quarter of 2024, the company expects to report top-line 26-week data from the phase IIb portion of the COVALENT-111 study with approximately 200 patients. Top-line data readout from the phase IIa portion of the COVALENT-112 study of the candidate, with approximately 20 patients, is also expected in the fourth quarter.
Additionally, Biomea stated that it will announce a third development candidate, a potent, selective, oral small molecule GLP-1 receptor agonist, by the end of this year.
Other Programs in BMEA’s Clinical-Stage Pipeline
Apart from the diabetes indication, Biomea is also developing BMF-219 for several oncology indications. Two separate early-stage studies are currently ongoing (COVALENT-101 and COVALENT-102), which are evaluating the candidate in patients with liquid tumors and those with KRAS solid tumors, respectively.
Besides BMF-219, Biomea has another investigational candidate in its pipeline, BMF-500, which is currently being developed for the treatment of adult patients with relapsed or refractory acute leukemia in an early-stage COVALENT-103study. BMF-500 is a covalent FLT3 inhibitor, which has also been developed utilizing the FUSION System.
Biomea Fusion, Inc. Price and Consensus
Biomea Fusion, Inc. price-consensus-chart | Biomea Fusion, Inc. Quote
Zacks Rank & Stocks to Consider
Biomea currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals (ANIP - Free Report) , Krystal Biotech, Inc. (KRYS - Free Report) and Fulcrum Therapeutics (FULC - Free Report) . While KRYS and FULC currently sport a Zacks Rank #1 (Strong Buy) each, ANIP carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Krystal Biotech’s 2024 EPS have increased from $2.09 to $2.38. The consensus estimate for 2025 earnings has improved from $4.33 to $7.31. Year to date, shares of KRYS have jumped 43.8%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.33 to 28 cents. The consensus estimate for 2025 loss per share has narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 40.7%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have gained 5.7%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.