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Biomea Fusion (BMEA) Stock Surges 41% in a Month: Here's Why
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Biomea Fusion, Inc. (BMEA - Free Report) , a clinical-stage company, is focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases. The company uses its proprietary FUSION System to design and develop a pipeline of novel covalent therapies.
BMEA’s lead product candidate, BMF-219, is an investigational novel covalent menin inhibitor, which is currently being evaluated in several early-mid-stage studies for various indications, including diabetes, liquid tumors and KRAS mutated solid tumors.
Apart from BMF-219, Biomea Fusion 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 study. BMF-500 is the company’s covalent FLT3 inhibitor, which has also been developed utilizing the FUSION System.
In the past month, shares of BMEA have surged 40.6% compared with the industry’s 5.3% rise.
Image Source: Zacks Investment Research
The steep rise in the stock price was observed after the company announced that it will share updated results from the phase II study of its lead candidate, BMF-219, for the type II diabetes (T2D) indication.
Biomea Fusion recently announced positive top-line data from the 200 mg dose cohorts of its ongoing mid-stage study of its investigational candidate, BMF-219, for the treatment of adult patients with T2D uncontrolled by current therapies.
Data from the study observed that at week 26, 22 weeks after the last dose of BMF-219, treatment with the 200 mg dose of the candidate increased the percentage of patients with durable HbA1c reduction of 1% or more to approximately 40% compared with the 20% reduction reported earlier in the 100 mg cohorts.
A high HbA1c is an indicator of high blood sugar, which means that a patient is more likely to develop diabetes complications.
The ongoing phase II COVALENT-111 study is evaluating the efficacy and safety of BMF-219 in multiple ascending dose cohorts in the treatment of T2D patients. The range of doses under evaluation includes 50 mg, 100 mg and 200 mg.
The company is currently analyzing the available data from the study and expects to provide further updates in March 2024.
Additionally, Biomea Fusion reported that patients across all dosing cohorts have consistently experienced generally meaningful HbA1c reductions after only four weeks of dosing with BMF-219 in the dose escalation portion, to date.
Results have demonstrated greater pharmacokinetic exposure of BMF-219 in patient cohorts at higher dose levels. Per the company, the variability seen in HbA1c reduction is fueled by several factors, including patients’ prior lines of therapies, years since diagnosis, beta cell function scores and others.
BMEA stated that so far, the best result has been observed in cohort 3 (100 mg without food) of the COVALENT-111 study, where treatment with BMF-219 caused a mean HbA1c reduction of 0.81% after only four weeks of dosing. In all other cohorts of the study, the mean HbA1c reduction was observed between 0.4% and 0.5% after four weeks of dosing.
Based on the consistency of the reported data on responses to treatment with different doses of BMF-219, Biomea Fusion believes that it has confirmed clinically meaningful activity across all dosing cohorts.
Further updates from the study are expected to be presented by the company at a medical conference in 2024.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share has remained constant at 72 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 earnings per share has increased from 62 cents to 64 cents. PBYI stock failed to deliver any returns in the past month.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 6 cents to 3 cents. The consensus estimate for ADMA Biologics’ 2024 earnings per share is pegged at 16 cents. In the past month, shares of ADMA have lost 1.1%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Agenus’ 2023 loss per share has remained constant at 63 cents. During the same time frame, the consensus estimate for Agenus’ 2024 loss per share has remained constant at 45 cents. In the past month, shares of AGEN have gained 8.3%.
AGEN beat estimates in one of the trailing four quarters, matching in one and missing the mark on the other two occasions, delivering an average earnings surprise of 0.49%.
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Biomea Fusion (BMEA) Stock Surges 41% in a Month: Here's Why
Biomea Fusion, Inc. (BMEA - Free Report) , a clinical-stage company, is focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases. The company uses its proprietary FUSION System to design and develop a pipeline of novel covalent therapies.
BMEA’s lead product candidate, BMF-219, is an investigational novel covalent menin inhibitor, which is currently being evaluated in several early-mid-stage studies for various indications, including diabetes, liquid tumors and KRAS mutated solid tumors.
Apart from BMF-219, Biomea Fusion 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 study. BMF-500 is the company’s covalent FLT3 inhibitor, which has also been developed utilizing the FUSION System.
In the past month, shares of BMEA have surged 40.6% compared with the industry’s 5.3% rise.
Image Source: Zacks Investment Research
The steep rise in the stock price was observed after the company announced that it will share updated results from the phase II study of its lead candidate, BMF-219, for the type II diabetes (T2D) indication.
Biomea Fusion recently announced positive top-line data from the 200 mg dose cohorts of its ongoing mid-stage study of its investigational candidate, BMF-219, for the treatment of adult patients with T2D uncontrolled by current therapies.
Data from the study observed that at week 26, 22 weeks after the last dose of BMF-219, treatment with the 200 mg dose of the candidate increased the percentage of patients with durable HbA1c reduction of 1% or more to approximately 40% compared with the 20% reduction reported earlier in the 100 mg cohorts.
A high HbA1c is an indicator of high blood sugar, which means that a patient is more likely to develop diabetes complications.
The ongoing phase II COVALENT-111 study is evaluating the efficacy and safety of BMF-219 in multiple ascending dose cohorts in the treatment of T2D patients. The range of doses under evaluation includes 50 mg, 100 mg and 200 mg.
The company is currently analyzing the available data from the study and expects to provide further updates in March 2024.
Additionally, Biomea Fusion reported that patients across all dosing cohorts have consistently experienced generally meaningful HbA1c reductions after only four weeks of dosing with BMF-219 in the dose escalation portion, to date.
Results have demonstrated greater pharmacokinetic exposure of BMF-219 in patient cohorts at higher dose levels. Per the company, the variability seen in HbA1c reduction is fueled by several factors, including patients’ prior lines of therapies, years since diagnosis, beta cell function scores and others.
BMEA stated that so far, the best result has been observed in cohort 3 (100 mg without food) of the COVALENT-111 study, where treatment with BMF-219 caused a mean HbA1c reduction of 0.81% after only four weeks of dosing. In all other cohorts of the study, the mean HbA1c reduction was observed between 0.4% and 0.5% after four weeks of dosing.
Based on the consistency of the reported data on responses to treatment with different doses of BMF-219, Biomea Fusion believes that it has confirmed clinically meaningful activity across all dosing cohorts.
Further updates from the study are expected to be presented by the company at a medical conference in 2024.
Biomea Fusion, Inc. Price and Consensus
Biomea Fusion, Inc. price-consensus-chart | Biomea Fusion, Inc. Quote
Zacks Rank and Stocks to Consider
Biomea Fusion currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks worth mentioning are Puma Biotechnology, Inc. (PBYI - Free Report) , ADMA Biologics (ADMA - Free Report) and Agenus (AGEN - Free Report) . While PBYI sports a Zacks Rank #1 (Strong Buy), ADMA and AGEN carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share has remained constant at 72 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 earnings per share has increased from 62 cents to 64 cents. PBYI stock failed to deliver any returns in the past month.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 6 cents to 3 cents. The consensus estimate for ADMA Biologics’ 2024 earnings per share is pegged at 16 cents. In the past month, shares of ADMA have lost 1.1%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Agenus’ 2023 loss per share has remained constant at 63 cents. During the same time frame, the consensus estimate for Agenus’ 2024 loss per share has remained constant at 45 cents. In the past month, shares of AGEN have gained 8.3%.
AGEN beat estimates in one of the trailing four quarters, matching in one and missing the mark on the other two occasions, delivering an average earnings surprise of 0.49%.