FDA Lifts Clinical Hold on BMF-219 in Type 2 and Type 1
WEB11 hours ago — 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 …
FDA Lifts Clinical Hold on BMF-219 in Type 2 and Type 1 Diabetes …
WEBCOVALENT-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.
FDA Removes Clinical Hold On Biomea Fusion's Early-Stage Trials …
WEB5 hours ago — Friday, the FDA lifted the clinical hold on Biomea Fusion, Inc.’s (NASDAQ:BMEA) ongoing Phase 1/2 clinical trials of the company’s investigational covalent menin inhibitor BMF-219 in type 2 ...
US FDA lifts clinical hold on Biomea’s diabetes trials after safety ...
WEB21 hours ago — The regulator had placed a hold on two trials of its lead drug, BMF-219, in June due to liver toxicity concerns. Biomea’s shares have declined 22 per cent since, but closed 9.1 per cent higher ...
US FDA lifts clinical hold on Biomea's diabetes trials after ... - MSN
WEBThe regulator had placed a hold on two trials of its lead drug, BMF-219, in June due to liver toxicity concerns. Biomea's shares have declined 22% since, but closed 9.1% higher at $9.57 on Thursday.
Biomea’s stock bounces back as FDA lifts clinical hold on diabetes …
WEB6 hours ago — This news led to a 65.57% decline in Biomea’s stock price. ... BMF-219 is an investigational irreversible covalent inhibitor of menin. It inhibits menin’s ability to interact with transcriptional partners that drive the expression of cell cycle protein regulators, including those that prevent the replication and expansion of beta cells. ...
Biomea Fusion: FDA Lifts Hold on Diabetes-Treatment Trials
WEB1 day ago — Chief Executive Thomas Butler on Thursday said the in-depth review of data confirmed the Redwood City, Calif, company's belief that the treatment, called BMF-219, is a first-in-class agent for the ...
US FDA lifts clinical hold on Biomea's diabetes trials - MSN
WEBThe drug, BMF-219, is being tested in an early-to-mid stage study for type 2 diabetes and a mid-stage study for type 1 diabetes. The hold was placed by the regulator in June due to liver toxicity ...
BMF-219 Induces Complete Responses in Target Acute ... - Biomea …
WEBBMF-219 is a covalently binding inhibitor of menin, a protein known to play an essential role in oncogenic signaling in genetically defined leukemias as well as in diabetes. Preclinically, BMF-219 has demonstrated in well-established acute leukemia cell lines robust downregulation of key leukemogenic genes in addition to menin itself.
Biomea Fusion Announces Positive Data from Initial Cohorts
WEBMar 28, 2023 — In Cohort 3, after 4 weeks of once-daily 100 mg dosing with the investigational, oral covalent menin inhibitor, BMF-219, 89% of patients achieved a reduction in A1c, 78% of patients achieved at least a 0.5% reduction in A1c, and 56% achieved at least a 1% reduction in A1c.