Biomea Fusion, Inc. (NASDAQ:BMEA) shares fell 28.58% to $0.90 in after-hours trading Tuesday. The company announced Phase 1 results for BMF-650, its investigational oral GLP-1 receptor agonist being developed for weight management.

Biomea Fusion is a clinical-stage biopharmaceutical company developing oral small-molecule treatments for diabetes and obesity.

BMF-650 Phase 1 Results

According to a press release published Tuesday, the Phase 1 GLP-131 study evaluated the safety, tolerability and weight-reduction effects of BMF-650 in overweight or obese adults.

In Cohorts 1 through 4, mean weight reduction ranged from 1.5% to 3.2% at Day 29, compared with 0.1% for pooled placebo participants in those cohorts.

In Cohort 5, participants received 200 mg once daily for one week, followed by 400 mg once daily for three weeks. Mean weight reduction reached 6.1%, or 6.2 kilograms, at Day 29. The company said the results should be interpreted separately because confinement appeared to affect participants’ eating behavior.

Safety and Development Plans

Across the five active-dose multiple ascending dose cohorts, involving 40 participants, all reported treatment-emergent adverse events were mild or moderate. The company reported no severe or serious adverse events, treatment-related dose modifications or treatment-related discontinuations.

Biomea said additional data analysis is ongoing and that it expects to present further results at a future medical meeting. Longer-term studies and additional clinical data will be needed to characterize the drug’s optimal dosing regimen.

The company also said further development of BMF-650 will require longer-term toxicology studies. Biomea intends to continue that work while positioning the program for a potential strategic partnership.

Trading Metrics, Technical Analysis

Biomea Fusion has a market capitalization of approximately $91.33 million.

Over the past year, Biomea Fusion shares have fallen 24.55%.

The stock has traded between a 52-week high of $2.24 and a 52-week low of $0.87. 

Benzinga’s Edge Stock Rankings indicate a negative price trend in the short term and positive trends in the medium and long term.

Price Action: In the regular session, Biomea Fusion shares fell 7.35% to close at $1.26 on Tuesday.

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