FDA Clears Beta Bionics’ Mint Patch Pump

Beta Bionics Inc (BBNX) rose 2.2% to $16.93 after FDA cleared its Mint patch pump and announced a partnership with Senseonics. The company expects a Q1 2027 launch for Mint and a Q4 2026 launch for the combined diabetes management solution. However, 2026 revenue guidance was reduced by $10 million, and the company faces securities fraud lawsuits.

Beta Bionics Inc (BBNX) shares rose 2.2% after FDA cleared its Mint patch pump, but the company lowered 2026 revenue guidance to $121M-$126M. Mint's U.S. launch is expected in Q1 2027, with full commercialization planned through pharmacies. The company also submitted its 3D Intelligence insulin dosing algorithm to the FDA.

Beta Bionics (BBNX) received FDA clearance for its Mint patch pump, aiming for a Q1 2027 U.S. launch. The company also unveiled 3D Intelligence, a next-gen insulin dosing algorithm. Beta Bionics lowered its 2026 revenue outlook to $121M-$126M, citing potential revenue deferral. A partnership with Senseonics (SENS) was announced for integrating Eversense 365 with iLet Bionic Pancreas.

Beta Bionics reported Q2 2026 revenue of $32M and gross margin of 59%, up from 54% a year earlier, while posting a wider-than-expected adjusted loss of 53 cents per share. The company reaffirmed full-year 2026 revenue guidance of $131M to $136M and raised gross margin guidance to 58.5% to 59.5%.

Beta Bionics reported Q2 2026 EPS of -$0.53, worse than analysts’ -$0.34, on revenue of $32M, up 38% year over year. Gross margin improved to 59.0%. The company reaffirmed full-year revenue guidance of $131M-$136M and raised gross margin guidance to 58.5%-59.5%. Shares fell 4.18% to $15.14, then rose 2.18% after hours.

Beta Bionics (Nasdaq:BBNX) reported Q2 results that beat consensus. For the quarter ended June 30, 2026, it posted a $23.4M loss (53¢/share) on $32.0M revenue, with sales up about 38% versus a year earlier. DME sales were $20.4M (+9%) and PBP sales $11.6M (+153%). It reaffirmed 2026 revenue guidance of $131M to $136M.