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Beta Bionics Faces Securities Fraud Suit Over iLet Pump Disclosures

Los Angeles – September 10, 2026 -- DJS Law Group has reminded shareholders of a class action lawsuit filed against Beta Bionics, Inc. (NASDAQ: BBNX) alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934. The suit covers investors who purchased BBNX shares between July 30, 2025 and February 24, 2026, with a lead plaintiff filing deadline set for November 3, 2026.

Complaint alleges Beta Bionics downplayed FDA findings on its iLet insulin pump

The complaint centers on the iLet Bionic Pancreas insulin pump, Beta Bionics' sole commercialized product. After the company disclosed that the FDA had issued a Form 483 following a manufacturing facility inspection, defendants allegedly told investors the agency's observations were limited to complaint-reporting criteria and did not reflect underlying device problems.

FDA observations reportedly extended to quality systems and risk analysis

According to the complaint, the FDA's findings in fact reached the company's quality management system, its handling of known device malfunctions, and the risk analysis for the device itself. The unreported events the company was required to disclose allegedly included serious injuries, not the minor, non-medical-intervention incidents defendants had described to the market.

Defendants continued characterizing FDA concerns as procedural, complaint states

The complaint alleges that even as additional information surfaced showing the unreported events were more serious than represented, and that the FDA's objections went beyond a difference in regulatory interpretation, defendants continued to frame the agency's concerns as procedural. Based on these allegations, Beta Bionics' public statements are claimed to have been false and materially misleading throughout the class period.

Shareholders who suffered losses on BBNX stock during the class period are being invited to contact DJS Law Group regarding possible lead plaintiff appointments, which are not required to participate in any eventual recovery.

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