• Beta Bionics, Inc. (NASDAQ: BBNX) shareholders should email [email protected]

NEW YORK, Oct. 19, 2026 /PRNewswire/ --

What is the Investigation About?

On January 8, 2026, after the market closed, Beta Bionics reported an unexpected shortfall in new patient starts for its iLet Bionic Pancreas insulin pump. This announcement followed a December 2025 report by The Capitol Forum that made public an FDA Form 483 concerning the device.

Following this news, the price of Beta Bionics stock fell $11.85 per share, or approximately 37%, to close at $20.14 per share on January 9, 2026.

On January 30, 2026, Beta Bionics disclosed that the FDA had issued a warning letter related to the earlier inspection observations. The concerns extended beyond complaint handling to its quality management system, medical device reporting, and corrective actions. On February 24, 2026, the FDA publicly released the warning letter, stating that malfunctions potentially causing death or serious injury must be reported, including hypoglycemic episodes requiring medical intervention even when resolved with glucose drinks or candy.

If you own Beta Bionics, Inc. (NASDAQ: BBNX) securities, please contact Fletcher Moore at [email protected].

You may be able to seek monetary damages, corporate governance reforms, reimbursement to the company, and a court approved incentive award at no cost to you whatsoever. All representation is on a contingency fee basis. Shareholders pay no fees or expenses.

MOORE LAW PLLC
30 Wall Street, 8^th Floor
New York, NY 10005
[email protected]
www.fmoorelaw.com

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SOURCE Moore Law PLLC