BBNX INVESTORS: Contact Kirby McInerney LLP About the Securities Fraud Lawsuit Filed on Behalf of Beta Bionics, Inc. Shareholders

NEW YORK, Sept. 16, 2026 (GLOBE NEWSWIRE) -- Kirby McInerney LLP reminds investors who purchased Beta Bionics, Inc. (“Beta Bionics” or the “Company”) (NASDAQ: BBNX) securities to contact Lauren Molinaro of Kirby McInerney LLP by email at investigations@kmllp.com, or fill out the contact form below by November 3, 2026, to discuss your rights or interests in the securities fraud class action at no cost.

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What Is The Lawsuit About?

The lawsuit has been filed on behalf of investors who purchased securities during the period of July 30, 2025 through February 24, 2026, inclusive (“the Class Period”). The lawsuit alleges that Beta Bionics made false and/or misleading statements and failed to disclose to investors that: (i) the Company’s iLet Bionic Pancreas insulin pump (“iLet”) was malfunctioning and dosing patients with dangerously high levels of insulin, causing hypoglycemic events; (ii) the FDA had raised these issues in a Form 483 it sent to Beta Bionics; (iii) there were thousands of customer complaints back-filed with the FDA in response to the Form 483, including hundreds of life-threatening events requiring significant medical intervention; and (iv) the FDA was not satisfied with the Company’s response to the issue, as Beta Bionics had failed to implement meaningful corrective actions.

On January 8, 2026, Beta Bionics reported its fourth quarter 2025 earnings results, revealing an unexpected miss on new iLet patient starts. On this news, Beta Bionics’ stock price dropped $11.85, or 37%, to close at $20.14 per share on January 9, 2026.

On January 30, 2026, Beta Bionics filed a Form 8-K with the U.S. Securities & Exchange Commission, revealing that the FDA had sent the Company a warning letter connected to its earlier Form 483. The Company revealed that the FDA’s concerns were more serious than they had previously acknowledged, and that the FDA took issue with Beta Bionics’ quality management system for iLet and the Company’s failure to take corrective action based on the Form 483. On this news, Beta Bionics’ stock price fell $0.96, or 6.5%, to close at $13.83 per share on January 30, 2026.

Then, on February 24, 2026, the FDA publicly released its warning letter, revealing the FDA’s concerns with iLet’s underlying issues and stating that any iLet malfunction or hypoglycemia requiring medical intervention must be reported to the FDA. On this news, Beta Bionics’ stock price fell $0.50, or 3.7%, to close at $12.89 per share on February 25, 2026.

[CLICK HERE TO LEARN MORE ABOUT THE CLASS ACTION]

What Should I Do?

If you purchased or otherwise acquired Beta Bionics securities, have information, or would like to learn more about this investigation, please contact Lauren Molinaro of Kirby McInerney LLP by email at investigations@kmllp.com, or fill out the contact form below, to discuss your rights or interests with respect to these matters at no cost.

Courts do not consider lead plaintiff applications submitted after the relevant deadline. The lead plaintiff oversees the litigation on behalf of the class and may influence key decisions, including litigation strategy and settlement. Courts regularly appoint individual investors as lead plaintiffs, not only institutions. Learn more about the lead plaintiff process and eligibility requirements here.

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Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP’s website.

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Contacts
Kirby McInerney LLP        
Lauren Molinaro, Esq.
212-699-1171
https://www.kmllp.com
https://securitiesleadplaintiff.com/
investigations@kmllp.com