New York, New York--(Newsfile Corp. - October 22, 2026) - If you suffered a loss on your investment in Beta Bionics, Inc. ("Beta Bionics" or the "Company") (NASDAQ: BBNX), contact Lauren Molinaro by email at investigations@kmllp.com, or fill out the contact form below to discuss your rights or interests in the securities fraud class action lawsuit at no cost. Investors have until November 3, 2026 to ask the Court to appoint them as lead plaintiff. Courts do not consider applications filed after this deadline.

[CONTACT THE FIRM IF YOU SUFFERED A LOSS]

What Is The Lawsuit About?

The lawsuit has been filed on behalf of investors who purchased securities during the period of July 30, 2025 and 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.

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.

[LEARN MORE ABOUT THE LEAD PLAINTIFF PROCESS]

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 on Kirby McInerney LLP's website.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/320089

Source: Kirby McInerney LLP