Disclosure under scrutiny: the lawsuit contends Beta Bionics’ SEC filings described the FDA’s Warning Letter as flagging “non-conformities” in its Quality Management System while allegedly omitting that hundreds of unreported iLet complaints involved life-threatening hypoglycemia.

NEW YORK, Sept. 10, 2026 /PRNewswire/ — SueWallSt notifies investors in Beta Bionics, Inc. (NASDAQ: BBNX) that a securities class action has been filed on behalf of shareholders who purchased securities between July 30, 2025 and February 24, 2026. Find out if you might qualify for recovery. You may also contact Joseph E. Levi, Esq. at jlevi@SueWallSt.com or (888) SueWallSt.

BBNX slid from a Class Period high of $31.99 on January 8, 2026 to under $9 per share by April 10, 2026, a decline of roughly $23.09 per share, or approximately 72%, erasing hundreds of millions of dollars in market value. LEAD PLAINTIFF DEADLINE: November 3, 2026.

What the Company Disclosed

The Company’s January 30, 2026 Form 8-K stated that the FDA’s Warning Letter “highlights non-conformities observed by the FDA in relation to the Company’s Quality Management System, Medical Device Reporting, and Correction and Removals, which were previously communicated by the FDA in the Form 483.” Earlier disclosure language indicated the underlying June 2025 Form 483 concerned how the Company defined a reportable complaint rather than how the iLet insulin pump performed.

Disclosure Gaps Alleged

• The Form 483 documented more than 18,000 unreported iLet complaints over roughly two years, measured against 29,419 total iLet users reflected in contemporaneous SEC filings, the complaint states.
• Disclosure language framed a definitional disagreement over reportable events, while the action alleges hundreds of back-filed reports described life-threatening hypoglycemia requiring hospitalization.
• The 8-K referenced “non-conformities” without quantifying complaint volume or severity, the complaint challenges.
• The FDA allegedly found that no corrective actions were taken and that there was no justification for their absence given the risk to patients.
• The complaint alleges investors were not told the iLet reached market without a functioning built-in safety net against excess dosing.
• The June 2025 inspection finding was not acknowledged publicly until late October 2025, roughly four months after issuance.

Why Generic Warnings May Not Protect

On February 24, 2026, the FDA publicly released the 10-page Warning Letter, which stated that any malfunction that could lead to death or serious injury must be reported, and that hypoglycemia requiring intervention is reportable even when treated with glucose drinks or candies. The lawsuit contends that publication contradicted months of reassurance and that shares continued to fall thereafter.

“Generic risk factor language cannot substitute for disclosing specific, known problems already affecting a company’s operations. Here, the complaint alleges that a Form 483 citing more than 18,000 unreported complaints was described to shareholders as a reporting definition issue.” — Joseph E. Levi, Esq.

Submit your information now or call (888) SueWallSt.

WHY SUEWALLST: SueWallSt is powered by Levi & Korsinsky LLP. Levi & Korsinsky LLP has established itself as a nationally-recognized securities litigation firm that has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. The firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services’ Top 50 Report as one of the top securities litigation firms in the United States.

Frequently Asked Questions About the BBNX Lawsuit

Q: When did Beta Bionics allegedly mislead investors? A: The Class Period runs from July 30, 2025 to February 24, 2026. The complaint alleges that corrective disclosures revealed information that caused a significant stock decline.

Q: What court was the BBNX class action filed in? A: The case was filed in the United States District Court for the Central District of California, governed by the Private Securities Litigation Reform Act of 1995.

Q: Who are the defendants named in the BBNX lawsuit? A: The complaint names Beta Bionics, Inc. and individual defendants including senior executives who signed SEC filings, made public statements, or certified financial disclosures under Sarbanes-Oxley.

Q: What do BBNX investors need to do right now? A: Investors may gather brokerage records showing purchase dates, share quantities, and prices paid. Submit your information for a no-cost, no-obligation evaluation of your potential recovery. No immediate action is required to remain eligible as an absent class member.

Q: What is a lead plaintiff and why does it matter? A: A lead plaintiff is the investor appointed by the court to represent the entire class. Lead plaintiffs are typically investors with the largest documented losses. Being appointed does not increase individual recovery but gives direct oversight of how the case is run.

Q: What if I already sold my BBNX shares — can I still recover losses? A: Yes. Eligibility is based on when you purchased, not whether you still hold the shares. Investors who bought during the Class Period and sold at a loss may still be eligible to participate.

Q: What does it cost me to participate? A: There is no upfront cost to submit your information and review whether you may be eligible to recover. Should you choose to participate in the securities class action, they are generally handled on a contingency basis, with any attorneys’ fees and expenses subject to court approval.

Q: Can I join a different law firm’s lawsuit instead? A: Yes. Investors may choose which law firm to contact. Multiple firms often file competing complaints. The court may consolidate related cases and appoint a single lead counsel.

CONTACT:

Levi & Korsinsky, LLP

Joseph E. Levi, Esq.

33 Whitehall Street, 27th Floor

New York, NY 10004

jlevi@SueWallSt.com

Tel: (888) SueWallSt

Fax: (212) 363-7171

Attorney Advertising. Prior results do not guarantee similar outcomes.

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SOURCE SueWallSt.com