Beta Bionics, Inc. (BBNX) Securities Class Action

During the Class Period, the company and its management heavily promoted its iLet medical device as demanding “the least engagement from the user” and delivering “the most automated adaptation of any” automated insulin delivery system. Beta Bionics also assured investors that healthcare professionals “are seeing good results from their patients and becoming more comfortable prescribing the iLet[.]”

On October 28, 2025, Beta Bionics’ management discussed their receipt of a Form 483 from the FDA after its inspection of Beta Bionics’ iLet manufacturing, they called the 483 “primarily related to our customer complaint handling system,” downplayed the inspection as “not unusual in our industry,” and said “[w]e’re confident that our new complaint handling system and reporting system meets or exceeds the expectations laid out by the agency in their Form 483 observations.”  CEO Sean Saint emphasized “[t]he 483 itself had nothing to do with the actual complaints being received[….] It had to do solely with the definition the reports being filed as complaints, and that’s all.” 

The complaint alleges these and other statements misled investors because, unknown to them, Beta Bionics concealed its receipt of thousands of iLet safety complaints, including numerous life-threatening hypoglycemic events, and failed to investigate or report the events to the FDA as it was required to do.

By February 24, 2026, when the FDA published its January 28, 2026 WARNING LETTER to CEO Saint, investors learned the truth. The FDA, citing its inspection, was brutal:

• “Your firm failed to adequately analyze quality data, such as complaints, to identify existing and potential causes of nonconforming product or other quality problems[;]”
• “Your firm failed to implement corrective and preventative actions […] for complaints related to device malfunctions that led to serious adverse health outcomes[;]” and
• “Significant violations include […] [f]ailure to report to the FDA information […] no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets may have caused or contributed to a death or serious injury[.]”

FREQUENTLY ASKED QUESTIONS ABOUT THE CASE

What is the BBNX investigation about?

We are focused on whether Beta Bionics may have intentionally misled investors by placing revenues ahead of patient safety.

WHAT SHOULD I DO?

I worked at BBNX. What should I do?

If you were an employee of BBNX, you may have valuable information that could be relevant to the investigation. Hagens Berman is one of the nation’s top whistleblower law firms, and has successfully represented many individuals who come forward with information regarding corporate malfeasance. Under the new SEC Whistleblower program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, contact Reed Kathrein at 844-916-0895 or [email protected].

There are multiple law firms participating, do I need to contact all of them?

No, you do not need to contact all participating law firms. Generally, class-action investigations and lawsuits are consolidated into a single case to streamline the legal process, and attorneys from only a few law firms are selected to serve in a leadership role on the consolidated case. Hagens Berman has a proven track record of being appointed to leadership roles in complex, multidistrict litigation regarding investor fraud and other consumer rights issues, and your claim will be handled by attorneys who have helped secure approximately $325 billion in class-action settlements on behalf of individuals who have suffered due to corporate malfeasance and the wrongdoing of other powerful institutions.

AM I ELIGIBLE?

What is the threshold amount to be eligible? What are “substantial” losses?

The threshold amount and the definition of "substantial" losses may vary depending on a number of factors specific to the case, including the size of the company, market cap, shares outstanding and who holds them and the damages alleged by the fraud. In general, to be eligible to participate in a class-action lawsuit, you must be able to demonstrate that you suffered financial losses as a result of the alleged wrongdoing and that your losses meet the criteria set by the court or law firm. Fill out the form and submit your losses.

CAN I PARTICIPATE?

Am I affected? What do I need to do to participate?

If you were an investor in BBNX, you may be affected and eligible to participate in the case. To determine your eligibility and potential involvement, fill out the form and submit your losses.

Can any BBNX investor participate?

In most class-action investigations and cases, any investor who meets the eligibility criteria, including purchasing the shares during the relevant period, can participate, regardless of the size of their investment. Fill out the form to find out your rights.

I bought on a non-U.S. Exchange. Can I participate?

No. This investigation only covers shares bought on a U.S. exchange, i.e. NASDAQ or NYSE. Fill out the form to find out your rights.

Am I included if I still hold my shares, or do I need to sell to participate?

Participation is based on purchasing shares during the relevant period, rather than your current holdings. Accordingly, you do not need to sell to participate. Fill out the form to find out your rights.