- Class action filed in U.S. District Court for the Central District of California, case Holtzman v. Beta Bionics, Inc., No. 26-cv-9999.
- Allegations: Beta Bionics misled investors about iLet safety and commercial success.
- FDA Form 483 cited with over 18,000 unreported complaints since iLet launch in 2023.
- Complaints include life-threatening hypoglycemia due to aggressive insulin dosing algorithm.
- Stock dropped 37% on Jan 8-9, 2026 after missing new-patient-start estimates by nearly 10%.
- Stock dropped 4.9% on Feb 24-25, 2026 after FDA warning letter became public.
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