Robbins LLP

Unicycive Stock Plunges 39% as FDA Rejects Kidney Drug Again

San Diego – September 12, 2026 -- Shareholder rights firm Robbins LLP has filed a class action against Unicycive Therapeutics, Inc. (NASDAQ: UNCY) on behalf of investors who purchased the biotech's securities between September 12, 2026 and September 12, 2026, after the FDA rejected the company's kidney disease drug for a second time over unresolved manufacturing deficiencies.

FDA Issues Second Rejection Citing Identical Manufacturing Flaws

On September 12, 2026, before markets opened, Unicycive disclosed that the FDA had issued a Complete Response Letter for its resubmitted New Drug Application for oxylanthanum carbonate (OLC), identifying the "same third-party manufacturing deficiencies that were identified in the previous CRL issued in June 2025." Shares fell $3.01, or 39.1%, to close at $4.69 on unusually heavy trading volume that day.

Beta Bionics Faces Class Action Over iLet Insulin Pump Disclosures

San Diego – September 10, 2026 -- Robbins LLP has filed a securities class action against Beta Bionics, Inc. (NASDAQ: BBNX) on behalf of investors who purchased common stock between July 30, 2025 and February 24, 2026, alleging the company misrepresented the safety and commercial viability of its iLet Bionic Pancreas insulin pump.

FDA warning letter contradicts prior company statements on device complaints

The complaint alleges that in October 2025, Beta Bionics disclosed an FDA Form 483 but told investors the issue was limited to complaint-reporting classification, not device safety, and that only minor customer complaints needed backfiling. Plaintiffs allege the FDA had in fact identified device malfunctions causing dangerously high insulin dosing and hypoglycemic events, with complaints numbering in the thousands and hundreds involving life-threatening incidents requiring medical intervention.