Law firms probe Unicycive after FDA letter sent shares down 39%

Glancy Prongay Wolke & Rotter joined earlier scrutiny after Unicycive disclosed a second Complete Response Letter tied to the same third-party manufacturing deficiencies flagged in June 2025.

Summary

Glancy Prongay Wolke & Rotter LLP said it has begun an investigation into Unicycive Therapeutics, Inc. over possible federal securities law violations after the company disclosed a second Complete Response Letter from the FDA on June 30, 2026. The letter concerned Unicycive’s resubmitted New Drug Application for oxylanthanum, a kidney disease therapy, and identified the same third-party manufacturing deficiencies cited in a previous CRL issued in June 2025. Unicycive’s stock fell $3.01, or 39.1%, to close at $4.69 on June 30, 2026. The new announcement adds to an earlier investigation disclosed by Kirby McInerney LLP following the same share-price drop.

Terms & Concepts
  • Complete Response Letter: An FDA notice stating that a drug application cannot be approved in its current form.
  • New Drug Application: A formal submission seeking U.S. approval to market a new medicine.
  • third-party manufacturing deficiencies: Problems identified at an outside manufacturer involved in producing a drug or its components.