Unicycive Therapeutics, Inc.
Case Overview
| Status: | Status: Investigating |
| Company Name: | Company Name: Unicycive Therapeutics, Inc. |
| Ticker: | Ticker: UNCY |
| Related Attorneys: | Lead Attorneys: Thomas W. Elrod |
| Related Practices: | Related Practices: Securities |
On June 30, 2026, Unicycive announced that the FDA had issued a second Complete Response Letter (“CRL”) regarding the Company’s resubmitted New Drug Application for oxylanthanum carbonate for kidney disease therapy. The Company disclosed that the CRL was based on the same third-party manufacturing deficiencies identified in the prior June 2025 CRL. On this news, the price of Unicycive shares declined by $3.01 per share, or approximately 39%, from $7.70 per share on June 29, 2026 to close at $4.69 on June 30, 2026.