Unicycive Therapeutics Share Price Today

Unicycive Therapeutics class action deadline hits November 2, 2026

Lead plaintiff filing deadline for Unicycive Therapeutics is November 2, 2026. Stock fell 39.1% to $4.69 after second FDA CRL disclosure on June 30, 2026. Class period runs from December 29, 2025, to June 29, 2026. Institutional investors urged to assess recoverable losses from artificial inflation.

Unicycive FDA accepts OLC NDA resubmission; PDUFA set for March 2027

FDA accepted Unicycive's OLC NDA resubmission with a PDUFA date of March 25, 2027. Shares fell 39.1% to $4.69 following a June 2026 Complete Response Letter citing manufacturing deficiencies. Lead plaintiff motions for the securities fraud class action are due by November 2, 2026. The Law Offices of Frank R. Cruz joins other firms urging investors to submit loss information before the deadline.

Unicycive resubmits OLC NDA with new vendor data and $61.4 million cash

Resubmitted NDA includes CMC data from a new third-party vendor with "No Action Indicated" FDA status. Expects FDA acceptance within 30 days and a new PDUFA date six months from September 29, 2026. Reported $61.4 million in cash and equivalents as of June 30, 2026, supporting runway into 2H 2027. Retains both drug product vendors to ensure supply chain redundancy amid pending inspections.

Unicycive Therapeutics CEO to present at Wainwright investment conference

CEO Shalabh Gupta to present at H.C. Wainwright conference on September 15, 2026. Lead asset oxylanthanum carbonate targets hyperphosphatemia in dialysis patients. Second asset UNI-494 holds FDA orphan drug designation for kidney transplant care. Phase 1 safety study for UNI-494 completed in healthy volunteers.

Unicycive Q2 EPS beats by 82%; FDA assigns OLC vendor inspection

Unicycive Therapeutics reported Q2 FY26 EPS of $(0.06), beating estimates by 82% and reducing YoY losses by 88%. Net loss narrowed to $1.7M from $6.5M, aided by an $8.4M warrant liability gain. Operating expenses rose to $10.1M. The FDA assigned a facility inspection for its OLC vendor, enabling potential NDA resubmission. Cash stood at $61.4M.

Block & Leviton investigates Unicycive after second FDA CRL

Block & Leviton LLP has launched an investigation into Unicycive Therapeutics, Inc. regarding potential securities law violations after the company received a second FDA Complete Response Letter for its OLC NDA. The investigation centers on whether Unicycive made false statements or failed to disclose material information regarding third-party manufacturing deficiencies. Investors who suffered losses are encouraged to contact the firm to discuss their legal rights.