Unicycive Therapeutics, Inc.
0 products tracked · names used in filings: Unicycive Therapeutics, Inc.
Upcoming milestones
No upcoming milestones listed.
Recent milestones
Unicycive Therapeutics, Inc.: PDUFA target action date
Unicycive Therapeutics, Inc. (UNCY); "…12 months of OLC drug product stability data from the new manufacturing vendor - Company anticipates FDA acceptance of the NDA within 30 days of resubmission; new assigned PDUFA date expected to be 6 months from resubmission - Current cash position allows runway into 2H 2027 MOUNTAIN VIEW, Calif., September 29,…"; filed 2026-09-29 · source
OLC: PDUFA target action date (hyperphosphatemia in patients with CKD on dialysis)
Unicycive Therapeutics, Inc. (UNCY); oxylanthanum carbonate; NDA; status: set; "Food and Drug Administration (FDA) review of oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission remains on track, with a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026 - Commercial readiness activities continue in anticipation of the potential commercial launch of"; filed 2026-05-12 · source
Oxylanthanum carbonate (OLC): PDUFA target action date (hyperphosphatemia in patients with CKD on dialysis)
Unicycive Therapeutics, Inc. (UNCY); oxylanthanum carbonate; NDA; status: set; "Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026 - Commercial readiness activities ongoing in anticipation of potential commercial launch of OLC in 3Q26 - As of March 3"; filed 2026-03-30 · source
Products
No products recorded.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.