Every material Form 8-K Unicycive Therapeutics, Inc. has filed with the SEC since August 12, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Unicycive Therapeutics resubmitted its New Drug Application for oxylanthanum carbonate (OLC) on September 29, 2026, with chemistry and manufacturing data from a new third-party drug product vendor. The company expects FDA acceptance within 30 days and a new PDUFA date six months from resubmission, following a June 2026 Complete Response Letter. The company also appointed Meredith S. Manning as an independent director effective October 1, 2026.
NDA resubmitted September 29, 2026, including CMC data from a new third-party drug product manufacturing vendor and 12 months of OLC drug product stability data.
Company anticipates FDA acceptance within 30 days; new PDUFA date expected six months from resubmission.
June 2026 CRL cited the same third-party manufacturing deficiencies as the June 2025 CRL; the original vendor's FDA inspection had not occurred as of September 29, 2026.
Meredith S. Manning appointed independent director effective October 1, 2026; cash, equivalents and marketable securities were $61.4 million as of June 30, 2026.
Unicycive Therapeutics disclosed that a securities class action was filed on September 3, 2026, in the U.S. District Court for the Northern District of California against the company and certain officers. The suit alleges violations of federal securities laws tied to public statements about the company's new drug application for oxylanthanum carbonate phosphate binder. The company says the claims are meritless and plans to defend the lawsuit vigorously, but the filing does not state any financial impact.
Class action filed September 3, 2026, in U.S. District Court for the Northern District of California
Suit names the company and certain officers and alleges federal securities law violations
Allegations relate to public statements about the new drug application for oxylanthanum carbonate phosphate binder for hyperphosphatemia in dialysis patients with chronic kidney disease
Company says the claims are meritless and intends to vigorously defend
Unicycive reported a second-quarter 2026 net loss of $1.7 million, or $(0.06) per share, versus $6.5 million, or $(0.52) per share, a year earlier, mainly because of an $8.0 million increase in the fair value of its warrant liability. Operating expenses rose to $10.1 million from $7.0 million, and the company disclosed a June 2026 FDA Complete Response Letter for its oxylanthanum carbonate NDA that cites the same third-party manufacturing deficiencies as a June 2025 letter.
Net loss was $1.7 million ($(0.06) per share) for the quarter ended June 30, 2026, down from $6.5 million ($(0.52) per share) a year earlier.
Change in fair value of warrant liability was a gain of $8.0 million, compared with $0.4 million in the prior-year quarter.
Operating expenses were $10.1 million, including G&A of $7.4 million and R&D of $2.8 million.
Cash, cash equivalents and marketable securities totaled $61.4 million as of June 30, 2026, with expected runway into 2027.
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