Unicycive resubmits NDA and HC Wainwright targets Unicycive Therapeutics stock

Unicycive Therapeutics (ISIN US90466Y2028) resubmitted its oxylanthanum carbonate New Drug Application on September 29, 2026, with 12 months of stability data from a new manufacturing vendor. FinanzNachrichten reported that the filing uses Chemistry, Manufacturing, and Controls data from an alternative vendor and could lead to a new FDA decision date six months after resubmission.

Three regulatory milestones

In June 2025, the FDA issued a Complete Response Letter on the initial application, according to FinanzNachrichten. In June 2026, a second Complete Response Letter cited the same manufacturing deficiencies, while the FDA did not raise clinical efficacy or safety concerns.

On September 29, 2026, Unicycive submitted the revised application with data from a new vendor whose facility received a No Action Indicated classification after a March 2024 inspection, as FinanzNachrichten reported.

What does the resubmission change?

The company said it anticipates FDA acceptance within 30 days and a new PDUFA date approximately six months after the filing. The package also includes 12 months of stability studies and bridging data between the original and replacement vendors, giving the regulatory path a defined timetable while leaving the FDA decision unresolved.

Unicycive said its cash position supported a runway into the second half of 2027 as of September 29, 2026. The lead candidate targets hyperphosphatemia in dialysis patients, while UNI-494 remains in development for acute kidney injury.

Analyst target and reporting date

MarketBeat reported on October 1, 2026 that HC Wainwright maintained a Buy rating and a USD 13.00 price target while raising its third-quarter 2026 earnings-per-share estimate to a USD 0.39 loss from a USD 0.40 loss. MarketBeat also reported that five analysts had Buy ratings, one had a Hold rating and one had a Sell rating, with an average target of USD 18.25.

MarketBeat identified November 2, 2026 as the deadline for lead-plaintiff applications in a securities lawsuit. The next earnings date was listed as an estimate rather than a company-confirmed reporting date, so the regulatory timetable remains the clearer dated milestone for Unicycive.

Market value and regulatory timing

Unicycive had a market capitalization of USD 99.6 million and a 52-week range of USD 3.67 to USD 8.74 as of October 13, 2026. Those market figures frame a company whose regulatory opportunity is tied to manufacturing documentation rather than a new clinical efficacy package.

Unicycive is listed on Nasdaq under ticker UNCY and operates in the Healthcare sector and Biotechnology industry. Market context: Market report S&P 500.

More news and analyses on Unicycive Therapeutics stock