Unicycive Therapeutics Receives Complete Response Letter from FDA Regarding Resubmitted ...

Unicycive hits another hurdle with hyperphosphataemia drug

Unicycive Therapeutics' hopes of getting FDA approval of its drug for hyperphosphataemia in dialysis patients have been knocked back again.

Unicycive Therapeutics Receives Complete Response Letter from FDA Regarding Resubmitted ...

- Complete Response Letter relates to deficiencies previously identified at third-party manufacturing vendor -

Unicycive Therapeutics Receives Complete Response Letter from FDA Regarding Resubmitted Oxylanthanum Carbonate (OLC) New Drug Application (NDA)

- Complete Response Letter relates to deficiencies previously identified at third-party manufacturing vendor -- -- FDA inspection of third-party facility...

Release - Unicycive Therapeutics Receives Complete Response Letter from FDA Regarding Resubmitted Oxylanthanum Carbonate (OLC) New Drug Application (NDA) - Channelchek

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Unicycive slides as FDA delay, dilution weigh premarket

NEW YORK, June 30, 2026, 09:06 EDT Unicycive traded at $4.02 before the bell, sinking 47.76% from its $7.70 finish on Monday. Volume was running over four times the usual level. (Google) The FDA issued a second complete response letter for oxylanthanum carbonate, this time due to third-party manufacturing issues rather than questions on safety…

Unicycive gets second CRL for kidney drug as manufacturing woes continue

Unicycive Therapeutics’ chronic kidney disease drug was rejected by the FDA for a second time over persistent issues at a third-party contract manufacturer. The company’s phosphate binder drug oxylanthanum carbonate (OLC) was being reviewed as ...