Unicycive Therapeutics said it received a Complete Response Letter from the U.S. Food and Drug Administration due to previously identified deficiencies at a third-party manufacturing facility.
- The company had received its first CRL last June over the same issue.
- Unicycive stated that the FDA did not raise any concerns about the drug’s clinical efficacy or safety and did not request any additional clinical data.
- Last month, Unicycive said it possessed enough resources to fund operations into 2027.
Shares of Unicycive Therapeutics (UNCY) crashed more than 45% on Tuesday following a regulatory setback for its kidney disease drug candidate, which is set to delay its approval.
UNCY shares recorded their biggest ever single-day decline. The stock also cracked below the crucial 200-day moving average for the first time since November 2025.
Why Did FDA Issue A CRL Again?
The biotech firm said it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its resubmitted New Drug Application (NDA) seeking approval of Oxylanthanum Carbonate (OLC), an investigational treatment for hyperphosphatemia in patients with chronic kidney disease on dialysis.
A CRL is the FDA’s response to a company’s NDA, which suggests that the drug cannot be approved in its current form.
The company said the CRL was tied to previously identified deficiencies at a third-party manufacturing facility and not to the drug itself. The company received its first CRL last June.
No Concerns Regarding OLC’s Safety And Efficacy
Unicycive stated that the FDA raised no concerns about OLC’s clinical efficacy or safety and requested no additional clinical data.
According to the company, the FDA has not yet inspected the third-party manufacturing site as part of its review of the resubmitted application. Unicycive said it had resubmitted the NDA after believing the manufacturer had made progress in addressing earlier compliance issues.
“We are in active and ongoing discussion with the FDA regarding label and packaging, and we are optimistic that there will be a successful inspection of the third-party manufacturing vendor and that we will be able to expeditiously resubmit the NDA,” said CEO Shalabh Gupta.
Last month, Unicycive reported unaudited cash, cash equivalents, and marketable securities of $57.1 million, which the company said are expected to fund its planned operations into 2027. The new CRL could change the outlook.
Retail Expects UNCY To Slump Further
Retail sentiment surrounding UNCY on Stocktwits remained in the ‘extremely bullish’ territory over the past 24 hours, while message volumes surged by over 380%.
One user said the CRL was a failure on the FDA’s part and not the company’s.
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Another user said the stock dropping to $3 cannot be ruled out. This implies a further 25% crash.
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The stock has gained around 33% so far this year.
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