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Unicycive Therapeutics , Inc. (NASDAQ:UNCY), a $72 million market cap biotech company whose stock has gained 52% over the past year despite showing significant volatility, disclosed Monday that it became aware of a securities class action lawsuit filed in the United States District Court for the Northern District of California. The lawsuit names the company and certain of its officers as defendants.
According to the company’s statement in a press release, the legal action alleges violations of federal securities laws related to public statements made by Unicycive Therapeutics concerning its new drug application for oxylanthanum carbonate phosphate binder. This drug is intended for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis.
Unicycive Therapeutics stated that it believes the claims are without merit and that it plans to defend the lawsuit vigorously.
The information in this article is based on a press release statement included in the company’s filing with the Securities and Exchange Commission.
In other recent news, Unicycive Therapeutics, Inc. has been granted a U.S. patent for its investigational drug UNI-494, aimed at treating Chronic Kidney Disease. This marks the second patent for UNI-494, following an earlier patent for treating Acute Kidney Injury, and the company has completed a Phase 1 clinical study in healthy volunteers. Additionally, Unicycive has regained compliance with Nasdaq’s minimum share price requirement after implementing a 1:10 reverse stock split. The Nasdaq Stock Market confirmed that the company met the necessary criteria as of July 3.
On a different note, Unicycive announced that the FDA plans to issue a Complete Response Letter (CRL) for its Oxylanthanum Carbonate (OLC) New Drug Application. The CRL cited deficiencies at a third-party manufacturing vendor, although these were not related to the OLC itself. Unicycive plans to seek a Type A meeting with the FDA to address these issues. The FDA did not express concerns about the pre-clinical, clinical, or safety data in its response.
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