UNCY Retail Buzz Explodes 150% This Week as Traders Bet Big on Experimental Drug Approval

• The FDA is expected to decide on the application by June 29, as per the company. 
• The FDA in June refused to approve the company’s application citing manufacturing issues at a third-party manufacturing vendor. 
• The company is now looking to launch OLC in the third quarter.

Shares of Unicycive Therapeutics Inc (UNCY) jumped 9% on Wednesday as retail investors contemplated the possibility of approval for the company’s Oxylanthanum carbonate.

UNCY has resubmitted its application seeking the U.S. Food and Drug Administration’s approval for Oxylanthanum carbonate for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis following a previous rejection. The FDA is expected to decide on the application by June 29, as per the company.

The FDA in June refused to approve the company’s application citing manufacturing issues at a third-party manufacturing vendor.

The company is now looking to launch OLC in the third quarter and is continuing to strengthen its commercial infrastructure and advance market readiness initiatives in the meantime.

How Did Retail Traders React?

On Stocktwits, retail sentiment around UNCY jumped from ‘neutral’ to ‘bullish’ territory over the past 24 hours, while message volume increased from ‘normal’ to ‘high’ levels. Over the past week, message volume rose 150%, according to Stocktwits data.

A Stocktwits user predicted revenue of as much as $600 million for OLC in 2029.

Yet another sees 80% chances for the drug’s approval this time.

Management Commentary

“This year is shaping up to be pivotal for Unicycive, underscored by the U.S. Food and Drug Administration’s acceptance of our New Drug Application resubmission for OLC and the potential for approval and launch later this year,” said CEO Shalabh Gupta earlier this week. “With hyperphosphatemia still uncontrolled in nearly 75% of U.S. patients with chronic kidney disease undergoing dialysis, OLC, if approved, has the potential to offer a meaningful new treatment option characterized by a differentiated clinical profile and reduced pill burden compared to currently available phosphate binders.”

Hyperphosphatemia is a condition characterized by excessively high levels of phosphate in the blood.

UNCY stock has gained nearly 32% over the past 12 months. 

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