Unicycive Therapeutics (NASDAQ:UNCY) stock is falling on Friday after the medical company provided investors with an update from regulators.
According to the clinical-stage biotechnology company, the Food and Drug Administration (FDA) wants further information concerning lanthanum dioxycarbonate (LDC). This is a treatment in development for hyperphosphatemia in chronic kidney disease patients on dialysis.
Unicycive Therapeutics notes that the FDA wants more info on risk assessment and clinical data to discern the tolerability of LDC in patients. That’s despite the company providing it with new data from a six-month toxicity study in mice.
Shalabh Gupta, MD, CEO of Unicycive Therapeutics, said the following about the FDA update:
“We will work diligently to gain alignment with the FDA on the additional data requirements and plan to provide further updates regarding the program in the third quarter of this year. We remain undeterred in our enthusiasm for the potential best-in-class profile of LDC and are dedicated to bringing this important new treatment option to patients as soon as possible.”
What This Means for UNCY Stock
Any delay in approval for Unicycive Therapeutics’ new treatment weighs on the company’s stock. That’s due to it stalling out profits the company could be generating sooner rather than later. It also causes concerns for investors in UNCY stock as it casts doubts on the approval of the treatment.
UNCY stock is down 24.2% as of Friday morning.
Investors looking for more of the most recent stock market news will want to keep reading!
We have all of the hottest stock market news that traders need to know about on Friday! That includes why shares of Root (NASDAQ:ROOT), Lion Group (NASDAQ:LGHL), and Renalytix (NASDAQ:RNLX) stock are on the move today. You can find out more on these matters at the links below!
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
