>>> FDA Slams Kura Oncology With A Clinical Hold — And Investors Slam Its Stock
Investor's Business Daily
ALLISON GATLIN
11/24/2021
The Food and Drug Administration placed Kura Oncology's (KURA) leukemia study on partial hold Wednesday after a patient died — and the biotech stock plummeted.
Kura is testing its drug, dubbed KO-539, in patients with acute myeloid leukemia. Researchers believe the patient's death is tied to differentiation syndrome, a known side effect in acute myeloid leukemia treatment, Kura said in a news release. Potentially fatal, differentiation syndrome can cause fever, low blood pressure, weight gain and breathing complications.
As a result, Kura can't enroll new patients in the study — a bearish point for the biotech stock. But already enrolled patients can continue to receive KO-539. Patients in the study have relapsed or their cancer doesn't respond to other drugs.
On the stock market today, Kura stock tumbled 15.5% to 14.02. That put the biotech stock at its lowest point since May 2020.
Biotech Stock Dives On FDA Hold
Until the partial hold is resolved, Kura is suspending its guidance on testing timelines.
During its third-quarter report this month, Kura said it expected to enroll 12 patients in each group of the study by the end of the first quarter. The company is evaluating low and high doses of KO-539. The biotech stock briefly popped after its earnings report.
Chief Executive Troy Wilson said Kura is now working to ensure physicians are aware of differentiation syndrome and how to treat it.
Overall, the biotech stock has trended down this year. The biotech stock is now well below its 50-day and 200-day moving averages, according to MarketSmith.com.
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