Eagle Pharmaceuticals (EGRX) plunged Thursday — diving below a flat base — after enrolling just one-tenth of the 70 patients it expected for a study of a heat stroke treatment.
XThe drugmaker has spent years trying to expand uses for its malignant hyperthermia drug, Ryanodex. On Thursday, Eagle said it enrolled just seven patients in a study of Ryanodex as a heat stroke treatment. It had planned to enroll 70 over six days in Saudi Arabia.
"Overall emergency room visits were dramatically decreased from previous years due to well-implemented crowd management, lower temperatures, lower humidity and other external factors," Eagle said in a news release.
On the stock market today, Eagle stock tumbled 16.3%, to 68.34, in higher-than-normal volume. Shares collapsed below a flat base and an 85.76 buy point it had spent a month forming. Eagle stock neared a three-month low.
Replicating A 2015 Study
The study attempted to replicate a 2015 test during Hajj in Saudi Arabia. Hajj is the pilgrimage to Mecca that every Muslim must make at least once.
The study in 2015 enrolled a total of 34 patients. But the study in 2018 "didn't exactly go as planned," Piper Jaffray analyst David Amsellem said.
As a result, Eagle likely doesn't have enough data to ask for approval, he said in a report to clients.
"Though management cited some evidence of a clinical benefit vs. standard-of-care cooling methods alone, the reality is that Eagle did not expand the body of data surrounding Ryanodex meaningfully, and as such, it is difficult to conclude that this will satisfy the FDA," he said.
Lowering Body Temperature
Eagle, though, says it still plans to meet with the Food and Drug Administration to discuss its next steps. Patients in the recent study received standard-of-care treatment including body cooling. Four of the seven received Ryanodex in addition to standard-of-care techniques.
Both groups of patients had similar baseline characteristics, including a mean core body temperature north of 107 degrees Fahrenheit and a Glasgow Coma Score of 5, indicating severe brain injury. On this scale, a score of 3 is the worst while 15 is the best.
Of those who received Ryanodex, two were restored to normal neurological functioning. A third showed substantial improvement. The fourth patient had an initial core body temperature of 112.1 degrees Fahrenheit, which remained unchanged.
In the standard-of-care alone group, one was restored to normal neurological function. Another still had severe impairment and the third worsened.
Difficult To Draw Conclusions
Mizuho analyst Irina Koffler noted that it's difficult to draw any conclusions from the data. Both studies in 2015 and 2018 suggest numerical trends favoring Ryanodex.
In the 2015 study, 29.4% of Ryanodex-treated patients reached a Glasgow Coma Score of 13 at 90 minutes. In comparison, just 11.8% of those who just received the standard-of-care reached the same measure.
It's also possible that malignant hyperthermia and exertional heat stroke don't have the same underlying factors, Koffler said.
"We also point to the fact that the majority of patients in the pooled Ryanodex-treated group did not improve at all, suggesting that the mechanism underlying exertional heat stroke is different from malignant hyperthermia, in which virtually all patients respond to the drug," she said in a note to clients.
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