Shares of Eagle Pharmaceuticals $EGRX tanked Wednesday afternoon after the biotech reported that the FDA has snubbed its pitch to market its drug Ryanodex for heat stroke. And this rejection may take awhile to overcome.
Eagle didn’t say why the FDA rejected its drug Ryanodex (dantrolene sodium), which is approved for malignant hyperthermia, limiting itself to a terse statement that
the agency wants another clinical study before it will reconsider its marketing application.
The biotech’s shares nose-dived on the news, falling 28%.
The FDA had issued a priority review for this drug, lopping four months off the usual review time to come up with a speedy decision. Eagle touted that fact far and wide, claiming that the drug was a transformational approach to treating exertional heat stroke, with no drugs currently approved for that condition.
But in promoting the application, the company may also have illuminated its trouble. Eagle filed the drug along with results from a “real world” study in an acute setting, augmenting it with “pivotal” animal data.
It would be a rare event for regulators to accept any animal study as “pivotal,” possibly explaining the FDA’s demand for an actual trial. That can be both time consuming and expensive.
“We are reviewing our options and will evaluate the FDA’s response to chart a path forward for Ryanodex for this important indication and life-threatening condition,” said Scott Tarriff, the CEO of Woodcliff Lake, NJ-based Eagle.
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