QCOR surged in early trading, tapping $10.63 at one point (up ~9.5% from opening mark), in anticipation of FDA's drug approval. The stock closed at $10.38 and shed 70% of the day's gain in after-hour trading with news of FDA's second delay in PDUFA action date. Company press release halts major sell-off.
Just as health care providers and investors geared up to embrace FDA's approval of Questcor's infantile spasm drug, Acthar, another delay was dished out by the drug regulator 3 days before the scheduled action date. Questcor informed the public about the status of their supplementary NDA (New Drug Application) today in its press release stating that
the U.S. Food and Drug Administration (FDA) has informed Questcor that the FDA will require additional time beyond the current action date of September 11, 2010 to complete its review of Questcor's supplemental new drug application (sNDA) for H.P. Acthar Gel (repository corticotropin injection) in the treatment of infantile spasms (IS).
"We are pleased to be nearing the finish line and look forward to the FDA finalizing its review of our sNDA," indicated Don M. Bailey, Questcor's president and CEO, who remains optimistic about the status of review and reassured investors of a healthy balance sheet for the 3rd quarter of 2010. Once again, the FDA never fails to surprise everyone last minute.
Satisfied with the early run-up, I exited all my positions at $10.58 just when the price started to dip down - 9% return in 8 days =)
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