Progenics Pharmaceuticals: Don't Worry About Azedra's PDUFA Delay [Seeking Alpha]
PROGENICS PHARMACEUTICALS (PGNX)
Last progenics pharmaceuticals earnings: 8/9 07:30 am
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US:NASDAQ Investor Relations:
progenics.com
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Source: Seeking Alpha
Progenics Pharmaceuticals: Don't Worry About Azedra's PDUFA DelaySummaryOn March 22, Progenics announced that the FDA had delayed its PDUFA decision for drug candidate Azedra by 3 months; the new PDUFA action date is July 30.The delay is apparently due to the submission of supplemental Chemistry, Manufacturing, and Controls information that the FDA requires further time to review.Shares fell sharply on news of the delay; some investors preparing for an April catalyst and now faced with a longer wait decided to bail.Azedra treats malignant adrenal gland tumors for which there is currently no FDA-approved treatment.Despite the delay, this ultra-orphan therapy remains on track to win approval, and should yield very significant financial rewards for the company and its shareholders.
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