Wednesday's 9% rise in Adolor
Adolor's opioid-induced and post-operative ileus treatment Entereg, partnered with GlaxoSmithKline
Earlier in the year, Adolor's hopes of fixing the FDA's safety concerns appeared dashed, after new adverse events popped up in a study intended to assuage the agency's safety concerns about the drug. Entereg-treated patients experienced a previously unseen increased rate of neoplasms (abnormal cell growth that can sometimes lead to cancer) compared to placebo patients.
Despite the new safety issues from this long-term-use study, Adolor persisted in filing another Entereg marketing application for post-operative ileus (POI). POI patients will only be taking Entereg for a short time, and may not experience the same risks as with its long-term use.
It's hard to see Entereg getting FDA approval after the negative safety data popped up. An advisory panel hearing means that the fate of Entereg for POI may be slightly less negative than before, though.
Investors in shares of Progenics Pharmaceuticals
Investors should mark their calendars; the Entereg advisory committee is scheduled to meet Jan. 23. With a PDUFA date less than three weeks later on Feb. 10, the meeting results will help investors make a better -- but by no means sure -- bet on which way the FDA is leaning.
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