Jefferies analyst, Gena Wang, sees the FDA extension for Progenics Pharmaceuticals' (NASDAQ: PGNX) oral Relistor as a timing setback only. No change to Buy rating or $9 PT.

The FDA extended the PDUFA by 3mon (to July 19) for oral Relistor in opioidinduced constipation in order to review additional info submitted by partner VRX. While slight setback may provide some marketing benefit for competitor’s drug Movantik, we see minimum changes on potential approval since 1) no new data requested by the FDA, and 2) on-par efficacy/safety profiles vs. approved drugs based on KOL feedback. They see favorable risk/reward ahead of the PDUFA date.

Following the announcement, they spoke with one KOL who believes the delay should not change the approvability, given the similar efficacy and a better safety profile of oral Relistor vs. approved Movantik. Oral Relistor showed significant improvement on response rate (defined as ≥3 rescue free bowel movement per week, 51% for 450mg dose and 48% for 300mg dose) vs. placebo (37%), which appears largely in-line with subQ Relistor (58%) and Movantik (35-40%) in OIC pts with chronic non-cancer pain.

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Shares of Progenics Pharmaceuticals closed at $4.10 yesterday.