ARIAD Pharmaceuticals (ARIA) Full Iclusig Approval, Label Update Incremental Positive - Leerink
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Leerink Partners analyst Michael Schmidt reiterated an Outperform rating and $20 price target on ARIAD Pharmaceuticals (NASDAQ: ARIA) after the company announced that the FDA granted full approval of Iclusig and also approved the sNDA to include long-term follow-up data from the pivotal PACE Ph II trial in the label ~2 weeks ahead of the PDUFA date on 12/12.
Schmidt commented, "This is incrementally positive for ARIA, but by-and-large expected. Based on our prior checks with chronic myelogenous leukemia (CML) key opinion leaders (KOLs) and our detailed analysis of the CML market (LINK), inclusion of the long-term PACE data should provide incremental additional prescriber comfort with using the drug, while results of the pending OPTIC trial in late 2017 represent an important dataset, which if positive could support broader use of the drug beyond use predominantly in academic centers. Next key event for ARIA is the PDUFA date for brigatinib in ALK+ NSCLC (non-small cell lung cancer) on 4/29/2017. We reiterate our OP rating on the stock as we expect Iclusig sales to continue to grow in the US and ROW, while Street expectations for the company's potential best-in-class pipeline products addressing genetically defined cancers including brigatinib and AP32788 (EGFR inhibitor) are only modest, providing key sources of upside, in our view."
Shares of ARIAD Pharmaceuticals closed at $13.70 yesterday.
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