Roth Keeps Pharmacyclics (PCYC) at 'Buy'; Imbruvica sNDA Selected for Priority Review by FDA

Roth Capital affirms its Buy rating and $183 price target on Pharmacyclics (Nasdaq: PCYC) following news that the FDA has accepted the company's sNDA filing for Imbruvica for priority review with a October 7, 2014, PDUFA date.

Analyst Joseph Pantginis commented on the impact of the event: We expect Imbruvica will receive full approval based on the recently announced positive, randomized Phase III RESONATE study of Imbruvica versus ofatumumab in 391 previously treated CLL/SLL patients. The data showed statistically significant benefit in OS, PFS, and ORR for patients treated with Imbruvica. Imbruvica led to a 78% reduction in the risk of progression or death versus ofatumumab. Recall that this is the first Phase III study is to show improved PFS and OS over the CLL standard of care. We believe the drug may now be viewed as a real alternative to chemotherapy. Supporting data also showed that Imbruvica led to long term, durable responses in CLL/SLL. PCYC also announced data showing compelling results for the combination of Imbruvica + ofatumumab in heavily pretreated CLL. At a KOL panel at ASCO last week, physicians from leading academic medical centers praised Imbruvica's effectiveness and commented that patients love the drug due to its clean side effect profile. Janssen and PCYC are conducting 45 ongoing trials, including 11 Phase III studies, with Imbruvica.

For an analyst ratings summary and ratings history on Pharmacyclics click here. For more ratings news on Pharmacyclics click here.

Pharmacyclics closed at $93.50 yesterday.

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