Roth Capital Comments on Pharmacyclics (PCYC) Following Expanded IMBRUVICA Coverage; Affirms 'Buy' Rating

Roth Capital comments on Pharmacyclics (Nasdaq: PCYC) following news earlier that the U.S. Food and Drug Administration (FDA) has granted IMBRUVICA (ibrutinib) regular (full) approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, and for the treatment of CLL patients with deletion of the short arm of chromosome 17 (del 17p CLL), including treatment naive and previously treated del 17p CLL patients. The firm has Pharmacyclics at Buy with a price target of $183.

Analyst Joseph Pantginis commented, We believe this new approval and labeling change will continue to strengthen Imbruvica's foothold as a new potential cornerstone in treating B-cell lymphomas. Recall that CHMP recently recommended E.U. approval for the drug as well and we expect approval by year end. Hoping to change the status from "accelerated" to "full", PCYC also announced that the FDA has accepted the sNDA filing for Imbruvica for the treatment of CLL/SLL in patients who have received at least one prior therapy. The FDA has granted the submission Priority Review and has assigned a PDUFA date of October 7, 2014. 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 to show improved PFS and OS over the CLL standard of care. Supporting data also showed that Imbruvica led to long term, durable responses in CLL/SLL. We believe the drug may now be viewed as a real alternative to chemotherapy. There are currently 10 active Phase III studies being run in conjunction with worldwide partner Janssen.

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

Pharmacyclics closed at $104.82 yesterday.

You May Also Be Interested In

• Erste Group Downgrades AMD (AMD) to Hold on valuation "significantly higher than peer group"
• Sage Therapeutics (SAGE) PT Lowered to $18 at Mizuho
• Range Resources (RRC) PT Raised to $41 at Mizuho