Pharmacyclics jumps on ibrutinib data

Pharmacyclics Inc. (NASDAQ:PCYC) jumped $20.84 (20%) to $125.90 on Tuesday after stopping early the Phase III RESONATE (PCYC-1112-CA) trial on the recommendation of an independent DMC after an interim analysis showed Pharmacyclics' Imbruvica ibrutinib met the primary endpoint in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small cell lymphocytic lymphoma (SLL). The interim analysis showed once-daily oral Imbruvica met the primary endpoint of improving progression-free survival (PFS) vs. IV Arzerra ofatumumab from Genmab A/S (CSE:GEN; OTCBB:GMXAY) and partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). Imbruvica also met the secondary endpoint of improving overall survival (OS) vs. ofatumumab. The open-label, international trial enrolled 391 patients and was designed to evaluate superiority of Imbruvica compared to ofatumumab.

Pharmacyclics and partner Johnson & Johnson (NYSE:JNJ) plan to discuss next steps for Imbruvica with FDA and EMA and will submit a comprehensive study report to the agencies in the "coming months." Imbruvica has accelerated approval in the U.S. for relapsed or refractory mantle cell lymphoma (MCL) and is under Priority Review in the U.S. for relapsed or refractory CLL or SLL, with a Feb. 28 PDUFA date. The drug has breakthrough therapy designation from FDA for MCL and for CLL or SLL in patients with chromosome 17p deletion, as well as for Waldenstrom's macroglobulinemia. An MAA for Imbruvica -- a Bruton's tyrosine kinase (Btk) inhibitor that covalently binds to cysteine residue 481 -- is under EMA review for MCL and CLL or SLL. ...