pharmacyclics inc (PCYC) Key Developments
Pharmacyclics Inc. and Janssen Biotech, Inc. Announce U.S. FDA Approves IMBRUVICA (Ibrutinib) for Treatment of Waldenstrom's Macroglobulinemia
Jan 29 15
Pharmacyclics, Inc. announced that the U.S. Food and Drug Administration has granted single-agent IMBRUVICA (ibrutinib) regular (full) approval in all lines of therapy as the first and only treatment for patients with Waldenstrom's macroglobulinemia (WM), a rare, indolent type of B-cell lymphoma. This is the fourth indication for IMBRUVICA, an oral therapy, which received FDA Breakthrough Therapy Designation for this indication in February 2013. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc. The approval is based on results from a multi-center, Phase II study that evaluated the efficacy and tolerability of IMBRUVICA in 63 patients with previously treated WM. In this study, IMBRUVICA demonstrated a response rate of 62% according to an Independent Review Committee. Very good partial responses (VGPR) of 11% and partial responses (PR) of 51% were observed. These responses were maintained and the median duration of response (DOR) has not been reached, with a range of 2.8+ to 18.8+ months.
Pharmacyclics, Inc. Announces Preliminary U.S. Net Product Revenue Results for the Fourth Quarter and Fiscal Year Ended December 31, 2014 and Provides U.S. Net Product Revenue Guidance for Fiscal Year 2015
Jan 12 15
Pharmacyclics Inc. provided preliminary unaudited 2014 U.S. net product revenue results For the fiscal year ended December 31, 2014, U.S. net product revenue for is expected to be approximately $492 million.
For the fourth quarter of 2014, U.S. net product revenue is expected to be approximately $185 million, which would represent an approximately 31% sequential increase compared to the quarter ended September 30, 2014.
For 2015, the company anticipates U.S. net product revenue of approximately $1 billion for IMBRUVICA, representing a 103% increase over the expected 2014 U.S. net product revenue.
Pharmacyclics Inc. Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-12-2015 02:30 PM
Jan 6 15
Pharmacyclics Inc. Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-12-2015 02:30 PM. Venue: Westin St. Francis Hotel, San Francisco, California, United States. Speakers: Robert W. Duggan, Chairman and Chief Executive Officer.
Pharmacyclics Inc.(NasdaqGS:PCYC) added to NASDAQ Biotechnology Index
Dec 22 14
Pharmacyclics Inc. will be added to the NASDAQ Biotechnology Index.
Pharmacyclics Inc. Presents at The Trout Group 's Annual 1x1 Management Access Event, Jan-12-2015
Dec 15 14
Pharmacyclics Inc. Presents at The Trout Group 's Annual 1x1 Management Access Event, Jan-12-2015 . Venue: The Handlery Hotel, 351 Geary Street, Union Square, San Francisco, California, United States.