pharmacyclics inc (PCYC) Key Developments
Pharmacyclics, Inc. Announces Initiation of PCYC-1135-CA, Multi-Center Study
Apr 1 15
Pharmacyclics Inc. announced the initiation of PCYC-1135-CA, a multi-center study that will investigate the use of ibrutinib (IMBRUVICA®) in combination with MEDI4736, an investigational, anti-PD-L1 immune checkpoint inhibitor being developed by AstraZeneca. The Phase Ib/II study will examine the safety, tolerability and effectiveness of this investigational combination in individuals with relapsed or refractory (R/R) non-small cell lung cancer (NSCLC), breast cancer, and pancreatic cancer. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech Inc. The Phase Ib portion of the study will primarily seek to determine the safety, tolerability, and appropriate dose of ibrutinib when combined with MEDI4736 to treat individuals with these cancers. The Phase II portion of the study will be conducted in three distinct cohorts to determine the safety and effectiveness of the treatment combination in individuals with R/R NSCLC, breast and pancreatic cancers. The clinical study will aim to enroll approximately 160 subjects at approximately 20 sites in the U.S.
Pharmacyclics Inc. Announces New Pre-Clinical and Clinical Data for ibrutinib (IMBRUVICA)
Mar 19 15
Pharmacyclics Inc. announced that new pre-clinical and clinical data for ibrutinib (IMBRUVICA®) will be highlighted at the 2015 American Association for Cancer Research (AACR) Annual Meeting to be held April 18 " 22, 2015, in Philadelphia, PA. Several company-sponsored and investigator-initiated abstracts have been accepted for presentation as oral and poster sessions highlighting data in solid tumor and blood cancers. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech Inc. Long-term treatment with single-agent ibrutinib 420 mg leads to durable responses including complete responses in CLL (Abstract CT132) Clinical Trials Minisymposium. IMBRUVICA (ibrutinib) is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton's tyrosine kinase (BTK).1 BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells.1,2 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.
AbbVie Inc., Pharmacyclics Inc. - M&A Call
Mar 5 15
To consider definitive agreement under which AbbVie will acquire Pharmacyclics, and its Imbruvica® (ibrutinib), a highly effective treatment for hematologic malignancies
Pharmacyclics Inc. Announces Unaudited Consolidated Financial Results for the Fourth Quarter and Year Ended December 31, 2014
Feb 18 15
Pharmacyclics Inc. announced unaudited consolidated financial results for the fourth quarter and year ended December 31, 2014. The company reported revenue of $290 million, up from $124 million in the year ago quarter, primarily due to a $172 million increase in Imbruvica net product revenue year over year. Non-GAAP earnings were $0.96, up from $0.30 per share last year. GAAP net income for the quarter ended December 31, 2014 was $63 million, or $0.81 per diluted share, compared to GAAP net income of $64 million or $0.82 per diluted share for the quarter ended December 31, 2013. Income from operations was $92.991 million against $85.431 million a year ago. Income before income taxes was $93.052 million against $85.439 million a year ago. Non-GAAP net income was $75.197 million or $0.96 per diluted share against $23.642 million or $0.30 per diluted share a year ago.
For the year, the company reported total revenue of $729.729 million against $260.169 million a year ago. Income from operations was $122.381 million against $97.924 million a year ago. Income before income taxes was $122.447 million against $98.136 million a year ago. Net income was $86.124 million or $1.10 per diluted share against $67.010 million or $0.87 per diluted share a year ago. Non-GAAP net income was $140.385 million or $1.80 per diluted share against $1.083 million or $0.01 per basic and diluted share a year ago. Total revenue was increased primarily due to $479 million increase in IMBRUVICA net product revenue, as the year ended December 31, 2014 was first full year of IMBRUVICA product sales.
Pharmacyclics Inc. to Report Q4, 2014 Results on Feb 18, 2015
Feb 12 15
Pharmacyclics Inc. announced that they will report Q4, 2014 results at 5:00 PM, Eastern Standard Time on Feb 18, 2015