Last $89.77 USD
Change Today -0.27 / -0.30%
Volume 809.4K
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As of 3:16 PM 04/17/14 All times are local (Market data is delayed by at least 15 minutes).

pharmacyclics inc (PCYC) Snapshot

Open
$89.75
Previous Close
$90.04
Day High
$92.61
Day Low
$88.18
52 Week High
02/21/14 - $154.89
52 Week Low
04/17/13 - $72.91
Market Cap
6.7B
Average Volume 10 Days
1.8M
EPS TTM
$0.80
Shares Outstanding
75.0M
EX-Date
--
P/E TM
112.2x
Dividend
--
Dividend Yield
--
Current Stock Chart for PHARMACYCLICS INC (PCYC)

pharmacyclics inc (PCYC) Related Businessweek News

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pharmacyclics inc (PCYC) Details

Pharmacyclics, Inc., a biopharmaceutical company, designs, develops, and commercializes small-molecule drugs for the treatment of cancer and immune mediated diseases in the United States and internationally. The company offers IMBRUVICATM as a single agent for the treatment of patients with chronic lymphocytic leukemia who have received at least one prior therapy. Its products candidate in clinical development includes IMBRUVICA BTK inhibitor, which is under multiple Phase I, II, III clinical trials for the treatment of naive and relapsed/refractory chronic lymphocytic leukemia, naive and relapsed/refractory diffuse large B-cell lymphoma, naive follicular lymphoma, relapsed/refractory mantle cell lymphoma, relapsed/refractory follicular lymphoma, relapsed/refractory multiple myeloma, Waldenstrom's macroglobulinemia, and relapsed/refractory marginal zone lymphoma. The company is also developing a BTK inhibitor lead optimization program, which is in Phase I clinical trials targeting anti-inflammatory and autoimmune indications; PCI-27483, an inhibitor of Factor VIIa that is in multiple Phase I, II clinical trials for the treatment of cancer; and PCI-24781, a HDAC inhibitor abexinostat, which is in multiple Phase I, II clinical trials for the treatment of relapsed/refractory lymphomas and solid tumors. The company’s clinical development and product candidates are small-molecule enzyme inhibitors designed to target key biochemical pathways involved in human diseases with critical unmet needs. It has a collaboration and license agreement with Janssen Biotech, Inc. to develop and commercialize ibrutinib and related compounds; collaboration and license agreement with Les Laboratoires Servier to develop and commercialize abexinostat; and license agreement with Novo Nordisk A/S to research and develop PCI-27483. Pharmacyclics, Inc. was founded in 1991 and is headquartered in Sunnyvale, California.

484 Employees
Last Reported Date: 02/26/14
Founded in 1991

pharmacyclics inc (PCYC) Top Compensated Officers

Chairman and Chief Executive Officer
Total Annual Compensation: --
Chief Financial Officer and Principal Account...
Total Annual Compensation: $541.1K
Chief Operating Officer
Total Annual Compensation: $849.2K
Chief of Quality & Technical Operations
Total Annual Compensation: $704.3K
Senior Vice President of Investor Relations a...
Total Annual Compensation: $126.2K
Compensation as of Fiscal Year 2013.

pharmacyclics inc (PCYC) Key Developments

Janssen Research & Development, LLC Announces the Submission of Supplemental New Drug Application for IMBRUVICA to the U.S. Food and Drug Administration by Pharmacyclics, Inc

Janssen Research & Development, LLC announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA(TM) (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics Inc. This regulatory submission is based on data from the Phase 3 RESONATE(TM) study in relapsed or refractory chronic lymphocytic leukemia (CLL). IMBRUVICA is being jointly developed and commercialized by Janssen and Pharmacyclics. In February 2014, IMBRUVICA received FDA approval to treat patients with CLL who have received at least one prior therapy. This indication is based on an overall response rate (ORR) from Phase 2 data and an improvement in survival or disease-related symptoms has not been established. The current approval was granted under the FDA's Accelerated Approval regulations and required the completion of an additional, larger Phase 3 trial to verify clinical benefit. The Phase 3 PCYC-1112 (RESONATE) study is a randomized, multi-center, open-label study, which compares once-daily oral IMBRUVICA versus intravenous ofatumumab in 391 patients with CLL or small lymphocytic lymphoma (SLL), who had received at least one prior therapy. The RESONATE trial was halted early in January 2014 based on the recommendation of an Independent Data Monitoring Committee (IDMC) at the formal pre-planned interim analysis, which found IMBRUVICA was associated with a significant improvement in progression-free survival (the primary endpoint of the study) versus ofatumumab, and in overall survival (a key secondary endpoint of the trial). Data from this study were accepted and will be presented at the upcoming 50(th) annual meeting of the American Society of Clinical Oncology.

Pharmacyclics Inc. Files Supplemental New Drug Application for IMBRUVICA with Phase III CLL Study Data

Pharmacyclics Inc. announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA), based on data from the randomized, multi-center, open-label Phase III RESONATE(TM) study, PCYC-1112, a head-to-head comparison of single agent IMBRUVICA(TM) (ibrutinib) versus ofatumumab in 391 patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who had received at least one prior therapy. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech Inc. The FDA granted an accelerated approval for IMBRUVICA as a single agent for the treatment of patients with MCL or CLL, who have received at least one prior therapy. The accelerated approval for these indications was based on the overall response rate (ORR) of patients in the Phase II clinical studies of PCYC-1102 and PCYC-1104. An improvement in survival or disease-related symptoms was not established in these studies. IMBRUVICA is the first once-daily, single-agent, oral kinase inhibitor for patients with MCL or CLL who have received one prior therapy. CLL is a slow-growing blood cancer of the white blood cells (lymphocytes), most commonly B-cells. CLL is the most common adult leukemia. Approximately 16,000 patients in the U.S. are diagnosed each year with CLL. The prevalence of CLL is approximately 114,500 in the U.S. CLL is a chronic disease that predominantly occurs in the elderly and the average age of diagnosis is 72. The five-year survival is approximately 82%. MCL is also a blood cancer; it is an aggressive type of B-cell non-Hodgkin lymphoma (NHL) that usually occurs in older adults. The disease typically involves the lymph nodes, but can spread to other tissues, such as bone marrow, liver, spleen, and gastrointestinal tract. The prevalence of MCL is approximately 11,300 in the U.S. and patients survive an average of five years. CLL and MCL are both classified as orphan or rare diseases, defined as agents which affect fewer than 200,000 Americans. Patients commonly receive multiple lines of treatment over the course of their disease.

Former Employee Files a Complaint against Pharmacyclics, Inc

Pharmacyclics Inc. announced that a former employee filed a complaint against the company in Superior Court of Santa Clara, California. The company believes that the claims asserted in the complaint are without merit and intends to vigorously defend itself against them.

 

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