Last $1.26 USD
Change Today -0.02 / -1.56%
Volume 296.5K
ARQL On Other Exchanges
Symbol
Exchange
NASDAQ GM
As of 8:10 PM 11/21/14 All times are local (Market data is delayed by at least 15 minutes).

arqule inc (ARQL) Snapshot

Open
$1.30
Previous Close
$1.28
Day High
$1.30
Day Low
$1.26
52 Week High
01/17/14 - $2.92
52 Week Low
10/15/14 - $1.04
Market Cap
79.1M
Average Volume 10 Days
633.2K
EPS TTM
$2.50
Shares Outstanding
62.8M
EX-Date
--
P/E TM
0.5x
Dividend
--
Dividend Yield
--
Current Stock Chart for ARQULE INC (ARQL)

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arqule inc (ARQL) Details

ArQule, Inc., a clinical-stage biotechnology company, researches and develops cancer therapeutics. Its lead product candidate tivantinib is an inhibitor of the c-Met receptor tyrosine kinase and its biological pathway, which is in Phase 3 clinical trial for the treatment of non-small cell lung and liver cancer; and Phase 2 clinical trial for the treatment of colorectal cancer. The company’s early clinical-stage products include ARQ 092, an inhibitor of the Akt protein kinase; ARQ 087, a multi-kinase inhibitor with pan-fibroblast growth factor receptor activity; ARQ 761, a NQ01 inhibitor; ARQ 621, an inhibitor of the Eg5 kinesin motor protein; and ARQ 736, an inhibitor of the RAF kinases. It has partnership agreement with Daiichi Sankyo Co., Ltd. and Kyowa Hakko Kirin Co., Ltd. for implementing a clinical development program designed to realize the potential of tivantinib as a single agent; and in combination with other anti-cancer therapies in various disease indications. In addition, the company has research collaboration with Daiichi Sankyo Co., Ltd. to discover therapeutic compounds that selectively inhibit certain kinases in the field of oncology based on its ArQule Kinase Inhibitor Platform (AKIP) technology. ArQule, Inc. was founded in 1993 and is headquartered in Woburn, Massachusetts.

46 Employees
Last Reported Date: 11/10/14
Founded in 1993

arqule inc (ARQL) Top Compensated Officers

Chief Executive Officer and Director
Total Annual Compensation: $489.3K
President, Chief Operating Officer, Principal...
Total Annual Compensation: $413.9K
Chief Medical Officer and Senior Vice Preside...
Total Annual Compensation: $380.3K
Compensation as of Fiscal Year 2013.

arqule inc (ARQL) Key Developments

ArQule, Inc. Announces Agreement with National Human Genome Research Institute for Providing for the Clinical Development of ARQ 092

ArQule Inc. announced an agreement with the National Human Genome Research Institute (NHGRI) of the National Institutes of Health (NIH) providing for the clinical development of ARQ 092, an orally available, selective small molecule inhibitor of AKT, in Proteus syndrome, a rare disease characterized by overgrowth of the skeleton, skin, adipose tissue and central nervous system. The NIH Proteus syndrome team is led by researchers who originally discovered the somatic single (point) mutation in the AKT 1 oncogene that causes Proteus syndrome. On that basis, the NIH entered into a collaboration with ArQule focused on pre-clinical testing of ARQ 092. Results from that pre-clinical research recently presented by the NIH team at the 2014 meeting of the American Society of Human Genetics (ASHG, Abstract # 2180M) demonstrate that treatment with ARQ 092 caused a rapid shutdown of AKT signaling and a reduction in the viability of Proteus syndrome cells taken from patients compared to untreated diseased cells. These findings represent pre-clinical proof-of-concept for advancement of ARQ 092 into clinical testing in this indication.

ArQule Inc. Announces Positive Top-Line Results of NIH-Sponsored Phase 2 Trial of Tivantinib in Prostate Cancer

ArQule Inc. announced positive top-line results from a randomized, double-blind, placebo-controlled Phase 2 clinical trial of tivantinib as a single agent in metastatic prostate cancer. This trial (identifier NCT01519414) was conducted under a cooperative research and development agreement with the National Cancer Institute's Cancer Therapy Evaluation Program (a randomized, double-Blind, Placebo-Controlled Phase 2 study of ARQ 197 (tivantinib) in Men with Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer, NCI Protocol # 8986). The principal investigator was J. Paul Monk, M.D. of The Ohio State University, Arthur G. James Cancer Hospital and Solove Research Institute. In this trial, 78 patients were randomized 2 to 1 to receive either tivantinib as a single agent or placebo. During a pre-planned analysis, it was found that the trial met its primary endpoint of improving median progression-free survival (PFS) with tivantinib alone as compared to placebo. The results were highly statistically significant. Safety data were consistent with those observed in other trials of tivantinib. The results of the trial are the subject of ongoing analyses and will be submitted by the investigators for presentation at a future medical conference. As final data emerge from this trial, ArQule and its partner, Daiichi Sankyo Company, Limited, will discuss with the National Institutes of Health the potential for additional trials in this indication. Uncontrolled, signal generation data from additional NIH-sponsored trials with tivantinib in breast cancer and multiple myeloma did not meet their primary endpoint of response rate. As a result, the company does not plan to prioritize development in these indications at this time. This study is a randomized Phase 2 trial in which men with asymptomatic or minimally symptomatic metastatic castrate resistant, chemotherapy-naïve prostate cancer were randomized 2 to 1 to receive tivantinib 360 milligrams BID or placebo. The primary objective of the trial is PFS. Secondary objectives include PSA response rate at 12 weeks, radiographic response rate at 12 weeks, proportion of patients who are progression-free at 12 weeks, and safety and tolerability. The study is designed to detect an improvement in the median PFS from 3 months to 6 months with tivantinib treatment. The proposed sample of 78 patients (26 in the placebo arm, 52 in the tivantinib arm) provides 90% power to detect an improvement from 3 months median PFS with placebo to a median PFS of at least 6 months with tivantinib. This design is based on the assumption of having 58 cumulative events (progressions or deaths).

ArQule Inc. Announces Unaudited Financial Results for the Third Quarter and Nine Months Ended September 30, 2014; Confirms Earnings Guidance for the Year 2014

ArQule Inc. announced unaudited financial results for the third quarter and nine months ended September 30, 2014. For the quarter, the company reported research and development revenue of $2,662,000 against $3,542,000 a year ago, due to lower revenue from its Daiichi Sankyo tivantinib program due to a change in the estimated development period. Loss from operations was $6,448,000 against $6,193,000 a year ago. Net loss was $6,399,000 against $6,083,000 a year ago. Basic and diluted net loss share was $0.10 against $0.10 a year ago. For the nine months, the company reported research and development revenue of $8,239,000 against $13,639,000 a year ago, due to revenue decreases of $1.3 million from Daichii Sankyo ARQ 092 agreement that ended in June 2013, $2.3 million from Daiichi Sankyo tivantinib program due to a change in the estimated development period and $1.8 million of other revenue related to a one-time research project that was completed in the nine months ended September 30, 2013. Loss from operations was $20,159,000 against $18,957,000 a year ago. Net loss was $19,879,000 against $18,644,000 a year ago. Basic and diluted net loss share was $0.32 against $0.30 a year ago. For 2014, the company expects net use of cash to range between $35 million and $38 million. Revenues are expected to range between $8 million and $10 million. Net loss is expected to range between $30 million and $33 million, and net loss per share is expected to range between $0.48 and $0.52.

 

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