Key Developments For ArQule Inc
ArQule Inc (ARQL.O) (Consolidated Issue listed on NASDAQ Global Market)
ArQule, Inc. Reaffirms FY 2009 Guidance
ArQule, Inc. reaffirmed fiscal 2009 guidance and expects revenues to range between $21-$24 million, net loss to range between $44-$47 million and net loss per share (EPS) to range between $0.98-$1.05. According to Reuters Estimates, analysts were expecting the Company to report EPS of $(0.98) on revenue of $23 million for the same period.
ArQule, Inc. Announces Grant Of Orphan Drug Designation To ARQ 197 By European Medicines Evaluation Agency
ArQule, Inc. announced that the European Medicines Evaluation Agency (EMEA) has designated ARQ 197 as an orphan medical product for the treatment of soft tissue sarcoma. Under the guidelines of the EMEA, medicinal products are designated as orphan drugs when they are used to treat illnesses affecting small numbers of patients, such as soft tissue sarcoma. Such designation provides for incentives for investment in the research and development of such drugs, including exclusive distribution rights throughout the European Union for ten years, during which period no other product with the same active ingredient would be authorized for use for the same therapeutic application. ArQule is conducting a Phase 2 clinical trial with ARQ 197 in a sub-group of soft tissue sarcoma known as MiT (Microphthalmia Transcription Factor)-associated tumors. The designation of ARQ 197 as an orphan medical product in soft tissue sarcoma, combined with the evaluation of clinical data from this trial expected to be available in early 2010, will inform the decisions related to the advancement of the program.
ArQule, Inc. Provides Clinical Update On ARQ 197
ArQule, Inc. announced that patient enrollment in a Phase 2 trial with ARQ 197 in non-small cell lung cancer (NSCLC) has been completed. Approximately 160 patients were enrolled in the NSCLC trial, which is a randomized, double-blind trial comparing combination therapy with ARQ 197 and erlotinib against erlotinib and placebo in EGFR (epidermal growth factor receptor) inhibitor-naïve patients in second and third line settings, with the primary endpoint being progression-free survival. Final data from this trial is expected to be available in the first half of 2010. The Company also announced that patient enrollment in a Phase 2 trial with ARQ 197 in hepatocellular carcinoma (HCC) has been initiated. The Phase 2 initiation follows the successfully completed evaluation of patients enrolled in a safety trial in this indication. Approximately 100 patients with unresectable HCC who have failed one prior systemic therapy are expected to be enrolled in the HCC trial, which is a randomized, double-blind trial comparing patients treated with ARQ 197 to those treated with placebo, with the primary endpoint being time-to-progression. Separately and as part of the HCC tumor program, a Phase 1 safety trial in HCC is being conducted with the combination therapy of ARQ 197 and sorafenib.
ArQule, Inc. Reaffirms FY 2009 Guidance
ArQule, Inc. reaffirmed fiscal 2009 guidance and expects revenues to range between $21-$24 million, net loss to range between $44-$47 million and net loss per share (EPS) to range between $0.98-$1.05. According to Reuters Estimates, analysts were expecting the Company to report revenues of $23 million, net income of $(44) million and EPS of $(1.00) for the same period.
ArQule, Inc. Reaffirms FY 2009 Guidance
ArQule, Inc. announced that it has confirmed fiscal 2009 guidance and expects revenue to range between $21 and $24 million, net loss to range between $44 and $47 million, and net loss per share to range between $0.98 and $1.05. According to Reuters Estimates, analysts are expecting the Company to report revenue of $24 million and net loss of $44 million for fiscal 2009.
