Key Developments For Array BioPharma Inc
Array BioPharma Inc (ARRY.O) (Consolidated Issue listed on NASDAQ Global Market)
Array BioPharma, Inc. Issues Q2 2010 Guidance Below Analysts' Estimates; Comments On H2 2010 Guidance-Conference Call
Array BioPharma, Inc. announced that for second quarter of 2010, it expects revenue to be about $6 million and loss per share (EPS) to be about $0.56. For second half of 2010, it expects to be improved for revenue and loss per share, and this is based on the expectation of a partnership. According to Reuters Estimates, analysts were expecting the Company to report revenue of $7.6 million and EPS of $(0.55) for second quarter of 2010; revenue of $10.04 million and EPS of $(0.48) for third quarter of 2010; revenue of $10.65 million and EPS of $(0.46) for fourth quarter of 2010.
Array BioPharma, Inc. Announces Clinical Results On Diabetes Drug
Array BioPharma, Inc. announced results on poster on ARRY-403, a oral glucokinase activator (GKA). The data presented are consistent with the positive top-line results announced in August 2009 showing that ARRY-403 met its primary and secondary endpoints of safety, pharmacokinetics and glucose control in a Phase 1 SAD study. The study included seven dose cohorts, with a total of 41 patients with type 2 diabetes who received either placebo or a single dose of ARRY-403 ranging from 25 mg to 400 mg. ARRY-403 was well tolerated at all doses. ARRY-403 was rapidly absorbed, and exposure was dose-dependent. The pharmacokinetic profile is consistent with once-daily therapeutic dosing. ARRY-403 provided dose-dependent reduction in glucose excursions in response to a standardized meal as well as reduction in 24-hour fasting blood glucose.
Array BioPharma, Inc. Announces Top Line Results From Rheumatoid Arthritis Phase 2 Trial
Array BioPharma, Inc. announced its preliminary analysis of results from a study examining ARRY-162, a small molecule MEK inhibitor, in a 12-week Phase 2 clinical trial with 201 patients. The patients had active rheumatoid arthritis (RA) that was not completely responsive to methotrexate. This study included a placebo group and three different dose groups of ARRY-162, all on a stable background of methotrexate. None of the treatment groups demonstrated a statistically significant ACR20 response rate compared to the placebo group at 12 weeks (p=0.459), therefore the study did not meet the primary endpoint. Overall, the placebo response rates in this study were higher than expected for this patient population and showed regional differences, with patients in South America (99 patients) having substantially higher placebo response rates than those in Eastern Europe (101 patients). In Eastern Europe when patients in the three active treatment arms were combined, there was a trend towards efficacy, as measured by DAS28-4(CRP) (p=0.067), Good EULAR response (p=0.105) and ACR20 response rate (p=0.115). Array is conducting a full analysis of safety, efficacy and pharmacokinetic data from this study.
Array BioPharma, Inc. Issues FY 2010 Guidance In Line With Analysts' Estimates; Issues Q1 2010 Guidance; EPS Guidance Below Analysts' Estimates-Conference Call
Array BioPharma, Inc. announced that for fiscal 2010, it expects revenue to increase from $25 million achieved in fiscal 2009 to a range of $36-$38 million. The Company loss of approximately $100 million, but the appropriate range for the loss per share (EPS) to between $1.95 and $2.05 a share, including the compensation from options. For first quarter of 2009, it expects revenue to be about $7.5 million and loss per share in the range of $0.55 to $0.57. According to Reuters Estimates, analysts were expecting the Company to report revenues of $36 million and EPS of $(1.95) for fiscal 2010; revenues of $7.5 million and EPS of $(0.52) for first quarter of 2010.
Array BioPharma, Inc. Announces Positive Results of Oral Glucokinase Activator in Type 2 Diabetes Patients
Array BioPharma, Inc. announced positive top-line data from a Phase 1 clinical trial in patients with Type 2 diabetes with its small molecule glucokinase activator (GKA), ARRY-403. The drug met its primary and secondary endpoints of safety, pharmacokinetics and glucose control. ARRY-403 was evaluated in a Phase 1 single ascending dose study. The study included seven dose cohorts, with a total of 41 patients with Type 2 diabetes receiving either placebo or single doses of ARRY-403 ranging from 25 mg to 400 mg. ARRY-403 was well tolerated at all doses. ARRY-403 was rapidly absorbed, and exposure was dose-dependent. The pharmacokinetic profile is consistent with once daily therapeutic dosing. ARRY-403 provided dose-dependent reduction in glucose excursions in response to a standardized meal as well as reduction in 24-hour fasting blood glucose. Array is initiating a multiple ascending dose study in patients with Type 2 diabetes to evaluate safety, exposure and glucose control over a 10-day period. The Company plans to report the combined Phase 1 results at an upcoming scientific meeting during the first half of 2010.
