Shares of Array Biopharma Inc (NASDAQ:ARRY) ended Monday session in green amid volatile trading. The shares closed up +2.96 points or 81.10% at $6.61 with 102.35 million shares getting traded. Post opening the session at $4.65, the shares hit an intraday low of $4.59 and an intraday high of $6.65 and the price vacillated in this range throughout the day. The company has a market cap of $948.21 million and the numbers of outstanding shares have been calculated to be 145.02 million shares.
On Sept. 26, 2016 Array BioPharma (ARRY) and Pierre Fabre jointly announced top-line results from Part 1 of the Phase 3 COLUMBUS (Combined LGX818 Used with MEK162 in BRAF Mutant Unresectable Skin Cancer) study evaluating LGX818 (encorafenib), a BRAF inhibitor, and MEK162 (binimetinib), a MEK inhibitor, in patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The study met its primary endpoint, significantly improving progression free survival (PFS) compared with vemurafenib, a BRAF inhibitor, alone.
“The COLUMBUS Part 1 trial results demonstrate a robust PFS benefit associated with the combination of binimetinib plus encorafenib versus vemurafenib in patients with BRAF-mutant melanoma,” said Ron Squarer, Chief Executive Officer, Array BioPharma. “We look forward to working with global regulatory authorities as they evaluate our planned submission.”
In the analysis of the primary endpoint, the median PFS for patients treated with the combination of encorafenib plus binimetinib (“combination”) was 14.9 months versus 7.3 months for patients treated with vemurafenib; HR (0.54), [95% CI 0.41-0.71], p<0.001. The combination was generally well-tolerated and reported adverse events were overall consistent with previous combination encorafenib plus binimetinib clinical trial results in BRAF-mutant melanoma patients.
“The preliminary results from Part 1 of COLUMBUS suggest that the combination of encorafenib plus binimetinib represents a potentially unique therapy for the BRAF-mutant melanoma population,” said Keith T. Flaherty, M.D., Director of the Termeer Center for Targeted Therapy, Massachusetts General Hospital and Professor of Medicine, Harvard Medical School. “In addition to the robust activity observed in Part 1, the combination appeared to be generally well-tolerated.”
Shares of Novavax, Inc. (NASDAQ:NVAX) ended Monday session in green amid volatile trading. The shares closed up +0.09 points or 3.98% at $2.35 with 37.92 million shares getting traded. Post opening the session at $2.30, the shares hit an intraday low of $2.27 and an intraday high of $2.43 and the price vacillated in this range throughout the day. The company has a market cap of $669.90 million and the numbers of outstanding shares have been calculated to be 271.19 million shares.
Novavax, Inc. (NVAX) on September 16, 2016 announced topline data from two clinical trials of its RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) in older adults. The Resolve(TM) trial, a Phase 3 trial of our RSV F Vaccine in 11,856 older adults (60 years of age and older), did not meet the pre-specified primary or the secondary efficacy objectives, and did not demonstrate vaccine efficacy. Consistent with our previous clinical experience, the vaccine was well tolerated.
Phase 3 Resolve(TM) Trial
The trial was a randomized, observer-blinded, placebo-controlled trial conducted at 60 sites in the United States. The primary objective of the Resolve trial was to demonstrate efficacy in the prevention of moderate-severe RSV-associated lower respiratory tract disease (RSV msLRTD), as defined by the presence of multiple lower respiratory tract symptoms. The secondary objective of the trial was to demonstrate efficacy of the RSV F Vaccine in reducing the incidence of all symptomatic respiratory disease due to RSV (RSV ARD). Finally, the trial also evaluated the safety of the unadjuvanted, 135 microgram dose of the RSV F Vaccine compared to placebo.