September 1st 2016. Array Biopharma announced today that the US FDA formally accepted its NDA application for binimetinib for NRAS mutant melanoma life extending treatment. Array Biopharma is preparing for the formal orientation meeting with FDA in September
August 30th 2016 Array BioPharma (Nasdaq: ARRY) announced today results from a Phase 2 study of ARRY-797, an oral, selective p38 mitogen-activated protein kinase inhibitor, in patients with lamin A/C-related dilated cardiomyopathy (LMNA-related DCM), a rare, degenerative cardiovascular disease caused by mutations in the LMNA gene and characterized by poor prognosis. The trial results were presented at the European Society of Cardiology Congress 2016 in Rome, Italy. The results demonstrated an absolute mean change from baseline of 69 meters on the six-minute walk test (6MWT) at week 12, the study's primary endpoint (baseline 6MWT ranged from 246 to 412 meters). This magnitude of improvement exceeded historical benchmarks for 6MWT that have served as the basis for recent approvals of other drugs in other rare diseases.
"We are excited to be presenting data today from our wholly-owned drug, ARRY-797 and are encouraged by the results of this pilot study in this rare cardiovascular disease which has a significant unmet need," said Victor Sandor, M.D., Chief Medical Officer, Array BioPharma. "We look forward to continuing to report on results for ARRY-797 in this disease, for which no treatment options, other than standard of care for chronic heart failure, exist."
Taken together, the data to date suggest a path forward for this program, and Array has met with regulators to discuss the design of a study that could be the basis for marketing approval. Array is evaluating different options to advance the ARRY-797 program, including advancing it on its own, partnering the program for further development and commercialization or creating a separate company based on this asset.
August 24 2016 Transenterix Director Andrea Biffi purchased 40 000 shares of the company at the average price of $1.4 on Monday August 22. Shares of Transenterix went up 13% after the news and closed at $1.62 on Tuesday.
August 19th, 2016. Array BioPharma Inc. (NASDAQ: ARRY) today announced that results from a Phase 2 study of ARRY-797 will be presented at the 2016 European Society of Cardiology (ESC) Congress, which will be held August 27 – 31, 2016 in Rome, Italy. Presentation will be held at 10.19 CEST on August 30th.
Phase 2 has shown that treatment with A797 was well tolerated and resulted in meaningful, sustained increases in functional capacity and cardiac function in patients with LMNA-related DCM as measured by changes in 6MWT, NT-proBNP, LVEF and QoL.