Array Biopharma Inc (NASDAQ:ARRY) joined other drug companies in Rome, Italy, to discuss its pipeline progress. The company told the 2016 European Society of Cardiology Congress that its candidate called ARRY-797 impressed all through in a Phase 2 study.
Array Biopharma said that ARRY-797, which is being tested as a treatment for LMNA-related DCM, met both the primary and secondary endpoints of the study, thus paving the way for the company to continue its development.
In the Phase 2 trial whose outcomes were shared at the ESC in Rome, two different doses of ARRY-797 were administered to participating patients. Some subjects received a 100 mg dose while others were given a 400 mg dose. Both patient groups showed remarkable improvement in their conditions, but the 400 mg arm showed the greatest improvement in cardiac function.
What’s the way forward?
Given its determination to bring ARRY-797 to market, Array Biopharma has discussed with regulatory agencies the future study pathway for the candidate. The next stage of trial that ARRY will be taking the candidate through will be crucial in its marketing approval.
Though Array Biopharma has largely worked on the ARRY-797 program on its own, the company is currently evaluation options on the development and commercialization of the candidate. Among the options the company is considering is whether it should continue advancing the ARRY-797 program on its own or it should bring on board a partner. The other option the company could pursue is creating a separate company that will own ARRY-797.
There is currently no information on the potential partners Array Biopharma could reach out to in developing and marketing ARRY-797. However, investors should keep in mind that the company is partnering with AstraZeneca Plc (NYSE:AZN) on its other pipeline candidate called selumetinib.
Outside ARRY-797 and selumetinib, Array Biopharma has two other cancer candidates – encorafenib (LGX818) and binimetinib (MEK162).
2Q2016 outcome
In 2Q2016, Array Biopharma posted EPS loss of $0.17, missing the consensus estimate of EPS loss of $0.14. However, revenue of $43.2 million not only rose a whopping 250.6% YoY, but also outpaced the consensus estimate by $1.69 million.
