Shares of Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) ended Monday session in green amid volatile trading. The shares closed up +0.51 points or 3.95% at $13.41 with 11.43 million shares getting traded. Post opening the session at $13.30, the shares hit an intraday low of $12.83 and an intraday high of $13.45 and the price vacillated in this range throughout the day. The company has a market cap of $2.75 billion and the numbers of outstanding shares have been calculated to be 192.71 million shares.
Ariad Pharmaceuticals, Inc. (ARIA) on August 30, 2016 announced it has completed the rolling submission of the New Drug Application (NDA) for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the U.S. Food and Drug Administration (FDA). ARIAD is seeking U.S. marketing approval of brigatinib for patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who are resistant or intolerant to crizotinib. The Company is seeking accelerated approval for brigatinib from the FDA and has requested a priority review of the application, which, if granted, would allow for approval of brigatinib eight months after the NDA submission, as opposed to 12 months for a standard review.
“Many patients with ALK-positive non-small cell lung cancer eventually develop disease progression,” said Corey Langer, M.D., director of thoracic oncology in the Abramson Cancer Center of the University of Pennsylvania and a professor of Hematology-Oncology in Penn’s Perelman School of Medicine. “We are excited that the brigatinib NDA submission is now complete and are hopeful that brigatinib’s data, including the observation of complete responses and activity in the central nervous system, will provide patients and their oncologists with a new treatment option.”
Shares of Bristol-Myers Squibb Co (NYSE:BMY) ended Monday session in green amid volatile trading. The shares closed up +0.37 points or 0.67% at $55.93 with 11.65 million shares getting traded. Post opening the session at $55.86, the shares hit an intraday low of $55.26 and an intraday high of $56.12 and the price vacillated in this range throughout the day. The company has a market cap of $94.27 billion and the numbers of outstanding shares have been calculated to be 1.66 billion shares.
Bristol-Myers Squibb Co (BMY) on September 20, 2016 announced that the European Medicines Agency (EMA) validated its type II variation application, which seeks to extend the current indications for Opdivo to include the treatment of locally advanced unresectable or metastatic urothelial carcinoma (mUC) in adults after failure of prior platinum-containing therapy. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
“The high frequency of metastatic urothelial carcinoma and its relapsing nature highlight the substantial need for new treatment approaches with high and durable responses,” said Fouad Namouni, M.D., head of development, Oncology, Bristol-Myers Squibb. “We look forward to working with the EMA to potentially extend the use of Opdivo and bring the science of Immuno-Oncology to help patients in Europe fight this difficult-to-treat, advanced form of bladder cancer.”
The application primarily included data from CheckMate -275, a Phase 2, open-label, single-arm study assessing the safety and efficacy of Opdivo in patients with locally advanced unresectable or mUC that has progressed after a platinum-containing therapy. The primary endpoint in CheckMate -275 trial is objective response rate, and additional efficacy measures included durability of response and overall survival. Data from this study will be presented at the 2016 European Society for Medical Oncology Congress.