Shares of Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) ended Thursday session in green amid volatile trading. The shares closed up +0.02 points or 0.19% at $10.41 with 3.82 million shares getting traded. Post opening the session at $10.38, the shares hit an intraday low of $10.13 and an intraday high of $10.50 and the price vacillated in this range throughout the day. The company has a market cap of $2.00 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 Allergan plc Ordinary Shares (NYSE:AGN) ended Thursday session in green amid volatile trading. The shares closed up +3.27 points or 1.37% at $241.69 with 2.55 million shares getting traded. Post opening the session at $238.01, the shares hit an intraday low of $237.38 and an intraday high of $242.27 and the price vacillated in this range throughout the day. The company has a market cap of $94.40 billion and the numbers of outstanding shares have been calculated to be 395.95 million shares.
On Sept. 7, 2016 Medicines360, a nonprofit global women’s health pharmaceutical company, and Allergan, plc (AGN), a leading global pharmaceutical company, announced the publication of five-year levonorgestrel release rates for LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg in the September 2016 issue of the medical journal Contraception.
“This study was conducted to understand the duration of action for LILETTA,” said lead author Mitchell Creinin, MD, Professor and Director of Family Planning in the Department of Obstetrics and Gynecology at the University of California, Davis.
The study evaluated the remaining hormone content in LILETTA systems that had been removed from women at various time points during the first five years of the ongoing seven-year ACCESS IUS (A Comprehensive Contraceptive Efficacy and Safety Study of an IUS) clinical trial, the largest ever IUS clinical trial conducted in the US. The remaining amount of levonorgestrel, the active hormone in LILETTA, was used to calculate the hormone release rate over five years.
“The study’s findings,” according to Dr. Creinin, “show that the amount of levonorgestrel remaining in the system and the amount still being released each year support the continued evaluation of LILETTA as a contraceptive for up to five years.”
“In addition, the study results support our planned future FDA submission for a five-year duration of use for LILETTA,” said Dr. Jessica Grossman, CEO of Medicines360.