Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) shares were up 23.30% on Wednesday to $11.43 and additional 0.52% in after-hours trading. Share prices have been trading in a 52-week range of $4.37 to $14.34. The company has a market cap of $2.12 billion at 194.20 million shares outstanding.
Ariad Pharmaceuticals is an oncology company that is focused on transforming the lives of cancer patients with medicines. Its product pipeline includes Iclusig, brigatinib, AP32788 and ridaforolimus. Iclusig is a tyrosine kinase inhibitorthat is approved in the United States, the European Union, Australia, Switzerland, Israel and Canada for the treatment of adult patients with chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. Brigatinib is an investigational inhibitor of anaplastic lymphoma kinase. AP32788 is a TKI, which is designed as a targeted therapy for patients with non-small cell lung cancer and Ridaforolimus is an investigational inhibitor of the mammalian target of rapamycin.
In a press release yesterday, Ariad Pharmaceuticals announced that clinical data on its investigational anaplastic lymphoma kinase inhibitor, Brigatinib, was published in The Lancet Oncology this week. The company has submitted a New Drug Application to the U.S. Food and Drug Administration seeking U.S. marketing approval for patients with metastatic ALK-positive non-small cell lung cancer who are resistant or intolerant to crizotinib.
Brigatinib yielded responses in the majority of patients with crizotinib-treated ALK+ NSCLC, with median progression free survival of over one year. Additionally, responses in the brain were achieved in this crizotinib refractory population. Early onset pulmonary adverse events, which occurred in eight percent of patients, generally within 48 hours of first dose, appeared to be related to starting dose,” explained Scott N. Gettinger, M.D., associate professor of medicine at Yale Cancer Center.
The data published also included safety analyses on all patients in the trial and efficacy analyses on all patients with ALK+ NSCLC. Of the 79 patients, all but eight had previously been treated with crizotinib. Data from the phase 1/2 trial and pivotal ALTA trial of brigatinib have been included in the NDA submitted to the FDA, which has granted Arial Pharmaceuticals Priority Review and has set an action date of April 29, 2017 under the Prescription Drug User Fee Act.
In addition, Ariad Pharmaceuticals is eeking accelerated U.S. marketing approval for brigatinib in patients with metastatic ALK+ NSCLC who are resistant or intolerant to crizotinib and plans to submit a Marketing Authorization Application for brigatinib to the European Medicines Agency early next year.
This in-depth publication provides a thorough review of the Phase 1/2 trial of brigatinib, ARIAD’s internally developed targeted cancer candidate under regulatory review,” stated Timothy Clackson, Ph.D., president of research and development and chief scientific officer at Arial Pharmaceuticals. “We are excited to continue to work with academic collaborators to provide additional clinical detail on the brigatinib trials, including upcoming presentations at the World Conference on Lung Cancer in December.”
On its daily time frame, Ariad Pharmaceuticals stock juts recently bounced off an area of interest or former resistance turned support. This suggests that the upside breakout from the ceiling around $9 could continue to enjoy a strong bullish run, possibly until the latest high at $14.34. Volume is slowly starting to pickup, reflecting strengthening investor interest and even more buyers hopping in the uptrend on positive company prospects.
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