Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) announced the submission of a Marketing Authorization Application (MAA) for its investigational oral anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the European Medicines Agency (EMA). ARIAD is seeking marketing approval in the European Union of brigatinib in adult patients with anaplastic lymphoma kinase (ALK+) non-small cell lung cancer (NSCLC) who have been previously treated with crizotinib. The U.S. Food and Drug Administration (FDA) is currently reviewing a New Drug Application for brigatinib filed by ARIAD and has set an action date of April 29, 2017under the Prescription Drug User Fee Act (PDUFA).

“ARIAD’s submission of the brigatinib MAA to the EMA is one of many recent milestones highlighting our strong investment in internally discovered rare cancer therapies,” said Paris Panayiotopoulos, president and chief executive officer of ARIAD. “Since announcing our definitive agreement to combine with Takeda, we remain focused on our accountability to our patients by propelling brigatinib forward and by preparing for its anticipated U.S. launch.”

“The brigatinib clinical trials have provided patients with refractory ALK+ NSCLC, including those patients who have metastatic brain lesions, with a potential important treatment option,” said Maurice Perol, MD, Léon Bérard Cancer Center, Lyon, France. “Based on the clinical data we’ve seen to date, we are really excited by the prospect that appropriate patients in the EU may have access to brigatinib as a new targeted treatment.”

Shares of Ariad Pharmaceuticals closed last Friday at $23.80, up $0.02 or 0.06%. ARIA has a 1-year high of $23.85 and a 1-year low of $4.37. The stock’s 50-day moving average is $19.18 and its 200-day moving average is $13.21.

On the ratings front, ARIA has been the subject of a number of recent research reports. In a report issued on January 11, Suntrust Robinson Humphrey analyst Yatin Suneja downgraded ARIA to Hold. Separately, on January 10, Jefferies’ Eun Yang downgraded the stock to Hold .

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Yatin Suneja and Eun Yang have a yearly average loss of -2.3% and a return of 4.5% respectively. Suneja has a success rate of 42% and is ranked #3261 out of 4374 analysts, while Yang has a success rate of 52% and is ranked #738.

Overall, one research analyst has rated the stock with a Sell rating, 3 research analysts have assigned a Hold rating and 3 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $15.00 which is -37.0% under where the stock closed last Friday.

ARIAD Pharmaceuticals, Inc. operates as an oncology company, which engages in the discovery, development, and commercialization of small-molecule drugs for the treatment of cancer. Its products include Iclusig and Caregivers.