Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) announced that the FDA has accepted for review the New Drug Application (NDA) for ARIAD’s investigational oral anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, in patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who have progressed on crizotinib. The FDA granted ARIAD’s request for Priority Review and has set an action date of April 29, 2017 under the Prescription Drug User Fee Act (PDUFA).
“The FDA acceptance of our application is an important milestone in our ongoing efforts to discover, develop and deliver highly innovative treatments for patients with rare cancers,” said Paris Panayiotopoulos, president and chief executive officer of ARIAD. “We are pleased that our significant R&D investments in brigatinib and our work with the FDA are bringing us closer to potentially offering a treatment option for patients with ALK+ NSCLC who are refractory to crizotinib. We look forward to continuing to work closely with the FDA during the brigatinib NDA review and remain committed to developing critical therapies for unserved and underserved small patient populations suffering from rare cancers.”
ARIAD’s NDA submission includes clinical data from its Phase 1/2 and pivotal Phase 2 ALTA trials of brigatinib. The FDA’s Priority Review status accelerates the review time from 10 months to a goal of six months from the filing of the application. Brigatinib received Breakthrough Therapy designation from the FDA for the treatment of patients with ALK+ NSCLC whose tumors are resistant to crizotinib, and was granted orphan drug designation by the FDA for the treatment of ALK-positive, ROS1-positive, and EGFR-positive NSCLC. ARIAD plans to submit a Marketing Authorization Application (MAA) for brigatinib to the European Medicines Agency (EMA) in early 2017. (Original Source)
Shares of Ariad Pharmaceuticals are up nearly 3% to $9.05 in pre-market trading Monday. ARIA has a 1-year high of $14.34 and a 1-year low of $4.37. The stock’s 50-day moving average is $12.73 and its 200-day moving average is $9.32.
On the ratings front, ARIA has been the subject of a number of recent research reports. In a report issued on October 26, William Blair analyst Y Katherine Xu maintained a Buy rating on ARIA, with a price target of $15, which implies an upside of 71% from current levels. Separately, on the same day, Jefferies’ Eun Yang reiterated a Buy rating on the stock and has a price target of $11.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Y Katherine Xu and Eun Yang have a yearly average loss of 0.8% and 2.5% respectively. Xu has a success rate of 40% and is ranked #2822 out of 4178 analysts, while Yang has a success rate of 46% and is ranked #3570.
The street is mostly Bullish on ARIA stock. Out of 7 analysts who cover the stock, 5 suggest a Buy rating, one suggests a Sell and one recommends to Hold the stock.
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. The company was founded by Harvey J. Berger in April 1991 and is headquartered in Cambridge, MA.