Shares of Ariad Pharmaceuticals Inc. (NASDAQ: ARIA) saw a modest gain early Monday after the company announced a recent U.S. Food and Drug Administration (FDA) decision. Specifically, the FDA said that it accepted the New Drug Application (NDA) for Ariad’s investigational oral anaplastic lymphoma kinase (ALK) inhibitor, brigatinib.
The treatment is for 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 company’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.
Also Ariad plans to submit a Marketing Authorization Application (MAA) for brigatinib to the European Medicines Agency (EMA) in early 2017.
Paris Panayiotopoulos, president and CEO of Ariad, commented:
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. 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.
Shares of Ariad closed Friday at $8.78, with a consensus analyst price target of $13.44 and a 52-week trading range of $4.37 to $14.34. Following the announcement, the stock was up over 2% at $8.99 in early trading indications Monday.
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