--> ARIA +3.08% in Pre-Open "9.05 vs 8.78 - 9.01/9.05 - 30k shares traded
Ariad Pharm announces the FDA has accepted for review the NDA for its brigatinib in patients with metastatic ALK-positive non-small cell lung cancer 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 PDUFA.
- Co's NDA submission includes clinical data from its Phase 1/2 and pivotal Phase 2 ALTA trials of brigatinib.
- Co plans to submit a MAA for brigatinib to the EMA in early 2017.