Shots:

• The US FDA’s ODD may enable Axsome a seven years of marketing exclusivity in the US- with incentives and reduction in user fees of product required for PDUFA act
• In Q4’18- Axsome plans for onset of P-II trial of AXS-12 for the treatment of symptoms of narcolepsy with expected results in H1’19
• AXS-12 is a novel- PO norepinephrine reuptake inhibitor indicated for Narcolepsy. Additionally- Axsome has four clinical-stage candidates- AXS-05- AXS-07- AXS-09- and AXS-12 indicated in various neurological disorder

Ref: Axsome Therapeutics | Image: RTE