March 30 Quick Takes: Axsome misses in treatment-resistant depression, on track for NDA; plus AstraZeneca and Innovent-Alector

Axsome dips on Phase III depression data
AXS-05 from Axsome Therapeutics Inc. (NASDAQ:AXSM) missed the primary endpoint of depressive symptoms compared with bupropion at week 6 in the Phase III STRIDE-1 trial for treatment-resistant depression. The combination of dextromethorphan and bupropion did meet key secondary endpoints and is slated to enter another Phase III trial for the indication in 3Q20. Axsome said it remains on track to submit an NDA to FDA for AXS-05 in 4Q20 to treat major depressive disorder. Axsome lost $5.69 to $57.58 Monday (see “Axsome Continues Ascent”).

Expanded label for AstraZeneca’s Imfinzi
FDA approved Imfinzi durvalumab from AstraZeneca plc (LSE:AZN; NYSE:AZN) in combination with etoposide plus either carboplatin or cisplatin as first-line treatment for extensive-stage small cell lung cancer (SCLC). The anti-PD-L1 therapy, which is approved for the indication in Singapore, is already approved for non-small cell lung cancer and advanced bladder cancer. ...