BTIG launched coverage of Axsome Therapeutics (NASDAQ:AXSM) with a “buy” rating and $14 price target. The stock closed at $3.80 on May 18.
Axsome is developing novel therapies for pain and central nervous system disorders. It has two material assets in pivotal clinical studies: AXS-05 and AXS-02.
Analyst Robert Hazlett writes that AXS-05, a fixed dose combination of dextromethorphan and bupropion, is in pivotal trials for treatment-resistant depression, and will soon begin a Phase 3 program for agitation in Alzheimer's disease. Fast track designation has been granted for both indications.
“Other approaches to modify dextromethorphan (DM) exist, but AXS-05 uniquely uses the antidepressant, bupropion, to both enhance DM plasma levels and potentially also provide additional antidepressant activity,” he added.
The novel AXS-05 combination could have material potential in a number of uses, he added. For example, top line Phase 3 data for treatment-resistant depression will be available in early 2018.
In addition, he said AXS-02, an oral version of zoledronate, has been granted fast track for complex regional pain syndrome and knee osteoarthritis, with bone marrow lesions, and also is being developed for chronic low back pain with modic changes.
Interim Phase 3 readouts for AXS-02 for debilitating complex regional pain syndrome is expected in the fourth quarter this year and for knee OA with bone marrow lesions in the third quarter this year. “With success, AXS-02 could being initially launched in the EU in 2019,” he added.