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Axsome Shares Rally After FDA OKs Expedited Regulatory Filings For Depression Drug

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Axsome Shares Rally After FDA OKs Expedited Regulatory Filings For Depression Drug

Axsome Therapeutics Inc (NASDAQ: AXSM) has been a standout performer among biotech stocks year-to-date. From $2.50 at the start of the year, shares now trade above the $18 level.

What Happened

Axsome announced Monday that the FDA granted Breakthrough Therapy Designation for its AXS-05, which is being evaluated for major depressive disorder, or MDD, and treatment-resistant depression, or TRD.

AXS-05 is Axsome's investigational NMDA receptor antagonist with multimodal activity.

With the expedited development program, the company said its previously completed ASCEND Phase 2 trial is adequate to file an NDA for MDD. The company said it might choose to conduct a placebo-controlled Phase 3 trial of AXS-05 in MDD.

As part of the expedited program, Axsome said it can file an NDA for the TRD indication — supported by a placebo-controlled Phase 3 trial in TRD — in conjunction with the ongoing STRIDE-1 active-controlled trial, if positive, and the completed ASCEND trial.

Why It's Important

The expedited development program accelerates the potential filing of an NDA from the current schedule of 2020, according to Axsome. 

"If successfully developed, AXS-05 would represent a novel antidepressant with one of the first new mechanisms of action in several decades for the treatment of patients with this debilitating condition," the company said.

What's Next

The placebo-controlled Phase 3 MDD trial is scheduled to be initiated in the second quarter of 2019, according to Axsome. 

Patient screening in the STRIDE-1 Phase 3 trial will continue despite the enrollment reaching the target so that the agreed-upon patient safety database required for an NDA filing can be built, the company said. 

The biotech expects to release topline results of both a STRIDE-1 Phase 3 trial in TRD and a planned placebo-controlled Phase 3 trial in MDD in the second half of 2019.

Axsome shares were trading up 6.85 percent at $19.18 at the time of publication Monday. 

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