Axsome Therapeutics, Inc. AXSM announced that it has completed a successful pre-new drug application (NDA) meeting with the FDA authorities for one of its lead pipeline candidates AXS-07 for the acute treatment of migraine. The company remains on track to submit the planned NDA in the fourth quarter of 2020.

Acceptance of the final NDA will be subject to the regulatory body’s review of the complete filing.

Per the press release, the whole idea behind the meeting was to reach agreement consensus with the regulatory agency on the proposed content and format of the planned NDA submission along with the clinical and nonclinical requirements. Based on the feedback from the FDA, management believes that the company’s regulatory data package for AXS-07 will be enough to support the NDA.

Notably, Axsome is evaluating AXS-07 in the phase III MOMENTUM study as an acute treatment of migraine and in the phase III INTERCEPT study as an early treatment of migraine. Results from both analyses demonstrated that AXS-07 was safe and well tolerated.

In April, AXS-07 met the two regulatory co-primary endpoints in the phase III INTERCEPT study. The co-primary goals were freedom from migraine pain and freedom from most bothersome symptoms compared to placebo in the study. The candidate substantially and significantly eliminated the migraine pain and also in the same way prevented progression of migraine pain intensity in the late-stage study that evaluated the candidate for an early-stage treatment of migraine.

We remind investors that in December 2019, AXS-07 met the two regulatory co-primary endpoints in the phase III MOMENTUM study, which evaluated the candidate for acute treatment of migraine.

Shares of Axsome have plunged 22.4% so far this year against the industry’s increase of 2.7%.

Meanwhile, the successful pre-NDA meeting for AXS-07 follows a similar pre-NDA conference with the FDA officials, which Axsome announced in July for another lead pipeline candidate AXS-05, which is being developed for the treatment of major depressive disorder (MDD). The NDA for AXS-05 too is planned to be filed in the fourth quarter of 2020.

A prospective regulatory approval of AXS-05 and AXS-07 will lend a significant boost to the company as it can have its first marketed product in its portfolio and start generating revenues from the same.

Zacks Rank & Stocks to Consider

Axsome currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. EBS, Horizon Therapeutics Public Limited Company HZNP and Repligen Corporation RGEN, all presently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Emergent’s earnings estimates have been revised 62.3% upward for 2020 and 78.8% for 2021 over the past 60 days. The stock has skyrocketed 143% year to date.

Horizon Therapeutics’ earnings estimates have moved 61.6% north for 2020 and 57.7% for 2021 over the past 60 days. The stock has surged 107.5% year to date.

Repligen’s earnings estimates have been revised 11.6% upward for 2020 and 7.6% for 2021 over the past 60 days. The stock has soared 63.1% year to date.

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