Axsome Shares Flirt With Record High: How Much Upside Is Left?

Axsome Therapeutics Inc AXSM by far has been the hottest biotech of the year, clocking in gains of about 1,000% in 2019. Its market capitalization has swelled to close to $1 billion thanks to the year's gravity-defying rally.

Axsome, which develops novel therapies for treating central nervous system disorders, has a robust clinical pipeline with two Phase 3 assets. Its lead product candidate AXS-05, a combo therapy of bupropion and dextromethorphan, is evaluated for multiple indications, namely:

  • Treatment resistant depression, or TRD.
  • Agitation in Alzheimer's disease.
  • Major depressive disorder, or MDD.
  • Smoking cessation.

If AXS-05 gains approval for TRD, Axsome could be facing off with large-cap pharma company Johnson & Johnson JNJ, which snagged FDA approval for its Spravato for the indication in March.

AXS-07 is Axsome's second late-stage asset, which is an oral fixed-dose combination of meloxicam and rizatriptan being evaluated as an acute treatment option for migraine.

Good Tidings Abound

In early January, Axsome reported positive top-line data from the Phase 2 study of AXS-05 in MDD.

In March, AXS-05 was accorded Breakthrough Therapy Designation for MDD.

The company announced positive results from the midstage study of AXS-05 in smoking cessation in mid-April.

On Sept. 5, the company presented positive Phase 1 pharmacokinetic data for AXS-07 at the 19th Congress of the International Headache Society in Dublin.

The results showed that AXS-07 is rapidly absorbed after oral administration, with the MoSEIC meloxicam component also displaying an extended plasma half-life, suggesting the potential for enhanced and sustained efficacy.

More To Come?

Axsome is due to release topline results from the Phase 3 STRIDE-1 trial in TRD and Phase 3 GEMINI study in MDD in the second half of 2019.

The topline readout from the Phase 3 MOMENTUM trial is also due in the second half of 2019. Following the end-of-Phase 2 meeting the company held with the FDA, it has been determined that MOMENTUM is the only efficacy trial needed to support an NDA filing.

Topline data from the Phase 2 study of AXS-12 in narcolepsy is expected in the second half of 2019.

The Stock

Axsome shares are clearly on a bullish trend, as it has been making higher highs and higher lows in successive sessions. After hitting a record intraday high of $30.50 on Tuesday, the stock closed the session below the level.

Wednesday's rally has not given the stock enough momentum to revisit the highs above $30.

The average analyst price target for Axsome is $36.83, according to the Yahoo database, with the Street-high estimate being $50.

Axsome shares were rising 0.85% to $28.45 at the time of publication. 

Related Links:

The Daily Biotech Pulse: NewLink Genetics Rallies, Breakthrough Designation For Roche, IGM Biosciences Debuts

Biotech Stock On The Radar: vTv Therapeutics' Diabetes Pipeline

Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechNewsTrading IdeasGeneral
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!