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Why Axsome Therapeutics Stock Is Jumping Today

By Keith Speights – Aug 23, 2021 at 12:15PM

Key Points

  • The FDA did not meet its scheduled date to make an approval decision about AXS-05 as a treatment for major depressive disorder.
  • The news was not a big surprise since Axsome had previously warned investors about a potential delay.
  • The FDA didn't ask for any additional information and is continuing to review the approval application for AXS-05.

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Investors are happy that the FDA didn't ask for more information to supplement Axsome's regulatory filing for AXS-05.

What happened

Shares of Axsome Therapeutics (AXSM -5.22%) were up by 7.5% as of 11:55 a.m. EDT Monday. The gain came after the company announced a delay in the Food and Drug Administration's review of its application for AXS-05 to be approved as a treatment for major depressive disorder.

So what

The FDA had originally set a Prescription Drug User Fee Act (PDUFA) date of Aug. 22 to complete its review of the regulatory filing for AXS-05. However, Axsome said that the agency informed it on Aug. 20 that it wouldn't meet that target date.

A hand holding yellow blocks spelling FDA.

Image source: Getty Images.

Ordinarily, this kind of announcement would cause a drugmaker's shares to fall. However, Axsome had already told investors in its second-quarter update earlier this month that the FDA had "identified deficiencies" in its regulatory filing. The company warned then that there could be a delay in the approval process.

Investors were likely pleased with Monday's news because Axsome said that the FDA had not requested any additional information; the agency is continuing to review the company's application. 

Now what

There's one big question for Axsome now: When will the FDA make its decision on AXS-05? Unfortunately, the agency didn't provide a new date. Axsome is also waiting on the FDA to announce its decision on acceptance of its filing for AXS-07 in treating migraine.

Keith Speights has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

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Stocks Mentioned

Axsome Therapeutics Stock Quote
Axsome Therapeutics
AXSM
$70.84 (-5.22%) $-3.90

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