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>>> Why Is Axsome Therapeutics (AXSM) Stock Shooting Higher On Monday?

Benzinga

by Vandana Singh

August 23, 2021


https://finance.yahoo.com/news/why-axsome-therapeutics-axsm-stock-122802327.html


Axsome Therapeutics Inc (NASDAQ: AXSM) stock is rising in premarket due to an update for its US marketing application seeking approval for AXS-05 for major depressive disorder (MDD).

The FDA informed that it would not meet the target action date of August 22 for the application.

Investors are probably cheering because the agency did not ask for any additional information, and the application review is ongoing.

Related Content: Axsome received an FDA letter for the AXS-05 application for MDD, citing deficiencies that preclude discussion of labeling and post-marketing requirements/commitments.

AXS-05 (dextromethorphan-bupropion) is an NMDA receptor antagonist with multimodal activity under development to treat MDD and other central nervous system disorders.

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>>> Why Axsome Therapeutics Stock Is Jumping Today

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


Motley Fool

by Keith Speights

Aug 23, 2021


https://www.fool.com/investing/2021/08/23/why-axsome-therapeutics-stock-is-jumping-today/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article


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.

What happened

Shares of Axsome Therapeutics (NASDAQ:AXSM) 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.

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.

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