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Axsome's NDA for AXS-12 in Narcolepsy Gets FDA Acceptance
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Key Takeaways
Axsome's NDA for AXS-12 to treat cataplexy in narcolepsy has been accepted for FDA review.
Axsome expects the FDA's final decision on the AXS-12 application by May 1, 2027.
The FDA does not currently plan to hold an advisory committee meeting to discuss the AXS-12 NDA.
Axsome Therapeutics (AXSM - Free Report) announced that the FDA has accepted the company’s new drug application (NDA) seeking approval for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy.
With the FDA accepting the NDA for review, a decision from the regulatory body is expected on May 1, 2027.
The regulatory agency has also indicated that it does not plan to hold an advisory committee meeting to discuss the NDA currently.
Axsome recently submitted an NDA to the FDA seeking approval for AXS-12 for the treatment of cataplexy in narcolepsy.
AXSM’s Price Performance
Year to date, shares of Axsome have rallied 30.1% compared with the industry’s rise of 1.9%.
Image Source: Zacks Investment Research
AXSM Eyes Expansion With Potential Nod to AXS-12
A potential nod to AXS-12 should boost Axsome’s narcolepsy franchise.
Axsome completed its acquisition of a commercialized drug targeting narcolepsy, Sunosi (solriamfetol), from Jazz Pharmaceuticals (JAZZ - Free Report) in 2022.
Sunosi’s net product sales were $33.9 million in the first quarter of 2026, up 34% from the year-ago quarter’s level.
The acquisition of Sunosi from Jazz diversified Axsome’s commercial portfolio. The drug has become an important revenue driver for Axsome.
However, competition in the target market is growing, which remains a concern.
Alkermes (ALKS - Free Report) is developing alixorexton, a novel, investigational, oral, selective orexin 2 receptor agonist, in late-stage studies for the treatment of narcolepsy type 1 and narcolepsy type 2.
ALKS is also developing alixorexton in mid-stage studies for treating idiopathic hypersomnia. The successful development and potential approval of alixorexton is likely to induce acute competition for Axsome’s Sunosi as well as AXS-12.
Jazz’s other sleep disorder drugs, Xyrem and Xywav, also have a strong foothold in the target market.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $4.92 during the same time. LQDA shares have surged 125.4% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.
View the Zacks #1 Rank List
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Axsome's NDA for AXS-12 in Narcolepsy Gets FDA Acceptance
Key Takeaways
Axsome Therapeutics (AXSM - Free Report) announced that the FDA has accepted the company’s new drug application (NDA) seeking approval for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy.
With the FDA accepting the NDA for review, a decision from the regulatory body is expected on May 1, 2027.
The regulatory agency has also indicated that it does not plan to hold an advisory committee meeting to discuss the NDA currently.
Axsome recently submitted an NDA to the FDA seeking approval for AXS-12 for the treatment of cataplexy in narcolepsy.
AXSM’s Price Performance
Year to date, shares of Axsome have rallied 30.1% compared with the industry’s rise of 1.9%.
Image Source: Zacks Investment Research
AXSM Eyes Expansion With Potential Nod to AXS-12
A potential nod to AXS-12 should boost Axsome’s narcolepsy franchise.
Axsome completed its acquisition of a commercialized drug targeting narcolepsy, Sunosi (solriamfetol), from Jazz Pharmaceuticals (JAZZ - Free Report) in 2022.
Sunosi’s net product sales were $33.9 million in the first quarter of 2026, up 34% from the year-ago quarter’s level.
The acquisition of Sunosi from Jazz diversified Axsome’s commercial portfolio. The drug has become an important revenue driver for Axsome.
However, competition in the target market is growing, which remains a concern.
Alkermes (ALKS - Free Report) is developing alixorexton, a novel, investigational, oral, selective orexin 2 receptor agonist, in late-stage studies for the treatment of narcolepsy type 1 and narcolepsy type 2.
ALKS is also developing alixorexton in mid-stage studies for treating idiopathic hypersomnia. The successful development and potential approval of alixorexton is likely to induce acute competition for Axsome’s Sunosi as well as AXS-12.
Jazz’s other sleep disorder drugs, Xyrem and Xywav, also have a strong foothold in the target market.
AXSM's Zacks Rank & Stock to Consider
Axsome currently carries a Zacks Rank #4 (Sell).
A better-ranked stock in the biotech sector is Liquidia Corporation (LQDA - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $4.92 during the same time. LQDA shares have surged 125.4% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.