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Axsome's (AXSM) Narcolepsy Drug Study Meets Primary Goal
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Axsome Therapeutics (AXSM - Free Report) announced encouraging data from the phase III SYMPHONY study on its investigational narcolepsy drug AXS-12. The study achieved its primary endpoint of a rapid and significant reduction in weekly cataplexy events.
Data from the study showed that treatment with AXS-12 reduced cataplexy attacks by 83% over five weeks compared with 66% for placebo. In fact, treatment with AXS-12 rapidly reduced weekly cataplexy attacks, as it achieved a reduction of 56% in the first week compared to 31% for placebo.
Treatment with AXS-12 also induced an increase in remission of cataplexy (100% reduction from baseline) and increased cataplexy-free days (days with zero cataplexy attacks). Per management, 33% of patients who received AXS-12 achieved remission of cataplexy compared to 9.5% of placebo patients. Treatment with the therapy increased the percentage of cataplexy-free days to 84%, compared to 22% for placebo.
The drug was also well-tolerated by study participants. In fact, those who received AXS-12 also experienced a reduction in other symptoms of narcolepsy, such as excessive daytime sleepiness (EDS) and inadvertent naps. Treatment with the drug also showed improvements in cognitive function and memory.
Before applying for marketing approval for AXS-12, Axsome intends to complete the ongoing open-label extension study to assess the long-term safety and effectiveness of the drug in narcolepsy patients. It plans to report detailed results from the SYMPHONY study at future medical meetings.
Shares of Axsome have lost 2.8% year to date compared with the industry’s 0.9% fall.
Image Source: Zacks Investment Research
Axsome’s AXS-12 was granted orphan drug designation (ODD) by the FDA for treating narcolepsy in 2018. The agency grants an ODD tag to candidates developed to treat, diagnose or prevent a rare disease or condition. This FDA designation makes the sponsor eligible for seven years of market exclusivity, following the potential approval and tax credit for qualified clinical studies.
A chronic sleep disorder, narcolepsy causes overwhelming daytime drowsiness. It is marked by multiple symptoms, which include cataplexy, EDS, hypnagogic hallucinations, sleep paralysis, and disrupted nocturnal sleep. Per management, around 70% of patients with narcolepsy experience cataplexy episodes.
If approved, AXS-12 would add another sleep disorder therapy to Axsome’s portfolio. In May 2022, Axsome acquired the U.S. rights to Sunosi, a commercialized drug targeting narcolepsy, from Jazz Pharmaceuticals (JAZZ - Free Report) . It began selling Sunosi in the U.S. market in May 2022 and certain international markets in November 2022.
In February 2023, Axsome out-licensed its ex-U.S. marketing rights of Sunosi to Pharmanovia. JAZZ is entitled to receive high single-digit royalty from AXSM on net sales of Sunosi in the United States.
Since its acquisition, Sunosi has become a significant revenue driver for Axsome. In 2023, management generated $74.8 million from Sunosi product sales, reflecting an increase of 67% on a year-over-year basis.
Notably, Jazz also markets its sleep disorder drugs — Xywav and Xyrem — both of which are approved for treating cataplexy and EDS in narcolepsy patients. Jazz expects to record $2 billion in revenues from the combined Xyrem and Xywav sales by 2025.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 22 cents to 30 cents. During the same period, EPS estimates for 2025 have improved from 32 cents to 50 cents. Year to date, shares of ADMA have risen 41.4%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same on one occasion. ADMA delivered a four-quarter average earnings surprise of 85.00%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have risen from $4.06 to $4.43. Meanwhile, during the same period, EPS estimates for 2025 have improved from $4.80 to $5.04. Year to date, shares of ANIP have risen 26.2%.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters. ANI delivered a four-quarter average earnings surprise of 109.06%.
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Axsome's (AXSM) Narcolepsy Drug Study Meets Primary Goal
Axsome Therapeutics (AXSM - Free Report) announced encouraging data from the phase III SYMPHONY study on its investigational narcolepsy drug AXS-12. The study achieved its primary endpoint of a rapid and significant reduction in weekly cataplexy events.
Data from the study showed that treatment with AXS-12 reduced cataplexy attacks by 83% over five weeks compared with 66% for placebo. In fact, treatment with AXS-12 rapidly reduced weekly cataplexy attacks, as it achieved a reduction of 56% in the first week compared to 31% for placebo.
Treatment with AXS-12 also induced an increase in remission of cataplexy (100% reduction from baseline) and increased cataplexy-free days (days with zero cataplexy attacks). Per management, 33% of patients who received AXS-12 achieved remission of cataplexy compared to 9.5% of placebo patients. Treatment with the therapy increased the percentage of cataplexy-free days to 84%, compared to 22% for placebo.
The drug was also well-tolerated by study participants. In fact, those who received AXS-12 also experienced a reduction in other symptoms of narcolepsy, such as excessive daytime sleepiness (EDS) and inadvertent naps. Treatment with the drug also showed improvements in cognitive function and memory.
Before applying for marketing approval for AXS-12, Axsome intends to complete the ongoing open-label extension study to assess the long-term safety and effectiveness of the drug in narcolepsy patients. It plans to report detailed results from the SYMPHONY study at future medical meetings.
Shares of Axsome have lost 2.8% year to date compared with the industry’s 0.9% fall.
Image Source: Zacks Investment Research
Axsome’s AXS-12 was granted orphan drug designation (ODD) by the FDA for treating narcolepsy in 2018. The agency grants an ODD tag to candidates developed to treat, diagnose or prevent a rare disease or condition. This FDA designation makes the sponsor eligible for seven years of market exclusivity, following the potential approval and tax credit for qualified clinical studies.
A chronic sleep disorder, narcolepsy causes overwhelming daytime drowsiness. It is marked by multiple symptoms, which include cataplexy, EDS, hypnagogic hallucinations, sleep paralysis, and disrupted nocturnal sleep. Per management, around 70% of patients with narcolepsy experience cataplexy episodes.
If approved, AXS-12 would add another sleep disorder therapy to Axsome’s portfolio. In May 2022, Axsome acquired the U.S. rights to Sunosi, a commercialized drug targeting narcolepsy, from Jazz Pharmaceuticals (JAZZ - Free Report) . It began selling Sunosi in the U.S. market in May 2022 and certain international markets in November 2022.
In February 2023, Axsome out-licensed its ex-U.S. marketing rights of Sunosi to Pharmanovia. JAZZ is entitled to receive high single-digit royalty from AXSM on net sales of Sunosi in the United States.
Since its acquisition, Sunosi has become a significant revenue driver for Axsome. In 2023, management generated $74.8 million from Sunosi product sales, reflecting an increase of 67% on a year-over-year basis.
Notably, Jazz also markets its sleep disorder drugs — Xywav and Xyrem — both of which are approved for treating cataplexy and EDS in narcolepsy patients. Jazz expects to record $2 billion in revenues from the combined Xyrem and Xywav sales by 2025.
Axsome Therapeutics, Inc. Price
Axsome Therapeutics, Inc. price | Axsome Therapeutics, Inc. Quote
Zacks Rank & Key Picks
Axsome currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector are ADMA Biologics (ADMA - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 22 cents to 30 cents. During the same period, EPS estimates for 2025 have improved from 32 cents to 50 cents. Year to date, shares of ADMA have risen 41.4%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same on one occasion. ADMA delivered a four-quarter average earnings surprise of 85.00%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have risen from $4.06 to $4.43. Meanwhile, during the same period, EPS estimates for 2025 have improved from $4.80 to $5.04. Year to date, shares of ANIP have risen 26.2%.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters. ANI delivered a four-quarter average earnings surprise of 109.06%.