Summary: Axsome Therapeutics’ Q1 2024 report highlights advancements in its slumber drugs pipeline, with beneficial phase 3 results for AXS-12 in narcolepsy procedure and profits development for Sunosi, reflecting potent monetary functionality and progress in addressing slumber disorders. Additionally, the organization showcases promising developments in its neuroscience portfolio, including ongoing medical trials for solriamfetol in ADHD, significant depressive ailment, binge feeding on disorder, and shift function ailment.
Vital Takeaways:
- Axsome Therapeutics claimed strong fiscal success for Q1 2024, with total net product revenue reaching $75 million, marking 160% 12 months-around-year development. Sunosi, a crucial item in Axsome’s business portfolio, contributed to this expansion with a profits raise of 64% as opposed to the prior year.
- The business showcased progress in its rest medicine pipeline, specifically with the announcement of beneficial phase 3 final results for AXS-12 in narcolepsy procedure.
- Axsome is actively advancing its neuroscience portfolio, with the ongoing growth of solriamfetol for a variety of diseases, together with change do the job condition.
Axsome Therapeutics introduced its 1st quarter 2024 company highlights and economical outcomes, showcasing breakthroughs in its rest medicine portfolio, which include beneficial period 3 outcomes for AXS-12 in narcolepsy cure and revenue development for Sunosi.
Sunosi is authorized to deal with wakefulness for excessive daytime sleepiness thanks to obstructive rest apnea or narcolepsy.
“The to start with quarter was marked by strong financial functionality for our on-sector merchandise which are delivering critical and differentiated treatment possibilities for individuals living with despair, narcolepsy, and obstructive slumber apnea,” states Herriot Tabuteau, MD, CEO of Axsome Therapeutics, in a launch. “We also significantly superior our modern neuroscience pipeline in the quarter. We introduced beneficial phase 3 effects for AXS-12 in narcolepsy, a main action toward producing this new drugs out there to sufferers dwelling with this debilitating condition.”
Initially quarter 2024 economic highlights:
- Full internet solution income for the first quarter of 2024 was $75 million, representing 160% year-around-calendar year expansion. Full net product revenue for the comparable interval in 2023 was $28.8 million. All round whole income for the initial quarter of 2023 was $94.6 million which involved a 1-time $65.7 million upfront payment obtained for the out-licensing of Sunosi commercialization legal rights in Europe and certain nations in the Middle East and North Africa region.
- Sunosi internet product or service income was $21.6 million for the initially quarter of 2024, consisting of $20.7 million in internet product income and $.9 million in royalty revenue associated with gross sales in out-accredited territories, representing 64% year-around-12 months development. Sunosi internet product or service profits for the comparable period of time in 2023 was $13.2 million, consisting of $12.9 million in internet product gross sales and $.3 million in royalty income.
Professional highlights for Sunosi:
- About 42,000 prescriptions have been composed for Sunosi in the US in the to start with quarter of 2024, representing a 1.6% minimize compared to the fourth quarter of 2023.
- Sunosi maintains broad payer coverage in the professional channel with 95% of life lined. Presently 83% of overall lives throughout all channels are covered.
Axsome’s Sleep Medicine Enhancement Pipeline
Axsome is advancing its neuroscience portfolio encompassing five late-phase, patent-secured solution candidates for 10 psychiatric and neurologic conditions, which have an effect on extra than 150 million people in the US by itself. Recent and anticipated progress for essential pipeline plans in sleep drugs is summarized below.
AXS-12
AXS-12 (reboxetine) is Axsome’s novel, oral, strong, investigational remarkably selective norepinephrine reuptake inhibitor and cortical dopamine modulator for the procedure of narcolepsy. AXS-12 has been granted US Foods and Drug Administration Orphan Drug designation for the treatment method of narcolepsy.
- Narcolepsy: In March 2024, Axsome announced favourable topline benefits from the SYMPHONY trial, a stage 3, randomized, double-blind, multicenter, placebo-controlled demo of AXS-12 in patients with narcolepsy. AXS-12 obtained the principal endpoint by substantially decreasing the frequency of cataplexy assaults as in comparison to placebo in people with narcolepsy. AXS-12 also lowered extreme daytime sleepiness severity, enhanced cognitive perform, decreased total narcolepsy severity, and enhanced individual perform and quality of everyday living, as in comparison to placebo. AXS-12 was nicely tolerated in the trial.
- A stage 3 open-label safety extension trial of AXS-12 is at present ongoing with completion predicted in the fourth quarter of 2024.
- In March 2024, the company also introduced topline final results from the CRESCENDO (Characterizing Individual Perspectives on Unmet Requires in Narcolepsy) study of 203 narcolepsy sufferers with cataplexy (narcolepsy form 1) who are at present obtaining therapy. The success shown superior prices of persistent signs or symptoms with 77%, 64%, and 74% continuing to experience cataplexy, abnormal daytime sleepiness, and cognitive impairment, respectively, irrespective of remaining on latest remedies. CRESCENDO was performed by a 3rd-bash research company that labored with Narcolepsy Network to make sure patient privateness. Narcolepsy Network is a national non-profit individual guidance business for folks with narcolepsy, idiopathic hypersomnia and related snooze disorders.
Solriamfetol
Solriamfetol is Axsome’s dopamine and norepinephrine reuptake inhibitor and TAAR1 agonist in advancement for the treatment method of focus deficit hyperactivity dysfunction (ADHD), major depressive dysfunction, binge consuming ailment, and too much sleepiness connected with shift work condition.
- Change operate condition: The firm is on keep track of to initiate a section 3 trial of solriamfetol for the procedure of excessive sleepiness involved with change perform disorder in the second quarter of 2024.
- ADHD: Axsome is conducting the Target research, a period 3, randomized, double-blind, placebo-managed, multicenter trial to assess the efficacy and basic safety of solriamfetol for the treatment method of ADHD in grownups. The business anticipates topline final results from the Concentrate review in the second 50 percent of 2024.
- Significant depressive disorder: In March 2024, Axsome initiated the PARADIGM study, a phase 3, randomized, double-blind, placebo-managed, multicenter trial of solriamfetol for the therapy of important depressive dysfunction. The company anticipates topline benefits from the PARADIGM examine in 2025.
- Binge taking in condition: In March 2024, Axsome initiated the Have interaction research, a stage 3, randomized, double-blind, placebo-controlled, multicenter demo of solriamfetol for the procedure of binge consuming ailment. The business anticipates topline final results from the Engage review in 2025.
Expected milestones:
- Medical trial topline success:
- Section 3 open up-label safety extension demo of AXS-12 in narcolepsy (2H 2024)
- Scientific trial initiations and progress:
- Stage 3 demo of solriamfetol in change work disorder, initiation (2Q 2024)
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