$199.020
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AXSM 资讯
AXSM 事件
Axsome Reports Q2 Revenue of $218.38M, Below Expectations
Reports Q2 revenue $218.38M, consensus $221.78M. "The second quarter was highly productive for Axsome. Our commercial business grew robustly, driven by strong underlying demand for our products, and we made important regulatory and clinical progress across our innovative neuroscience pipeline," said Herriot Tabuteau, Chief Executive Officer of Axsome Therapeutics. "We expect our commercial momentum to build over the balance of the year, in particular with anticipated continued Auvelity growth in Alzheimer's disease agitation and major depressive disorder. With a focus on commercial execution and advancement of our broad late-stage neuroscience pipeline targeting high unmet needs, novel indications, first-in-class mechanisms of action, and best-in-class product profiles, Axsome is well positioned to deliver substantial value to patients and shareholders."
Axsome Therapeutics AXS-12 New Drug Application Accepted by FDA
Axsome Therapeutics announced that the FDA has accepted for filing the company's new drug application for AXS-12 for the treatment of cataplexy in narcolepsy. The FDA has set a Prescription Drug User Fee Act target action date of May 1, 2027. The FDA also indicated that it does not currently plan to hold an advisory committee meeting to discuss the application.
Axsome Therapeutics Doses First Patient in FOCUS-3 Trial
Axsome Therapeutics announced that the first patient has been dosed in the FOCUS-3 Phase 3 trial evaluating solriamfetol as a treatment for adolescents with attention deficit hyperactivity disorder, or ADHD.
Axsome Therapeutics Resolves Sunosi Patent Litigation
Axsome Therapeutics announced that it has resolved all patent litigation related to Axsome's product Sunosi. The litigations resulted from submission of abbreviated new drug applications to the FDA by companies seeking approval to market a generic version of Sunosi in the United States. Axsome resolved all outstanding Sunosi patent litigation upon entering into a settlement agreement with the only remaining first-to-file generic applicant with pending patent litigation related to Axsome's product Sunosi. As part of the resolution of these lawsuits, Axsome will grant five companies the right to sell generic versions of Sunosi beginning on or after September 1, 2040, if pediatric exclusivity is granted for Sunosi, or on or after March 1, 2040, if no pediatric exclusivity is granted, subject to FDA approval and conditions and exceptions customary for agreements of this type. No other patent litigation relating to Sunosi remains pending. As required by law, Axsome will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
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