Xenon Pauses Psychiatry Trials Enrollment Despite Positive NDA Data

AbbVie announced top-line results from a Phase 3 clinical trial showing its migraine treatment Qulipta significantly reduced migraine days versus placebo during the perimenstrual period in patients with menstrual migraine, the study's primary endpoint, while also meeting all secondary endpoints with no new safety signals. Qulipta, first approved in the U.S. in 2021 for migraine prevention and later expanded to chronic migraine in adults, could become the first medicine approved specifically for menstrual migraine, a niche with no approved treatments; AbbVie estimates a potential U.S. market of more than nine million adult patients in this indication. In the second quarter, Qulipta posted $350 million in sales, up 31% year over year, and some analysts expect peak sales of over $2 billion, against $1 billion in revenue last year, though AbbVie's total second-quarter revenue grew 10% year over year to $17 billion. AbbVie's larger growth drivers remain the immunology drugs Skyrizi and Rinvoq, which management expects to generate more than $31 billion in combined revenue this year, a milestone originally forecast for 2027 and raised by $4 billion from an earlier projection. The company also recently closed its $10.9 billion acquisition of Apogee Therapeutics, gaining zumilokibart, a late-stage immunology asset that some analysts say could reach $5.2 billion in peak eczema sales alone.

Axsome Therapeutics said AUVELITY prescriptions are accelerating after its sales-force expansion and the drug's launch in Alzheimer's disease agitation, with weekly new-to-brand prescriptions reaching a record 3,800. Speaking at Morgan Stanley's Global Healthcare Conference, Chief Financial Officer Nick Pizzie said patients aged 65 and older now account for about 31% of new-to-brand prescriptions, up from roughly 19% before the indication's approval, and that agitation is the fastest-growing segment. Average weekly new-to-brand prescriptions were about 2,400 in the first quarter and 3,000 in the second quarter. Management reiterated its $8 billion long-term peak-sales outlook for AUVELITY, split evenly between $4 billion in major depressive disorder and $4 billion in Alzheimer's disease agitation, and reported 89% coverage of total covered lives, including 100% Medicare coverage. Pizzie said second-quarter selling, general and administrative expense of $208 million should be a reasonable reference point for the back half of the year, while research and development expense of $46 million is expected to rise modestly, and management expects revenue to grow faster than operating expenses on a very clear path toward positive cash flow and profitability.