Axsome Therapeutics (NASDAQ:AXSM) executives provided updates on the company’s commercial portfolio and pipeline during a discussion hosted by Leerink Partners biopharma analyst Marc Goodman. Mark Jacobson, the company’s COO, and Nick Pizzie, CFO, outlined plans for the antidepressant Auvelity, the early launch of migraine product Symbravo, continued growth for Sunosi, and progress across several development programs.
Auvelity: Sales force expansion, coverage gains, and DTC learnings
Management said Auvelity finished last year “annualizing just north of $600 million” in revenue, marking its third full year on the market since its 2022 launch. Jacobson said the company has been pleased with performance, including revenue and prescription growth, and emphasized that results were achieved with what he described as a smaller field force that has expanded over time—from 160 representatives initially, to 260 in 2024, and about 300 in 2025.
Pizzie said market access has improved to 86% coverage of total covered lives, including 100% coverage in the government channel and 100% of Medicare Part D lives. He added commercial coverage is 78%. On gross-to-net, Pizzie said the company has not conceded much as access expanded, describing average gross-to-net as around 50% last year, with mid-50% levels in the first half and high-40% levels in the second half.
The executives also described prescribing trends. Jacobson said more than 50% of scripts are now first- or second-line, with first-line at around 15% and second-line around 35%, and that this mix has been increasing over time. He added that more than half of use is monotherapy and that primary care now accounts for about one-third of scripts, a figure he said is rising. The company also noted Auvelity’s current penetration is roughly 0.2% (20 basis points) of the overall antidepressant market, which management said underscores room for growth.
On direct-to-consumer advertising, Jacobson said mass media television DTC began in September and ran through the fourth quarter, producing learnings about channel allocation across linear and connected TV. The company went off air in January and February and returned in March. Executives said resources are being reallocated toward the planned field force expansion, with the view that additional “boots on the ground” can improve DTC pull-through and ROI over time.
Auvelity in ADA agitation: PDUFA date approaching
On the regulatory path for Auvelity in ADA agitation, the company reiterated that the program has Breakthrough Therapy designation, was filed and accepted with priority review, and has a PDUFA date of April 30. Jacobson noted that labeling discussions typically begin about 30 days ahead of the PDUFA date and said the company was still outside that window. He added that, from the company’s vantage point, the review is “where you would expect” it to be at this stage.
Symbravo: Limited launch, early real-world feedback, and access building
Executives said Symbravo’s early launch is proceeding well and that real-world experience is aligning with the clinical profile the company has described, including efficacy, durability, and tolerability. Jacobson said initial use is generally later line, reflecting typical clinician practice and payer management in the migraine market, though he added the company has observed utilization across segments, including both pre- and post-CGRP use, without providing quantified detail.
The company said it is intentionally keeping the launch “discreet” with about 100 representatives, focusing on early utilization among headache specialists and headache centers to understand prescribing patterns and calibrate patient support and savings programs. Pizzie added that market access is a central focus and said Symbravo is at roughly 50% covered lives. He also said the company has signed three GPO contracts intended to facilitate payer negotiations and improve coverage.
Sunosi: Growth and multiple development programs
Management said Sunosi grew 40% year over year and remains a “healthy business,” supported by a relatively small commercial footprint of roughly 70 representatives. Executives discussed four development programs connected to Sunosi: shift work disorder, binge eating disorder, ADHD, and MDD. Jacobson said the company previously received FDA feedback that only one trial may be needed for shift work disorder because of its proximity to the current label, while two studies are planned for other indications.
For binge eating disorder, Jacobson said the phase 3 ENGAGE trial is underway, with top-line results expected in the second half of the year. For ADHD, the company plans two pediatric studies—one in children and one in adolescents—run in parallel to complement a completed positive phase 3 trial in adults. Jacobson said the FDA expects pediatric assessments to be part of an initial ADHD submission. For MDD, he said the company has started a study in individuals with major depressive disorder who have symptoms of excessive daytime sleepiness, following an earlier proof-of-concept effort that evaluated patients with and without those symptoms.
Pipeline updates: AXS-14, AXS-17, and AXS-12
Jacobson discussed AXS-14 (esreboxetine) for fibromyalgia, describing the market as underserved. He said Pfizer previously generated positive phase 2 and phase 3 studies in the indication but shelved the asset. Axsome submitted an NDA last year but received a Refuse to File from the FDA’s pain division based on an objection to the design of the phase 2 study—an eight-week flexible-dose trial. The agency requested a second trial analogous to the prior 12-week fixed-dose phase 3 study, which Jacobson said was the “only comment” leading to the RTF.
The company has now launched a new phase 3 trial “a few weeks ago” using a randomized withdrawal design, citing rising placebo response rates and the need for signal detection. Jacobson confirmed pain is an endpoint and said that, once the trial is completed, the company expects to resubmit.
On AXS-17, executives said the company licensed a subtype-selective GABAA molecule with prior clinical experience in generalized anxiety disorder, but Axsome’s current development focus is epilepsy. Jacobson said 2026 will center on phase 2 enabling work and indication selection, along with required tech transfer, and that the existing GAD data should help inform safety and tolerability.
Finally, Jacobson said AXS-12—reboxetine for narcolepsy with a clinical focus on cataplexy—is at the NDA stage and that the company is “about to” submit to the FDA’s psychiatry division. He noted narcolepsy is an orphan indication and said the company expects a standard review, adding that the product would fit within its existing sleep team.
About Axsome Therapeutics (NASDAQ:AXSM)
Axsome Therapeutics, Inc is a clinical-stage biopharmaceutical company dedicated to developing novel therapies for central nervous system (CNS) disorders. The company focuses on small-molecule drugs designed to address unmet medical needs in areas such as depression, migraine, narcolepsy and fibromyalgia. Axsome employs a precision medicine approach, leveraging pharmacologic innovation to target underlying mechanisms of disease and improve patient outcomes.
Axsome’s pipeline includes several late-stage and approved product candidates.
