Axsome Therapeutics (AXSM) Leerink Global Healthcare Conference 2026 summary

Auvelity commercial strategy and performance

• Annualized revenue surpassed $600 million at the end of last year, with strong script growth and 86% market access coverage.

• Sales force expanded from 160 to 300 reps, with plans to double to 600 in 2026 to support both MDD and anticipated ADA indication.

• Over 50% of scripts now come from first or second line use, and primary care accounts for about a third of prescriptions.

• DTC advertising was paused in early 2024 to reallocate resources to sales force expansion, but resumed in March with improved channel efficiency.

• Gross-to-net remained stable at around 50% despite increased coverage, with 100% Medicare Part D and 78% commercial coverage.

Pipeline and regulatory updates

• ADA agitation indication for Auvelity has a PDUFA date of April 30, with preparations underway for launch pending approval.

• Smoking cessation program for Auvelity is progressing, with clinical operations set up and study details to be shared soon.

• Symbravo launched with a focused 100-rep sales force, targeting later-line migraine patients and achieving about 50% coverage.

• Sunosi grew 40% year-over-year, supported by a 70-rep team and four ongoing label expansion studies, including shift work disorder, binge eating, ADHD, and MDD.

• Binge eating ENGAGE trial expects top-line results in the second half of the year; ADHD pediatric studies are underway following a positive adult phase 3 trial.

R&D and portfolio expansion

• AXS-14 for fibromyalgia is in a new phase 3 trial after a previous Refuse to File; pain is a key endpoint and prior studies were highly positive.

• AXS-17, a subtype-selective GABAA molecule, was recently licensed for epilepsy, with phase 2 enabling work planned for 2026.

• AXS-12 (reboxetine for narcolepsy) is at NDA stage, with submission imminent and focus on cataplexy; fits with the current sleep team.

• Portfolio is described as deep for late 2020s launches, with AXS-17 positioned for early 2030s.