Matthew Harrison

Matthew Harrison asked about the likely label language for Auvelity in Alzheimer's disease agitation (ADA) reflecting differentiation versus Rexulti, and the biggest advantages for Auvelity considering its safety profile in elderly patients.

Answer

Herriot Tabuteau (CEO, Axsome Therapeutics) stated it's too early to comment on potential label language given the ongoing priority review, but expects the safety profile in that patient population to be described. Ari Maizel (Chief Commercial Officer, Axsome Therapeutics) highlighted Auvelity's rapid onset of action, durability of response, low side effects, non-antipsychotic nature, and monotherapy approval in MDD (with comorbidity in ADA) as key differentiators.

Matthew, on behalf of Alec Stranahan, asked for an update on the development timeline for other in vivo and ex vivo pipeline candidates beyond the lead programs in HAE and ATTR.

Answer

CEO John Leonard stated that the company's primary focus is on its late-stage clinical programs, as they are the nearest-term value drivers. While significant work is underway on other candidates, including alpha-1 antitrypsin deficiency and gene writing technologies, the company is prioritizing execution on its pivotal trials and will share more on the pipeline as programs mature.

Matthew Harrison, on behalf of Alec Stranahan at Bank of America, asked for clarification on the timing of the elironrasib-pembrolizumab combo data and inquired about the company's approach to collaboration opportunities.

Answer

CEO Dr. Mark Goldsmith clarified that the elironrasib-pembro safety data, previously guided for Q1 2025, was released early in Q4 2024. He noted it was primarily a safety assessment. Regarding collaborations, he confirmed the company is actively engaged in partnerships, citing the ongoing clinical collaboration with Tango Therapeutics to study their PRMT5 inhibitor with Revolution's RAS inhibitors.