Senior Biotech Analyst Charles C. Duncan, PhD moderated day two of the 2023 Virtual #BrainWeek. Day two fireside chats featured:

Axsome Therapeutics, Inc.: Mark Jacobson, COO and Nick Pizzie, CEO
•Â #Axsome management discussed #AUVELITY’s potential as a first-line branded MDD drug, via its differentiated glutamatergic MoA and favorable clinical/safety profile
• Early launch metrics continue to look optimistic with Axsome’s commercial execution, including its DCC platform, enabling the field force to target and interact with HCPs efficiently
• AXS-05 Advance-2 in ADA and near-term AXS-07 NDA filling in migraine in next ~6-9 months should enhance visibility on pipeline-driven top-line growth that leverages existing commercial capabilities

Crinetics Pharmaceuticals: R Scott Struthers, Ph.D., Founder/CEO, Marc W., CFO, and Alan Krasner, MD, CMO
• The Crinetics team discussed its #PATHFNDR studies as well as the #TAM expansion opportunity for #paltusotine (paltu’) in carcinoid syndrome
•Â #Crinitecs also highlighted the recent announcement of new data from ENDO 2023 that demonstrated stable biochemical and symptom levels associated with two years of treatment with paltu’
• Data from ongoing P3 program (PATHFNDR-1) in 3Q has high PoS, to be followed by P2 PoC in NETS in 4Q, and PATHFNDR-2 in 1Q24 sets-up period of uncommon value creation potential

Denali Therapeutics: Joe Lewcock, Ph.D., CSO
• Discussions with #Denali’s CSO yielded key insights into recent #NfL data with #DNL310 in MPS II, which may bolster proof of therapeutic benefit in conjunction with clinical measures
• Further data (from the Phase 1/2 study of DNL310 highlighted in an oral presentation at the Society for the Study of Inborn Errors of Metabolism (#SSIEM) Annual Symposium 2023 in Aug.) and ongoing regulatory discussions may present opportunities for an accelerated approval application given the unmet need in MPS II, and usher-in broader pipeline initiatives in rare neurodevelopmental disorders