Cantor Virtual Brain Week – Day Three Highlights

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

Harmony Biosciences: Jeffrey Dayno, MD, President/CEO, Sandip Kapadia, CFO, and Jeffrey Dierks, CCO
•Â #HRMY’s management team discussed #WAKIX in narcolepsy and the P3 INTUNE study of pitolisant (marketed as #WAKIX) in IH (data guided for 4Q23)
• WAKIX has been exceeding expectations, as the company noted strong prescription demand and new patient starts thus far
• Additionally, the company anticipates sharing additional updates to the PWS indication in the next earnings call

Intra-Cellular Therapies: Sharon Mates, Ph.D., CEO, Mark Neumann, CCO, and Suresh Durgam, M.D., CMO
• The #ITCI team focused on the growth potential of #CAPLYTA (shown by expanding breadth/depth of prescribers) made possible by its differentiated efficacy and favorable safety/tolerability
• Positive P3 data in mixed features with BPD/MDD exhibits #lumateperone’s (aka CAPLYTA) robust antidepressant effect (which will be submitted to the FDA for a future meeting)
• As such, mixed features and adjunctive MDD treatment (sNDA submission guided for 2024) are promising TAM-expanding opportunities

Marinus Pharma: Scott Braunstein, M.D., CEO
• Discussions with the CEO centered on the positive performance metrics for #ZTALMY in CDD and pipeline initiatives: the RAISE study of IV-GNX in RSE; the TrustTSC study of oral GNX in TSC
• With the RAISE study, we believe this is the most compelling value driver for the company, which has data guided for YE23 (consider also the life-threatening nature of RSE)
• Learnings from the CDD program will be crucial to launch in TSC, which the company has guided to be its next orphan indication