Soleno Therapeutics (SLNO) 2024 Cantor Global Healthcare Conference summary

Regulatory and clinical progress

• FDA accepted NDA for DCCR with priority review; PDUFA date set for December 27, with an AdCom expected.

• Submission includes pivotal efficacy data from the randomized withdrawal study (602), confirmatory evidence from prior studies (601), long-term efficacy, and natural history comparisons.

• Patient interviews and comprehensive CMC, quality, and manufacturing data are included in the NDA.

• Advocacy groups are actively supporting the AdCom process, with petitions and plans for patient and caregiver participation.

• FDA's psych division is now well-versed in Prader-Willi syndrome due to prior applications and advocacy efforts.

Commercial launch preparation

• Company expanded from about 28 to over 70 employees in the past year, focusing on commercial and adjacent functions.

• Chief Commercial Officer and leadership team are in place; hiring for field medical roles and sales force will continue through approval and launch.

• Special hires target group home patient populations, leveraging staff with experience in these care settings.

• Commercial strategy includes engaging both pediatric and psychiatric providers, as well as group home operators and families.

Patient community and market landscape

• Prader-Willi syndrome community is tightly knit, with families and patients highly connected through conferences and support groups.

• Patient identification is straightforward, with most diagnosed young and regularly seeing physicians.

• No geographic or ethnic predisposition; patient distribution tracks population centers, with some regional exceptions.

• A small number of physicians manage a large share of patients, concentrating prescribing influence.