Soleno Therapeutics Q3 net loss $76.6M; NDA for DCCR in PWS accepted with Priority Review, PDUFA Dec 27, 2024

SOLENO THERAPEUTICS INC

2024-Q3 EPS reported -$3.08

NDA for DCCR (diazoxide choline) for Prader-Willi syndrome accepted by FDA with Priority Review; PDUFA target action date December 27, 2024.
Net loss $76.6M ($1.83/sh) vs $10.9M ($0.95/sh) in Q3 2023; increase driven by non-cash stock-based compensation tied to NDA milestones.
R&D expense $30.1M (includes $18.5M stock comp); G&A expense $49.2M (includes $38.1M stock comp), both up significantly from prior year.
Cash, cash equivalents and marketable securities $284.7M as of Sept 30, 2024; cash used in operations $14.9M in Q3.
Board appointed Dawn Carter Bir and Matthew Pauls assumed Lead Independent Director role.

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