regulatory
confidence high
sentiment positive
materiality 0.70
ARS Pharma to submit CRL response in early Q2 2024; Q4 net loss $7.2M, cash $228.4M
ARS Pharmaceuticals, Inc.
- CRL response for neffy (epinephrine nasal spray) to be submitted early Q2 2024; FDA action and potential launch expected H2 2024.
- Phase 2 urticaria trial met primary endpoints with rapid symptom control; outpatient study planned later in 2024.
- Cash, equivalents and short-term investments $228.4M as of Dec 31, 2023; runway at least three years.
- Net loss $7.2M in Q4, $54.4M full year 2023; R&D costs $3.4M in Q4, G&A $6.8M.
- EMA MAA decision for neffy expected mid-2024; new U.S. patent issued covering intranasal epinephrine methods.