Yeji
NDA/BLA filedconf 0.95

reproxalap — NDA/BLA filed

$ALDX · Aldeyra Therapeutics, Inc. · dry eye disease
Event date
Date TBD
Sponsor runway
38 mo
$65.0M liquid

Evidence

the U.S. Food and Drug Administration (FDA) has accepted for review the Company's resubmitted New Drug Application (NDA) for reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of dry eye disease, and has assigned a Prescription Drug User Fee Act (PDUFA) date of April 2, 2025.
Source: 8-K filed 2024-11-18View on EDGAR ↗0001213900-24-099333

Comparable historical nda/bla fileds· last 5 years · same indication

TickerDrugDateOutcome
$ALDXreproxalap2025-07-17unknown
$ALDXreproxalap2024-11-01unknown
$ALDXreproxalap2023-02-07unknown
$ALDXreproxalap2023-02-01unknown

Recent insider activity· ±90 days

No insider Form 4 activity reported on $ALDX in the 90 days around this event.