Yeji
NDA/BLA filedoutcome: unknownconf 0.99

reproxalap — NDA/BLA filed

$ALDX · Aldeyra Therapeutics, Inc. · dry eye disease
Event date
February 7, 2023
1215 days ago
Sponsor runway
38 mo
$65.0M liquid

Evidence

the U.S. Food and Drug Administration (FDA) has accepted for review the Company's 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 November 23, 2023.
Source: 8-K filed 2023-02-07View on EDGAR ↗0001157523-23-000181

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

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

Recent insider activity· ±90 days

4 insiders · 1 buys · 0 sells
Buy
2023-04-12
Miller-Rich Nancy
Director
509 @ $10.13$5K
Grant
2023-02-28
Machatha Stephen
Chief Development Officer
220,258 @
Grant
2023-02-28
Greenberg Bruce
See Remarks
110,028 @
Grant
2023-02-28
Brady Todd C
President and CEO
238,750 @
Grant
2023-02-28
Brady Todd C
President and CEO
250,000 @