Yeji
NDA/BLA filedoutcome: unknownconf 0.95

reproxalap — NDA/BLA filed

$ALDX · Aldeyra Therapeutics, Inc. · dry eye disease
Event date
July 17, 2025
324 days ago
Sponsor runway
38 mo
$65.0M liquid

Evidence

the U.S. Food and Drug Administration ("FDA") has accepted for review Aldeyra'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") target action date of December 16, 2025.
Source: 8-K filed 2025-07-17View on EDGAR ↗0001213900-25-064869

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

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

Recent insider activity· ±90 days

8 insiders · 1 buys · 1 sells
Buy
2025-08-13
Alfieri Michael
Principal Financial Officer
2,500 @ $5.30$13K
Sell
2025-08-11
Machatha Stephen
Chief Development Officer
22,073 @ $5.15$114K
Grant
2025-06-10
JOYCE MARTIN JOSEPH
Director
7,238 @
Grant
2025-06-10
Phillips Gary M.
Director
62,728 @
Grant
2025-06-10
Phillips Gary M.
Director
4,825 @
Grant
2025-06-10
Phillips Gary M.
Director
3,619 @
Grant
2025-06-10
Bronstein Ben
Director
62,728 @
Grant
2025-06-10
Bronstein Ben
Director
3,619 @
Grant
2025-06-10
Walker Neal
Director
62,728 @
Grant
2025-06-10
Walker Neal
Director
2,413 @
Grant
2025-06-10
DOUGLAS RICHARD
Director
62,728 @
Grant
2025-06-10
DOUGLAS RICHARD
Director
14,476 @
Grant
2025-06-10
DOUGLAS RICHARD
Director
1,689 @
Grant
2025-06-10
Miller-Rich Nancy
Director
62,728 @
Grant
2025-06-10
JOYCE MARTIN JOSEPH
Director
62,728 @
Grant
2025-06-10
Miller-Rich Nancy
Director
2,413 @
Grant
2025-06-10
JOYCE MARTIN JOSEPH
Director
1,689 @