Yeji
PDUFAoutcome: failureconf 0.99

reproxalap — PDUFA

$ALDX · Aldeyra Therapeutics, Inc. · dry eye disease
Event date
April 2, 2025
430 days ago
Sponsor runway
38 mo
$65.0M liquid

Evidence

In November 2024, the FDA accepted the reproxalap NDA for filing and set a Prescription Drug User Fee Act date of April 2, 2025.
Source: 8-K filed 2026-03-17View on EDGAR ↗0001193125-26-109511

Comparable historical pdufas· last 5 years · same indication

0% hit rate (0/1)
TickerDrugDateOutcome
$ALDXreproxalap2025-12-16unknown
$ALDXreproxalap2023-11-23failure

Recent insider activity· ±90 days

10 insiders · 0 buys · 1 sells
Grant
2025-06-10
Miller-Rich Nancy
Director
2,413 @
Grant
2025-06-10
JOYCE MARTIN JOSEPH
Director
62,728 @
Grant
2025-06-10
JOYCE MARTIN JOSEPH
Director
1,689 @
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
2025-04-17
Clark William D
Director
76,760 @
Sell
2025-04-03
PERCEPTIVE ADVISORS LLC
10%+ Owner
3,400,000 @ $1.42$4.83M
Grant
2025-03-04
Machatha Stephen
Chief Development Officer
202,427 @
Grant
2025-03-04
Brady Todd C
President and CEO
809,710 @