Yeji
NDA/BLA filedoutcome: unknownconf 0.95

adx-2191 — NDA/BLA filed

$ALDX · Aldeyra Therapeutics, Inc. · primary vitreoretinal lymphoma
Event date
March 2, 2023
1192 days ago
Sponsor runway
38 mo
$65.0M liquid

Evidence

the U.S. Food and Drug Administration (FDA) accepted for Priority Review the New Drug Application (NDA) for ADX 2191 (methotrexate injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma.
Source: 8-K filed 2023-03-02View on EDGAR ↗0001157523-23-000387

Comparable historical nda/bla fileds· last 5 years · same event type

TickerDrugDateOutcome
$AXSM2025-12-31unknown
$RCKTkresladi2025-10-14unknown
$ALDXreproxalap2025-07-17unknown
$ETONet-6002025-07-08unknown
$BCRXorladeyo (berotralstat)2025-05-14unknown
$CORTrelacorilant2025-03-03unknown
$ALDXreproxalap2024-11-01unknown
$AXSMaxs-072024-09-04unknown
$RCKTkresladi2023-10-02unknown
$GERNimetelstat2023-08-21unknown

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 @