Yeji

$ALDX

Aldeyra Therapeutics, Inc.

Runway:38 mo
NasdaqMarket cap: —CIK 0001341235

Upcoming catalysts

12 surfaced
NDA/BLA filedDate TBD~ low confidence
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“received minutes (the Minutes) from a Type A meeting, held on June 10, 2026 with the U.S. Food and Drug Administration (FDA), regarding potential resubmission of the New Drug Application (NDA) of reproxalap for the treatment of dry eye disease”
PDUFADate TBD
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act ("PDUFA") date for topical ocular reproxalap, an investigational new drug candidate, for the treatment of signs and symptoms of dry eye disease.”
NDA/BLA filedDate TBD~ low confidence
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“On June 17, 2025, Aldeyra Therapeutics, Inc. (the ”
NDA/BLA filedDate TBD
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“In November 2024, the FDA accepted the reproxalap NDA for filing and set a Prescription Drug User Fee Act date of April 2, 2025.”
NDA/BLA filedDate TBD
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“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.”
NDA/BLA filedDate TBD~ low confidence
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“On October 3, 2024, Aldeyra Therapeutics, Inc. (the ”
CRLDate TBD~ low confidence
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“it may issue a Complete Response Letter and require that Aldeyra conduct additional clinical trials and submit the results of those clinical trials before the application will be reconsidered.”
CRLDate TBD
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“Aldeyra Received a Complete Response Letter for Reproxalap for the Treatment of Dry Eye Disease The Complete Response Letter stated that the NDA ”
NDA/BLA filedDate TBD
$ALDXAldeyra Therapeutics, Inc.
adx-2191 · primary vitreoretinal lymphoma
“FDA Accepts for Priority Review ADX-2191 New Drug Application for the Treatment of Primary Vitreoretinal Lymphoma”
CRLDate TBD
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“Aldeyra Received a Complete Response Letter for Reproxalap for the Treatment of Dry Eye Disease The letter stated that the NDA did not demonstrate "efficacy in treating ocular symptoms associated with dry eyes" and that "at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye" should be conducted.”
NDA/BLA filedDate TBD~ low confidence
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“standardized treatment estimates and confidence intervals for the primary endpoints of all proposed commercial dosing regimen efficacy clinical trials of reproxalap submitted to the New Drug Application for the treatment of dry eye disease”
CRLDate TBD
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“Aldeyra Received a Complete Response Letter for Reproxalap for the Treatment of Dry Eye Disease The Complete Response Letter stated that "there is a lack of substantial evidence consisting of adequate and well-controlled investigations … that the drug product will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in its proposed labeling" and that "the application has failed to demonstrate efficacy in adequate and well controlled studies in the treatment of signs and symptoms of dry eye disease."”

Drug pipeline

reproxalap
dry eye disease
adx-2191
primary vitreoretinal lymphoma
ADX-102 Ophthalmic Drops (0.5%)
Conjunctivitis, Allergic
Reproxalap Ophthalmic Solution (0.25% Novel Formulation) QID to BID
Dry Eye
ICM ADX-2191 injection
Primary Vitreoretinal Lymphoma
Active topical NS2 1% dermatologic cream
Sjögren-Larsson Syndrome
NS2
Non-infectious Anterior Uveitis
Reproxalap Ophthalmic Solution (0.25%)
Dry Eye Syndrome
ADX-102 Ophthalmic Solution (0.5%)
Dry Eye Syndromes
ADX-102 1% Topical Dermal Cream (reproxalap)
Sjogren-Larsson Syndrome
ADX-2191 (intravitreal methotrexate 0.8%)
Proliferative Vitreoretinopathy
ADX-629
Ethanol Intoxication
NS2 Ophthalmic Drops (0.5%)
Allergic Conjunctivitis
Reproxalap Ophthalmic Solution (0.25%) QID
Dry Eye
ADX-629 (Open-label)
Atopic Dermatitis

Recent & active trials

NCTDrugPhaseStatusPrimary completion
NCT07402876ICM ADX-2191 injectionPhase 3Recruiting2026-12-01
NCT06685692ADX-629 (Open-label)Phase 2Completed2025-06-18
NCT06493604Reproxalap Ophthalmic Solution (0.25%)Phase 3Completed2025-02-27
NCT06424444Reproxalap Ophthalmic Solution (0.25%)Phase 3Completed2024-11-03
NCT06389214Reproxalap Ophthalmic Solution (0.25%)Phase 3Completed2024-06-11
NCT05717920ADX-629 (Open-label)Phase 2Completed2023-11-21
NCT05392179adx-2191Phase 2Completed2023-06-23
NCT05599815ADX-629 (Open-label)Phase 2Withdrawn2023-05-01
NCT05234554Reproxalap Ophthalmic Solution (0.25%)Phase 3Completed2023-04-22
NCT05392192ADX-629 (Open-label)Phase 2Completed2023-04-13
NCT04735393Reproxalap Ophthalmic Solution (0.25%)Phase 3Completed2022-10-11
NCT04136366adx-2191Phase 3Completed2022-06-14
NCT05487404ADX-629 (Open-label)Phase 2Completed2022-05-29
NCT05424549Reproxalap Ophthalmic Solution (0.25%)Phase 2Completed2022-05-09
NCT05062330Reproxalap Ophthalmic Solution (0.25%)Phase 3Completed2022-03-04
NCT04908514ADX-629 (Open-label)Phase 2Completed2022-01-21
NCT04728711ADX-629 (Open-label)Phase 2Completed2022-01-18
NCT05102409Reproxalap Ophthalmic Solution (0.25%)Phase 2Completed2021-10-25
NCT04847544ADX-629 (Open-label)Phase 2Completed2021-10-15
NCT04674358Reproxalap Ophthalmic Solution (0.25%)Phase 3Completed2021-09-12

Recent catalysts

CRLMar 17, 2026· 132d ago
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“On March 17, 2026, Aldeyra Therapeutics, Inc. ("Aldeyra" or the "Company") issued a press release (the "Press Release") to announce receipt of a Complete Response Letter ("2026 Complete Response Letter") from the U.S. Food & Drug Administration ("FDA") regarding the Company's New Drug Application for reproxalap ("reproxalap NDA"), an investigational drug candidate, for the treatment of dry eye disease.”
PDUFAMar 16, 2026· 133d ago
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“The extended PDUFA target action date is March 16, 2026.”
PDUFADec 16, 2025· 223d ago· unknown
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“has assigned a Prescription Drug User Fee Act ("PDUFA") target action date of December 16, 2025.”
NDA/BLA filedJul 17, 2025· 375d ago· unknown
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“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.”
NDA/BLA filedJul 16, 2025· 376d ago
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“the NDA was accepted for review as a "complete class 2 response" by the FDA on July 16, 2025, with a target PDUFA action date of December 16, 2025.”
CRLApr 3, 2025· 480d ago
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“On April 3, 2025, Aldeyra issued the Press Release to announce that it had received a Complete Response Letter ("2025 Complete Response Letter") from the U.S. Food & Drug Administration ("FDA") regarding the Company's resubmitted New Drug Application ("resubmitted NDA") for reproxalap, an investigational drug candidate, for the treatment of dry eye disease.”
PDUFAApr 2, 2025· 481d ago· failure
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“In November 2024, the FDA accepted the reproxalap NDA for filing and set a Prescription Drug User Fee Act date of April 2, 2025.”
NDA/BLA filedNov 1, 2024· 633d ago~ low confidence· unknown
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“In November 2024, the FDA accepted the reproxalap NDA for filing and set a Prescription Drug User Fee Act date of April 2, 2025.”
CRLNov 27, 2023· 973d ago
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“On November 27, 2023, Aldeyra announced that it had received a Complete Response Letter from the FDA. In the Complete Response Letter, the FDA stated that the NDA did not demonstrate "efficacy in treating ocular symptoms associated with dry eyes"”
PDUFANov 23, 2023· 977d ago· failure
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“In February 2023, the FDA accepted the reproxalap NDA for filing and set a Prescription Drug User Fee Act date of November 23, 2023.”
CRLJun 21, 2023· 1132d ago
$ALDXAldeyra Therapeutics, Inc.
adx-2191 · primary vitreoretinal lymphoma
“the Company received a Complete Response Letter from the FDA for the 505(b)(2) New Drug Application of ADX-2191 (methotrexate for injection, USP) for the treatment of primary vitreoretinal lymphoma”
PDUFAJun 21, 2023· 1132d ago· failure
$ALDXAldeyra Therapeutics, Inc.
adx-2191 · primary vitreoretinal lymphoma
“The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of June 21, 2023.”
NDA/BLA filedMar 2, 2023· 1243d ago· unknown
$ALDXAldeyra Therapeutics, Inc.
adx-2191 · primary vitreoretinal lymphoma
“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.”
NDA/BLA filedFeb 7, 2023· 1266d ago· unknown
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“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.”
NDA/BLA filedFeb 1, 2023· 1272d ago~ low confidence· unknown
$ALDXAldeyra Therapeutics, Inc.
reproxalap · dry eye disease
“In February 2023, the FDA accepted the reproxalap NDA for filing and set a Prescription Drug User Fee Act date of November 23, 2023.”