Aldeyra Therapeutics (ALDX) Company Report

Aldeyra Therapeutics' lead candidate, reproxalap, a RASP modulator for dry eye disease (DED), has an extended PDUFA date of March 16, 2026, for its NDA resubmission.
The company has an exclusive option agreement with AbbVie for reproxalap, which includes a potential $100 million upfront payment (less option fees) and a $100 million milestone payment upon U.S. FDA approval in DED, along with a 60% AbbVie / 40% Aldeyra profit and loss share in the U.S..
Aldeyra reported a cash position of $75.3 million as of September 30, 2025, which is expected to fund operations into the second half of 2027.
Other pipeline developments include an anticipated NDA resubmission for ADX-2191 in Q1 2026 for rare retinal inflammatory diseases, and planned Phase 1 clinical trial initiation for ADX-246 in 2026 for systemic diseases.
Phase 3 clinical trial initiation for ADX-2191 in Primary Vitreoretinal Lymphoma is expected in H2 2025, and a Phase 2/3 clinical trial for ADX-2191 in Retinitis Pigmentosa is expected in H1 2026.

Dec 17, 2025, 12:00 PM

Presentation

Aldeyra Therapeutics Announces PDUFA Extension for Reproxalap NDA

ALDX

Product Launch

Regulatory

Aldeyra Therapeutics announced on December 15, 2025, that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the reproxalap New Drug Application (NDA).
The extended PDUFA target action date for the treatment of dry eye disease is now March 16, 2026.

Dec 17, 2025, 7:56 AM

Press Release

Aldeyra Therapeutics Announces 90-Day PDUFA Target Action Date Extension for Reproxalap

ALDX

Product Launch

Guidance Update

Aldeyra Therapeutics announced a 90-day extension of the PDUFA target action date for the New Drug Application (NDA) of reproxalap for dry eye disease, which was originally set for December 16, 2025.
The extension was triggered by the FDA's Office of Specialty Medicine considering the submission of a clinical study report (CSR) for the field trial as a major amendment, despite a prior written agreement with the Division of Ophthalmology not to include it in the NDA.
The FDA noted that if no major deficiencies are identified during the extended review, labeling requests and potential post-marketing requirements will be communicated by February 16, 2026.
The company confirmed that the extension does not impact the terms of the AbbVie option agreement, which grants AbbVie 10 business days to exercise the option following NDA approval.

Dec 16, 2025, 1:00 PM

Transcript

Aldeyra Therapeutics Announces PDUFA Date Extension for Reproxalap

ALDX

Regulatory

Product Launch

Aldeyra Therapeutics announced an extension of the PDUFA target action date for its reproxalap new drug application (NDA) for the treatment of dry eye disease.
The original PDUFA date of December 16, 2025, was extended by 90 days because the FDA considered the submission of a clinical study report (CSR) for a field trial a major amendment.
This request for the CSR came from the Office of Specialty Medicine, despite a prior written agreement with the Division of Ophthalmology not to include this specific trial in the NDA.
If no major deficiencies are identified during the extended review, labeling requests and potential post-marketing requirements will be communicated by February 16, 2026.
The extension does not alter the terms of the AbbVie option agreement, which allows AbbVie 10 business days to exercise the option following NDA approval.

Dec 16, 2025, 1:00 PM

Transcript

Aldeyra Therapeutics Announces PDUFA Date Extension for Reproxalap NDA

ALDX

New Projects/Investments

Product Launch

Aldeyra Therapeutics announced an extension of the PDUFA target action date for its reproxalap New Drug Application (NDA) for the treatment of dry eye disease.
The original target action date of December 16, 2025, was extended by 90 days because the FDA considered the submission of a Clinical Study Report (CSR) for a field trial as a major amendment.
The FDA's Office of Specialty Medicine requested the CSR submission, despite a prior written agreement with the Division of Ophthalmology not to include this specific trial in the NDA.
If no major deficiencies are identified during the extended review, labeling requests and potential post-marketing requirements are expected to be communicated by February 16, 2026.
The extension does not alter the terms of the AbbVie option agreement, which grants AbbVie 10 business days to exercise the option following NDA approval.

Dec 16, 2025, 1:00 PM

Transcript

Aldeyra Therapeutics Announces PDUFA Extension for Reproxalap NDA

ALDX

New Projects/Investments

Product Launch

Aldeyra Therapeutics announced the extension of the Prescription Drug User Fee Act (PDUFA) target action date for the reproxalap New Drug Application (NDA) for the treatment of dry eye disease.
The new PDUFA target action date is March 16, 2026, extended from the original target date of December 16, 2025.
The extension resulted from an FDA request on December 12, 2025, for the submission of the Clinical Study Report (CSR) for the dry eye disease field trial, which was considered a major amendment to the NDA.
The field trial, while supportive of reproxalap's activity, did not meet the primary endpoint of improvement in dry eye symptoms relative to the vehicle control.

Dec 16, 2025, 12:49 AM

8-K

Aldeyra Therapeutics Announces PDUFA Extension for Reproxalap NDA

ALDX

Product Launch

Aldeyra Therapeutics announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the reproxalap New Drug Application (NDA) for the treatment of dry eye disease to March 16, 2026.
The extension resulted from the FDA's request for the submission of the Clinical Study Report (CSR) for the dry eye disease field trial, which was considered a major amendment to the NDA. The original target PDUFA action date was December 16, 2025.
The field trial, while supportive of reproxalap's activity, did not meet the primary endpoint of improvement in dry eye symptoms relative to the vehicle control.
The FDA intends to communicate proposed labeling requests and any anticipated postmarketing requirements by February 16, 2026, provided no major deficiencies are identified during the extended review.

Dec 16, 2025, 12:30 AM

Press Release

Aldeyra Therapeutics Discusses Reproxalap PDUFA Decision and AbbVie Partnership

ALDX

Product Launch

New Projects/Investments

Guidance Update

Aldeyra Therapeutics is awaiting a PDUFA decision on December 16th for reproxalap for the treatment of dry eye disease.
A positive PDUFA decision would trigger an AbbVie co-promotion option, valued at $194 million for Aldeyra, which AbbVie has 10 business days (until December 31st) to exercise.
Reproxalap is highlighted for its rapid onset of action (minutes) and anti-redness activity in dry eye treatment, differentiating it from existing therapies.
The company also has positive pivotal Phase 3 data for reproxalap in allergic conjunctivitis and anticipates being cash flow positive with the AbbVie partnership.
Aldeyra has guided its cash runway into the second half of 2027, with potential for further extension if AbbVie opts in.

Dec 4, 2025, 1:30 PM

Transcript

Aldeyra Therapeutics Awaits Reproxalap PDUFA Decision and Potential AbbVie Partnership Opt-in

ALDX

Product Launch

New Projects/Investments

Guidance Update

Aldeyra Therapeutics has a PDUFA date of December 16th for reproxalap for the treatment of dry eye disease.
If the PDUFA is positive, AbbVie has 10 business days (until December 31st) to exercise a co-promotion option, which would result in an upfront payment of approximately $194 million to Aldeyra.
The partnership also includes two additional $100 million milestones and a 60/40 P&L split for the U.S. market, with Aldeyra's loss exposure capped at low single-digit tens of millions.
Reproxalap is highlighted for its rapid onset of action and anti-redness properties, which are considered commercially unique. There is also potential for a supplemental NDA for allergic conjunctivitis in 2026.
With the AbbVie opt-in, Aldeyra's cash runway would be significantly extended; without it, the company has guided into the second half of 2027.

Dec 4, 2025, 1:30 PM

Transcript

Aldeyra Therapeutics Provides Update on Reproxalap PDUFA, AbbVie Partnership, and Pipeline

ALDX

Product Launch

New Projects/Investments

Aldeyra Therapeutics anticipates an FDA decision on its lead asset, reproxalap, for dry eye disease by its PDUFA date of December 16. The NDA was resubmitted in June following an FDA finding of a baseline imbalance in a previous trial, with the new submission including a trial showing no imbalance and a positive post-hoc analysis.
The company has a co-development and co-promotion agreement with AbbVie for reproxalap, which includes an opt-in fee of $94 million upfront (after approval) and an additional $100 million milestone upon opt-in. The P&L will be shared 60/40 (AbbVie/Aldeyra) with Aldeyra's expenses capped annually.
The dry eye market opportunity in the U.S. is significant, with approximately 40 million people affected and 5%-10% currently treated, a number expected to grow due to technology use and aging.
Beyond dry eye, Aldeyra is advancing other programs, including ADX-248, an oral RASP modulator in Phase 1 for atopic dermatitis, and a novel methotrexate formulation (2191 modulators) for ocular lymphoma, with a single pivotal trial expected to start by the end of the year.