Aldeyra Therapeutics (ALDX) Company Report

Aldeyra Therapeutics is awaiting an extended PDUFA date of March 16th for Reproxalap for dry eye disease, with the CEO expressing optimism for a positive outcome after a quiet review process.
Should Reproxalap be approved, AbbVie holds an option to commercialize the drug, which, if exercised, would provide Aldeyra with $194 million upfront (after $6 million already paid) and a 60/40 profit split in favor of AbbVie.
Reproxalap is highlighted for its potential to be a differentiated asset in dry eye disease, offering rapid onset of action and the potential for redness on the label for chronic use.
The company reported $75 million in cash as of the end of Q3, providing approximately 2 years of runway, with significant capitalization expected post-AbbVie option exercise.

3 days ago

Transcript

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

ALDX

Product Launch

New Projects/Investments

M&A

Aldeyra Therapeutics' lead product, reproxalap, for dry eye disease has an extended PDUFA date of March 16th. The CEO anticipates a positive approval decision, noting a "quiet review".
If approved, AbbVie has an option to exercise within 10 business days after approval, which would result in $194 million upfront (after $6 million already paid) and potential future milestones, with a 60/40 profit split (AbbVie/Aldeyra).
The company reported $75 million in cash as of Q3, providing approximately 2 years of runway, with an AbbVie exercise expected to significantly enhance capitalization.
Other pipeline developments include ADX-2191 for primary vitreoretinal lymphoma, with data expected late 2026 or early 2027, and ADX-248 for atopic dermatitis, with Phase 2 planned for late 2026.

3 days ago

Transcript

Aldeyra Therapeutics Awaits Reproxalap PDUFA Decision on March 16th

ALDX

Product Launch

New Projects/Investments

Guidance Update

Aldeyra Therapeutics is awaiting a PDUFA decision for its lead product candidate, reproxalap, for dry eye disease, with an extended date of March 16th. The company anticipates a positive outcome, noting a "quiet review" from the FDA despite previous regulatory challenges.
If approved, AbbVie holds an option to commercialize reproxalap, which expires 10 days after approval. Exercise of this option would result in $194 million upfront (net of $6 million already paid), two additional $100 million milestones, and a 60/40 profit split (AbbVie/Aldeyra).
Reproxalap is positioned as a differentiated asset due to its rapid onset of action and potential to be the only drug with redness on the label, with the possibility of also being approved for allergic conjunctivitis.
The company reported $75 million in cash as of Q3, providing approximately 2 years of runway (until the end of next year), with significant capitalization expected upon AbbVie's option exercise.
Other pipeline updates include ADX-2191 for ocular lymphoma, with data expected end of this year or early next year, and ADX-248 for atopic dermatitis, with Phase 2 anticipated to start mid-2026 and data next year.

3 days ago

Transcript

Aldeyra Therapeutics Provides Pipeline and Financial Updates

ALDX

Product Launch

New Projects/Investments

Guidance Update

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.