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Aldeyra Therapeutics (ALDX) investor relations material
Aldeyra Therapeutics Jefferies London Healthcare Conference 2025 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Jefferies London Healthcare Conference 2025 summary20 Nov, 2025
Key milestones and regulatory updates
Awaiting FDA decision on lead asset for dry eye disease with PDUFA date set for December 16, following a resubmitted NDA in June after addressing prior trial imbalances and a Complete Response Letter.
Recent FDA inspections of manufacturing and product formulation sites were successful, with no CMC issues reported.
Post-hoc analysis of Reproxalap data showed highly statistically significant results, supporting the NDA submission.
Commercial preparations are underway with a co-development and co-promotion agreement with AbbVie, including a $194 million opt-in fee and future milestone payments.
No changes to the AbbVie partnership following the previous Complete Response Letter; AbbVie is preparing for launch.
Pipeline and clinical development
Reproxalap is also in late-stage development for allergic conjunctivitis, with phase 3 trials showing improvement in redness and itching; potential for label expansion.
Next-generation RASP modulators, ADX-248 (oral, in phase 1 for atopic dermatitis) and ADX-246 (injectable for dry AMD), are prioritized for their potency and pharmacokinetics.
Preclinical data show RASP modulators have efficacy in animal models of Parkinson’s, ALS, and other CNS diseases, indicating future expansion into neurological indications.
Phase 1 study of ADX-248 is ongoing, with dose escalation showing good safety and tolerability; phase 2 in atopic dermatitis planned for next year.
Additional programs and market opportunity
Intravitreal methotrexate (acquired via Helio) is advancing toward a pivotal trial for ocular lymphoma, with potential for approval after a single trial.
Open-label trial in retinitis pigmentosa showed promising results; fast track designation received.
Dry AMD program will focus on improving night vision, a key patient concern, rather than just lesion size.
Dry eye disease market in the US is estimated at 40 million people, with only 5-10% currently treated; market expected to grow due to increased screen use and aging population.
Pipeline prioritization is based on diversification across molecules, indications, and stages, with Reproxalap, ocular lymphoma, and atopic dermatitis as near-term priorities.
Reproxalap's commercial edge in dry eye market?
How does RASP pharmacology redefine drug development?
Beyond DED, what drives Aldeyra's growth?
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Next Aldeyra Therapeutics earnings date
Q4 20255 Mar, 2026
Next Aldeyra Therapeutics earnings date
Q4 20255 Mar, 2026
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Frequently asked questions
Aldeyra Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing therapies for immune-mediated diseases. The company is engaged in advancing its pipeline of drug candidates, which target diseases caused by inflammation and tissue damage. Aldeyra's approach is centered on modulating immune responses to treat conditions such as ocular and systemic inflammatory diseases. Its lead therapeutic areas include ophthalmology, with treatments aimed at conditions like dry eye disease and allergic conjunctivitis. The company's goal is to provide new treatment options for diseases with limited or inadequate therapies. The company is headquartered in Lexington, Massachusetts, and its shares are listed on the NASDAQ.
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