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Visual22 Oct 2025
Epiroc's cash spent on M&A
Aldeyra Therapeutics (ALDX) investor relations material
Aldeyra Therapeutics H.C. Wainwright 27th Annual Global Investment Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.H.C. Wainwright 27th Annual Global Investment Conference summary8 Sep, 2025
Lead candidate and regulatory milestones
Reproxalap's PDUFA date is set for December 16, with a potential $194 million option exercise by AbbVie within 10 business days post-approval.
NDA resubmission addressed prior FDA concerns about baseline imbalances; new trial showed only a two-point difference between arms.
Accepted NDA includes phase 3 dry eye chamber trial data, supporting rapid onset of efficacy for ocular discomfort and redness.
Over 2,000 patients have been treated with reproxalap, with no known safety issues reported in the field trial safety update.
AbbVie remains highly engaged, with expanded commercial supply rights and ongoing pre-commercial and development activities.
Product differentiation and market opportunity
Reproxalap is positioned as the only chronic dry eye drug with redness data on the label, addressing both signs and symptoms rapidly.
The drug's RASP modulation mechanism targets multiple inflammatory pathways, potentially improving both redness and discomfort.
Market opportunity is significant due to increasing dry eye prevalence from behavioral and environmental factors.
Current treatments require weeks or months for efficacy; reproxalap aims to provide relief in minutes, especially for flare-ups.
No other dry eye drug has dry eye chamber flare data in its label, offering a unique commercial advantage.
Pipeline progress and future catalysts
ADX-2191, an intravitreal methotrexate, is in a pivotal trial for ocular lymphoma, with data expected by end of next year.
ADX-2191 also holds Fast Track and EMA orphan designations for retinitis pigmentosa and primary vitreoretinal lymphoma.
RASP pipeline includes ADX-248 (oral for atopic dermatitis, phase 1 ongoing) and ADX-246 (injectable for dry age-related macular degeneration, phase 1 planned).
ADX-248 aims to be the first oral drug for mild to moderate atopic dermatitis, addressing a large unmet need, especially in pediatrics.
Multiple late-stage and early-stage catalysts are anticipated through 2025 and 2026, ensuring regular news flow.
How reproxalap improves dry eye standard of care?
What indicates AbbVie's commitment to reproxalap?
What is the significance of ADX-2191 for lymphoma?
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Next Aldeyra Therapeutics earnings date
Q3 20256 Nov, 2025
Next Aldeyra Therapeutics earnings date
Q3 20256 Nov, 2025
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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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