Highest-materiality recent filing
FDA issues second Complete Response Letter for Aldeyra's reproxalap NDA; efficacy concerns cited
CRL states 'lack of substantial evidence' and 'failed to demonstrate efficacy' for dry eye disease signs and symptoms.
Aldeyra: FDA extends reproxalap PDUFA to March 16, 2026 after requesting failed trial report
PDUFA target action date extended three months to March 16, 2026 from original Dec 16, 2025.
Aldeyra expands RASP platform to CNS diseases; reproxalap manufacturing inspections closed
ADX-248 preclinical results in Parkinson's & ALS models showed improved grip strength, balance, and CNS biomarkers.
ADX-629 Phase 2 trial in mild-to-moderate alcohol-associated hepatitis showed significant improvement in MELD score (P=0.001), triglycerides (P<0.0001), and CRP (P<0.0001).
FDA accepts Aldeyra's reproxalap NDA resubmission for dry eye disease; PDUFA Dec 16, 2025
FDA accepted for review the resubmitted NDA for topical ocular reproxalap, a first-in-class candidate for dry eye disease.
Aldeyra receives FDA Special Protocol Assessment for ADX-2191 in primary vitreoretinal lymphoma
SPA agreement provides FDA alignment on clinical trial design for ADX-2191 (methotrexate injection) to treat PVRL, a rare and fatal cancer with no approved therapy.
Aldeyra resubmits reproxalap NDA for dry eye disease after CRL, Phase 3 trial met primary endpoint
Resubmitted NDA to FDA for topical ocular reproxalap to treat signs and symptoms of dry eye disease.
Reproxalap statistically superior to vehicle on ocular discomfort (LS mean diff -6.5, P=0.002) in Phase 3 chamber trial (n=58 per arm).
FDA issues Complete Response Letter for Aldeyra's reproxalap dry eye NDA; additional study required
FDA CRL states reproxalap 'failed to demonstrate efficacy' in adequate studies; no safety or manufacturing issues.
Aldeyra's reproxalap NDA accepted by FDA with April 2, 2025 PDUFA; expands AbbVie option deal
FDA accepted resubmitted NDA for reproxalap for dry eye disease; PDUFA date April 2, 2025.
Aldeyra resubmits reproxalap NDA for dry eye disease after positive Phase 3 trial
Resubmission includes positive results from FDA-requested symptom trial.
Aldeyra appoints Michael Alfieri as principal financial officer, Bruce Greenberg steps down
Michael Alfieri appointed as principal financial officer and principal accounting officer, effective Aug 31, 2024, via consulting agreement with Danforth Global, Inc.
Primary endpoint of ocular discomfort met (p=0.004) vs vehicle in 132-patient Phase 3 dry eye chamber trial.
Aldeyra completes enrollment in Phase 3 dry eye trial of reproxalap; results expected in Q3 2024
Phase 3 dry eye chamber trial of 0.25% reproxalap enrolled 132 patients; primary endpoint is ocular discomfort.
Aldeyra R&D Day: reproxalap NDA resubmission H2 2024; positive preclinical data for ADX-246, ADX-629
Reproxalap NDA resubmission expected H2 2024, pending Phase 3 dry eye chamber trial results and FDA discussions.
Aldeyra plans reproxalap NDA resubmission for dry eye disease in H2 2024
Dry eye chamber trial to start H1 2024; NDA resubmission expected H2 2024 if positive.
Positive biomarker results from ADX-629 in Sjögren-Larsson Syndrome adult cohort; pediatric expansion submission expected H1 2024.
AbbVie extends option for Aldeyra's reproxalap with $5M fee
AbbVie paid $5M non-refundable fee to extend option period for reproxalap co-development license.
Aldeyra announces positive Phase 2 data for ADX-629 in atopic dermatitis; advancing ADX-246
Phase 2 trial of ADX-629 in 8 mild-to-moderate atopic dermatitis patients showed statistically significant improvement from baseline in EASI (p=0.0006) and IGA (p<0.0001).
FDA issues Complete Response Letter for reproxalap NDA in dry eye disease; additional trial required
FDA CRL states NDA did not demonstrate efficacy on ocular symptoms; requires at least one additional adequate and well-controlled study.
Aldeyra grants AbbVie exclusive option to co-develop reproxalap; $1M upfront, $100M upon exercise
AbbVie pays $1M non-refundable option fee; can extend option for $5M if FDA decision delayed past Dec 15, 2023.
Aldeyra: FDA may not approve reproxalap NDA by Nov 23 PDUFA; additional trial needed
FDA late-cycle review states reproxalap lacks data to support clinical relevance of ocular signs for dry eye.
Aldeyra reports positive Phase 2 data for ADX-2191 in retinitis pigmentosa
Statistically significant improvement in best corrected visual acuity (P<0.0001) and low-light visual acuity (P=0.0001).
Awake cough frequency reduced vs placebo (P=0.01); 24-hr cough frequency (P=0.001).
FDA issues Complete Response Letter for Aldeyra's ADX-2191 NDA for PVRL
FDA cited lack of substantial evidence due to no adequate well-controlled studies in literature-based NDA.
Aldeyra announces positive Phase 3 INVIGORATE-2 trial for reproxalap in allergic conjunctivitis
Primary endpoint met: ocular itching reduction at all 11 timepoints (p<0.0001).
Aldeyra Q1 net loss $15.6M; PDUFA dates set; clinical readouts in Q2 2023
Net loss $15.6M ($0.27 loss per share) vs $16.8M ($0.29) in Q1 2022.
Net loss $62.0M ($1.06/share) vs $57.8M ($1.07/share) in 2021; R&D $47.3M, G&A $15.4M.
FDA accepts Aldeyra's NDA for ADX-2191 with Priority Review; PDUFA June 21, 2023
FDA accepted NDA for ADX-2191 (methotrexate injection) for primary vitreoretinal lymphoma with Priority Review.
the Board appointed Darlene Deptula-Hicks as a Class III director, with her initial term expiring at the Company’s 2029 annual meeting of stockholders.
the Board elected William (Chip) Clark as a Class I director
On August 29, 2024, the board of directors of Aldeyra Therapeutics, Inc. (the “Company”) approved the appointment of Michael Alfieri as the Company’s principal financial officer and principal accounting officer effective as of August 31, 2024 (the “Effective Date”).
As previously disclosed by the Company, Bruce Greenberg stepped down from his positions with the Company, including as the Company’s Senior Vice President of Finance, Interim Chief Financial Officer and principal financial officer and principal accounting officer as of the Effective Date.
Max materiality 0.90 · Median 0.68 · Most common event other_material