Highest-materiality recent filing
Aldeyra Therapeutics Appoints Darlene Deptula-Hicks as New Director and Audit Committee Chair
Darlene Deptula-Hicks appointed Class III director and Audit Committee Chair on June 9, 2026.
Aldeyra provides reproxalap trial endpoint estimates and FDA stance in corporate overview
Standardized treatment estimates and confidence intervals disclosed for reproxalap dry eye disease clinical trials primary endpoints.
Director Martin J. Joyce will not stand for re-election at 2026 annual meeting
Martin J. Joyce notified Aldeyra on April 20, 2026 of his decision not to stand for re-election.
Aldeyra repays $15M Hercules loan, terminates credit facility
Paid off $15M outstanding borrowings and terminated all commitments under Hercules Credit Facility on April 1, 2026.
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 CDO Stephen Machatha resigns; transition through March 2026 with $176K severance
Chief Development Officer Stephen G. Machatha voluntarily resigns effective on/before March 31, 2026.
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).
Aldeyra receives FDA Fast Track Designation for ADX-2191 in retinitis pigmentosa
FDA granted Fast Track Designation for ADX-2191 (methotrexate intravitreal injection) for retinitis pigmentosa.
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.
Aldeyra shareholders elect directors, ratify BDO, approve executive pay at 2025 annual meeting
Elected Richard H. Douglas, Gary M. Phillips, and Neal S. Walker as Class II directors with over 21M votes each; broker non-votes ~18.7M.
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).
Aldeyra Therapeutics appoints Chip Clark to board of directors
William (Chip) Clark elected as Class I director on April 17, 2025; term expires at 2027 annual meeting.
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 extends Hercules loan maturity to April 2026; interest rate floor 11.10%
Fourth Amendment extends interest-only period to April 1, 2026 and maturity to same date.
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 Therapeutics enters into $75M at-the-market equity offering with Jefferies
New Open Market Sale Agreement with Jefferies LLC to sell up to $75M of common stock.
ADX-629 advanced to pediatric cohort in Sjögren-Larsson Syndrome Phase 2; top-line results from ~5 patients expected 2025.
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 annual meeting results: directors elected, auditor ratified, say-on-pay approved
Directors Nancy B. Miller-Rich (21.9M for, 12.6M withheld) and Ben R. Bronstein (22.7M for, 11.8M withheld) elected as Class I directors.
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.
CEO Todd Brady participates virtually in fireside chat at Oppenheimer 34th Annual Healthcare Life Sciences Conference on Feb 13, 2024.
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 shareholders elect Brady and Joyce as Class III directors, approve 2023 equity plan
Director Todd C. Brady reelected with 21,007,679 votes for, 7,405,955 withheld.
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.
Aldeyra Therapeutics discloses no exposure to Silicon Valley Bank
Company confirms it holds no cash deposits or securities with Silicon Valley Bank.
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