Business
Aldeyra Therapeutics Reports Full-Year 2022 Financial Results and Recent Corporate Highlights
NDA Priority Review PDUFA Date for ADX-2191 for the Treatment of Primary Vitreoretinal Lymphoma is June 21, 2023 NDA PDUFA Date for Reproxalap for the
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":"\n\nNDA Priority Review PDUFA Date for ADX-2191 for the Treatment of Primary Vitreoretinal Lymphoma is June 21, 2023\n\n\nNDA PDUFA Date for Reproxalap for the Treatment of Dry Eye Disease is November 23, 2023\n\n\nTop-Line Results from the Phase 3 INVIGORATE-2 Trial of Reproxalap in Allergic Conjunctivitis Expected in the First Half of 2023\n\n\nTop-Line Results from the Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa Expected in the First Half of 2023\n\n\nTop-Line Results from the Phase 2 Clinical Trial of ADX-629 in Chronic Cough Expected in the First Half of 2023\n\n\nCash, Cash Equivalents, and Marketable Securities of $174.3 Million as of December 31, 2022\n\n\nManagement to Host Conference Call at 8:00 a.m. ET Today\n\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today reported recent corporate highlights and financial results for the year ended December 31, 2022.\n\n“Now with Priority Review Designation for the treatment of primary vitreoretinal lymphoma, ADX‑2191 joins reproxalap as the second investigational drug candidate at Aldeyra under NDA review at the U.S. Food and Drug Administration,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “In addition to potential approvals and supplemental NDA submissions, 2023 promises to be a catalyst-rich year for Aldeyra, as we continue to advance an industry-leading pipeline of novel RASP modulators for the treatment of systemic and retinal immune-mediated diseases.”\n\n\nRecent Corporate Highlights\n\n\nPriority Review Designation Granted for NDA of ADX-2191 for the Treatment of Primary Vitreoretinal Lymphoma: The New Drug Application (NDA) submission of ADX‑2191 (methotrexate injection, USP), an investigational drug candidate, is supported by a combination of published literature on the safety and efficacy of intravitreal methotrexate for the treatment of primary vitreoretinal lymphoma and safety data from the recently completed Phase 3 GUARD Trial of ADX‑2191 for the prevention of proliferative vitreoretinopathy. During the Phase 3 GUARD Trial, no safety signals were observed, and ADX‑2191 was well tolerated; there were no observed treatment-emergent serio...