ALDX News

Aldeyra Therapeutics Announces PDUFA Extension of the New Drug Application of Reproxalap for the Treatment of Dry Eye Disease

ALDX

LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the reproxalap New Drug Application (NDA) for the treatment of dry eye disease. The extended PDUFA target action date is March 16, 2026. Fol

December 16, 2025
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Aldeyra Therapeutics to Participate in the H.C. Wainwright 27th Annual Global Investment Conference

ALDX

(NASDAQ:ALDX) LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today announced that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025. Dr. Brady’s conversation with Matthew Caufield, Director, Eq

September 3, 2025Conference
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Aldeyra Therapeutics Receives Orphan Designation from the European Medicines Agency for ADX-2191 for the Treatment of Primary Large B-Cell Lymphomas of Immune-Privileged Sites, including Primary Vitreoretinal Lymphoma

ALDX

LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the European Medicines Agency (EMA) has granted Orphan Designation for ADX-2191 (methotrexate intravitreal injection, USP) for the treatment of primary large B-Cell lymphomas of immune-privileged sites, including primary vitreoretinal lymphoma. There is currently no approved treatment for patients with primary vitreoretinal lymphoma, a rare, aggressive, high-grade cancer that affects appr

August 28, 2025Orphan
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Aldeyra Therapeutics Receives Fast Track Designation for ADX‑2191 for the Treatment of Retinitis Pigmentosa

ALDX

LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for ADX-2191 (methotrexate intravitreal injection, USP) for the treatment of retinitis pigmentosa. There is currently no approved treatment for patients with most forms of retinitis pigmentosa, a clinical group of rare genetic eye diseases characterized by retinal cell death and loss of vision. Retinitis pigmen

Aldeyra Therapeutics to Participate in the H.C. Wainwright 5th Annual Ophthalmology Virtual Conference

ALDX

LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today announced that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 5th Annual Ophthalmology Virtual Conference on August 13, 2025. Dr. Brady’s conversation with Matthew Caufield, Director, E

Aldeyra Therapeutics Resubmits Reproxalap New Drug Application for the Treatment of Dry Eye Disease

ALDX

LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune‑mediated and metabolic diseases, today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, an investigational new drug candidate, for the treatment of signs and symptoms of dry eye disease. Per FDA agreement, the only

HC Wainwright & Co. Reiterates Buy on Aldeyra Therapeutics, Maintains $10 Price Target

ALDX

May 19, 2025
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12 Health Care Stocks Moving In Tuesday's Pre-Market Session

ALDX

May 6, 2025
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Aldeyra Therapeutics To Announce Topline Results From Phase 3 Dry Eye Disease Clinical Trials Of Reproxalap At Conference Call Scheduled On May 6, 2025

ALDX

May 5, 2025
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BTIG Maintains Buy on Aldeyra Therapeutics, Lowers Price Target to $9

ALDX

April 7, 2025
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HC Wainwright & Co. Reiterates Buy on Aldeyra Therapeutics, Maintains $10 Price Target

ALDX

April 4, 2025
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11 Health Care Stocks Moving In Thursday's Intraday Session

ALDX

April 3, 2025
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Dow Tumbles Over 1,100 Points; US Initial Jobless Claims Fall

ALDX

April 3, 2025
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FDA Rejects Aldeyra's Reproxalap For Dry Eye Disease Again, Citing Efficacy Concerns

ALDX

The FDA rejected Aldeyra's resubmission for reproxalap, citing efficacy concerns. The company plans another trial and aims to resubmit the NDA by mid-2025.

April 3, 2025
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Aldeyra Therapeutics Receives Complete Response Letter From The U.S. FDA For The Reproxalap New Drug Application For The Treatment Of Signs And Symptoms Of Dry Eye Disease

ALDX

April 3, 2025
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12 Health Care Stocks Moving In Thursday's Pre-Market Session

ALDX

April 3, 2025
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HC Wainwright & Co. Reiterates Buy on Aldeyra Therapeutics, Maintains $10 Price Target

ALDX

March 3, 2025
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Aldeyra Therapeutics Announces FDA Acceptance For Review Of The Resubmitted New Drug Application For Reproxalap In Treatment Of Dry Eye Disease; Based On FDA Acceptance, Co. Announces Expansion Of Option Agreement With AbbVie

ALDX

November 18, 2024
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Aldeyra Therapeutics Announces Receipt Of Minutes From Dry Eye Disease Pre-NDA Meeting With FDA tones

ALDX

September 14, 2022
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How To Attend Aldeyra Therapeutics Q1 2022 Earnings Conference Call

ALDX

Aldeyra Therapeutics (NASDAQ:ALDX) will host a conference call at 08:00 AM ET on May 5, 2022, to discuss Q1 2022 earnings results.

April 29, 2022
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Aldeyra Therapeutics CFO Joshua Reed To Resign; Bruce Greenberg Appointed Interim CFO

ALDX

April 28, 2022
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