Aldeyra Therapeutics

284 articles with Aldeyra Therapeutics

• Aldeyra Therapeutics Announces Completion of Enrollment in Phase 2 Clinical Trial of ADX‑2191 in Retinitis Pigmentosa

  3/16/2023

  Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the completion of enrollment in the Phase 2 clinical trial of ADX‑2191.

• Aldeyra Therapeutics Reports Full-Year 2022 Financial Results and Recent Corporate Highlights

  3/9/2023

  Aldeyra 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.

• FDA Accepts for Priority Review ADX-2191 New Drug Application for the Treatment of Primary Vitreoretinal Lymphoma

  3/2/2023

  Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review the New Drug Application (NDA) for ADX-2191.

• Aldeyra Therapeutics Schedules Webcast and Conference Call to Report Full-Year 2022 Financial Results and Discuss Recent Corporate Highlights

  3/1/2023

  Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) will host a conference call at 8:00 a.m. ET Thursday, March 9, 2023 to report financial results for the year ended December 31, 2022 and discuss recent corporate highlights.

• Aldeyra Therapeutics Announces Positive Top-Line Results from 12-Month Safety Clinical Trial of Reproxalap in Patients with Dry Eye Disease

  2/28/2023

  Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced top-line results from a 12-month, vehicle-controlled, multicenter, parallel-group safety clinical trial of reproxalap, an investigational new drug, in dry eye disease patients.

• Aldeyra Therapeutics Announces Next-Generation RASP-Modulator Drug Candidates Expected to Begin Clinical Trials for Systemic Immune-Mediated Diseases and Geographic Atrophy

  2/23/2023

  Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the advancement of two investigational new drug candidates, ADX‑246 and ADX‑248, to clinical testing, pending completion of U.S. Food and Drug Administration Investigational New Drug (IND) requirements.

• Aldeyra Therapeutics Advances Investigational Oral RASP Modulator ADX‑629 Into New Phase 2 Systemic Disease Trials

  2/16/2023

  Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the initiation of Phase 2 clinical trials evaluating the safety and efficacy of ADX‑629, a novel, internally developed, investigational oral RASP modulator, for the treatment of minimal change disease and Sjögren-Larsson Syndrome.

• Aldeyra Therapeutics to Participate in Fireside Chat at the SVB Securities Global Biopharma Conference

  2/9/2023

  Aldeyra Therapeutics, Inc. today announced that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the SVB Securities Global Biopharma Conference.

• Aldeyra Therapeutics Announces FDA Acceptance of New Drug Application for Reproxalap for the Treatment of Dry Eye Disease

  2/7/2023

  Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of dry eye disease.

• Aldeyra Therapeutics Submits New Drug Application to the U.S. Food and Drug Administration for ADX‑2191 for the Treatment of Primary Vitreoretinal Lymphoma

  12/21/2022

  Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ADX‑2191 (methotrexate injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma, a rare but potentially fatal cancer with no FDA-approved therapy.

• Aldeyra Therapeutics’ Investigational RASP Modulator ADX-629 Improved Signs of Intoxication in Alcohol Challenge Phase 2 Clinical Trial

  12/13/2022

  Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced demonstration of target engagement and improvement in the signs of alcohol intoxication in a sequence-randomized, double-masked, placebo-controlled crossover Phase 2 clinical trial of ADX-629, a first-in-class orally administered investigational new drug candidate.

• Aldeyra Therapeutics Announces Positive Primary Vitreoretinal Lymphoma Pre-NDA Meeting with the FDA

  12/1/2022

  Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that, following the recent receipt of official minutes from its pre-NDA (New Drug Application) meeting with the U.S. Food and Drug Administration (FDA), the Company plans to submit an NDA as soon as the end of 2022 for marketing approval of the investigational drug candidate ADX-2191 for the treatment of primary vitreoretinal lymphoma.

• Aldeyra Therapeutics Submits New Drug Application to the U.S. Food and Drug Administration for Reproxalap for the Treatment of Signs and Symptoms of Dry Eye Disease

  11/29/2022

  Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the submission 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.

• Aldeyra Therapeutics Reports Third-Quarter 2022 Financial Results and Recent Corporate Highlights

  11/10/2022

  Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company developing innovative therapies designed to treat immune-mediated diseases, today reported recent corporate highlights and financial results for the quarter ended September 30, 2022.

• Aldeyra Therapeutics Schedules Webcast and Conference Call to Report Third-Quarter 2022 Financial Results and Discuss Recent Corporate Highlights

  11/3/2022

  Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) will host a conference call at 8:00 a.m. ET Thursday, November 10, 2022 to report financial results for the quarter ended September 30, 2022 and discuss recent corporate highlights.

• Aldeyra Therapeutics Announces Oral Presentation of Phase 3 Data at the American Academy of Optometry 2022 Annual Meeting

  10/26/2022

  Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that an oral presentation highlighting clinical data from the Phase 3 INVIGORATE allergen chamber trial of reproxalap in allergic conjunctivitis will be presented at the American Academy of Optometry 2022 Annual Meeting, taking place in San Diego October 26-29, 2022.

• Aldeyra Therapeutics Achieves Primary Endpoint in Part 1 of Phase 3 GUARD Trial of ADX-2191 in Proliferative Vitreoretinopathy

  10/6/2022

  Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra or the Company) today announced the achievement of the primary endpoint in Part 1 of the Phase 3 GUARD Trial of ADX-2191 (methotrexate injection, USP1) for intravitreal administration, an investigational drug candidate, for the prevention of proliferative vitreoretinopathy (PVR), a rare sight-threatening retinal disease with no approved therapy.

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  Clinical Catch-Up: Adocia, Allecra and Aldeyra

  10/6/2022

  ​​​​​​​Adocia, Allecra Therapeutics and Aldeyra Therapeutics announced promising results in Type I Diabetes, urinary tract infections and retinal diseases.  

• Aldeyra Therapeutics Schedules Conference Call and Webcast to Announce Top-Line Results from Part 1 of the Phase 3 GUARD Trial of ADX-2191 in Proliferative Vitreoretinopathy

  10/5/2022

  Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced it will host a webcast and conference call on Thursday, October 6, 2022, at 8:00 a.m. (ET) to report top-line results from Part 1 of the Phase 3 GUARD Trial of ADX-2191 (methotrexate injection, United States Pharmacopeia) for intravitreal administration in patients with proliferative vitreoretinopathy (PVR), a rare, sight-threatening ocular disease with no approved therapy.

• Aldeyra Therapeutics Announces Positive Dry Eye Disease Pre-NDA Meeting with the FDA and Highlights Upcoming Corporate Milestones

  9/14/2022

  Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that, following the recent receipt of official minutes from its pre-NDA (New Drug Application) meeting with the U.S. Food and Drug Administration (FDA), the Company remains on schedule to submit an NDA in the fourth quarter of 2022 requesting marketing approval of the novel RASP modulator reproxalap, an investigational new drug, for the treatment of dry eye disease.