Aldeyra Therapeutics

Aldeyra Therapeutics, Inc. operates as a biotechnology company. It primarily focuses on the development of new products for immune-mediated, inflammatory, orphan and other diseases that are thought to be caused in part by naturally occurring toxic chemical species known as free aldehydes. The company was founded by Thomas A. Jordan and John E. Dowling on August 13, 2004 and is headquartered in Lexington, MA.

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Aldeyra Therapeutics reports positive milestones and financial stability in Q4 2022

Aldeyra Therapeutics showcased positive performance in key milestones, financial stability, and progress in clinical studies, positioning the company for future growth.
Despite challenges in managing expenses and meeting enrollment deadlines, Aldeyra's strengths in its pipeline and financial position offer opportunities for success.
The upcoming year holds promise for Aldeyra with novel therapies addressing unmet medical needs and significant milestones expected in key trials.
Overall, Aldeyra's focus on advancing treatments for ocular and systemic conditions underscores its commitment to innovation and patient care.

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Aldeyra Therapeutics, Inc. is a biotechnology company, which engages in research and development activities with related general business planning, including raising capital. It engages in the discovery of therapies designed to treat immune-mediated diseases. The company was founded by Thomas A. Jordan and John E. Dowling on August 13, 2004 and is headquartered in Lexington, MA.

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 positive top-line results from the Phase 3 INVIGORATE-2 Clinical Trial of 0.25% reproxalap ophthalmic solution (reproxalap), an investigational new drug, in patients with allergic conjunctivitis. The clinical trial successfully achieved statistical significance for th.

Aldeyra Therapeutics Announces Achievement of Statistical Significance for Primary Endpoint and All Secondary Endpoints in Phase 3 INVIGORATE‑2 Trial of Reproxalap in Allergic Conjunctivitis

LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced it will host a webcast and conference call on Thursday, June 15, 2023, at 8:00 a.m. (ET) to provide top-line results from the Phase 3 INVIGORATE‑2 Trial of reproxalap in allergic conjunctivitis. The dial-in numbers are (833) 470-1428 for domestic callers and (404) 975-4839 for international callers. The access code is 349573. A live audio webcast of the conference call also will be accessible.

Aldeyra Therapeutics Schedules Conference Call and Webcast to Announce Top-Line Results from the Phase 3 INVIGORATE‑2 Trial in Allergic Conjunctivitis

LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company developing innovative therapies for the treatment of immune-mediated diseases, today announced that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the Jefferies Global Healthcare Conference. Dr. Brady's conversation with Kelly Shi, Ph.D., Senior Research Analyst at Jefferies, is scheduled to begin at 9:30 a.m. E.

Aldeyra Therapeutics to Participate in Fireside Chat at the Jefferies Global Healthcare Conference

They headlined 3 top-line results coming in Q2 2023. An all-important PDUFA Date is on tap in June.

Buy Aldeyra Therapeutics For Consecutive Runups

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 reported recent corporate highlights and financial results for the quarter ended March 31, 2023. “Aldeyra continues to build a robust pipeline of novel drug candidates for the treatment of immune-mediated diseases,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executi.

Aldeyra Therapeutics Reports First-Quarter 2023 Financial Results and Recent Corporate Highlights

LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced completion of enrollment in the Phase 3 INVIGORATE-2 clinical trial of topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of allergic conjunctivitis. “Today, millions of allergic conjunctivitis patients rely on therapies that may not provide sufficient relief or cannot be used chronically due to serious side effects,” stated Todd C. Brady, M.D.

Aldeyra Therapeutics Completes Enrollment in Phase 3 INVIGORATE-2 Clinical Trial in Allergic Conjunctivitis

LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced enrollment of the first patient in the Phase 2 clinical trial of orally administered RASP modulator ADX‑629, an investigational new drug, for the treatment of atopic dermatitis. The multicenter, adaptive, two-part Phase 2 clinical trial will evaluate the safety and efficacy of ADX‑629 alone and in combination with standard of care in adults with mild, moderate, or severe atopic dermatitis.

Aldeyra Therapeutics Enrolls First Patient in Phase 2 Clinical Trial of ADX-629 in Atopic Dermatitis

LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the completion of enrollment in the Phase 2 clinical trial of the orally administered RASP modulator ADX-629, an investigational new drug, for the treatment of chronic cough.

Aldeyra Therapeutics Announces Completion of Enrollment in Phase 2 Clinical Trial of ADX-629 in Chronic Cough

LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the completion of enrollment in the Phase 2 clinical trial of ADX‑2191 (methotrexate injection, USP), an investigational drug candidate, for the treatment of retinitis pigmentosa, a group of rare genetic eye diseases characterized by retinal cell death and loss of vision, for which there is no U.S. Food and Drug Administration (FDA)-approved treatment.

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

Aldeyra Therapeutics, Inc. (NASDAQ:ALDX ) Q4 2022 Earnings Conference Call March 9, 2023 8:00 AM ET Company Participants Bruce Greenberg - Interim Chief Financial Officer Todd Brady - President and Chief Executive Officer Conference Call Participants Marc Goodman - SVB Securities Yigal Nochomovitz - Citigroup Justin Kim - Oppenheimer & Co. Catherine Novack - Jones Research Yale Jen - Laidlaw & Company Operator Ladies and gentlemen, thank you for standing by, and welcome to the Aldeyra Therapeutics Full Year 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode.

Aldeyra Therapeutics, Inc. (ALDX) Q4 2022 Earnings Call Transcript

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 reported recent corporate highlights and financial results for the year ended December 31, 2022.

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

LEXINGTON, Mass.--(BUSINESS WIRE)--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 (methotrexate injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of June 21, 2023. The FDA noted that no potential filing review issues have been identified.

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

LEXINGTON, Mass.--(BUSINESS WIRE)--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. The dial-in numbers are (833) 470-1428 for domestic callers and (404) 975-4839 for international callers. The access code is 202679.

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

LEXINGTON, Mass.--(BUSINESS WIRE)--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. The primary endpoints of treatment-related serious adverse events in ocular safety were not observed in any patient. Ocular safety events were similar across reproxalap and vehicle treatment groups.

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

LEXINGTON, Mass.--(BUSINESS WIRE)--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 Announces Next-Generation RASP-Modulator Drug Candidates Expected to Begin Clinical Trials for Systemic Immune-Mediated Diseases and Geographic Atrophy

LEXINGTON, Mass.--(BUSINESS WIRE)--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 Advances Investigational Oral RASP Modulator ADX‑629 Into New Phase 2 Systemic Disease Trials

LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company developing innovative therapies for the treatment of immune-mediated diseases, 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. The conference is being conducted in a virtual format February 14-16, 2023. Dr.

Aldeyra Therapeutics to Participate in 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

LEXINGTON, Mass.--( BUSINESS WIRE )--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 Submits New Drug Application to the U.S. Food and Drug Administration for ADX‑2191 for the Treatment of Primary Vitreoretinal Lymphoma

LEXINGTON, Mass.--( BUSINESS WIRE )--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. Relative to placebo, ADX-629 reduced dermal flushing (P=0.0007), increased Romberg test balance time (P=0.02), and lowered levels of the ethanol RASP metabolite acetaldehyde (P=0.03) following acute exposure to alcohol.

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

New Drug Application of Reproxalap for the treatment of patients with dry eye disease submitted on November 29, 2022; Potential FDA approval possible in late 2023. Results from the phase 3 INVIGORATE-2 study using reproxalap for the treatment of patients with allergic conjunctivitis are expected in 2023.

Aldeyra Therapeutics: NDA Submission For Large Multi-Billion Dollar Market

LEXINGTON, Mass.--( BUSINESS WIRE )--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 Announces Positive Primary Vitreoretinal Lymphoma Pre-NDA Meeting with the FDA

LEXINGTON, Mass.--( BUSINESS WIRE )--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 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

Aldeyra Therapeutics, Inc. (NASDAQ:ALDX ) Q3 2022 Earnings Conference Call November 10, 2022 8:00 AM ET Company Participants Bruce Greenberg - Interim Chief Financial Officer Todd Brady - President and Chief Executive Officer Conference Call Participants Marc Goodman - SVB Securities Justin Kim - Oppenheimer Yale Jen - Laidlaw & Co. Catherine Novack - Jones Research Operator Ladies and gentlemen, thank you for standing by and welcome to the Aldeyra Therapeutics Third Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode.

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