PDUFA Date is April 2, 2025 LEXINGTON, Mass. / Nov 18, 2024 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted 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. The FDA assigned a... Read More

LEXINGTON, Mass. / Nov 14, 2024 / 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 Jefferies London Healthcare Conference 2024. The... Read More

LEXINGTON, Mass. / Oct 31, 2024 / 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 Tomasz Stryjewski, M.D., Chief Medical Advisor - Retina, will present at the Disruptive Innovations Symposium during the Ocular Surgery News (OSN) New York Retina... Read More

LEXINGTON, Mass. / Oct 03, 2024 / 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,... Read More

LEXINGTON, Mass. / Sep 05, 2024 / 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 26 th Annual Global Investment... Read More

New Drug Application Resubmission Anticipated in 2024 LEXINGTON, Mass. / Aug 08, 2024 / 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... Read More

LEXINGTON, Mass. / Aug 07, 2024 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced it will host a webcast and conference call on Thursday, August 8, 2024, at 9:00 a.m. (ET) to provide top-line results from the Phase 3 dry eye disease clinical trial of reproxalap. The dial-in numbers are (888) 596-4144 for domestic callers and (646) 968-2525 for international callers. The access code is... Read More

Live Webcast Scheduled to Begin at 8:00 a.m. ET Today LEXINGTON, Mass. / Jun 20, 2024 / 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 advancement of... Read More

Clinical Trial Results and Potential New Drug Application Resubmission Expected in the Second Half of 2024 LEXINGTON, Mass. / Jun 13, 2024 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated... Read More

Event Scheduled for Thursday, June 20 at 8:00 a.m. ET LEXINGTON, Mass. / Jun 12, 2024 / 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 the company will host an Investor Roundtable Q&A via webcast on Thursday, June 20, 2024 at 8:00 a.m. ET. The... Read More

LEXINGTON, Mass. / May 29, 2024 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company developing innovative therapies for the treatment of 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 Jefferies Global Healthcare Conference. Dr. Brady’s... Read More

Clinical Results and Potential New Drug Application Submission Expected in the Second Half of 2024 LEXINGTON, Mass. / May 08, 2024 / 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 enrollment of the first patient in a Phase 3 dry eye chamber clinical... Read More

Live Webcast Scheduled to Begin at 9 am EDT Today LEXINGTON, Mass. / Apr 25, 2024 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) will host the Aldeyra 2024 Research & Development Day with investors and financial analysts in New York City to present recent pipeline developments relating to the RASP... Read More

LEXINGTON, Mass. / Apr 18, 2024 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company developing innovative therapies for the treatment of immune-mediated and metabolic diseases, today announced that the company will host a Research & Development Day from 9:00a.m. to 1:00p.m. ET on Thursday, April 25, 2024 in New York City. Aldeyra will provide an in-depth review of... Read More

LEXINGTON, Mass. / Mar 28, 2024 / 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 clinical development plan intended to enable resubmission of a New Drug Application (NDA) of topical ocular 0.25% reproxalap, an investigational RASP modulator, for... Read More

LEXINGTON, Mass. / Feb 06, 2024 / 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 Oppenheimer 34th Annual Healthcare Life Sciences Conference. The conference... Read More

Based on positive biomarker results observed in adult cohort of Phase 2 clinical trial of ADX-629 in Sjögren-Larsson Syndrome, proposed expansion to include pediatric patients expected to be submitted to the US Food and Drug Administration (FDA) in the first half of 2024 Phase 2 clinical trial of ADX-629 in moderate alcoholic... Read More

Statistically significant improvement from baseline observed in investigator-assessed Eczema Area and Severity Index (EASI, p=0.0006) and Investigator Global Assessment (IGA, p<0.0001) EASI 75% improvement (EASI-75) threshold observed in three patients (38%), and affected body surface area was completely cleared in one patient (13%) Patient-reported itching eliminated in two patients (25%) and clinically relevant threshold... Read More

LEXINGTON, Mass. / Dec 18, 2023 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced it will host a webcast and conference call on Tuesday, December 19, 2023, at 8:00 a.m. (ET) to provide top-line results from a Phase 2 clinical trial of ADX‑629 in patients with atopic dermatitis. The dial-in numbers are (888) 415-4305 for domestic callers and (646) 960-0336 for international callers. The... Read More

Additional Trial Required to Demonstrate Positive Effect on the Treatment of Ocular Symptoms in Dry Eye Disease Special Protocol Assessment Submitted on November 16, 2023 for Dry Eye Disease Chamber Crossover Clinical Trial Proposed Trial Top-Line Results and Potential NDA Resubmission Anticipated in First Half of 2024 Cash Runway Extended into Late 2025 LEXINGTON, Mass. / Nov 27, 2023 / Business Wire / Aldeyra Therapeutics,... Read More

LEXINGTON, Mass. / Nov 01, 2023 / 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 it has entered into an exclusive option agreement with AbbVie Inc. (AbbVie). Under the terms of the option agreement, AbbVie has the option to acquire a co-exclusive license to... Read More

LEXINGTON, Mass. / Jul 06, 2023 / 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 the SVB Securities Therapeutics Forum. The Forum will be held July 11-12, 2023, in New York City.... Read More

Best Corrected and Low‑Light Visual Acuity Statistically Significantly Improved As Assessed by Electroretinography, Time to Retinal Response Statistically Significantly Improved As Assessed by Macular and Dark-Adapted Perimetry, Retinal Sensitivity Statistically Significantly Improved ADX‑2191 Was Well Tolerated and No Safety Concerns Were Identified Planned Phase 2/3 Clinical Trial to be Discussed with Regulatory... Read More

LEXINGTON, Mass. / Jun 28, 2023 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced it will host a webcast and conference call on Thursday, June 29, 2023, at 8:00 a.m. (ET) to provide top-line results from the Phase 2 clinical trial of ADX‑2191 in patients with retinitis pigmentosa. The dial-in numbers are (888) 415-4305 for domestic callers and (646) 960-0336 for international callers. The... Read More

Relative to Placebo, Statistical Significance Achieved for Reduction in Awake Cough Frequency (P=0.01), 24‑Hour Cough Frequency (P=0.001), Awake Cough Count (P=0.001), and 24‑Hour Cough Count (P=0.001) ADX-629 Was Well Tolerated and No Safety Concerns Were Identified Company to Discuss Results in Conference Call and Webcast at 8:00 a.m. ET Today LEXINGTON, Mass. / Jun 27, 2023 / Business Wire / Aldeyra Therapeutics, Inc.... Read More

LEXINGTON, Mass. / Jun 26, 2023 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced it will host a webcast and conference call on Tuesday, June 27, 2023, at 8:00 a.m. (ET) to provide top-line results from the Phase 2 clinical trial of ADX‑629 in patients with chronic cough. The dial-in numbers are (888) 415‑4305 for domestic callers and (646) 960‑0336 for international callers. The access... Read More

LEXINGTON, Mass. / Jun 23, 2023 / Business Wire / Aldeyra Therapeutics (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced that it will be added to the Russell 2000® and the Russell 3000® indexes, effective after the U.S. equity markets close on June 23, 2023. Annual Russell indexes reconstitution captures the... Read More

Based on U.S. Food & Drug Administration (FDA) Determination of Lack of Adequate and Well Controlled Investigations in the Scientific Literature, Complete Response Letter Received for New Drug Application (NDA) of ADX-2191 (methotrexate injection, USP) for the Treatment of Primary Vitreoretinal Lymphoma (PVRL) Due to Shortage of Methotrexate, Lack of Approved Therapy for PVRL, and Inbound Requests for ADX-2191, Expanded... Read More

Statistical Significance Achieved for Primary Endpoint of Ocular Itching at All Prespecified Timepoints (P<0.0001) Statistical Significance Achieved for Key Secondary Endpoint of Ocular Redness (P=0.004) Statistical Significance Achieved for Secondary Endpoints of Ocular Tearing (P<0.0001) and Total Ocular Severity Score (P<0.0001) Results Consistent with Previous Phase 2 and Phase 3 Clinical Trials in Allergic... Read More

LEXINGTON, Mass. / Jun 14, 2023 / 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... Read More

LEXINGTON, Mass. / Jun 02, 2023 / 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... Read More

Top-Line Results from the Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa Expected in the Second Quarter of 2023 Top-Line Results from the Phase 2 Clinical Trial of ADX-629 in Chronic Cough Expected in the Second Quarter of 2023 Top-Line Results from the Phase 3 INVIGORATE-2 Trial of Reproxalap in Allergic Conjunctivitis Expected in the Second Quarter of 2023 NDA Priority Review PDUFA Date for ADX-2191 for the... Read More

Top-Line Results Expected in the First Half of 2023 LEXINGTON, Mass. / Apr 13, 2023 / 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... Read More

Top-Line Results from Part 1 of the Trial Expected in the Second Half of 2023 LEXINGTON, Mass. / Apr 06, 2023 / 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... Read More

Top-Line Results Expected in the First Half of 2023 LEXINGTON, Mass. / Mar 30, 2023 / 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... Read More

LEXINGTON, Mass. / Mar 16, 2023 / 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... Read More

LEXINGTON, Mass. / Mar 09, 2023 / 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. “Now with Priority Review Designation for the treatment of primary vitreoretinal lymphoma,... Read More

LEXINGTON, Mass. / Mar 02, 2023 / 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... Read More

LEXINGTON, Mass. / Mar 01, 2023 / 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. A live audio... Read More

LEXINGTON, Mass. / Feb 28, 2023 / 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... Read More

LEXINGTON, Mass. / Feb 23, 2023 / 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. ADX‑246 and ADX‑248 represent the most recent group of product candidates generated from Aldeyra’s... Read More

LEXINGTON, Mass. / Feb 16, 2023 / 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 also announced the expansion of the minimal change disease clinical... Read More

LEXINGTON, Mass. / Feb 09, 2023 / 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... Read More

LEXINGTON, Mass. / Feb 07, 2023 / Business Wire / 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. The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of... Read More

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. The NDA submission is supported by a combination of published... Read More

Relative to Placebo, ADX-629 Reduced Dermal Flushing (P=0.0007), Increased Romberg Test Balance Time (P=0.02), and Lowered Levels of Acetaldehyde (P=0.03) Following Exposure to Alcohol Aldeyra Plans to Support Investigator-Sponsored Phase 2 Clinical Trial of ADX-629 in Moderate Alcoholic Hepatitis, Expected to be Initiated in 2023 LEXINGTON, Mass.--( BUSINESS WIRE )-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today... Read More