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) 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.

Aldeyra Therapeutics, Inc. (ALDX) Q3 2022 Earnings Call Transcript

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

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

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

LEXINGTON, Mass.--(BUSINESS WIRE)--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. ADX-2191 was statistically superior to historical control2 for th

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

LEXINGTON, Mass.--(BUSINESS WIRE)--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. The dial-in numbers

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

Shares have bucked weakness in the biotech sector and risen 60% year to date. Dry eye disease is a lucrative indication for reproxalap (albeit with generic competition) and differentiation is apparent via fast onset of action and statistical significance across multiple signs.

Aldeyra Therapeutics: Dry Eye Is Just The Beginning For Novel MOA

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 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. “Based on the outcome of ou

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

LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company developing innovative therapies designed to treat immune-mediated diseases, today announced that Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra, will participate in the following investor conferences in September: Citi's 17th Annual BioPharma Conference (1x1 meetings only) Wednesday, September 7, 2022 Boston, Mass. H.C. Wainwright 24th Annu

Aldeyra Therapeutics to Participate in Upcoming Investor Conferences

When a stock experiences a golden cross technical event, good things could be on the horizon. How should investors react?

Aldeyra Therapeutics, Inc. (ALDX) Now Trades Above Golden Cross: Time to Buy?

Aldeyra Therapeutics, Inc. (NASDAQ:ALDX ) Q2 2022 Earnings Conference Call August 5, 2022 8:00 AM ET Company Participants Bruce Greenberg - Interim Chief Financial Officer Todd Brady - President & Chief Executive Officer Conference Call Participants Catherine Novack - Jones Research Yigal Nochomovitz - Citigroup Kelly Shi - Jefferies Tom Shrader - BTIG Justin Kim - Oppenheimer & Co. Yale Jen - Laidlaw & Company Operator Ladies and gentlemen, thank you for standing by and welcome to the Aldeyra Therapeutics Second Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode.

Aldeyra Therapeutics, Inc. (ALDX) CEO Todd Brady on Q2 2022 Results - Earnings Call Transcript

LEXINGTON, Mass.--(BUSINESS WIRE)--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 June 30, 2022. “The second half of 2022 is highlighted by planned new drug applications in dry eye disease and primary vitreoretinal lymphoma, two diseases that are currently sub-optimally treated,” stated Tod

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

Reproxalap seems poised for FDA approval for dry eye disease. Therapy has clear practical advantages over Restasis and Xiidra.

Aldeyra Therapeutics: Poised For Dry Eye Disease Therapy Monetization

LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) will host a conference call at 8:00 a.m. ET Friday, August 5, 2022 to report financial results for the quarter ended June 30, 2022 and discuss recent corporate highlights. The dial-in numbers are (844) 200-6205 for domestic callers and (929) 526-1599 for international callers. The access code is 908644. A live audio webcast of the conference call also will be accessible from the “Investors & Media” sectio

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

Aldeyra's (ALDX) vehicle-controlled crossover study evaluating 0.25% reproxalap ophthalmic solution for the treatment of dry eye disease meets primary endpoints. Shares up.

Aldeyra's (ALDX) Dry Eye Disease Chamber Study Meets Goals

Aldeyra Therapeutics Inc (NASDAQ: ALDX) achieved the primary endpoints in a crossover clinical trial of 0.25% reproxalap ophthalmic solution, an investigational new drug candidate for dry eye disease.  Relative to the vehicle, a statistically significant reduction in ocular.

Aldeyra's Reproxalap Hits Primary Goals In Dry Eye Disease Chamber Crossover Trial

LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the achievement of the primary endpoints in a sequence-randomized, double-masked, vehicle-controlled crossover clinical trial of 0.25% reproxalap ophthalmic solution, an investigational new drug candidate, for the treatment of dry eye disease. Reproxalap was statistically superior to vehicle for each of the two prespecified primary endpoints, ocular redness in a dry eye chamber (P=0.0004) and

Aldeyra Therapeutics Achieves Primary Endpoints in Dry Eye Disease Chamber Crossover Clinical Trial

LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced it will host a webcast and conference call on Tuesday, July 12, 2022, at 8:00 a.m. (ET) to report top-line results from the crossover clinical trial of reproxalap, an investigational new drug candidate, for the treatment of dry eye disease. The dial-in numbers are (844) 200-6205 for domestic callers and (646) 904-5544 for international callers. The access code is 853619. A live audio webcast o

Aldeyra Therapeutics Schedules Conference Call and Webcast to Announce Top-Line Results from the Dry Eye Disease Chamber Crossover Clinical Trial of Reproxalap

Aldeyra Therapeutics Inc's (NASDAQ: ALDX) Phase 3 TRANQUILITY-2 trial of reproxalap for dry eye disease has achieved the primary endpoint. Reproxalap was statistically superior to the vehicle for each of the two prespecified primary endpoints, Schirmer test and ≥10 mm Schirmer.

Why Aldeyra Therapeutics' Shares Are Soaring Today?

LEXINGTON, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the achievement of the primary endpoint in the Phase 3 TRANQUILITY-2 clinical trial (TRANQUILITY-2) of reproxalap, an investigational new drug candidate, for the treatment of dry eye disease. Reproxalap was statistically superior to vehicle for each of the two prespecified primary endpoints, Schirmer test (p=0.0001) and ≥10 mm Schirmer test responder proportions (p

Aldeyra Therapeutics Achieves Primary Endpoint in Phase 3 TRANQUILITY‑2 Trial in Dry Eye Disease and Intends to Submit New Drug Application for Symptoms and Three Sign Endpoints of Dry Eye Disease

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