Aldeyra Therapeu Stock Price, News & Analysis

Aldeyra Therapeutics (ALDX) announced positive findings from a post-hoc analysis of the Phase 3 TRANQUILITY trial for reproxalap, indicating statistical superiority (p=0.020) in reducing ocular redness, the primary endpoint. This follows a similar confirmation in the Phase 2 trial (p=0.003). Aldeyra plans to engage with the FDA, including ocular redness as an objective sign in its upcoming New Drug Application (NDA) expected mid-2022, contingent on discussions and outcomes from the ongoing TRANQUILITY-2 trial.

Aldeyra Therapeutics (Nasdaq: ALDX) reported its financial results for Q1 2022, with cash holdings of $216.9 million, expected to cover operations through 2023. The company completed enrollment for the Phase 3 TRANQUILITY-2 Trial of reproxalap in dry eye disease, with results anticipated in Q2 2022. Positive top-line data from Phase 2 trials of ADX-629 were also announced, leading to new indications in ethanol toxicity and chronic cough. Despite a net loss of $16.8 million, up from $11.3 million year-over-year, Aldeyra continues to progress in clinical trials across various indications.

Aldeyra Therapeutics (NASDAQ: ALDX) will be represented by Kelly Mizer, Vice President, at the MOD Live! 2022 meeting in Nashville, Tennessee, from May 5-7, 2022. The event focuses on innovative therapies in optometry, particularly in the session titled 'The Future of Optometry – Pipeline Game Changers'. Mizer will provide updates on reproxalap, an investigational drug in Phase 3 trials aimed at treating dry eye disease and allergic conjunctivitis.

Aldeyra specializes in therapies for immune-mediated diseases, with a focus on RASP modulators.

Aldeyra Therapeutics, Inc. (ALDX) will host a conference call on May 5, 2022, at 8:00 a.m. ET to discuss its financial results for Q1 2022, ending March 31, 2022. The call can be accessed via dial-in numbers for both domestic and international callers, with an access code provided. A live audio webcast will be available on Aldeyra's website, and the archived event will remain accessible for 90 days. Aldeyra focuses on therapies for immune-mediated diseases and has several clinical candidates in various stages, including reproxalap and ADX-629.

Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) has announced the presentation of results from the run-in cohort of the Phase 3 TRANQUILITY clinical trial of reproxalap for dry eye disease at the 2022 ASCRS Annual Meeting on April 23, 2022. Reproxalap is a first-in-class small-molecule modulator targeting reactive aldehyde species, currently in Phase 3 development. The company aims to provide innovative therapies for immune-mediated diseases, with a focus on dry eye disease and allergic conjunctivitis, significant markets in ophthalmology.

Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) announced the completion of enrollment in the Phase 3 TRANQUILITY-2 Trial for its investigational drug, reproxalap, aimed at treating dry eye disease. The multi-center study enrolled 361 patients and measured tear volume and ocular redness as primary endpoints. Top-line results are expected this quarter, and if successful, the data could support a New Drug Application (NDA) submission. Aldeyra plans to utilize data from completed clinical trials to meet FDA regulatory requirements.

Aldeyra Therapeutics announced promising signs of clinical activity for ADX-629 in three Phase 2 trials aimed at immune-mediated diseases. No safety issues were reported, and the company plans to expand ADX-629's development into new indications, including ethanol toxicity and chronic cough. Key results showed significant decreases in inflammation-related metrics in psoriasis, asthma, and COVID-19 patients. The company will present additional findings and plans during its R&D Day and expects to initiate new trials in 2023.

Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) will hold a Research & Development Day on March 29, 2022, from 10:00 a.m. to 12:30 p.m. ET in New York City. The event will reveal top-line data from Phase 2 clinical trials of ADX-629, a first-in-class orally administered RASP modulator, targeting three inflammatory diseases. Presentations will feature Aldeyra's senior leadership and Dr. Geoffrey M. Thiele from the University of Nebraska Medical Center. A live webcast will be available on their website, with replays for 90 days.

Aldeyra Therapeutics (ALDX) reported its financial results for 2021, highlighting a net loss of $57.8 million, or $1.07 per share, compared to $37.6 million, or $1.11 per share in 2020. The increase in loss is attributed to higher costs in clinical trials and R&D, totaling $44.9 million. As of December 31, 2021, cash and cash equivalents stood at $229.8 million, projected to support operations through 2023. Upcoming milestones include top-line data from ADX-629 trials by March 2022 and results from various Phase 3 trials for reproxalap and ADX-2191 expected throughout 2022.