Welcome to our dedicated page for Aldeyra Therapeu news (Ticker: ALDX), a resource for investors and traders seeking the latest updates and insights on Aldeyra Therapeu stock.
Aldeyra Therapeutics Inc (ALDX) is a clinical-stage biotechnology company developing treatments for inflammatory eye diseases through a novel aldehyde-sequestering mechanism. The company's news flow typically centers on clinical trial results, regulatory interactions with the FDA, and advancement of its lead product candidate reproxalap through development milestones.
Investors following Aldeyra can expect news related to clinical trial data readouts for multiple ophthalmic indications including noninfectious anterior uveitis, allergic conjunctivitis, and dry eye disease. The company regularly announces regulatory developments such as FDA meeting outcomes, orphan drug designations, fast track designations, special protocol assessments, and responses to regulatory submissions. These regulatory milestones significantly impact the company's development timeline and commercial pathway.
Additional news categories include corporate updates on clinical trial initiations, patient enrollment milestones, pipeline expansion into new indications, and presentations at medical and investor conferences. For a clinical-stage biotechnology company, regulatory decisions and clinical data releases represent the most material news events, as they directly affect the probability and timing of potential product approvals. Financial updates including quarterly earnings reports and capital raising activities also provide insight into the company's operational runway and funding status.
This news resource provides comprehensive coverage of all material developments affecting Aldeyra's business, helping investors track the company's progress through the complex and lengthy drug development process. Bookmark this page to stay informed about clinical trial outcomes, regulatory decisions, and corporate developments that shape Aldeyra's trajectory in the ophthalmic pharmaceutical market.
Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) announced that Dr. Todd C. Brady, President and CEO, will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 10, 2022, at 9:30 a.m. ET. The event will include a conversation with Dr. Kelly Shi, a Senior Research Analyst in Biotechnology. Investors can access the live webcast through Aldeyra's website, with a video replay available for 90 days afterwards. Aldeyra is focused on innovative therapies for immune-mediated diseases, including its lead candidates, reproxalap and ADX-629.
Aldeyra Therapeutics (ALDX) announced its achievement of the primary endpoint in the Phase 3 TRANQUILITY-2 clinical trial for reproxalap, a treatment for dry eye disease. The drug demonstrated statistical superiority in the Schirmer test (p=0.0001) and responder proportions (p<0.0001) after a single dose. The company plans to submit a New Drug Application (NDA) encompassing results from five controlled trials, potentially representing the most comprehensive submission for dry eye disease. A Pre-NDA meeting with the FDA is anticipated in Q3 2022, with results from an ongoing safety trial expected soon.
Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) will host a webcast and conference call on June 8, 2022, at 8:00 a.m. ET to discuss top-line results from its Phase 3 TRANQUILITY-2 Trial of reproxalap in treating dry eye disease. Interested participants can access the call via dial-in numbers or through a live audio webcast on Aldeyra's website. Following the event, a recording will be available on the site for 90 days. Aldeyra is focused on innovative therapies targeting immune-mediated diseases.
Aldeyra Therapeutics (NASDAQ: ALDX) announced Schirmer test designation as the primary endpoint in its Phase 3 TRANQUILITY-2 trial for reproxalap, targeting dry eye disease. This decision follows favorable post-hoc analyses from previous trials, indicating reproxalap’s statistically significant reduction in ocular redness. The company plans to use these results to support a New Drug Application (NDA) submission, pending ongoing safety trials. Results from TRANQUILITY-2 are expected in Q2 2022, highlighting the unmet need for quicker, non-steroidal treatment options in dry eye disease.
Aldeyra Therapeutics, a biotechnology company focused on immune-mediated diseases, announced that President and CEO Todd C. Brady will speak at the H.C. Wainwright Global Investment Conference. The fireside chat, featuring Vice President of Equity Research Matthew Caufield, will be available on demand starting 7:00 a.m. ET on May 24, 2022. Interested viewers can access the event through the Investors & Media section on Aldeyra's website, which will be archived for 90 days. Aldeyra's leading products include reproxalap and ADX-629, targeting immune-inflammation.
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.
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