Welcome to our dedicated page for Aldeyra Therapeutics news (Ticker: ALDX), a resource for investors and traders seeking the latest updates and insights on Aldeyra Therapeutics stock.
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) is a biotechnology company dedicated to improving lives by developing products that treat aldehyde-mediated diseases. The company's mission is to discover and develop innovative therapies designed to tackle immune-mediated diseases. Aldeyra focuses primarily on inflammation, inborn errors of metabolism, and other diseases associated with toxic and pro-inflammatory aldehydes.
Key highlights of Aldeyra's portfolio include:
- ADX-102: In development for noninfectious anterior uveitis, allergic conjunctivitis, and dry eye disease.
- Reproxalap: A first-in-class treatment in late-stage development for dry eye disease and allergic conjunctivitis.
- ADX-2191: A novel methotrexate formulation for proliferative vitreoretinopathy and retinitis pigmentosa.
Aldeyra's approach involves developing pharmaceuticals that modulate immunological systems, optimizing multiple pathways while minimizing toxicity. Recent achievements include positive top-line results from Phase 2 clinical trials and strategic partnerships, such as an exclusive option agreement with AbbVie.
The company is financially stable with sufficient resources projected to fund operations through late 2025, enabling continued advancement of its promising pipeline. Aldeyra’s innovative therapies hold the potential to address significant unmet medical needs in ophthalmology and systemic immune-mediated diseases.
Aldeyra Therapeutics (ALDX) announced key developments and financial results for Q3 2022, with cash reserves exceeding $185 million. The NDA for Reproxalap for dry eye disease is on track for submission in Q4 2022, following an FDA pre-NDA meeting. The company also reported favorable results for ADX-2191 in clinical trials related to proliferative vitreoretinopathy, and plans upcoming NDA submissions for lymphoma. The net loss for the quarter was $14.6 million, an improvement from $15.8 million the previous year, with reduced R&D expenses.
Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) will hold a conference call at 8:00 a.m. ET on November 10, 2022, to discuss financial results for the quarter ended September 30, 2022, and provide corporate highlights. Domestic callers can dial (844) 200-6205, and international callers can reach (929) 526-1599 with access code 048610. A live audio webcast will be available on the company's website and archived for 90 days.
Aldeyra Therapeutics (NASDAQ: ALDX) announced an upcoming oral presentation of clinical data from the Phase 3 INVIGORATE trial for reproxalap, designed to treat allergic conjunctivitis. Scheduled for October 26, 2022, at the American Academy of Optometry Annual Meeting in San Diego, the presentation will highlight clinically significant reductions in ocular itching and redness compared to a vehicle. Reproxalap is a first-in-class drug targeting reactive aldehyde species linked to ocular inflammation and is also in late-stage trials for dry eye disease.
Aldeyra Therapeutics (ALDX) announced that ADX-2191 achieved its primary endpoint in Part 1 of the Phase 3 GUARD Trial, demonstrating statistical superiority in preventing retinal detachment associated with proliferative vitreoretinopathy (PVR) (P=0.024). The trial involved 68 patients receiving ADX-2191 compared to 38 patients receiving routine surgical care. Notably, ADX-2191 was well tolerated with no significant safety concerns. The company plans discussions with the FDA regarding the completion of clinical development in the first half of 2023, aiming to address this rare disease's unmet medical needs.
Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) will host a webcast on October 6, 2022, at 8:00 a.m. ET to report top-line results from Part 1 of the Phase 3 GUARD Trial for ADX-2191, an innovative treatment for proliferative vitreoretinopathy (PVR), a vision-threatening condition without available therapies. The conference call can be accessed via a dial-in number or through a live audio webcast on the company’s website, with archived access for 90 days post-event.
Aldeyra Therapeutics (NASDAQ: ALDX) announced plans to submit a New Drug Application (NDA) for its investigational drug reproxalap for dry eye disease in Q4 2022, following a productive pre-NDA meeting with the FDA. The NDA will be supported by data from five completed clinical trials, showcasing rapid symptom relief and improved objective signs of dry eye disease. Additionally, upcoming milestones include a pre-NDA meeting for ADX-2191 and results from various clinical trials expected in late 2022 and early 2023.
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) announced that CEO Todd C. Brady will participate in key investor conferences in September 2022. The events include Citi's 17th Annual BioPharma Conference on September 7 in Boston, and H.C. Wainwright's 24th Annual Global Investment Conference on September 14 in New York. Dr. Brady's presentation at the latter is set for 10:00 a.m. ET and can be accessed via Aldeyra's website. Aldeyra focuses on innovative treatments for immune-mediated diseases, with products like reproxalap and ADX-629 in various clinical stages.
Aldeyra Therapeutics (Nasdaq: ALDX) reported significant progress in Q2 2022, with cash reserves of $196.7 million expected to support operations into 2023. Key upcoming milestones include pre-NDA meetings with the FDA for reproxalap, aimed at treating dry eye disease, and ADX-2191 for primary vitreoretinal lymphoma. Positive results from clinical trials of reproxalap indicated statistical superiority in reducing ocular discomfort. However, the company reported a net loss of $17.8 million for the quarter, an increase from the prior year, primarily due to rising R&D expenses.
Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) will host a conference call on August 5, 2022, at 8:00 a.m. ET to discuss its financial results for Q2 2022, which ended June 30, 2022, along with recent corporate highlights. Domestic callers can dial (844) 200-6205 or (929) 526-1599 for international calls, using access code 908644. A live audio webcast will also be available on Aldeyra's website and will remain archived for 90 days. Aldeyra focuses on innovative therapies for immune-mediated diseases, with key products in development addressing various conditions.
Aldeyra Therapeutics (NASDAQ: ALDX) announced positive results from its crossover clinical trial of the investigational drug reproxalap for dry eye disease. The study achieved primary endpoints, demonstrating statistical superiority over a vehicle for both ocular redness (P=0.0004) and the Schirmer test (P=0.0005). Secondary endpoints also showed significant improvements in dryness, discomfort, grittiness, stinging, burning, and itching symptoms. No safety issues were reported, and the FDA meeting for a New Drug Application is scheduled for Q3 2022, with submission plans for reproxalap data following.