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 (Nasdaq: ALDX) announced positive results from a Phase 2 clinical trial of reproxalap, a treatment for dry eye disease. The trial demonstrated statistically significant reductions in ocular discomfort (p=0.002) and itching (p=0.01) compared to Xiidra. Reproxalap, a novel RASP modulator, had no safety concerns reported. This data suggests reproxalap's potential as a first-line therapy. The trial included 56 patients and indicated improved tolerability over existing treatments, addressing compliance issues that often arise with current therapies.
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) announced that Dr. Todd C. Brady will participate in a fireside chat at the H.C. Wainwright BioConnect Virtual Conference. The conversation will be available on demand starting at 7:00 a.m. ET on January 10, 2022. Aldeyra specializes in therapies for immune-mediated diseases, with products like reproxalap and ADX-629 in various clinical trial phases. Reproxalap is in Phase 3 trials for dry eye disease and allergic conjunctivitis, while ADX-629 is in Phase 2 trials for psoriasis and COVID-19. The webcast can be accessed on their website.
Aldeyra Therapeutics (ALDX) has completed enrollment for Part 1 of its Phase 3 GUARD Trial evaluating ADX-2191 for preventing proliferative vitreoretinopathy (PVR), an ocular disease with no approved therapies. The trial, involving 110 patients in the U.S., aims to assess recurrent retinal detachment rates post-surgery. Results are expected in the second half of 2022. ADX-2191, a methotrexate formulation, has received fast track and orphan drug designations from the FDA, potentially expediting development and offering market exclusivity.
Aldeyra Therapeutics announced the top-line results of its Phase 3 TRANQUILITY trial for reproxalap, aimed at treating dry eye disease. While the primary endpoint of ocular redness was not achieved, significant results were recorded for the secondary endpoint, the Schirmer test (p=0.0001). The upcoming TRANQUILITY-2 trial's primary endpoint has been adjusted, allowing for either Schirmer test or ocular redness to satisfy it, with enrollment targets increasing to 400 patients. A New Drug Application submission for dry eye disease is anticipated by mid-2022, contingent on the trial outcomes.
Aldeyra Therapeutics, Inc. (NASDAQ: ALDX), a biotechnology firm focused on immune-modulating therapies for ocular and systemic diseases, has announced CEO Todd C. Brady's participation in several upcoming investor conferences. These include the Berenberg US CEO Conference on November 10, the Eyecelerator@AAO 2021 on November 11, the Jefferies London Healthcare Conference on November 18, and Ophthalmology Day at BTIG on November 30. Webcasts of these events will be accessible on their Investors & Media page for 90 days.
Aldeyra Therapeutics (NASDAQ: ALDX) has completed enrollment in the Phase 3 TRANQUILITY trial for reproxalap, targeting dry eye disease. Top-line results are expected this quarter. The recent Phase 2 trial achieved its primary endpoint of ocular redness, crucial for NDA submission. The company plans to submit two pivotal trials for NDA requirements, with an anticipated submission in early 2022. Reproxalap shows promise for the 34 million U.S. adults suffering from dry eye symptoms. Aldeyra aims to demonstrate efficacy in clinical trials as outlined by FDA regulations.
Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) announced the successful achievement of the primary endpoint in a Phase 2 clinical trial assessing ocular redness in patients with dry eye disease. The trial included 158 patients and revealed that those treated with 0.25% reproxalap had significantly lower ocular redness scores compared to the vehicle group (p = 0.016). Two Phase 3 trials, TRANQUILITY and TRANQUILITY-2, are ongoing with expected results by year-end. Reproxalap represents a novel approach to treating dry eye disease, targeting reactive aldehyde species to alleviate inflammation and improve patient quality of life.
Aldeyra Therapeutics (ALDX) announced it expects to release top-line results from the Phase 3 TRANQUILITY and TRANQUILITY-2 clinical trials for reproxalap in dry eye disease in Q4 2021. The company also plans to initiate a Phase 2 trial for ADX-2191 in retinitis pigmentosa this quarter and anticipate results from ADX-629 trials by early 2022. As of September 30, 2021, cash and cash equivalents totaled $241.4 million, sufficient to fund projected operating expenses through 2023. The net loss for Q3 2021 was $15.8 million, up from $8.9 million in Q3 2020.
Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) will conduct a conference call on October 28, 2021, at 8:00 a.m. ET to discuss financial results for the quarter ending September 30, 2021, alongside recent business achievements. Interested parties can join via dial-in or a live webcast available on their corporate website. Aldeyra is focused on developing immune-modulating therapies for ocular and systemic diseases, with key products in clinical trials targeting inflammation-related conditions. For further details, visit their website.
Aldeyra Therapeutics (NASDAQ: ALDX) will have its CEO, Todd C. Brady, participate in a fireside conversation at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22, 2021, at 9:55 a.m. ET. The event will be accessible via a live webcast on the company's Investors & Media page and archived for 90 days. Aldeyra focuses on developing novel therapies for ocular and systemic diseases, with lead candidates like reproxalap and ADX-629 in clinical trials for conditions such as dry eye disease.