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 (ALDX) is a clinical-stage biotechnology company developing innovative therapies targeting diseases mediated by toxic aldehydes, with active programs in ocular inflammation and systemic immune disorders. This page provides investors and industry professionals with comprehensive access to Aldeyra's official announcements, including clinical trial updates, regulatory milestones, and strategic partnerships.
Key resources include real-time updates on product candidates like reproxalap for dry eye disease, filings with regulatory agencies, and research collaborations. Users gain a centralized hub to track the company's progress in addressing conditions such as noninfectious anterior uveitis and metabolic disorders through its novel aldehyde sequestration platform.
Regular updates cover Phase clinical results, FDA communications, intellectual property developments, and scientific presentations. The curated news feed enables efficient monitoring of Aldeyra's pipeline advancements and market positioning within the precision medicine landscape.
Bookmark this page for direct access to verified ALDX disclosures and analysis essential for evaluating the company's therapeutic innovations and investment potential.
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.
Aldeyra Therapeutics, a biotechnology company focused on immune-modulating therapies for ocular and systemic diseases, announced participation in two upcoming investor conferences. President and CEO Todd C. Brady will present at Citi's 16th Annual BioPharma Virtual Conference on September 9, 2021, at 8:50 a.m. ET, discussing next-generation retinal therapeutics. Additionally, he will be featured at H.C. Wainwright's 23rd Annual Global Investment Conference on September 13, 2021, beginning at 7:00 a.m. ET. Archived versions of these events will be available on the company's website for 90 days.
Aldeyra Therapeutics (Nasdaq: ALDX) reported its financial results for Q2 2021, highlighting a net loss of $14.9 million compared to $7.5 million in Q2 2020. Cash reserves stand at $249.7 million, sufficient to fund operations through 2023. The company anticipates results from its Phase 3 TRANQUILITY trials for reproxalap in dry eye disease by Q4 2021, alongside outcomes from Phase 2 trials of ADX-629 for immune-mediated diseases. Additionally, the FDA granted orphan drug designation for ADX-2191 in two retinal diseases, enhancing development incentives.
Aldeyra Therapeutics (Nasdaq: ALDX) has received orphan drug designation from the FDA for ADX-2191, indicated for treating retinitis pigmentosa (RP), a rare genetic eye disease affecting up to 110,000 individuals in the U.S. This designation signifies the unmet medical need in ophthalmology. ADX-2191 also holds orphan drug designation for primary vitreoretinal lymphoma and fast track designation for preventing proliferative vitreoretinopathy. These regulatory recognitions offer financial incentives under the FDA's orphan drug program, including potential marketing exclusivity.
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) announced that President and CEO Todd C. Brady, M.D., Ph.D., will participate in analyst-led fireside chats at two upcoming virtual conferences.
- BTIG Virtual Biotechnology Conference
Date: August 9, 2021, Time: 9:30 a.m. ET - H.C. Wainwright Ophthalmology Virtual Conference
Date: August 17, 2021, Time: Available On-Demand from 7:00 a.m. ET
Access details are available on Aldeyra’s Investor & Media page, with archives for 90 days post-event.
Aldeyra Therapeutics (Nasdaq: ALDX) announced that the FDA has granted orphan drug designation for ADX-2191, a methotrexate treatment for primary vitreoretinal lymphoma (PVRL), a rare cancer affecting about 2,800 individuals in the U.S. annually. This designation supports clinical development and commercialization, providing tax incentives and potential seven-year marketing exclusivity. ADX-2191 is also in Phase 3 trials for preventing proliferative vitreoretinopathy, a major complication of retinal surgery. Orphan drug status can enhance funding and development prospects for Aldeyra's pipeline.
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