24/7 Market News Snapshot 26 June, 2025 – Aldeyra Therapeutics, Inc. (NASDAQ:ALDX)

June 26, 2025

DENVER, Colo., 26 June, 2025 (www.247marketnews.com) – (NASDAQ:ALDX) are discussed in this article.
Aldeyra Therapeutics, Inc. (ALDX) is experiencing notable bullish momentum in the market, having opened at $3.68 and now trading at $3.875, reflecting a substantial gain of 10.40% from a prior close of $3.51. The trading volume has surged to 1.85 million shares, indicating increased investor interest and active participation. Technical indicators may suggest bullish patterns, with the stock surpassing critical resistance levels. Market analysts urge investors to keep an eye on ongoing volume support and possible retracement levels to provide deeper insights into ALDX’s price movements as the trading day unfolds.

In parallel, Aldeyra Therapeutics has announced a significant milestone, having received a Special Protocol Assessment Agreement Letter from the U.S. Food and Drug Administration (FDA) regarding its investigational drug candidate, ADX-2191 (methotrexate injection, USP). This candidate is being developed as a treatment for primary vitreoretinal lymphoma (PVRL), a rare and aggressive form of eye cancer that currently lacks FDA-approved therapies. The company’s innovative formulation of ADX-2191 is aimed specifically for intraocular injection, potentially allowing for a reduced injection volume, as noted by Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra.

The recent FDA agreement follows a pre-New Drug Application (NDA) meeting in December 2022, which established the groundwork for a literature-based NDA submission that was accepted for Priority Review in March 2023. Despite receiving a Complete Response Letter in June 2023, indicating the need for additional controlled trials, the FDA has now confirmed that a single clinical trial, supplemented by existing literature, will suffice for the NDA resubmission.

This upcoming trial aims to assess the efficacy of ADX-2191 by evaluating the effectiveness of tumor clearance in patients receiving either a single intraocular injection or multiple injections over a 30-day period. Scheduled to commence in the latter half of 2025, the trial underscores Aldeyra’s commitment to advancing treatment options for patients grappling with this challenging condition. With FDA Orphan Drug Designation having been previously granted, ADX-2191 is on track to make an impactful difference in the therapeutic landscape of rare retinal diseases, reinforcing Aldeyra’s mission to innovate in immune-mediated and metabolic disease treatment.

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