DENVER, Colo., 08 August, 2024 (247marketnews.com) – (NASDAQ:ALDX) are discussed in this article.
Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) demonstrated a remarkable rise in its stock price, opening at $3.65 and climbing to $3.94, a notable increase from the previous close of $3.26. This surge, an impressive 20.89% gain from the opening, was underpinned by substantial trading activity, with a volume of 1.2 million shares. This bullish momentum broke through key resistance levels, signaling strong market interest and possibly attracting short-term traders looking to leverage the stock’s upward trajectory.
Contributing to this market enthusiasm, Aldeyra Therapeutics announced a pivotal achievement in its Phase 3 clinical trial for the dry eye disease treatment with 0.25% reproxalap ophthalmic solution. This trial successfully met its primary endpoint, showing statistical superiority over the vehicle in reducing ocular discomfort, a symptom recognized by the U.S. Food and Drug Administration (FDA). Conducted with 132 participants, the trial revealed that reproxalap significantly reduced discomfort within 80 to 100 minutes under simulated dry eye conditions, evidenced by a p-value of 0.004.
“This significant milestone is the first positive Phase 3 trial in a dry eye chamber using a symptom as the primary endpoint,” stated Todd C. Brady, M.D., Ph.D., President, and CEO of Aldeyra Therapeutics. The demonstrated efficacy underscores reproxalap’s potential for rapid relief from dry eye discomfort. This trial fulfills the FDA’s requirements for an additional controlled study showing a symptom improvement, with the company planning to resubmit its New Drug Application (NDA) in 2024 and anticipate a six-month review period thereafter.
Furthermore, reproxalap showcased a strong safety profile, with no significant adverse events and only mild, transient instillation site discomfort being reported. Having been administered to over 2,500 patients, the treatment continues to show promise as an effective solution for dry eye disease.
Aldeyra Therapeutics will host a conference call at 9:00 a.m. ET to delve into these trial results and outline NDA resubmission plans, with the webcast accessible on the company’s Investor Relations page and archived for future reference.
The company remains at the forefront of biotechnological innovation, focusing on treatments for immune-mediated and metabolic diseases, with reproxalap leading its robust pipeline of therapeutic candidates.
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