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LEXINGTON, Mass. - Aldeyra Therapeutics, Inc. (NASDAQ:ALDX), a biotech firm focusing on immune-mediated and metabolic diseases, has outlined its plans to resubmit a New Drug Application (NDA) for reproxalap, a treatment for dry eye disease, by mid-2025, pending positive results from ongoing trials and FDA discussions. According to InvestingPro data, the company, currently valued at $318 million, has seen its stock decline nearly 15% over the past week despite maintaining a strong financial health score.
The FDA previously issued a Complete Response Letter indicating the need for additional evidence of reproxalap’s efficacy in treating ocular symptoms associated with dry eyes. Aldeyra has since initiated three clinical trials to address these concerns, with top-line results from a field trial and a chamber clinical trial expected in the second quarter of 2025.
The company’s resubmission strategy follows the FDA’s guidance that requires two symptom trials and two sign trials for dry eye disease drug approval. Aldeyra’s reproxalap has already met the primary endpoint in a dry eye chamber trial and was resubmitted for NDA in October 2024. A Type A meeting with the FDA is anticipated within 30 days to discuss the resubmitted NDA and ongoing trials.
Aldeyra reported a strong financial position as of December 31, 2024, with $101 million in cash, cash equivalents, and marketable securities. The estimated cost for the dry eye clinical trials in 2025 is approximately $6 million, following the majority of expenses incurred in 2024. InvestingPro analysis shows the company maintains a healthy current ratio of 5.59, with liquid assets well exceeding short-term obligations. Want deeper insights? InvestingPro offers 8 additional key financial tips for ALDX.
Reproxalap, a RASP modulator, is being developed for both dry eye disease and allergic conjunctivitis. It has been studied in over 2,500 patients, showing promise in reducing ocular redness and discomfort without significant safety concerns.
The company will hold a conference call today to provide a regulatory update on reproxalap, with a live audio webcast available on Aldeyra’s website.
This article is based on a press release statement from Aldeyra Therapeutics.
In other recent news, Aldeyra Therapeutics has maintained a Buy rating from BTIG analysts, who have set a price target of $11.00. This positive outlook is influenced by the potential of Reproxalap, a drug for dry eye disease, which is expected to launch successfully with the marketing support of AbbVie. A significant milestone for Aldeyra is the upcoming Prescription Drug User Fee Act (PDUFA) date in April, which analysts view as crucial for the company’s progress. Despite a previous Complete Response Letter from the FDA, BTIG analysts remain optimistic due to the drug’s positive trial results. They also noted Aldeyra’s active participation in investment conferences, suggesting favorable discussions with the FDA.
BTIG anticipates Aldeyra’s future focus will shift towards systemic reactive aldehyde species (RASP) treatments, using funds from the Reproxalap franchise. The company is developing second-generation molecules and has released data implicating RASPs in various inflammatory diseases. Additionally, Aldeyra is progressing with ADX-248, an oral RASP inhibitor, currently in a Phase 1 study with healthy volunteers. No consistent adverse events have been reported, and target drug levels were achieved at the initial dose. The company plans to present Phase 1 data in the second half of 2025 and start a randomized trial for atopic dermatitis soon after.
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