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Aldeyra Therapeutics Receives FDA Complete Response Letter

Story Highlights
  • Aldeyra received a Complete Response Letter from the FDA for reproxalap, citing efficacy concerns.
  • Aldeyra plans additional trials and aims to resubmit the NDA by mid-2025, facing potential delays and increased costs.
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Aldeyra Therapeutics Receives FDA Complete Response Letter

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Aldeyra Therapeutics ( (ALDX) ) just unveiled an update.

On April 3, 2025, Aldeyra Therapeutics announced receiving a Complete Response Letter from the FDA regarding its resubmitted New Drug Application for reproxalap, intended for treating dry eye disease. The FDA highlighted the need for additional well-controlled studies due to concerns about the efficacy data and methodological issues in previous trials. Aldeyra plans to address these issues with ongoing trials and aims to resubmit the NDA by mid-2025, although this may require more resources and delay the drug’s approval and commercialization, impacting the company’s financial condition and market strategy.

More about Aldeyra Therapeutics

Aldeyra Therapeutics is a biotechnology company focused on developing innovative therapies for immune-mediated diseases. Its primary product candidate, reproxalap, is an investigational drug aimed at treating dry eye disease, among other conditions.

YTD Price Performance: 2.01%

Average Trading Volume: 622,049

Technical Sentiment Signal: Hold

Current Market Cap: $326.9M

For a thorough assessment of ALDX stock, go to TipRanks’ Stock Analysis page.

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