Aldeyra Therapeutics Inc (NASDAQ:ALDX) shares are trading lower by 62% to $2.07 during Monday’s pre-market session. The company on Monday morning received feedback from the U.S. Food and Drug Administration (FDA) regarding their new drug application (NDA) for reproxalap, intended for treating dry eye disease.
The FDA says it identified significant issues with the clinical data supporting the drug’s effectiveness for this indication.
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Although Aldeyra submitted responses to address these concerns, the FDA has not confirmed the adequacy of the submitted information and has indicated that an additional clinical trial may be necessary to meet efficacy requirements. Consequently, there is a risk that the FDA may not approve the NDA by the expected target action date of November 23, 2023, and may issue a Complete Response Letter.
This could result in the need for Aldeyra to conduct further clinical trials and submit their results before the application is reconsidered.
Aldeyra says the company’s ability to generate revenue depends heavily on the successful FDA approval and commercialization of reproxalap. Delays or limitations in FDA approval could significantly hinder their revenue generation efforts.
This situation meanwhile presents a notable risk to the company’s development and commercialization of reproxalap and other product candidates.
According to data from Benzinga Pro, ALDX has a 52-week high of $11.97 and a 52-week low of $4.95.
