Why did ALDX's EPS remain stagnant in recent quarters?
4/11/2025 01:10pm
The EPS of Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) remained stagnant in recent quarters due to a combination of factors:
1. **FDA Letter Impact**: The company received a Complete Response Letter (CRL) from the FDA for the resubmission of the New Drug Application (NDA) of reproxalap, an investigational drug candidate, for the treatment of dry eye disease. This letter stated that the NDA "failed to demonstrate efficacy in adequate and well controlled studies in treating ocular symptoms associated with dry eyes" and that "at least one additional adequate and well controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye" was required. This regulatory setback likely had a significant impact on the company's financial performance.
2. **Analyst Estimates**: Leerink Partners, an investment bank, lowered its FY2024 EPS estimates for Aldeyra Therapeutics in a research note. This indicates a lack of confidence in the company's earnings potential, which could reflect broader market concerns or specific issues within the company.
In conclusion, the combination of the FDA letter and the analyst estimates suggest that the stagnant EPS is a result of the FDA's rejection of the NDA and the broader market's response to this news.