1. FDA issued a Complete Response Letter to Aldeyra's NDA for reproxalap. 2. NDA failed to show efficacy; more studies needed for approval. 3. No manufacturing or safety issues identified with reproxalap. 4. Aldeyra plans to resubmit NDA mid-2025 after new trials. 5. ALDX stock dropped 74.5% to $1.36 in premarket trading.
The Complete Response Letter suggests significant setbacks in drug approval, impacting future financials similarly seen during previous rejections of drug candidates by other firms, which often lead to substantial stock declines.
The FDA's refusal to approve the NDA is crucial for ALDX's future viability and financial health, leading to immediate negative investor sentiment.
With an anticipated NDA resubmission and ongoing clinical trials, ALDX’s prospects hinge on results expected in 2025, extending uncertainty for investors.