Aldeyra crashes 21% as FDA rejects eye cancer therapy

• Aldeyra Therapeutics (NASDAQ:ALDX) fell ~21% in the morning hours Wednesday after announcing that the U.S. FDA declined to approve its marketing application for ADX-2191, an investigational therapy for primary vitreoretinal lymphoma (PVRL).
• In its Complete Response Letter (CRL), the FDA has not indicated any safety or manufacturing issues related to ADX-2191, a methotrexate injection. However, the company said that the weaknesses in its investigations into the treatment have led to the rejection.
• Citing prior discussions with the FDA, Aldeyra (ALDX) said it did not conduct any clinical trials to support its 505(b)(2) New Drug Application (NDA) for ADX-2191.
• Due to the current shortage of methotrexate and other reasons, including the lack of FDA-approved treatments for PVRL, the company intends to discuss with the FDA to pursue an Expanded Access Program for ADX-2191.

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