New Drug Application (NDA) Resubmission

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Aldeyra Therapeutics (ALDX) Earnings Call Presentation
2025-05-06 12:10
Reproxalap NDA Resubmission Plan - Aldeyra intends to resubmit the NDA for reproxalap for dry eye disease treatment based on new clinical trial results[5] - The company requested a Type A meeting with the FDA to discuss the potential NDA resubmission[8] - NDA resubmission is anticipated in mid-2025, pending the Type A meeting with the FDA[24] - The anticipated review period for the potential NDA resubmission is expected to be six months[25] Clinical Trial Results - The dry eye chamber trial achieved statistical significance in favor of reproxalap over vehicle (P=0.002)[7, 11] - In the dry eye chamber trial, the vehicle increase from baseline was more than 8x higher than that of reproxalap[10] - In the dry eye chamber trial, ocular discomfort baselines were balanced across treatment arms[12] - The field trial results were numerically supportive of reproxalap, but did not reach statistical significance[16] Financial Status - As of December 31, 2024, Aldeyra had $1012 million in cash, cash equivalents, and marketable securities[34] - Aldeyra believes this is sufficient to fund the company into 2027[34]