Maintaining Hold on Aldeyra as FDA CRL Clouds Reproxalap’s Dry Eye Path and Lowers Approval Odds

H.C. Wainwright analyst Matthew Caufield maintained a Hold rating on Aldeyra Therapeutics today and set a price target of $2.00.

Matthew Caufield has given his Hold rating due to a combination of factors surrounding Aldeyra’s lead asset, Reproxalap, in dry eye disease. The recent Complete Response Letter from the FDA highlighted that existing studies do not yet provide sufficiently consistent and robust evidence that the drug delivers the efficacy claimed in the proposed labeling, despite some prior positive findings on ocular discomfort and redness.

Given this regulatory setback, he sharply lowered the assumed probability of success for Reproxalap and cut his price target, reflecting increased uncertainty around eventual approval and commercialization. At the same time, the absence of clear FDA guidance on specific new trials or confirmatory work, and the pending Type A meeting to clarify next steps, argue against an outright bearish stance, leading him to maintain aNeutral, or Hold, recommendation while awaiting better visibility on the development path.

In another report released today, TipRanks – DeepSeek also reiterated a Hold rating on the stock with a $1.00 price target.