Aldeyra Stock Slumps After FDA Says Drug Candidate For Dry Eyes Treatment Failed To Show Efficacy – Retail Stays Optimistic

Shares of Aldeyra Therapeutics, Inc. (ALDX) slumped nearly 71% on Thursday morning after it said that the U.S. Food and Drug Administration (FDA) said the company’s investigational drug candidate reproxalap failed to demonstrate efficacy in treating ocular symptoms associated with dry eyes.

The FDA told the company to resubmit its application for reproxalap and called upon the company to conduct “at least one additional adequate and well-controlled study” to demonstrate the drug’s positive effect on treating ocular symptoms of dry eye.

The FDA, however, identified no manufacturing or safety issues with reproxalap, the company said.

Aldeyra first submitted an application to the FDA for reproxalap in November 2022, but the agency asked for more trials. The company subsequently resubmitted its application in October 2024.

Aldeyra Therapeutics CEO Todd C Brady said the company looks forward to a potential application resubmission by mid-year 2025, pending positive results from ongoing clinical trials and discussions with the FDA.

On Stocktwits, retail investor sentiment about Aldeyra jumped further into the ‘extremely bullish’ territory (96/100), while message volume remained ‘extremely high’ over the past 24 hours.

A Stocktwits user opined that the dip is a good opportunity to buy, highlighting the company’s cash balance. Aldeyra reported cash, cash equivalents, and marketable securities of $101 million as of the end of 2024.

Another user, however, speculated the company may be facing bankruptcy.

Aldeyra shares are down by over 70% this year and by over 60% over the past 12 months.

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