Aldeyra gains on plans for AbbVie-partnered eye disease drug

Shares of Aldeyra Therapeutics (NASDAQ:ALDX) gained on Thursday after the biotech announced plans to resubmit a marketing application for its eye disease therapy, reproxalap, co-developed with AbbVie (NYSE:ABBV).

In November, the U.S. FDA declined to approve reproxalap, Aldeyra’s (ALDX) lead asset, for dry eye disease, weeks after AbbVie (ABBV) inked an option agreement to obtain its commercial rights.

Following discussions with the agency, the company said it would resubmit a new drug application for the topical therapy in H2 2024, subject to positive results from a clinical trial expected to start in the first half of the year.

“The planned dry eye chamber clinical trial, if successful, could represent the first pivotal demonstration of rapid improvement in the symptoms of dry eye disease,” CEO Todd Brady remarked.

Reporting $142.8M in cash and equivalents as of 2023-end, the company also reaffirmed its previously disclosed cash runway guidance beyond 2026 based on its current operating plan.