Aldeyra Therapeutics Stock Down 24% After FDA Rejects Eye Cancer Treatment

By Sabela Ojea

Shares of Aldeyra Therapeutics dropped on Tuesday after the biotechnology company said the U.S. Food and Drug Administration denied approval for ADX-2191, a drug it is developing to treat a rare eye cancer.

At 12:34 p.m. ET, shares were down 24% at $8.07.

The FDA didn't identify safety or manufacturing issues with ADX-2191 but said there was a "lack of substantial evidence of effectiveness" and a "lack of adequate and well-controlled investigations" in the literature for its new drug application submission.

ADX-2191 is aimed at treating primary vitreoretinal lymphomas, a rare and aggressive intraocular cancer with a median survival of less than five years.

The drug is also under development for the treatment of the rare eye diseases proliferative vitreoretinopathy and retinitis pigmentosa.

Write to Sabela Ojea at [e-mail]; @sabelaojeaguix

(END) Dow Jones Newswires

06-21-23 1308ET