Shares of Aldeyra Therapeutics (ALDX 3.25%) were soaring 26.6% higher as of 10:54 a.m. EDT on Tuesday. The big jump came after the company announced positive top-line results from a late-stage study evaluating reproxalap in treating allergic conjunctivitis, inflammation of the eyes caused by allergies.
Biotech stocks usually rise on positive clinical results. But the really big gains come when the results are especially good. That's the case for Aldeyra.
Reproxalap easily achieved the primary endpoint of the study (reduction in eye itching) with a high level of statistical significance. It also achieved all of the secondary endpoints of the study with high levels of statistical significance.
The results were exactly what investors were hoping for. They weren't really surprising, though. Aldeyra previously reported positive results from another late-stage study of reproxalap in treating allergic conjunctivitis.
More than 66 million people in the U.S. are affected by allergic conjunctivitis. While some treatments are available, there hasn't been a new therapeutic mechanism in decades.
Aldeyra's next step is to meet with the U.S. Food and Drug Administration (FDA) about a path to approval for reproxalap. This meeting is expected to take place in the second half of this year, with a potential regulatory filing for approval on the way afterward.