The Food and Drug Administration accepted Apellis Pharmaceuticals' application for an eye-disease treatment on Tuesday, leading APLS stock to surge.
If approved, Apellis' treatment would be the first for geographic atrophy, an advanced form of age-related macular degeneration and a leading cause of blindness. The FDA will make its decision by Nov. 26. Notably, the FDA doesn't plan to ask its advisors to weigh the benefits and risks of the Apellis drug, a step known as an advisory committee meeting.
"This is a very exciting time for the retina community as we are closer than ever to having the first treatment for (geographic atrophy), an irreversible and devastating disease that causes a tremendous amount of vision loss," Dr. Charles Wykoff, Retina Consultants of Texas director of research, said in a written statement. Wykoff led one of Apellis' final-phase studies.
On today's stock market, APLS stock rocketed 6.3% to 52.06.
APLS Stock Breaks Out In High Volume
Apellis' application is based on studies that examined its drug, pegcetacoplan, for 12 and 18 months. In every study, pegcetacoplan recipients showed clinically meaningful reductions in lesions on their eyes, a symptom of geographic atrophy. The drug also proved safe in more than 1,500 patients tested.
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Importantly, the FDA granted Apellis a priority review for pegcetacoplan. This designation is applied to drugs that would treat a serious condition and provide a significant improvement for patients.
Next, Apellis plans to ask the European Medicines Agency for approval in the second half of 2022.
APLS stock easily topped a cup-with-handle and a buy point at 50.81, according to MarketSmith.com.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
