Apellis Pharmaceuticals said Friday the Food and Drug Administration will review its new eye-disease drug in February, and APLS stock surged.
The new review date is actually a delay at Apellis' behest. Earlier this month, Apellis said it planned to send 24-month test data from studies called Derby and Oaks in its request for approval of the drug, dubbed pegcetacoplan. Pegcetacoplan is being developed for patients with geographic atrophy, a progressive disease that impacts vision and often leads to blindness.
The submission counts as a "major amendment" to Apellis' original request, which had the FDA slated to make a decision on pegcetacoplan this month. Now, the FDA will review the drug Feb. 26. Importantly, the FDA said it doesn't plan to hold an advisory committee meeting to discuss Apellis' drug. Advisory committees make non-binding recommendations on drugs' benefits and risks.
In morning trading on the stock market today, APLS stock rocketed 16.7% to 50.45. Meanwhile, shares of rival Iveric Bio catapulted 25.6% to 21.65. On Thursday, Iveric said the FDA granted it a breakthrough designation for its geographic atrophy treatment.
APLS Stock: Better Launch Position
The move is a complete turnaround from when Apellis first announced its plans to include the 24-month data in an updated submission. Then, APLS stock crashed 16%.
Apellis says it's taking the delay to allow for a better launch position.
"With the inclusion of the 24-month data, we have the potential to have the best product profile at launch for pegcetacoplan, with minimal impact to launch timing," Chief Executive Cedric Francois said in a written statement.
Researchers tested patients with every-other-month and monthly doses of pegcetacoplan. Recipients showed "increasing and consistent effects," Apellis said in its news release. The company plans to ask the European Union to sign off on the eye-disease drug by the end of the year.
Wedbush analyst Laura Chico remains cautious on Apellis' chances for commercial success. The drug requires an injection in the eye, a procedure only specialists can perform. So, while there's a large market of patients, there aren't any many physicians who can handle the workload.
"Based on our recent survey data, we do think initial commercialization may be challenging and as such continue to hold a cautious view," she said in a report. She has a neutral rating and 47 price target on APLS stock.
Shares Have Middling Ratings
Apellis shares crashed below their 200-day moving average earlier this month when the company announced its updated plans for the eye-disease treatment. On Friday, APLS stock opened above that line, though ticked below at the close, according to MarketSmith.com.
Still, in the aftermath, APLS stock has a middling Relative Strength Rating of 36. According to IBD Digital, this puts shares in the lowest 36% of all stocks in terms of 12-month performance.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
