Apellis Pharmaceuticals (APLS) said on Friday that the Food and Drug Administration will review its new eye disease drug in February, and APLS stock rose.
The new revision date is actually a delay at the behest of Apellis. Earlier this month, Apellis said it planned to send 24 months of trial data from studies called Derby and Oaks in its application for approval of the drug, called pegcetacoplan. Pegcetacoplan is being developed for patients with geographic atrophy, a progressive disease that affects vision and often leads to blindness.
The submission counts as a “major amendment” to Apellis’ original request, which had set the FDA to make a decision on pegcetacoplan this month. Now, the FDA will review the drug on February 26. Importantly, the FDA said it does not plan to hold an advisory committee meeting to discuss Apellis’ drug. Advisory committees make non-binding recommendations about the benefits and risks of medicines.
In morning trading today, APLS stock jumped 20.2% to close at 52. Meanwhile, shares of rival Iveric Bio ( ISEE ) was up 22.6% by the 10/21 close. On Thursday, Iveric said the FDA granted it a breakthrough designation for the treatment of geographic atrophy.
Stock APLS: Best place to start
The move is a complete reversal from when Apellis first announced plans to include 24 months of data in an updated filing. APLS stock subsequently plunged 16%.
Apellis says it does the delay to allow for a better launch position.
“By including 24 months of data, we have the potential to have the best product profile at launch for pegcetacoplan, with minimal impact on the launch schedule,” CEO Cedric Francois said in a written statement.
The researchers looked at patients with every other monthly and monthly dose of pegcetacoplan. Recipients showed “increasing and consistent results,” Apellis said in its press release. The company plans to ask the European Union to sign off on the eye drug by the end of the year.
Wedbush analyst Laura Chico remains bullish on Apellis’ chances of commercial success. The drug requires an injection into the eye, a procedure that only specialists can perform. So while there is a large market for patients, there aren’t many doctors who can handle the workload.
“Based on our recent research data, we believe initial commercialization may be challenging and therefore continue to maintain a cautious view,” she said in a report. He has a neutral rating and price target of 47 on APLS stock.
The shares have medium ratings
Shares of Apellis fell below their 200-day moving average earlier this month when the company announced updated plans for the eye treatment. On Friday, APLS stock opened above that line, according to MarketSmith.com.
However, then APLS stock has an average relative strength score of 36. According to IBD Digital, this puts the stock in the bottom 36% of all stocks in terms of 12-month performance.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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