Apellis rises in a 180-degree turn;  The FDA will review the eye drug

Apellis Pharmaceuticals (APLS) said Friday that the Food and Drug Administration will review its new eye drug in February, and APLS stock jumped.


The new review date is actually a delay at the behest of Apellis. Earlier this month, Apellis said it planned to submit 24-month trial data from studies called Derby and Oaks in its request 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 filing is considered a “major amendment” to Apellis’ original request, which prompted the FDA to make a decision on pegcetacoplan this month. The FDA will now review the drug on February 26.

In the pre-market trade of the stock market today, APLS shares jumped 16.8% to close at 50.50. Meanwhile, the shares of the rival Iverick Bio (I SEE) catapulted 20.5% near 20.80.

APLS stock: Better starting position

The move is a complete reversal from when Apellis first announced plans to include 24 months of data in an updated presentation. APLS shares then fell 16%.

Apellis says it removes the delay to allow for a better starting position.

“With the inclusion of the 24-month data, we have the potential to have the best product-to-market profile for pegcetacoplan, with minimal impact on time to market,” CEO Cédric Francois said in a written statement.

The researchers tested patients with monthly and monthly doses of pegcetacoplan. Recipients showed “incremental and sustained 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.

The stock has an average rating

Apellis shares fell below theirs 200 day moving average earlier this month when the company announced its updated plans to treat eye diseases. APLS stock now looks likely to open near that line, according to MarketSmith.com.

Still, APLS shares have been average subsequently Relative strength assessment of 36. According to IBD Digitalthis puts the stock in the bottom 36% of all stocks in terms of 12-month performance.

Follow Alison Gatlin on Twitter at @IBD_AGatlin.


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