Apellis appears during a 180 degree turn;  FDA to review eye drug

Apellis appears during a 180 degree turn; FDA to review eye drug

Buzz Update Apellis appears during a 180 degree turn; FDA to review eye drug

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


The new review date is actually a delay at the request of Apellis. Earlier this month, Apellis said he planned to send 24-month test data from studies called Derby and Oaks in his application for approval of the drug, dubbed 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 application, which had expected 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 on the benefits and risks of drugs.

In morning trading in the stock market today, APLS stock soared 20.2% near 52. Meanwhile, shares of rival Organic chipboard (I SEE) catapulted 22.6% to 21.10. On Thursday, Iveric said the FDA granted him breakthrough designation for his treatment for geographic atrophy.

APLS action: best launch position

The move is a complete reversal from when Apellis first announced its intention to include the 24-month data in an updated submission. Then the APLS stock crashed 16%.

Apellis says he’s falling behind 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 on the launch schedule,” chief executive Cedric Francois said in a statement. writing.

The researchers tested patients with bimonthly and monthly doses of pegcetacoplan. Recipients showed “increasing and consistent effects,” Apellis said in his press release. The company plans to seek European Union approval for the eye disease drug by the end of the year.

Wedbush analyst Laura Chico remains cautious about Apellis’ chances of commercial success. The drug requires an injection into the eye, a procedure that only specialists can perform. So, even though there is a large market of patients, there are not many physicians who can handle the workload.

“Based on our recent survey data, we believe initial commercialization may be difficult and as such we continue to be cautious,” she said in a statement. It has a neutral rating and a price target of 47 on APLS shares.

Stocks have average ratings

Shares of Apellis slumped below their 200-day moving average earlier this month when the company announced its updated plans for treating eye disease. On Friday, APLS stock opened above that line, according to MarketSmith.com.

Yet in stride, APLS stock has an average relative strength rating of 36. According to IBD Digital, that puts the stock in the bottom 36% of any stock in terms of 12-month performance.

Follow Allison Gatlin on Twitter at @IBD_AGatlin.


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