Apellis Pharmaceuticals (APLS) said on Friday the Food and Drug Administration will review the new eye drug in February and APLS stock rallied.
X
The new assessment date is actually a delay at the behest of Apellis. Earlier this month, Apellis said it planned to submit 24 months of trial data from studies called Derby and Oaks to request approval of a 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 is considered a “major modification” to Apellis’ original request, which the FDA is expected to make a decision on pegcetacoplan this month. Now, the FDA will review the drug on February 26.
In the pre-marketing transaction on stock market today, APLS stock spiked 16.8% to nearly 50.50. Meanwhile, rival shares Iveric Biology (I SEE) increased by 20.5% near 20.80.
APLS Stock: Better Launch Position
The move is a complete turnaround since Apellis first announced plans to include 24-month data in an updated submission. After that, APLS stock fell 16%.
Apellis says it is using delay to get a better launch position.
CEO Cedric Francois said in a written statement: “With the inclusion of 24 months of data, we are likely to have the best product profile at launch for pegcetacoplan, with minimal impact to pegcetacoplan. release date.”
The researchers tested patients with monthly and monthly doses of pegcetacoplan. Apellis said in the press release that recipients have shown a “growing and consistent effect”. The company plans to ask the European Union to approve the drug for the eye disease later this year.
Stocks with an average rating
Apellis stock has fallen below their level 200-day moving average earlier this month when the company announced an updated plan to treat eye disease. Now, APLS stock looks set to open near that line, according to MarketSmith.com.
After that, however, APLS stock has an average Relative Strength Rating of 36. Theo Digital IBDthis puts the stock in the bottom 36% of all stocks in terms of 12-month performance.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
YOU MIGHT ALSO LIKE:
Biotech stocks head for neuroscience renaissance with Biogen, Amylyx at the helm
Pfizer, BioNTech Taking Next Step Towards Pan-Covid Vaccine – But Is The Demand There?
Get stock ideas from IBD experts every morning before opening
Stocks to buy and watch: Top IPOs, large and small caps, growth stocks
