Apellis Pharmaceuticals (NASDAQ:APLS), Inc. APLS and its partner Swedish Orphan Biovitrum AB (Sobi) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion on and has recommended marketing authorization to Aspaveli (pegcetacoplan) for the treatment of paroxysmal nocturnal hemoglobinuria (“PNH”) in adult patients who are anemic following treatment with a C5 inhibitor for at least three months. The opinion will now be reviewed by the European Commission.
Per the company, if approved in Europe, Aspaveli will become a new class of complement medicines for the treatment of PNH. The drug is marketed under the trade name Empaveli in the United States.
The positive CHMP opinion was based on data from the head-to-head phase III PEGASUS study that evaluated the safety and efficacy of Aspaveli versus Soliris (eculizumab) at 16 weeks in adult patients with PNH who had persistent anemia despite treatment with Soliris.
Shares of Apellis have plunged 39.5% so far this year compared with the industry’s decrease of 11%.
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We remind investors that in May 2021, the FDA approved Empaveli (pegcetacoplan) as a monotherapy treatment for adult patients suffering from PNH. A rare blood disorder, PNH is associated with abnormally low hemoglobin levels as the disease destroys red blood cells.
Empaveli is approved for treatment-naïve patients as well as for those switching from Alexion’s [now part of AstraZeneca (NASDAQ:AZN)’s AZN] C5 inhibitor therapies for PNH, namely Soliris and Ultomiris (ravulizumab).
Apart from PNH, Apellis is developing Empaveli with Sobi for systemic administration in several indications.
Pegcetacoplan as a monotherapy is being evaluated in two phase III studies, namely, DERBY and OAKS, for treating patients with geographic atrophy. In September 2021, Apellis announced mixed top-line data from the DERBY and OAKS studies. While the OAKS study met the primary endpoint, the DERBY study did not.
Empaveli is also being investigated in the phase II MERIDIAN study for treating amyotrophic lateral sclerosis or ALS. The company plans to complete enrollment in this study by 2021 end. A potential label expansion of the drug for any of the above indications will be a boost to the company’s top-line.
Zacks Rank & Stocks to Consider
Apellis currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Intercept Pharmaceuticals, Inc. ICPT and Athenex (NASDAQ:ATNX), Inc. ATNX, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Intercept Pharmaceuticals’ loss per share estimates have narrowed 2.6% for 2021 and 8.3% for 2022, over the past 60 days.
Athenex’s loss per share estimates have narrowed 9% for 2021 and 9.2% for 2022, over the past 60 days.
(We are reissuing this article to correct a mistake. The original article, issued on October 18, 2021, should no longer be relied upon.)
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