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Apellis Submits Pegcetacoplan Applications to FDA and EMA

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Apellis Pharmaceuticals, Inc. (APLS - Free Report) announced the submission of a new drug application (NDA) to the FDA and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for its investigational drug, pegcetacoplan, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in the United States and the European Union, respectively.

Shares of the company have gained 1.9% year to date compared with the industry’s growth of 2.1%.

The NDA and MAA submissions are based on results from the phase III PEGASUS study comparing pegcetacoplan monotherapy to Alexion’s (ALXN - Free Report) PNT drug, Soliris, in patients with PNH. The PEGASYS study met its primary endpoint of improvement in hemoglobin levels and pegcetacoplan showed its superiority to Soliris. The candidate also demonstrated non-inferiority to Soliris on two other metrics, including the number of individuals who were transfusion-free. Hence, the positive results from the study showed that pegcetacoplan has the potential to become a new standard of care for PNH. In June, the company reported new data from the PEGASYS study, which showed that the benefit of pegcetacoplan treatment was consistent across the study population, both in patients who had low or no transfusion requirements and high transfusion requirements.

The FDA and EMA decisions on the acceptance of the NDA and MAA submissions, respectively, are expected in the fourth quarter of 2020.

If approved, this will be the first marketed drug of the company and will bring in significant revenues.

Further, the company announced that the Australian Therapeutic Goods Administration (TGA) granted orphan drug designation to pegcetacoplan in PNH. This designation in Australia is granted to therapies for serious rare diseases that have the potential to provide a significant benefit in comparison to approved treatments. Apellis plans to submit a marketing application in Australia in the fourth quarter of 2020.

Pegcetacoplan is a promising candidate being developed for subcutaneous administration in several indications. Two phase III studies (DERBY and OAKS) evaluating pegcetacoplan in patients with geographic atrophy in age-related macular (GA) are ongoing and the company expects to announce data from these studies in the third quarter of 2021.

Pegcetacoplan is also being evaluated in phase II studies for the treatment of cold agglutinin disease (CAD). The company is also evaluating the candidate in phase II studies to treat four types of glomerular diseases— C3 glomerulopathy (C3G), IgA nephropathy, primary membranous nephropathy and lupus nephritis.

Zacks Rank &Stocks to Consider

Apellis currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. (EBS - Free Report) and Bio Techne Corp (TECH - Free Report) . While Emergent sports a Zacks Rank #1 (Strong Buy), Bio Techne carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Emergent’s earnings estimates have increased from $4.03 to $6.07 for 2020 and from $5.07 to $6.17 for 2021 over the past 60 days. Shares of the company have increased 90.4% year to date.

Bio Techne’s earnings estimates have increased from $5.33 to $5.48 for 2020 and from $6.41 to $6.50 for 2021 over the past 60 days. Shares of the company have increased 11.9% year to date.

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