Apellis Pharmaceuticals APLS Stock News

Apellis Pharmaceuticals Inc (NASDAQ: APLS) is flying for the top in the market this morning, gaining more than 20% early on. The gains come after the company announced new data, suggesting that it may hold the key to a primary competitor to Alexion Pharmaceuticals’ Solaris. Here’s what’s going on:

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APLS Stock Soars On Positive Data

In a press release issued early this morning, Apellis Pharmaceuticals announced positive results from a Phase 3 clinical study. The study, known as PEGASUS worked to evaluate pegcetacoplan (APL-2) as a potential option for adults with paroxysmal nocturnal hemoglobinuria.

In the release, APLS said that top-line data from the study show that the drug met its primary efficacy endpoint. To do so, the drug demonstrated superiority to eculizumab with a statistically significant improvement in adjusted means of 3.8 g/dL of hemoglobin at week 16.

The data show that at week 16, patients treated with the experimental drug had an adjusted mean hemoglobin increase of 2.4 g/dL from a baseline of 8.7 g/dL when compared to eculizumab-treated patients.

Importantly, pegcetacoplan showed promising results when it comes to secondary endpoints as well. The drug met non-inferiority on transfusion avoidance and absolute reticulocyte count endpoints. The drug also showed positive trends on lactate dehydrogenase and fatigue as measured by the Functional Assessment of Chronic Illness Therapy fatigue score.

In a statement, Federico Grossi, M.D., Ph.D., CMO at APLS, had the following to offer:

Pegcetacoplan is the first and only investigational therapy to demonstrate superiority compared to eculizumab on hemoglobin levels. We are also excited to see that 85% of patients treated with pegcetacoplan were transfusion free. At Apellis, we are focused on developing groundbreaking therapies, and these results show that pegcetacoplan has the potential to transform the lives of people with PNH. We look forward to meeting with regulators in the first half of the year to discuss next steps.

Why Investors Are Jumping On This Stock

Positive data is a great thing. However, at this stage of the game, it’s not just about positive data. First and foremost, it’s important to remember that PEGASUS is a Phase 3 clinical trial. This is generally the last phase before seeking approval from the FDA.

Considering the overwhelmingly positive results from the trial, it’s likely that Apellis Pharmaceuticals will be submitting a New Drug Application to the FDA relatively soon.

It’s also important to consider how the study was done. To test the efficacy of pegcetacoplan, APLS stood the drug head to head against a blockbuster treatment known as Solaris. Of course, as the data suggest, pegcetacoplan has proven to be the more effective option.

Should the FDA see this the same way, the drug could quickly become a cash cow. Think about it, with Solaris, Alexion Pharmaceuticals is generating more than $3 billion in annual revenue. While this will be a big blow to Alexion, for APLS, the news is huge!

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