WALTHAM, Mass. - Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) disclosed on Monday that the European Medicines Agency (EMA) has adjusted the review schedule for its marketing authorization application for pegcetacoplan, a treatment for geographic atrophy (GA).
The EMA has moved the review back to the final phase of its initial assessment, with an opinion from the Committee for Medicinal Products for Human Use (CHMP) anticipated by July 2024.
The decision to reset the review timeline follows a March 14, 2024, ruling from the Court of Justice of the European Union (CJEU) that addressed the organization of the EMA's expert groups. The CJEU's decision has led to changes in EMA's policy regarding the management of potential conflicts of interest among its experts.
The EMA's procedural adjustment is not a reflection of the data submitted for pegcetacoplan but is a response to the CJEU's judgment. Apellis will maintain its collaboration with the EMA throughout the renewed review process.
Geographic atrophy is a chronic, progressive retinal disease that often results in blindness and currently lacks approved treatments. Apellis, a global biopharmaceutical company, has been at the forefront of developing therapies for complex diseases, including the introduction of a new class of complement medicines over the past 15 years. The company has two approved drugs targeting the C3 protein, with pegcetacoplan being the first therapy for GA if authorized.
The company's commitment to addressing serious retinal, rare, and neurological diseases by targeting C3 is part of its broader mission to deliver life-altering therapies to patients facing challenging conditions.
This update is based on a press release statement from Apellis Pharmaceuticals, and the company's future plans for pegcetacoplan are subject to approval by regulatory agencies. The timeline for the CHMP's opinion is a projection and could change based on the regulatory review process.
InvestingPro Insights
As Apellis Pharmaceuticals (NASDAQ:APLS) navigates the European regulatory landscape for its promising treatment pegcetacoplan, investors are closely monitoring the company's financial health and market performance. With a current market capitalization of $5.78 billion, Apellis has shown an impressive revenue growth of 425.83% over the last twelve months as of Q4 2023, which aligns with the InvestingPro Tips indicating that analysts anticipate sales growth in the current year.
Despite this growth, Apellis faces some financial challenges. The company's gross profit margin was negative at -4.11% for the same period, underscoring the InvestingPro Tips that point out weak gross profit margins. Additionally, the company's operating income margin stood at a significant -130.39%, reinforcing the concern that analysts do not anticipate the company will be profitable this year.
Investors should note that Apellis's stock has experienced a downturn over the past month, with a one-month price total return of -18.76%. However, the company's long-term performance has been robust, with a strong return over the last five years. This mixed short-term and long-term performance may be of interest to different types of investors.
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