WALTHAM, Mass. - Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) has announced the acceptance of its Phase 3 VALIANT study abstract for an oral presentation at the American Society of Nephrology (ASN) Kidney Week. The study evaluates the efficacy and safety of pegcetacoplan in treating C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). The presentation is scheduled for Saturday, October 26, at the conference in San Diego, CA.
The VALIANT study is a significant randomized, placebo-controlled, double-blinded trial that includes both adolescent and adult patients with native and post-transplant kidneys. It is the largest single trial conducted for these patient populations, enrolling 124 participants who received either pegcetacoplan or a placebo twice weekly for 26 weeks. The primary endpoint was the change in the urine protein-to-creatinine ratio (uPCR) at Week 26 compared to baseline.
C3G and IC-MPGN are rare kidney disorders characterized by excessive C3c deposits, leading to inflammation, damage, and potentially kidney failure. There are currently no treatments targeting the underlying cause of these diseases. The conditions affect an estimated 5,000 people in the United States and up to 8,000 in Europe.
In addition to the oral presentation, two poster presentations are also slated for the same day, providing insights into pegcetacoplan's long-term safety and efficacy, as well as its use in post-transplant recurrent C3G or IC-MPGN.
Apellis Pharmaceuticals focuses on developing therapies for challenging diseases, with a particular emphasis on complement-mediated conditions. The company has already seen success with two approved C3-targeting medicines, including a treatment for geographic atrophy, a leading cause of blindness.
Following the ASN Kidney Week presentation, Apellis will host a webinar detailing the VALIANT study results. The webinar, featuring key study investigators, will take place on Saturday, October 26, at 12:30 p.m. PT. Access to the live audio webcast and replay will be available through the company's website.
The information presented in this article is based on a press release statement from Apellis Pharmaceuticals.
In other recent news, Apellis Pharmaceuticals reported a robust Q2 2024 growth with its products SYFOVRE and EMPAVELI generating significant revenues. SYFOVRE achieved over $0.5 billion in sales since its launch and $155 million in net product revenue in Q2 2024 alone, while EMPAVELI contributed notably with $24.5 million in sales. However, the company faced a setback after the European Medicines Agency's Committee for Medicinal Products for Human Use issued a final negative opinion on the potential European regulatory approval for SYFOVRE. This led Mizuho Securities to reduce its price target for Apellis to $39, while maintaining a Neutral rating. In contrast, Baird adjusted its price target for Apellis to $92, maintaining an Outperform rating, despite the EU setback. Meanwhile, Stifel sustained its Buy rating and $84.00 stock price target for Apellis, citing strong performance and demand in the U.S. market. These are some of the recent developments concerning Apellis Pharmaceuticals.
InvestingPro Insights
As Apellis Pharmaceuticals (NASDAQ:APLS) prepares to present its Phase 3 VALIANT study results at the upcoming ASN Kidney Week, investors may be keen to understand the company's financial position and market performance. According to InvestingPro data, Apellis has shown impressive revenue growth, with a 240.74% increase in the last twelve months as of Q2 2024. This strong growth aligns with the company's focus on developing innovative therapies for challenging diseases, including its recent successes in complement-mediated conditions.
However, it's important to note that despite the revenue growth, Apellis is not currently profitable. An InvestingPro Tip indicates that analysts do not anticipate the company will be profitable this year. This is not uncommon for biopharmaceutical companies investing heavily in research and development, especially those with promising pipelines like Apellis.
The company's market capitalization stands at $3.4 billion, reflecting investor expectations for future growth. Another InvestingPro Tip suggests that analysts anticipate sales growth in the current year, which could be driven by the potential success of treatments like pegcetacoplan, currently under study for C3G and IC-MPGN.
For investors interested in a deeper analysis, InvestingPro offers 10 additional tips for Apellis Pharmaceuticals, providing a more comprehensive view of the company's financial health and market position.
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