Empaveli

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Apellis Pharmaceuticals: Restart Of Growth Story After Empaveli's New Approval
Seeking Alpha· 2025-08-14 16:12
Core Insights - Apellis Pharmaceuticals (NASDAQ: APLS) has faced significant challenges over the past two years, including safety concerns regarding its product Syfovre, which have since been largely resolved, and a rejection from the European Medicines Agency [2]. Company Overview - Apellis Pharmaceuticals is currently navigating a recovery phase after overcoming a safety scare related to Syfovre, which has been a critical product for the company [2]. Investment Focus - The Growth Stock Forum, which covers Apellis Pharmaceuticals, emphasizes attractive risk/reward situations and closely tracks a model portfolio of 15-20 stocks, along with a top picks list of up to 10 stocks expected to perform well in the current calendar year [1].
Apellis Stock Rises on $300M Royalty Deal With Sobi for Aspaveli
ZACKS· 2025-07-02 15:36
Core Insights - Apellis Pharmaceuticals (APLS) shares increased by 3.2% following a capped royalty agreement with Sobi, allowing Apellis to receive up to $300 million for 90% of its future ex-U.S. royalties from Aspaveli [1][5] - The deal significantly enhances Apellis' financial position, providing operational flexibility with cash and marketable securities totaling $358.4 million as of the end of Q1 2025 [2] - The agreement includes a $275 million upfront payment and potential milestone payments of up to $25 million upon EU approval for Aspaveli in two severe kidney diseases [3][5] Financial Impact - The capped royalty deal will allow Sobi to receive 90% of ex-U.S. royalties until performance-based caps are met, after which all royalties will revert to Apellis [4] - Year-to-date, APLS shares have decreased by 44%, contrasting with a 3.4% decline in the industry [4] Regulatory Developments - Apellis and Sobi are seeking label expansion for Empaveli, with FDA and EU reviews currently underway for C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis [7] - A decision from the FDA is anticipated on July 28, 2025, while the EU decision is expected by year-end [7] Clinical Study Results - The phase III VALIANT study demonstrated a statistically significant 68% reduction in proteinuria for patients treated with Empaveli compared to placebo, indicating its effectiveness in C3G and IC-MPGN [9] - The study also showed that patients experienced stabilized kidney function, with 71% achieving complete clearance of C3c staining intensity [10][12]
Apellis Pharmaceuticals: Have Some Patience
Seeking Alpha· 2025-05-20 13:28
Group 1 - The market is highlighting the free cash flow (FCF) potential of Syfovre and Empaveli, with Syfovre projected to exceed $1 billion in annual sales despite initial rollout challenges due to infection reports [1] - The firm faced difficulties in launching Syfovre, but the outlook for its sales remains strong, indicating a recovery in market confidence [1] - A holistic investment approach is emphasized, considering both top-down and bottom-up valuation techniques, with a focus on capital structure and debt covenants impacting equity valuation [1]