Apellis is a commercial-stage biopharmaceutical company that focuses on the discovery, development, and commercialization of therapeutic compounds through the inhibition of the complement system for autoimmune and inflammatory diseases.
One of Apellis’s leading therapeutic treatments, “SYFOVRE,” is an intravitreal pegcetacoplan injection that is the first and only approved therapy for geographic atrophy (“GA”), a leading cause of blindness. SYFOVRE is designed to provide comprehensive control of the complement cascade, part of the body’s immune system. In February 2023, SYFOVRE was approved by the U.S. Food and Drug Administration in the United States for the treatment of GA secondary to age-related macular degeneration.
The Class Period begins on January 28, 2021, the day of Apellis’s Virtual Investor Event wherein Apellis gave an online presentation to shareholders titled, “Pegcetacoplan: Advancing the First Potential Treatment for Geographic Atrophy (GA),” which highlighted its ongoing Phase 3 “DERBY and OAKS” clinical trials and its completed Phase 2 “FILLY” clinical trial. In its presentation to shareholders, Apellis touted the efficacy of using pegcetacoplan in patients with GA, including that the Phase 2 FILLY trial showed decreased lesion growth and that safety was “in line with other studies of intravitreally administered agents.”
Throughout the Class Period, Defendants repeatedly represented that SYFOVRE “demonstrated a favorable safety profile” with minimal adverse effects and “no events of retinal vasculitis or retinal vein occlusion” observed.
Notwithstanding Defendants’ claims regarding the safety of SYFOVRE, investors began to learn the truth on July 15, 2023, when the American Society of Retina Specialists (“ASRS”) published a letter highlighting concerns with SYFOVRE. Specifically, the ASRS indicated that physicians have reported cases of eye inflammation in patients treated with SYFOVRE, including six instances of occlusive retinal vasculitis, a type of inflammation that blocks blood flow through the vessels that feed the retina and potentially results in blindness. On this news, the price of Apellis common stock declined $32.04 per share, or nearly 38%, from a close of $84.50 per share on July 14, 2023, to close at $52.46 per share on July 17, 2023.
After the market closed on July 17, 2023, Apellis issued a statement addressing the concerns raised by ASRS regarding vasculitis and SYFOVRE, explaining that, of the six occurrences of vasculitis following SYFOVRE treatment, “two of the events were confirmed as occlusive, one was confirmed as non-occlusive, and the remaining three were undetermined based on limited information and lack of imaging.” Apellis further acknowledged that “[t]he Company is continuing to conduct a thorough investigation of each of the events, working closely with the [ASRS] and several external specialists.” On this news, the price of Apellis common stock declined an additional $12.46 per share, or 23.75%, to close at $40.00 per share on July 18, 2023.
Then, prior to the open of the market on July 20, 2023, Wedbush downgraded Apellis’s price target by more than 50%, from $86.00 per share to $40.00 per share. On this news, the price of Apellis common stock declined $6.25 per share, or approximately 15%, from a close of $40.49 per share on July 19, 2023, to close at $34.24 per share on July 20, 2023.
Finally, on July 29, 2023, Apellis provided an update on the company’s review of the six events of retinal vasculitis reported by the ASRS concerning SYFOVRE treatments. In the update, Apellis confirmed a seventh event of retinal vasculitis resulting from SYFOVRE treatment as determined by Apellis’s internal safety committee and external retina/uveitis specialists. Apellis also stated that the company is evaluating an eighth reported event of retinal vasculitis, which Apellis had not yet confirmed. On this news, the price of Apellis common stock declined $6.27 per share, or 19%, from a close of $32.02 per share on July 28, 2023, to close at $25.75 per share on July 31, 2023.
The Complaint alleges that, throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts, about the company’s business and operations. Specifically, Defendants misrepresented and/or failed to disclose that: (1) the design of SYFOVRE’s clinical trials was insufficient to identify incidents of retinal vasculitis in patients receiving SYFOVRE injections; (2) as a result, the commercial adoption of SYFOVRE was subject to significant, unknown risk factors; and (3) therefore, Defendants’ statements about the company’s business, operations, and prospects lacked a reasonable basis.