Apellis Pharmaceuticals, Inc. - APLS STOCK NEWS

Apellis Pharmaceuticals announced FDA approval of EMPAVELI™ (pegcetacoplan), a groundbreaking targeted C3 therapy for adults with paroxysmal nocturnal hemoglobinuria (PNH). This therapy is approved for treatment-naïve patients and those switching from C5 inhibitors like Soliris® and Ultomiris®. In the pivotal Phase 3 PEGASUS study, EMPAVELI demonstrated superiority over Soliris in increasing hemoglobin levels and a significant 85% of EMPAVELI patients were transfusion-free at Week 16. However, EMPAVELI carries a boxed warning for serious infections, necessitating vaccinations before treatment.

Apellis Pharmaceuticals (Nasdaq: APLS) announced the acceptance of seven abstracts for the European Hematology Association (EHA) Virtual Congress from June 9-17, 2021, showcasing the potential of pegcetacoplan, a targeted C3 therapy, for paroxysmal nocturnal hemoglobinuria (PNH). An oral presentation and e-posters emphasize pegcetacoplan's efficacy and safety. The FDA has set a target action date of May 14, 2021, for its marketing application.

Apellis Pharmaceuticals (Nasdaq: APLS) announced the grant of equity awards to two new employees on May 3, 2021. The grant includes options for 13,200 shares at an exercise price of $50.20 and 7,100 restricted stock units (RSUs). The equity awards aim to incentivize new hires as part of the company's 2020 Inducement Stock Incentive Plan. Shares from the options will vest over four years, while RSUs will vest 25% annually. This move is compliant with Nasdaq Listing Rule 5635(c)(4).

Apellis Pharmaceuticals (APLS) announced its Q1 2021 financial results and key business developments. The FDA's review of pegcetacoplan for paroxysmal nocturnal hemoglobinuria (PNH) is ongoing, with a target action date of May 14, 2021. The company expects top-line results from the Phase 3 PRINCE study and GA studies in Q2 and Q3 2021, respectively. Cash reserves stand at $723.7 million, ensuring operational runway into late 2022. However, the company reported a Q1 net loss of $183.7 million, up from $168.8 million in 2020, driven by rising R&D and administrative expenses.

Apellis Pharmaceuticals (APLS) will hold a conference call on April 28, 2021, at 4:30 p.m. ET to discuss its Q1 2021 financial results. Investors can join the call by dialing (866) 774-0323 for domestic calls or (602) 563-8683 for international calls, entering conference ID # 7883183. The event can also be accessed via webcast from the company’s website. Apellis is focused on developing targeted C3 therapies for various diseases driven by excessive activation of the complement cascade.

Apellis Pharmaceuticals (APLS) announced the acceptance of 10 abstracts for presentation at the ARVO Annual Meeting from May 1-7, 2021. Key highlights include five oral presentations showcasing the potential of pegcetacoplan, an investigational C3 therapy, targeting geographic atrophy (GA). The presentations emphasize AI analytics for monitoring GA lesions and new safety and efficacy data from the Phase 2 FILLY study. Pegcetacoplan has received Fast Track designation for GA and is being evaluated across various clinical studies.

Apellis Pharmaceuticals (APLS) announced promising results from the Phase 1b APL2-103 study of pegcetacoplan, showing a 46% reduction in mean lesion growth in patients with geographic atrophy after 24 months (p=0.007). The study involved 12 patients, and data from eight patients demonstrated significant efficacy compared to untreated eyes. No significant inflammation was reported, with only 16% developing new onset exudation. The company expects top-line results from pivotal Phase 3 DERBY and OAKS studies in Q3 2021 and plans to invite participants from the 1b study to a long-term extension study.

Apellis Pharmaceuticals (APLS) announced that pegcetacoplan, a targeted C3 therapy, outperformed eculizumab in the Phase 3 PEGASUS study for treating paroxysmal nocturnal hemoglobinuria (PNH). The study demonstrated a statistically significant increase in hemoglobin levels of 3.8 g/dL (p<0.001) at 16 weeks. Additionally, 85% of patients receiving pegcetacoplan were transfusion-free compared to 15% with eculizumab. Marketing applications for pegcetacoplan are under Priority Review by the FDA, with a target action date of May 14, 2021, and are also under review by the EMA.

Apellis Pharmaceuticals (APLS) announced the publication of post hoc analyses from the Phase 2 FILLY study, validating the efficacy of pegcetacoplan, a C3 therapy for geographic atrophy (GA) secondary to AMD. The articles, featured in Ophthalmology and the American Journal of Ophthalmology, confirm consistent results across patient subgroups, indicating a significant unmet need in GA treatment, which currently lacks approved therapies. With over 1,200 patients enrolled in ongoing Phase 3 studies, Apellis aims to provide a breakthrough solution for approximately five million GA patients globally.