Apellis Pharmaceuticals, Inc. - APLS STOCK NEWS

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.

Apellis Pharmaceuticals (Nasdaq: APLS) announced the approval of equity awards for two new employees on March 1, 2021. The grants, consisting of options for 33,650 shares and 825 restricted stock units (RSUs), are part of the 2021 Inducement Stock Incentive Plan. The options have an exercise price of $47.68, matching the closing price on the grant date. Vesting is structured over four years, with a quarterly vesting schedule for options and annual vesting for RSUs. This move aligns with Nasdaq Listing Rule 5635(c)(4) and aims to enhance talent acquisition.

Apellis Pharmaceuticals (Nasdaq: APLS) announced it will cease further development of APL-9 for severe COVID-19 treatment. This decision follows an interim review by an independent data monitoring committee (DMC), which revealed no significant reduction in mortality rates in patients receiving APL-9 alongside standard care compared to those receiving standard care alone. However, the DMC reported no safety concerns. Full results will be shared at a scientific forum after data analysis.

Apellis Pharmaceuticals (APLS) announced its fourth quarter and full year 2020 financial results, revealing a net income of $78.3 million for Q4, compared to a net loss of $113.2 million in 2019. As of December 31, 2020, cash and investments totaled $877.6 million, supporting operations into late 2022. The FDA has accepted the NDA for pegcetacoplan for PNH with a PDUFA date of May 14, 2021. Positive Phase 3 data for pegcetacoplan indicates significant treatment benefits. Upcoming milestones include Phase 3 results for geographic atrophy expected in Q3 2021.

Apellis Pharmaceuticals (Nasdaq: APLS) announced its participation in three investor conferences in March 2021. The Raymond James 42nd Annual Institutional Investors Conference will feature a fireside chat on March 1 at 9:10 a.m. ET. The Cowen 41st Annual Health Care Conference will include a New Drug Launches panel on March 3 at 10:20 a.m. ET, while the Oppenheimer 31st Annual Healthcare Conference will host another fireside chat on March 17 at 8:40 a.m. ET. Webcasts will be available live and on a 90-day replay via the company’s website.