Apellis Pharmaceuticals, Inc. - APLS STOCK NEWS

Apellis Pharmaceuticals (APLS) has released 18-month data from the Phase 1b APL2-103 study, demonstrating that intravitreal pegcetacoplan effectively slows the growth of geographic atrophy (GA) lesions. The post hoc analysis of seven patients exhibited a 52% reduction in lesion growth in the treated eye compared to the untreated eye. With no reported inflammation and only one case of new-onset exudation, the results indicate the safety of pegcetacoplan. Top-line data from the ongoing Phase 3 DERBY and OAKS studies are expected in Q3 2021.

Apellis Pharmaceuticals (APLS) announced results from a 41-patient observational study showing that elevated systemic levels of C3a correlate with COVID-19 severity. In a Phase 1/2 interventional study, initial safety results from six patients indicate APL-9, a targeted C3 therapy, may improve outcomes in severe cases. Key findings include that 97.5% of patients had significantly high C3a levels, averaging 3.7 times the upper limit of normal. An independent committee recommended continuing the investigation of APL-9, which is currently enrolling 60 more patients.

Apellis Pharmaceuticals (Nasdaq: APLS) announced positive results from the Phase 2 DISCOVERY study on pegcetacoplan for C3 glomerulopathy (C3G). Patients exhibited a mean reduction of over 65% in proteinuria after 48 weeks, a key indicator of kidney damage. The study included eight C3G patients, where one showed a 73.3% decrease in proteinuria, alongside improvements in serum albumin and renal function. No severe adverse events were recorded, demonstrating the treatment's potential for this rare disease without approved therapies.

Apellis Pharmaceuticals has granted equity awards to four new employees as an inducement to join the company. The awards, totaling options for 25,962 shares and 4,275 restricted stock units (RSUs), were approved under the 2020 Inducement Stock Incentive Plan. The options have an exercise price of $31.77, equal to the stock's closing price on the grant date, October 1, 2020. Vesting for options occurs yearly after the first year, while RSUs vest at 25% annually. This initiative aims to enhance workforce engagement and retention.

Apellis Pharmaceuticals (APLS) announced the initiation of registrational programs for pegcetacoplan in treating C3 glomerulopathy (C3G) and amyotrophic lateral sclerosis (ALS). Both conditions currently lack approved treatments. The Phase 2 NOBLE study for C3G will dose its first patient by year-end, with data from the Phase 2 DISCOVERY trial supporting its advancement. Additionally, a potentially registrational Phase 2 study in ALS will enroll about 200 patients globally, with the first patient expected to be dosed by year-end 2020.

Apellis Pharmaceuticals reported a significant finding from the post hoc analysis of the Phase 2 FILLY study, demonstrating that monthly treatment with pegcetacoplan resulted in a 39% reduction in the progression rate from nascent Geographic Atrophy (GA) to GA compared to sham treatment. The analysis included 42 pegcetacoplan-treated and 69 sham-treated patients and the results were presented at the 2020 EURETINA conference. These findings suggest a potential benefit for earlier intervention in GA management, particularly since there are currently no approved treatments for this condition affecting millions globally.

Apellis Pharmaceuticals (Nasdaq: APLS) announced it will present at Stifel’s 2020 Immunology and Inflammation Virtual Summit on October 1, 2020, at 9:00 a.m. ET. Cedric Francois, M.D., Ph.D., will participate in a panel discussing “The Evolution of Complement Targeted Therapies.” The event can be accessed live via webcast on the company’s website, with a replay available for 90 days post-event. Apellis specializes in developing therapies for diseases linked to complement cascade activation.

Apellis Pharmaceuticals (Nasdaq: APLS) announced that a post hoc analysis from the Phase 2 FILLY study of pegcetacoplan for geographic atrophy (GA) associated with age-related macular degeneration (AMD) will be presented as a late-breaking session at EURETINA 2020. This analysis indicates pegcetacoplan effectively influences the progression of nascent GA, highlighting its potential as a targeted therapy. Currently, there are no approved treatments for GA, affecting approximately one million people in the U.S. alone.

Apellis Pharmaceuticals (Nasdaq: APLS) has submitted a New Drug Application to the FDA and a Marketing Authorization Application to the EMA for pegcetacoplan, targeting paroxysmal nocturnal hemoglobinuria (PNH). The submissions rely on successful Phase 3 PEGASUS study results, showing pegcetacoplan's superiority to eculizumab in improving hemoglobin levels and other key metrics. Additionally, Australian regulators granted orphan drug designation for pegcetacoplan. FDA and EMA decisions on the submissions are anticipated in Q4 2020.