Apellis Pharmace Stock Price, News & Analysis

Apellis Pharmaceuticals (Nasdaq: APLS) announced a conference call on August 8, 2022, at 4:30 p.m. ET to discuss its second quarter 2022 financial results. Investors can pre-register for the live call and access a webcast with accompanying slides on the company's website. Apellis is recognized for its leadership in complement therapeutics, having introduced the first new class of complement medicine in 15 years. The company aims to develop transformative therapies for rare, retinal, and neurological diseases.

Apellis Pharmaceuticals, Inc. (Nasdaq:APLS) announced on July 27, 2022, the completion of privately negotiated exchange agreements involving its 3.500% Convertible Senior Notes due 2026. Approximately $65.9 million of these Notes will be exchanged for 2,036,886 shares of common stock, while another $9.7 million will be swapped for additional shares based on a calculated valuation. The transactions are set to close by August 1, 2022, contingent on customary conditions. Notably, the shares issued will not be registered under the Securities Act, limiting their sale.

Apellis Pharmaceuticals (Nasdaq: APLS) announced that the FDA has accepted its New Drug Application (NDA) for pegcetacoplan, a targeted C3 therapy for the treatment of geographic atrophy (GA) due to age-related macular degeneration (AMD). The PDUFA target action date is set for November 26, 2022. This application has been granted a Priority Review designation, highlighting its potential as a breakthrough treatment. The submission is based on data from the Phase 2 FILLY and Phase 3 DERBY and OAKS studies, involving over 1,500 patients, showing clinically meaningful results and a favorable safety profile.

Apellis Pharmaceuticals (Nasdaq: APLS) announced significant new data from Phase 3 studies at the American Society of Retina Specialists Annual Meeting. The results support the efficacy of pegcetacoplan in slowing lesion growth in geographic atrophy (GA) associated with age-related macular degeneration (AMD). The company submitted a New Drug Application to the FDA in June 2022, with a decision on acceptance expected in August 2022. Pegcetacoplan has no current approved treatments for GA, highlighting an urgent need for effective therapies for this debilitating condition.

Apellis Pharmaceuticals (Nasdaq: APLS) announced the grant of equity awards to six new employees, effective July 1, 2022. This grant comprised options to purchase 20,295 restricted stock units (RSUs), which will vest 25% annually over four years, contingent on the employees' continued employment. This equity inducement aligns with Nasdaq Listing Rule 5635(c)(4) and aims to facilitate employee recruitment and retention. Apellis continues to focus on delivering innovative therapies in complement medicine and advancing treatments for rare diseases.

Apellis Pharmaceuticals (Nasdaq: APLS) has expanded its R&D collaboration with Affilogic to include Nanofitins® targeting the transferrin receptor (TfR), facilitating drug delivery across the blood-brain barrier. This partnership aims to develop brain-active C3 inhibitors to treat neurodegenerative diseases by combining technologies. Apellis also plans to submit IND applications for two promising candidates: APL-1030 for neurodegenerative conditions and APL-2006 for age-related macular degeneration. The agreement grants Apellis exclusive patent rights for all development projects.

Apellis Pharmaceuticals (APLS) and Sobi announced new analyses of Phase 3 studies on EMPAVELI (pegcetacoplan) for paroxysmal nocturnal hemoglobinuria (PNH), revealing its efficacy and safety. The results indicate significant quality of life improvements for treatment-naïve patients and comparable thrombosis rates to eculizumab. Additionally, a matching-adjusted indirect comparison (MAIC) showed better clinical outcomes for EMPAVELI compared to C5 inhibitors. These findings are set to be presented at the European Hematology Association Congress in Vienna.

Apellis Pharmaceuticals (APLS) and Sobi have commenced the Phase 3 VALIANT study for pegcetacoplan, targeting primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) and C3 glomerulopathy (C3G). This study addresses a significant unmet need, as these rare conditions currently lack approved treatments. The trial involves approximately 90 patients aged 12 and older, with a primary endpoint of achieving at least a 50% reduction in urine protein-to-creatinine ratio after 26 weeks. The results of this study could have substantial implications for patient care and market potential.

Apellis Pharmaceuticals (Nasdaq: APLS) announced the approval of equity inducement awards for thirteen new employees, effective June 1, 2022. These awards included options to purchase 55,900 shares and 72,711 restricted stock units (RSUs). The options were granted at an exercise price of $41.35, matching the stock's closing price on the grant date. Vesting will occur over four years for options and annually for RSUs, contingent on continued employment. This initiative aligns with Nasdaq Listing Rules, supporting talent acquisition in the competitive biopharmaceutical sector.