Apellis Pharmaceuticals, Inc. - APLS STOCK NEWS

Apellis Pharmaceuticals (APLS) announced significant updates in its Q2 2022 report, achieving $15.7 million in U.S. net revenue from EMPAVELI. The company received FDA acceptance for a New Drug Application for pegcetacoplan targeting geographic atrophy, with a review target date of November 26, 2022. Cash and investments totaled $852.8 million as of June 30, 2022, ensuring a runway into Q1 2024. Notably, Apellis also initiated a Phase 3 study for IC-MPGN and C3G, marking a transformative period for the company, as it advances multiple therapeutic programs.

Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced the grant of equity awards to two new employees as of August 1, 2022. These equity inducement awards are outside of the company's 2017 Stock Incentive Plan, aligning with the terms of the 2022 Inducement Stock Incentive Plan. Each employee received options for 2,409 restricted stock units (RSUs), which will vest at 25% annually over four years, contingent upon continued employment. This initiative is part of Apellis' strategy to attract top talent in the biopharmaceutical sector.

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.