Apellis Pharmaceuticals, Inc. - APLS STOCK NEWS

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.

Apellis Pharmaceuticals (APLS) announced the approval of equity awards for four new employees on September 1, 2020. The grant includes options for 151,342 shares at an exercise price of $30.45, equivalent to the company's closing stock price on the grant date. The vesting schedule allows for one-fourth of the shares to vest annually, with complete vesting occurring after four years. These awards are intended to incentivize employees and align their interests with the company’s growth trajectory.

Apellis Pharmaceuticals (Nasdaq: APLS) announced its participation in several investor conferences in September 2020. Key events include the Baird 2020 Global Healthcare Conference on September 9, the Citi 15th Annual BioPharma Virtual Conference on September 10, and the Cantor Virtual Global Healthcare Conference on September 15. CEO Cedric Francois will engage in discussions at these conferences, including a panel on ophthalmology at Citi's event. Live webcasts will be available on the company's website, with replays accessible for 90 days.

Apellis Pharmaceuticals (Nasdaq: APLS) announced the approval of an equity inducement award for a new employee on August 17, 2020. This award, compliant with Nasdaq Listing Rule 5635(c)(4), involves options to purchase 111,560 shares of common stock at an exercise price of $29.76, equal to the stock's closing price on the grant date. The shares will vest over four years, contingent on the employee's continued employment. This move reflects Apellis' strategic approach to talent acquisition in the competitive biopharmaceutical sector.

Apellis Pharmaceuticals (Nasdaq: APLS) announced the approval of equity awards for two new employees, granted on August 3, 2020. The awards consist of options to purchase 13,400 shares at an exercise price of $27.72, equivalent to the stock's closing price on the grant date. These options will vest over four years, starting with 25% after the first year. This move aims to incentivize employee retention and align interests with shareholders. The announcement adheres to Nasdaq regulations, reflecting the company’s commitment to attracting talent as it develops targeted C3 therapies.