Apellis Pharmaceuticals, Inc. - APLS STOCK NEWS

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.

Apellis Pharmaceuticals (APLS) reported its Q2 2020 results, highlighting a net loss of $118.6 million compared to $71.1 million in Q2 2019. The company has $833 million in cash as of June 30, 2020, up from $352 million at the end of 2019. Apellis is advancing pegcetacoplan for treating Paroxysmal Nocturnal Hemoglobinuria (PNH) and Geographic Atrophy (GA), with NDA and MAA submissions planned for late 2020. Enrollment in multiple Phase 3 trials is complete, with top-line data expected in 2021, indicating significant progress toward addressing complement-driven diseases.

Apellis Pharmaceuticals (NASDAQ: APLS) announced the completion of patient enrollment in its pivotal Phase 3 DERBY and OAKS studies, which target the treatment of geographic atrophy (GA) caused by age-related macular degeneration (AMD). A total of 1,259 patients are enrolled in the trials, assessing the efficacy of intravitreal pegcetacoplan, a targeted C3 therapy. The primary goal is to measure the reduction in GA lesion growth at 12 months. Top-line results are expected in Q3 2021. Currently, there are no approved treatments for GA, highlighting the significance of this research.

Apellis Pharmaceuticals (Nasdaq: APLS) announced its participation in the BMO 2020 Prescriptions for Success Healthcare Conference on June 23, 2020, at 11:30 a.m. ET. The event will be held virtually, featuring a fireside chat with Cedric Francois, M.D., Ph.D., co-founder and CEO. The presentation can be accessed via live webcast on the company’s website, with a replay available for 90 days. Apellis is focused on developing targeted C3 therapies for serious diseases affected by the complement cascade, including conditions in hematology, ophthalmology, and nephrology.

Apellis Pharmaceuticals (APLS) announced positive results from the Phase 3 PEGASUS study, confirming that pegcetacoplan significantly outperformed eculizumab in treating patients with paroxysmal nocturnal hemoglobinuria (PNH). 71% of pegcetacoplan-treated patients achieved LDH normalization, compared to 15% for eculizumab. The study also revealed 73% of pegcetacoplan patients noted a meaningful improvement in fatigue scores, while 85% were transfusion-free over 16 weeks. NDA and MAA submissions are planned for H2 2020.