Apellis Pharmaceuticals, Inc. - APLS STOCK NEWS

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.

Apellis Pharmaceuticals (Nasdaq: APLS) announced an investor conference call for June 12, 2020, to discuss detailed results from the Phase 3 PEGASUS study of pegcetacoplan (APL-2) against eculizumab for paroxysmal nocturnal hemoglobinuria (PNH). This comes ahead of its presentation at the 25th Annual Congress of the European Hematology Association. The call will feature Apellis management and key study investigator Peter Hillmen, providing insights into the study's findings and future implications.

Apellis Pharmaceuticals (Nasdaq: APLS) has announced the grant of equity awards to four new employees, effective June 1, 2020. This grant is part of the 2020 Inducement Stock Incentive Plan, with the options to purchase 37,800 shares at an exercise price of $34.01. The awards will vest over four years, with a quarter vesting after one year and the remainder monthly thereafter. Additionally, the company highlights its commitment to advancing targeted C3 therapies for severe diseases.

Apellis Pharmaceuticals (Nasdaq: APLS) will present at the Goldman Sachs 41st Annual Global Healthcare Conference on June 11, 2020, at 1:20 p.m. ET. The presentation will feature a fireside chat with co-founder and CEO Cedric Francois, M.D., Ph.D. The event is set to take place virtually and can be accessed live via the company's website. A replay of the webcast will be available for 90 days post-event. Apellis focuses on pioneering targeted C3 therapies aimed at treating debilitating diseases arising from excessive activation of the complement cascade.

Apellis Pharmaceuticals (Nasdaq: APLS) has granted an equity inducement award to a new employee, comprising an option to purchase 23,216 shares of common stock at an exercise price of $33.94, equal to the stock's closing price on the grant date, May 26, 2020. The award was approved on April 30, 2020, in compliance with Nasdaq Listing Rule 5635(c)(4). The shares will vest over four years, with one-fourth vesting on the one-year employment anniversary and the remainder vesting monthly thereafter.

Apellis Pharmaceuticals has initiated a Phase 1/2 clinical study of APL-9, a novel C3 inhibitor, targeting COVID-19 patients experiencing respiratory failure, including ARDS. This trial follows preliminary evidence showing complement activation is significantly elevated in COVID-19-related ARDS. The study will enroll 66 patients and aims to assess APL-9's safety alongside standard care, with secondary objectives related to hospital stay duration and survival rates. The FDA has expedited the review of APL-9, which may control the complement cascade and improve outcomes in severe COVID-19 cases.

Apellis Pharmaceuticals (APLS) plans to submit a New Drug Application (NDA) for pegcetacoplan targeting paroxysmal nocturnal hemoglobinuria (PNH) in H2 2020, following a successful pre-NDA meeting with the FDA. The NDA will include results from the Phase 3 PEGASUS trial, which demonstrated pegcetacoplan's superiority over eculizumab in improving hemoglobin levels. The study's safety profile was comparable to that of eculizumab. Regulatory discussions with EU authorities are also set for Q2 2020, as Apellis aims to further develop pegcetacoplan for PNH and other conditions.