FDA & Biotech

Aptevo Therapeutics Surges 46% on Breakthrough AML Drug Results

Early trial data shows 100% complete remission in a key patient group, boosting hopes for a new frontline leukemia treatment.

Shares of Aptevo Therapeutics (APVO) skyrocketed more than 46% in after-hours trading after the company announced highly promising clinical results for its novel treatment for acute myeloid leukemia (AML), a fast-growing cancer of the blood and bone marrow. The biotech firm's update has injected significant optimism into a stock that has otherwise struggled over the past year.

The catalyst for the surge was data from Cohort 3 of its Phase 1b/2 RAINIER trial, which is evaluating a combination therapy for newly diagnosed AML patients who are unfit for intensive chemotherapy. in this patient group, a significant finding for a difficult-to-treat population.

where the bone marrow produces abnormal myeloblasts, a type of white blood cell. The treatment landscape for AML represents a , and effective new therapies, particularly for older or less healthy patients, are in high demand. Aptevo’s treatment, a combination of mipletamig, venetoclax, and azacitidine, demonstrated a strong safety profile with no dose-limiting toxicities or cytokine release syndrome reported.

While the clinical news is a major step forward, it comes after a punishing period for the company's investors. Even with the after-hours rally, Aptevo's stock remains down more than 98% over the past year, reflecting the high-risk, high-reward nature of biotech investing. This breakthrough, however, could mark a potential turning point for the company and its lead therapeutic candidate.

Company executives expressed optimism about the drug's potential to redefine frontline treatment for the disease. Aptevo plans to continue enrollment for a fourth cohort in the trial and anticipates in the fourth quarter of the year. Investors will be closely watching for these future updates to see if the early promise translates into a long-term success story.