Aptevo Therapeutics stock price plummets despite positive trial data

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Investing.com – Aptevo Therapeutics Inc. (NASDAQ:APVO) stock fell 18% on Tuesday, despite the company announcing positive mid-stage clinical trial results for its acute myeloid leukemia (AML) treatment candidate mipletamig.

This clinical-stage biotech company announced that mipletamig, when used in combination with venetoclax and azacitidine, achieved an 86% clinical benefit rate in newly diagnosed elderly or unfit AML patients who are not suitable for intensive chemotherapy. The treatment regimen did not result in cases of cytokine release syndrome among all patients receiving first-line therapy.

In the RAINIER trial and completed dose-escalation studies involving 28 evaluable first-line patients, 79% achieved complete remission or complete remission with incomplete hematologic recovery, and 61% achieved complete remission. Additionally, 55% of patients who achieved remission reached measurable residual disease-negative levels with blast reduction.

The company reported that four treated patients have undergone allogeneic stem cell transplants so far. Notably, 35% of patients who achieved remission carried TP53 gene mutations, a high-risk biomarker often associated with poor prognosis in AML.

Aptevo Therapeutics Chief Medical Officer Dirk Huebner stated, “Emerging data on mipletamig in first-line AML treatment is very encouraging, highlighting the differentiated features we believe are necessary to advance first-line AML therapy.”

The RAINIER trial is a Phase 1b/2 dose-optimization, multi-center study recruiting AML adult patients aged 18 or older who are newly diagnosed and unfit for intensive induction chemotherapy. The Phase 1b trial includes 28-day treatment cycles across multiple cohorts.

Despite positive clinical data, the stock price decline suggests investors may have concerns about the company’s commercialization pathway or capital requirements.

This article was translated with the assistance of artificial intelligence. For more information, please see our Terms of Use.

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