Aptevo Therapeutics Inc APVO stock is surging on Wednesday.
As per data from Benzinga Pro, the stock is trading higher with a strong volume of 81.8 million compared to the average volume of 275.3k.
What Happened: Aptevo revealed new clinical data from its ongoing Phase 1b/2 RAINIER trial evaluating mipletamig, its first-in-class CD123 x CD3 bispecific antibody, in combination with standard-of-care venetoclax and azacitidine (ven/aza) for newly diagnosed patients with acute myeloid leukemia (AML) who are unfit for intensive chemotherapy.
Across two trials, the mipletamig triplet therapy delivered remissions in 85% of evaluable frontline AML patients, significantly exceeding results from competitor studies, including those achieved in the Viale A trial that evaluated venetoclax and azacitidine (ven/aza) as doublet therapy.
One patient who was taken off study and successfully received a transplant.
Also Read: Aptevo Therapeutics Says Two Additional Patients In Early-Stage Leukemia Trial Achieve Remission Within 30 Days of Treatment
One CR patient had no minimal residual disease (MRD-negative status) but did have the genetic biomarker TP53, which is associated with resistance to chemotherapy and some targeted therapeutics.
These updated results from the RAINIER dose expansion trial demonstrate a compelling efficacy advantage alongside a strong safety profile.
No cytokine release syndrome (CRS) was observed in either cohorts 1 or 2.
Cohort 3 Nears Full Enrollment at highest dose level evaluated to date in combination therapy.
Why It Matters: AML remains an aggressive and difficult-to-treat blood cancer, particularly for older or medically unfit patients, where treatment options are limited and outcomes are generally poor.
To date, results from the RAINIER trial demonstrate mipletamig’s increasingly impressive clinical profile, highlighting its potential as a differentiated, highly targeted immunotherapy with a compelling safety profile.
Additionally, on Wednesday, Aptevo Therapeutics announced a registered direct offering of $8 million.
The company offered 2.465 million shares or pre-funded warrants to purchase up to 12.325 million at $3.25 per share and associated warrants.
The warrants will have an exercise price of $3.25 per share.
Price Action: APVO stock is up 137.2% at $6.69 at the last check on Wednesday.
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