Delta-Fly Pharma’s Terminated Phase 3 AML Trial: What Investors Need to Know

Delta-Fly Pharma, Inc. (JP:4598) announced an update on their ongoing clinical study.

Study Overview

This Phase 3 study, officially titled “Phase 3 Randomized Trial of DFP-10917 vs Non-Intensive Reinduction (LoDAC, Azacitidine, Decitabine, Venetoclax Combination Regimens) or Intensive Reinduction (High & Intermediate Dose Cytarabine Regimens) for Acute Myelogenous Leukemia Patients in Second, Third, or Fourth Salvage,” was designed to compare Delta-Fly Pharma’s novel drug DFP-10917 with standard reinduction options in hard‑to‑treat acute myeloid leukemia. The aim was to see if DFP-10917 could extend survival and improve outcomes for patients who had already failed multiple prior treatments, a group with very limited options and high medical need.

Intervention/Treatment

The experimental treatment is DFP-10917, an anti‑cancer drug given as a continuous intravenous infusion over 14 days in a 28‑day cycle. It is meant to offer a more effective and potentially more tolerable option for patients whose leukemia has come back after several rounds of prior therapy. The control group received current standard approaches, which include both lower‑intensity drug regimens and aggressive chemotherapy combinations already used in this setting.

Study Design

This was a late‑stage, interventional study with patients randomly assigned to one of two groups: DFP-10917 or standard reinduction therapy. The design was parallel, meaning both groups were treated and followed at the same time. There was no blinding, so doctors and patients knew which treatment was given. The main goal was to treat the disease and compare survival and other key outcomes between the new drug and existing options.

Study Timeline

The trial was first submitted in April 2019, marking the formal start of clinical planning and site activation. The study status is now listed as terminated, which means it was stopped before full completion, although specific reasons are not provided in this extract. The most recent update to the record was submitted on January 21, 2026, signaling that Delta-Fly Pharma has refreshed or clarified the study information for investors, regulators, and clinicians. No results have yet been posted in the database at the time of the latest update.

Market Implications

The termination of this Phase 3 trial is a setback for Delta-Fly Pharma, as DFP-10917 was a key pipeline asset in a high‑value oncology niche. This development can weigh on investor sentiment and may increase share price volatility for JP:4598, at least in the near term, as the market reassesses the future revenue potential of the company’s pipeline. Larger competitors in acute myeloid leukemia—such as global pharma players with approved drugs like venetoclax‑based regimens and cytarabine‑based combinations—face little direct threat from DFP-10917 in the short run, which could modestly reinforce their entrenched position in this segment. For investors, the focus now shifts to Delta-Fly Pharma’s remaining candidates, cash runway, and any strategic pivots, such as partnerships, out‑licensing, or refocusing on earlier‑stage programs.

The study record for DFP-10917 in relapsed/refractory acute myeloid leukemia is now updated and terminated, with further details available on the ClinicalTrials portal.

To learn more about JP:4598’s potential, visit the Delta-Fly Pharma, Inc. drug pipeline page.