What are the expected regulatory pathways and timelines for FDA or EMA approval of TBS-2025, especially in combination therapy?

Regulatory roadmap

• U.S. (FDA) – With the acquisition of Kineta’s VISTA‑blocking mAb now called TBS‑2025, TuHURA will first file a new‑drug‑application (IND) amendment to add the planned 2H‑2025 Phase‑2 study of TBS‑2025 + a menin inhibitor in relapsed/refractory NPM1‑mutated AML. Because the trial targets a molecularly defined, high‑unmet‑need subset, the company is likely to pursue Fast‑Track and Breakthrough‑Therapy designations, which can accelerate the review of the pivotal data package. Assuming the Phase‑2 read‑out occurs in mid‑2026, the next step will be a registrational Phase‑3 trial (the “initiated Phase‑3” mentioned in the release) that could start in late‑2026 and run for ~24 months. A Biologics License Application (BLA) would be filed in the first half of 2028, with a 12‑month standard review (or 6‑month “priority” review if Breakthrough‑Therapy is granted). Realistically, FDA approval of TBS‑2025 as a monotherapy or in the menin‑combination indication would be expected late 2029 – early 2030.

• Europe (EMA) – Parallel to the U.S. filing, TuHURA can request the EMA PRIME scheme to obtain early scientific advice on the combination with the menin inhibitor. The EMA’s conditional marketing authorization (CMA) pathway is well‑suited to a targeted AML indication, allowing approval on the basis of Phase‑2 data with post‑marketing confirmatory studies. If the Phase‑2 data are positive (mid‑2026) and the Phase‑3 trial is completed by mid‑2028, the EMA submission would likely occur in H2 2028, with a standard 90‑day assessment (or 60‑day “accelerated assessment” if PRIME is granted). Expect EMA conditional approval by early 2030.

Trading implications

• The regulatory timeline compresses the next major catalyst to Q3 2025 (Phase‑2 start) and Q4 2026 (Phase‑2 read‑out). A positive read‑out would likely trigger a 30‑40 % rally as the path to a 2029‑30 approval becomes concrete, especially if Fast‑Track/PRIME designations are secured.
• The down‑side risk is the typical clinical‑trial volatility in AML and the added uncertainty of the menin‑inhibitor partner (potentially a third‑party asset). Until the Phase‑2 data are released, the stock remains high‑beta; a tight range (±5 % around current levels) is justified, with a buy‑on‑dip approach for traders looking to capture the upside from the anticipated regulatory milestones.