GT Biopharma Aktie

GT Biopharma signed an agreement with the Regents of the University of Minnesota under which the university will support the IND application for GTB-5550 and act as sponsor-investigator for a Phase 1a/1b clinical study of GTB-5550 (camB7-H3 TriKE) in advanced solid tumors. GT Biopharma will provide up to approximately $3.8 million in funding and resources over three years; both parties retain publication rights. The company also submitted an IND application to the FDA for GTB-5550 and plans to restate prior quarterly filings after incorrectly classifying greenshoe rights as equity rather than a liability. » Plus sur de.investing.com

GT Biopharma has submitted an IND to the FDA for GTB-5550 TriKE, an NK-cell engager therapy targeting B7-H3–expressing solid tumors. The company plans a 2026 phase 1 basket study with subcutaneous dosing in seven cohorts (including prostate cancer, ovarian cancer, breast cancer, head and neck tumors, NSCLC, pancreatic carcinoma, and bladder cancer). In parallel, GT Biopharma is recruiting patients for a phase 1 study of GTB-3650 in myeloid blood cancer; cash on hand was about USD 7 million as of 31 Dec 2025, with financial runway into Q3 2026. » Plus sur de.investing.com

GT Biopharma has successfully completed the safety review of the third cohort in its phase‑1 dose‑escalation study of GTB‑3650 and will soon begin the fourth cohort at 10 µg/kg/day. No safety or tolerability issues were observed in the six patients treated across the first three cohorts. Screening for cohort four is ongoing; this dose level could better reflect the potential efficacy threshold, supported by positive trends in immunological biomarkers. The company has a solid liquidity position, plans additional cohorts up to 100 µg/kg/day, and expects a study update in the first quarter of 2026. » Plus sur de.investing.com