GT Biopharma Completes Safety Review for GTB-3650 Phase 1 Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 04 2025
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Source: PRnewswire
- Clinical Progress: GT Biopharma has successfully completed the safety review for its GTB-3650 Phase 1 trial, with all six participants showing no safety or tolerability issues at progressively higher doses, indicating the therapy's potential in treating relapsed blood cancers.
- Dose Advancement: The company has moved into Cohort 4, where patients will receive a dose of 10μg/kg/day, which is expected to be closer to the clinical efficacy threshold, potentially enhancing treatment outcomes and improving patient prognosis.
- Patient Recruitment: GT Biopharma is actively screening patients for Cohort 4 and anticipates initiating dosing in the coming weeks, which will provide a more comprehensive clinical update in the first quarter of 2026.
- Technology Platform: GTB-3650 employs the company's proprietary TriKE platform technology, aiming to target cancer cells by stimulating patients' natural killer cells, showcasing innovative potential in treating acute myeloid leukemia and high-risk myelodysplastic syndrome.
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Analyst Views on GTBP
Wall Street analysts forecast GTBP stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for GTBP is 8.00 USD with a low forecast of 8.00 USD and a high forecast of 8.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 0.680
Low
8.00
Averages
8.00
High
8.00
Current: 0.680
Low
8.00
Averages
8.00
High
8.00
About GTBP
GT Biopharma, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on the development and commercialization of immuno-oncology therapeutic products based on its proprietary Tri-specific Killer Engager (TriKE) natural killer (NK) cell engager platform. Its TriKE platform is designed to harness and enhance the cancer-killing abilities of a patient’s immune system’s natural killer cells. Its product candidate pipeline includes GTB-3550, GTB-3650, GTB-5550, GTB-7550, GTB-6550, GTB-1050, and other product candidates. GTB-3550 is a TriKE comprised of two single-chain variable fragments (scFv) composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. GTB-3650 is a TriKE which targets CD33 on the surface of myeloid leukemias. The Company also has a worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE technology.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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