GT Biopharma Submits IND for GTB-5550, Aiming for 2026 Clinical Trials
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 15 2026
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Source: NASDAQ.COM
- IND Submission: GT Biopharma has submitted an IND application to the U.S. FDA for GTB-5550, targeting the B7-H3 protein to treat various solid tumors, potentially introducing a new therapeutic option in the $362 billion cancer market.
- Trial Design: The planned Phase 1 trial, set to begin in 2026, will include seven metastatic disease cohorts and utilize subcutaneous dosing, which is expected to enhance patient tolerability and convenience while monitoring progression-free survival and overall survival over a 12-month period.
- Platform Technology Advantage: GTB-5550 is built on the company's TriKE platform, featuring a dual nanobody design that activates NK cells and specifically binds to B7-H3 on tumor cells, potentially offering a more effective treatment approach for patients.
- Strong Financial Position: As of December 31, 2025, the company reported a preliminary cash balance of approximately $7 million, anticipated to extend its cash runway into the third quarter of 2026, thereby enhancing its R&D capabilities and market competitiveness.
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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: 0.722
Low
8.00
Averages
8.00
High
8.00
Current: 0.722
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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