GT Biopharma Receives FDA Clearance for GTB-5550 IND Application
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 5d ago
0mins
Should l Buy GTBP?
GT Biopharma announced FDA clearance of its IND application for GTB-5550, allowing the company to proceed with a Phase 1 clinical trial, which is anticipated to initiate in mid-2026. "FDA clearance of our third TriKE IND, GTB-5550, represents a defining moment for GT Biopharma as we bring another NK cell engager into the clinic", said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma. "We expect to commence enrollment of the Phase 1 basket trial in mid-2026. While the phase I trial is open to patients with common solid tumors that express B7-H3, in the dose-escalation component we will prioritize enrollment for advanced prostate, ovarian, and pancreatic cancer patients who have failed standard therapies. Based on the encouraging trends we have seen from our ongoing Phase 1 trial with GTB-3650 in AML patients, we are even more enthusiastic about the potential benefits of GTB-5550 treatment in patients with solid tumors known to express B7-H3."
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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: 0.496
Low
8.00
Averages
8.00
High
8.00
Current: 0.496
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.
GT Biopharma Initiates Phase 1 Trial for GTB-5550
- FDA Approval for Trial: GT Biopharma has received FDA clearance to proceed with the Phase 1 clinical trial for GTB-5550, expected to start in mid-2026, marking a significant advancement in NK cell therapy that could provide new treatment options for various solid tumor patients.
- Strong Cash Position: As of January 31, 2026, GT Biopharma anticipates an unaudited proforma cash balance of approximately $9 million, which is expected to extend its cash runway through Q4 2026, ensuring funding for its clinical trial operations.
- Innovative Trial Design: The Phase 1 trial of GTB-5550 will utilize a dual nanobody TriKE® approach administered via subcutaneous injection, testing up to six dose levels to identify the maximum tolerated dose (MTD), providing a more patient-friendly administration experience.
- Multiple Cancer Indications: The trial will prioritize enrollment of patients with advanced prostate, ovarian, and pancreatic cancers who have failed standard therapies, aiming to evaluate the safety and preliminary anti-tumor activity of GTB-5550 across various metastatic disease cohorts, which holds significant clinical implications.
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- Portable Technology Application: The company integrates multi-million dollar MRI capabilities into portable ultrasound devices, enabling hospital-grade cardiac diagnostics at primary care facilities, which reduces patient referral needs and improves healthcare service efficiency.
- Market Demand Response: As the healthcare industry faces increasing demand for visual diagnostics in 2026, Ventripoint's technological solutions not only meet urgent patient needs but also open new market opportunities, strengthening its strategic position in healthcare infrastructure development.
- Long-Term Growth Potential: By providing efficient cardiac diagnostic tools, Ventripoint is laying the groundwork for future healthcare infrastructure, showcasing its long-term growth potential in the global medical market.
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- Cardiac Diagnostic Innovation: Ventripoint Diagnostics partners with Nisg̱a'a Valley Health Authority to deploy AI-driven 3D heart mapping, eliminating geographic blind spots in cardiac care and enabling rapid access to high-quality diagnostics for patients in remote areas, significantly enhancing healthcare accessibility.
- Portable Technology Application: The company integrates multi-million dollar MRI capabilities into portable ultrasound devices, allowing hospital-grade diagnostics to be performed at primary care facilities, thereby reducing patient referral needs and improving healthcare efficiency and patient experience.
- Market Demand Response: As the demand for rapid heart diagnostics increases among patients, Ventripoint's technology not only meets this urgent need but also establishes a benchmark in healthcare infrastructure, potentially attracting more investment and partnership opportunities.
- Strategic Positioning: By introducing advanced diagnostic technology to primary healthcare, Ventripoint is providing a blueprint for future healthcare infrastructure development, demonstrating its strategic significance in improving public health and driving medical innovation.
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GT Biopharma Submits IND for GTB-5550 Targeting $362 Billion Solid Tumor Market
- Market Transformation: The precision medicine sector is projected to grow from $138 billion in 2026 to over $537 billion by 2035, marking a shift towards modular biologics that creates substantial market opportunities for companies like GT Biopharma.
- New Drug Application: GT Biopharma submitted an IND for GTB-5550 to the FDA in December 2025, targeting the B7-H3 protein to treat various solid tumors, which is expected to significantly enhance the company's competitiveness in cancer treatment.
- Clinical Trial Progress: The planned Phase 1 trial for GTB-5550 will evaluate its efficacy across seven distinct metastatic disease cohorts, potentially providing critical clinical data to further advance the company's product pipeline.
- Dual Program Advancement: GT Biopharma is concurrently advancing its Phase 1 trial of GTB-3650, having successfully treated multiple patients with a favorable safety profile, which is expected to significantly expand its addressable patient population.
See More
GT Biopharma Submits IND for GTB-5550, Aiming for 2026 Clinical Trials
- 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.
See More
GT Biopharma (GTBP) Submits IND Application for GTB-5550, Plans Phase 1 Trial in 2026
- IND Application Submitted: GT Biopharma has submitted an IND application to the U.S. FDA for GTB-5550 TriKE, targeting B7-H3 expressing solid tumor cancers, marking a significant advancement in its oncology treatment portfolio.
- Clinical Trial Plans: The company plans to initiate a Phase 1 trial of GTB-5550 in 2026, aimed at evaluating its efficacy across multiple solid tumors, thereby advancing its research pipeline.
- Cash Position: As of December 31, 2025, GT Biopharma reported a preliminary unaudited cash balance of approximately $7 million, which is expected to extend its cash runway into the third quarter of 2026, ensuring the continuity of its R&D activities.
- Additional Research Progress: The company is also conducting a Phase 1 study of GTB-3650 for myeloid blood cancers, with the next data readout anticipated in the first half of 2026, further enriching its product pipeline.
See More
GT Biopharma Initiates Phase 1 Trial for GTB-5550
- FDA Approval for Trial: GT Biopharma has received FDA clearance to proceed with the Phase 1 clinical trial for GTB-5550, expected to start in mid-2026, marking a significant advancement in NK cell therapy that could provide new treatment options for various solid tumor patients.
- Strong Cash Position: As of January 31, 2026, GT Biopharma anticipates an unaudited proforma cash balance of approximately $9 million, which is expected to extend its cash runway through Q4 2026, ensuring funding for its clinical trial operations.
- Innovative Trial Design: The Phase 1 trial of GTB-5550 will utilize a dual nanobody TriKE® approach administered via subcutaneous injection, testing up to six dose levels to identify the maximum tolerated dose (MTD), providing a more patient-friendly administration experience.
- Multiple Cancer Indications: The trial will prioritize enrollment of patients with advanced prostate, ovarian, and pancreatic cancers who have failed standard therapies, aiming to evaluate the safety and preliminary anti-tumor activity of GTB-5550 across various metastatic disease cohorts, which holds significant clinical implications.
See More
Ventripoint Partners with Nisg̱a'a to Enhance Cardiac Diagnostics with AI Technology
- Cardiac Diagnostic Innovation: Ventripoint Diagnostics partners with Nisg̱a'a Valley Health Authority to deploy AI-driven 3D heart mapping technology, significantly reducing diagnosis times and addressing accessibility issues for patients in remote areas, thereby enhancing the company's competitive edge in the medical technology sector.
- Portable Technology Application: The company integrates multi-million dollar MRI capabilities into portable ultrasound devices, enabling hospital-grade cardiac diagnostics at primary care facilities, which reduces patient referral needs and improves healthcare service efficiency.
- Market Demand Response: As the healthcare industry faces increasing demand for visual diagnostics in 2026, Ventripoint's technological solutions not only meet urgent patient needs but also open new market opportunities, strengthening its strategic position in healthcare infrastructure development.
- Long-Term Growth Potential: By providing efficient cardiac diagnostic tools, Ventripoint is laying the groundwork for future healthcare infrastructure, showcasing its long-term growth potential in the global medical market.
See More
Ventripoint Partners with Nisg̱a'a Valley to Enhance Cardiac Diagnostics
- Cardiac Diagnostic Innovation: Ventripoint Diagnostics partners with Nisg̱a'a Valley Health Authority to deploy AI-driven 3D heart mapping, eliminating geographic blind spots in cardiac care and enabling rapid access to high-quality diagnostics for patients in remote areas, significantly enhancing healthcare accessibility.
- Portable Technology Application: The company integrates multi-million dollar MRI capabilities into portable ultrasound devices, allowing hospital-grade diagnostics to be performed at primary care facilities, thereby reducing patient referral needs and improving healthcare efficiency and patient experience.
- Market Demand Response: As the demand for rapid heart diagnostics increases among patients, Ventripoint's technology not only meets this urgent need but also establishes a benchmark in healthcare infrastructure, potentially attracting more investment and partnership opportunities.
- Strategic Positioning: By introducing advanced diagnostic technology to primary healthcare, Ventripoint is providing a blueprint for future healthcare infrastructure development, demonstrating its strategic significance in improving public health and driving medical innovation.
See More
GT Biopharma Submits IND for GTB-5550 Targeting $362 Billion Solid Tumor Market
- Market Transformation: The precision medicine sector is projected to grow from $138 billion in 2026 to over $537 billion by 2035, marking a shift towards modular biologics that creates substantial market opportunities for companies like GT Biopharma.
- New Drug Application: GT Biopharma submitted an IND for GTB-5550 to the FDA in December 2025, targeting the B7-H3 protein to treat various solid tumors, which is expected to significantly enhance the company's competitiveness in cancer treatment.
- Clinical Trial Progress: The planned Phase 1 trial for GTB-5550 will evaluate its efficacy across seven distinct metastatic disease cohorts, potentially providing critical clinical data to further advance the company's product pipeline.
- Dual Program Advancement: GT Biopharma is concurrently advancing its Phase 1 trial of GTB-3650, having successfully treated multiple patients with a favorable safety profile, which is expected to significantly expand its addressable patient population.
See More
GT Biopharma Submits IND for GTB-5550, Aiming for 2026 Clinical Trials
- 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.
See More
GT Biopharma (GTBP) Submits IND Application for GTB-5550, Plans Phase 1 Trial in 2026
- IND Application Submitted: GT Biopharma has submitted an IND application to the U.S. FDA for GTB-5550 TriKE, targeting B7-H3 expressing solid tumor cancers, marking a significant advancement in its oncology treatment portfolio.
- Clinical Trial Plans: The company plans to initiate a Phase 1 trial of GTB-5550 in 2026, aimed at evaluating its efficacy across multiple solid tumors, thereby advancing its research pipeline.
- Cash Position: As of December 31, 2025, GT Biopharma reported a preliminary unaudited cash balance of approximately $7 million, which is expected to extend its cash runway into the third quarter of 2026, ensuring the continuity of its R&D activities.
- Additional Research Progress: The company is also conducting a Phase 1 study of GTB-3650 for myeloid blood cancers, with the next data readout anticipated in the first half of 2026, further enriching its product pipeline.
See More
