See Sources And More Here: GTBP Website. GTBP Presentation. -----
And as we mentioned earlier in the report, (Nasdaq: GTBP) has multiple potential catalysts on watch. Check them out:
#1. GTBP Potential Catalyst - The Company Can Proceed To A Phase 1 Clinical Trial Following FDA Clearance.
GT Biopharma Announces FDA Clearance of Investigational New Drug (IND) Application for GTB-5550 TriKE®, a B7-H3-Targeted Natural Killer (NK) Cell Engager for Solid Tumors Expressing B7-H3
GTB-5550 Phase 1 dose escalation basket trial expected to initiate mid-2026
Phase 1 protocol allows multiple solid tumor types known to express B7-H3
Unaudited proforma cash balance as of January 31, 2026 of approximately $9Mn anticipated to extend cash runway through Q4 2026
SAN FRANCISCO, CALIFORNIA, Feb. 03, 2026 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary TriKE® natural killer (NK) cell engager platform, today 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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Read the full article here. -----
#2. GTBP Potential Catalyst - Successful Completion Of The Cohort 3 Formal Safety Review Returns No Safety Or Tolerability Issues Observed.
GT Biopharma Provides Enrollment Update on GTB-3650 Phase 1 Trial in Patients with Relapsed or Refractory (r/r) CD33 Expressing Hematologic Malignancies
The formal safety review of Cohort 3 (5ug/kg/day) has been successfully completed with no safety or tolerability issues observed, allowing advancement into Cohort 4 with a dose of 10 ug/kg/day
Actively screening patients for Cohort 4; anticipate initiation of dosing in the coming weeks
Cohort 4 dose is potentially more reflective of the clinical efficacy threshold given positive trend in observations on multiple immunological biomarkers from the previous six patients in Cohorts 1 through 3, the absence of dose limiting toxicities, and the associated lower dose levels
SAN FRANCISCO, CALIFORNIA, Oct. 23, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary TriKE® natural killer (NK) cell engager platform, today announced successful completion of the Cohort 3 formal safety review with no safety or tolerability issues observed and advancement into Cohort 4 of its Phase 1 dose escalation trial evaluating GTB-3650 for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies.
The six patients in Cohorts 1 through 3 have been successfully treated with GTB-3650 and the formal safety review of Cohort 3 showed no safety or tolerability issues observed. This has allowed progression to actively screening patients for Cohort 4. With a dose of 10 ug/kg/day, Cohort 4 is more reflective of the potential efficacy threshold. The Phase 1 trial protocol allows for three additional cohorts with much higher dose levels ranging from 25 ug/kg/day with Cohort 5, 50 ug/kg/day with Cohort 6 and 100 ug/kg/day for Cohort 7, if necessary. ...
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Read the full article here. -----
#3. GTBP Potential Catalyst - Multiple Technical Indicators Point To This Profile Trending Around Oversold Levels On Wednesday.
At 2:30PM EST Wednesday, Barchart was reporting GTBP to have multiple oversold leaning technical indicators.
These technicals could be signaling a healthy reversal is approaching in the near term.
Here's the definition of a "reversal" from Investopedia:
"A reversal is a change in the price direction of an asset. A reversal can occur to the upside or downside. Following an uptrend, a reversal would be to the downside. Following a downtrend, a reversal would be to the upside. Reversals are based on overall price direction and are not typically based on one or two periods/bars on a chart."
Here's the technicals to pay close attention to (as of 2:30PM EST Wednesday):
- 9-Day Relative Strength Index: 36.85%
- 14-Day Relative Strength Index: 39.00%
When these numbers drop down to the 30% range and lower, they can be viewed as being in oversold territory. While in this territory, they can paint the picture of a profile that is undervalued.
- 9-Day Raw Stochastic %D: 2.05%
As the Raw Stochastic nears the 10% range and lower it may also be viewed as oversold and undervalued.
Keep an eye on these technicals closely. -----
#4. GTBP Potential Catalyst - There Is A Giant Market Opp. In Immuno-Oncology Drugs.
GT Biopharma could emerge as a disruptive force in the rapidly expanding immuno-oncology drugs market, valued at $120.37Bn in 2025 and projected to reach $226.31Bn by 2030, growing at a 13.5% CAGR.
As global cancer incidence rises, demand for more precise, scalable, and effective immune-based therapies is intensifying.
By advancing a novel NK cell engager platform that enhances targeted tumor killing while minimizing toxicity, GT Biopharma has the potential to address key limitations of current treatments.
Strategic clinical progress or partnerships could accelerate adoption and position the company at the forefront of next-generation immunotherapies across multiple cancer indications worldwide. -----
#5. GTBP Potential Catalyst - A Relatively Small Float May Help Establish An Environment For Heightened Volatility Potential.
According to info from the Yahoo Finance website, GTBP has a relatively low float.
The website reports this profile to have roughly 30.83Mn shares in its float.
Why is that important? It's important on one crucial level. Volatility potential.
If the company provides positive news during the first half of 2026, could it help provide a breakout spark when paired with this volatility potential? -----
(Nasdaq: GTBP) Recap - 5 Potential Catalysts Triggering Our Radar
#1. The Company Can Proceed To A Phase 1 Clinical Trial Following FDA Clearance.
#2. Successful Completion Of The Cohort 3 Formal Safety Review Returns No Safety Or Tolerability Issues Observed.
#3. Multiple Technical Indicators Point To This Profile Trending Around Oversold Levels On Wednesday.
#4. There Is A Giant Market Opp. In Immuno-Oncology Drugs.
#5. A Relatively Small Float May Help Establish An Environment For Heightened Volatility Potential. -----
Coverage is now officially underway on GT Biopharma, Inc. (Nasdaq: GTBP).
Be on the lookout for updates heading your way shortly. Talk soon.
Sincerely, FierceAnalyst | Jaks Swift Editorial Writer
(Always Remember The St-ock Prices Could Be Significantly Lower Now From The Dates I Provided.)
*FierceInvestor (FierceInvestor . com) is owned by SWN Media LLC, a limited liability company. Data is provided from third-party sources and FierceInvestor ("FI") is not responsible for its accuracy. Make sure to always do your own research and due diligence on any day and swing profile I bring to your attention. We do not provide personalized fin-ancial advice, are not finan-cial advisors, and our opinions are not suitable for all in-vest-ors.
Pursuant to an agreement between SWN Media LLC and TD Media LLC, SWN Media LLC has been hired for a period beginning on 05/13/2026 and ending on 05/14/2026 to publicly disseminate information about (GTBP:US) via digital communications. Under this agreement, TD Media LLC has paid SWN Media LLC twenty thousand USD ("Funds"). To date, including under the previously described agreement, SWN Media LLC has been paid twenty thousand USD ("Funds"). These Funds were part of the one hundred fifty thousand USD funds that TD Media LLC received from GT Biopharma Inc., the issuer of (GTBP:US).
Neither SWN Media LLC, TD Media LLC and their member own shares of (GTBP:US).
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