GT Biopharma Announces FDA Clearance for GTB-3650 IND Application; Phase 1 Trial to Begin in H2 2024 With Initial Data Expected in H1 2025
Portfolio Pulse from Benzinga Newsdesk
GT Biopharma has received FDA clearance for its GTB-3650 IND application, with a Phase 1 trial set to begin in H2 2024 and initial data expected in H1 2025. Additionally, the company plans to submit an IND for GTB-5550 in Q1 2025, targeting B7H3 positive solid tumors, with a Phase 1 trial to follow. The company's cash runway is expected to fund operations into 2025.
June 27, 2024 | 1:16 pm
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GT Biopharma has received FDA clearance for its GTB-3650 IND application, with a Phase 1 trial set to begin in H2 2024 and initial data expected in H1 2025. Additionally, the company plans to submit an IND for GTB-5550 in Q1 2025, targeting B7H3 positive solid tumors, with a Phase 1 trial to follow. The company's cash runway is expected to fund operations into 2025.
The FDA clearance for GTB-3650 and the upcoming trials for GTB-5550 are significant milestones for GT Biopharma. These developments are likely to boost investor confidence and positively impact the stock price in the short term. The company's sufficient cash runway into 2025 further supports a positive outlook.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100