After the company’s recent developments, GT Biopharma, Inc. (NASDAQ: GTBP) shares are climbing on the charts today. As of the most recent premarket check, GTBP stock was trading at $2.74 rising 35.64%. This increase follows the company’s disclosure about its regulatory filing withdrawal.
Registration Statement Withdrawal
GT Biopharma announced that it has formally requested to the U.S. Securities and Exchange Commission (SEC) to remove its previously filed Registration Statement on Form S-1 (File No. 333-284032).
This file was first made on December 23, 2024, before the SEC had determined that the registration statement was valid, and no securities were sold under this filing. Despite not including any completed offers or financial transactions so far, the withdrawal represents a significant upgrade in GT Biopharma’s regulatory approach.
Research on Cancer Treatment Advances
With the development of GTB-3650, a second-generation TriKE intended to treat relapsed or refractory CD33-expressing hematologic malignancies, GT Biopharma is making progress in the clinical arena.
In a Phase 1 study to assess the safety and effectiveness of GTB-3650, GTBP just administered its first dosage to a patient. By increasing potency and binding affinity through the use of camelid nanobody technology, this novel medication may provide better therapeutic results.
Phase 1 Trial and Prospects
In the current Phase 1 dosage escalation research, about 14 patients with refractory or relapsed hematologic malignancies, including high-risk myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), are participating. Depending on clinical benefit, patients will get therapy in two-week cycles for a maximum of four months.
Safety, pharmacokinetics, and the in vivo proliferation of natural killer cells in patients are among the many aspects that the experiment seeks to evaluate. In 2025, GT Biopharma plans to release the study’s preliminary findings, which would be a significant turning point in the clinical development of GTB-3650.