Oncternal Therapeutics Inc. (ONCT) shares surged 8.97% in after-hours on Tuesday, January 04, 2021, and closed the daily trading at $2.55. However, in the regular trading of Tuesday, ONCT’s stock lost 3.70%. ONCT shares have fallen 51.75% over the last 12 months, and they have moved down 0.00% in the past week. Over the past three months, the stock has lost 42.22%, while over the past six months, it has declined 46.82%.
Let’s see what’s going on recently with the company?
ONCT agreement with FDA
On January 04, 2022, Oncternal Therapeutics, Inc. (ONCT), and the U.S. Food and Drug Administration agreed on key elements of the company’s potentially pivotal Phase 3 clinical trial of zilovertamab for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL). The agreement was made after a successful End-of-Phase 2 meeting with the FDA for zilovertamab, the company’s investigational anti-ROR1 monoclonal antibody, for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL).
The FDA has also reviewed and agreed upon the key design features and operational details of the company’s Phase 3 clinical trial protocol and Statistical Analysis Plan, which is being finalized based on the FDA’s input.
Data presentation at ASH 2021
On December 13, 2021, Oncternal Therapeutics, Inc. (ONCT), presented updated interim clinical data from the ongoing Phase 1/2 CIRLL (Cirmtuzumab and Ibrutinib targeting ROR1 for Leukemia and Lymphoma) clinical trial, in a poster presentation at the American Society of Hematology (ASH) 2021 Annual Meeting.
The clinical trial was conducted in collaboration with UC San Diego and is partially funded by the California Institute for Regenerative Medicine (CIRM). zilovertamab is being evaluated in combination with ibrutinib in patients with MCL and CLL.
ONCT inducement award
The Board approved the award for Carina Freedman which consists of an option to purchase 34,100 shares of Oncternal common stock, with a 10-year term and an exercise price equal to the closing price of Oncternal’s common stock on the date of grant.
ONCT-216 clinical trial data presentation
Oncternal Therapeutics, Inc. (ONCT) presented updated interim clinical data, from the Phase 2 expansion cohort of its ongoing Phase 1/2 clinical trial evaluating ONCT-216 (formerly TK216), in patients with relapsed or refractory Ewing sarcoma, in an oral presentation at the Connective Tissue Oncology Society (CTOS) 2021 Virtual Annual Meeting, which was held on November 13, 2021.
The recent agreement with the FDA was the reason behind its turnaround in the after-hours on Tuesday and we can expect it to further surge in the coming trading sessions on Wednesday.