TuHURA Biosciences, Inc. (NASDAQ: HURA) had a notable surge in its shares during Monday’s extended session, closing at $3.04 after jumping 20.16%. Following the news of a completed merger agreement with Kineta, Inc., which was well received by both companies’ investors at their respective Special Meetings, the rally took place.
Shareholder Approvals and Strategic Reincorporation
All proposals, including one to expand the company’s authorized shares to 200 million and another to re-incorporate in Delaware, were approved by TuHURA shareholders at the Special Meeting of Stockholders. Likewise, the planned merger was approved by Kineta investors. According to the firms, if the remaining requirements are met or waived, the deal would be completed soon.
The FDA Approves the Phase 3 Clinical Trial
The U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on TuHURA’s Phase 3 study for IFx-2.0 due to manufacturing concerns. This is a separate but strategically connected event. The clearance allows the company to proceed with site activation and trial initiation under the previously agreed Special Protocol Assessment (SPA) with the FDA.
Milestone-Linked Funding Secured for Trial Progress
The removal of the FDA hold also marked the fulfillment of the second milestone tied to TuHURA’s recent private placement, unlocking an additional $2.23 million in funding. When used as a first-line therapy for patients with advanced or metastatic Merkel cell carcinoma (MCC), the Phase 3 study will assess IFx-2.0 in addition to Keytruda. About 118 participants from 22 to 25 clinical sites in the US will be a part of the experiment.
Focus on Efficacy and Safety Endpoints
Overall Response Rate (ORR) is the study’s main outcome, and safety, response length, overall survival, and progression free survival (PFS) are important secondary outcomes. While positive PFS results without sacrificing overall survival might remove the necessity for a confirmatory post-approval study and open the door to normal approval, success in the ORR measure could result in expedited approval.
