Rocket One's Hoth Therapeutics Reports Strong HT-001 Efficacy Results, Ends Phase 2a Early and Plans to Pursue Phase 3 to Bring Treatment to Cancer Patients
PR Newswire•03/11/2026•08:17 ET
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Key Highlights
- ➤HT-001 Phase 2a ends early after strong interim efficacy results
- ➤Hoth plans FDA feedback on potential Phase 3 clinical program
- ➤HT-001 remains investigational and is not FDA-approved for any indication
- ➤Rocket One (RKTO) owns Hoth Therapeutics, its biotechnology subsidiary
Expert Statements
Robb Knie, Chief Executive Officer of Rocket One
“We are encouraged by the strength of the interim findings and believe they support taking the next step toward a potential Phase 3 program.”
Robb Knie, Chief Executive Officer of Rocket One
“Our goal is to help patients manage the skin toxicity associated with EGFR inhibitor therapy so they can better tolerate their cancer treatment. We are now focused on presenting the data to the FDA and establishing the requirements for the next stage of HT-001's development.”
Robb Knie, Chief Executive Officer of Rocket One
“Moving toward a potential pivotal program is a meaningful development objective for Hoth.”
Robb Knie, Chief Executive Officer of Rocket One
“We believe these findings warrant a focused discussion with the FDA about how to evaluate HT-001 in a larger study and generate the evidence needed to support a potential registration pathway.”
Rocket One's Hoth Therapeutics Reports Strong HT-001 Efficacy Results, Ends Phase 2a Early and Plans to Pursue Phase 3 to Bring Treatment to Cancer Patients PR Newswire
Positive interim findings drive early trial conclusion; Hoth prepares to seek FDA alignment on a potential pivotal study for cancer treatment–related skin toxicity
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