Rocket One stock: Hoth ends HT-001 trial early, seeks FDA input
Published on 11/06/2026 at 00:23 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWSTrial Decision And Next Steps
- Rocket One says Hoth ended the HT-001 Phase 2a trial early after strong interim efficacy findings.
- The company plans to seek FDA feedback before pursuing a potential Phase 3 program.
Rocket One said on Tuesday, November 3, 2026, that its biotechnology subsidiary Hoth Therapeutics had ended the Phase 2a trial of HT-001 early after what the company described as strong interim efficacy findings. Morningstar carried the company release.
Trial Decision Supports Next Review
HT-001 is an investigational topical formulation of aprepitant, a neurokinin-1 receptor antagonist. Hoth is developing it for dermatologic toxicities associated with epidermal growth factor receptor inhibitor cancer therapies, including treatment-related rash and related symptoms.
Rocket One said the decision followed a review of interim efficacy and safety data. The company also said the interim findings remain preliminary and may change as additional data are collected and finalized.
FDA Feedback Comes Before Phase 3
Hoth plans to complete its remaining data review and analysis before seeking feedback from the U.S. Food and Drug Administration. The proposed discussions are expected to cover the design of a potential pivotal study, efficacy endpoints, the patient population, statistical considerations, safety requirements and manufacturing readiness.
A Phase 3 trial has not been announced as initiated. Rocket One said any move into a potential Phase 3 program will depend on regulatory feedback and completion of the required development work. HT-001 remains investigational and has not been approved by the FDA.
Rocket One Builds A Technology Portfolio
Rocket One is a US technology company with activities spanning artificial intelligence infrastructure, semiconductor technologies, space and defense systems, and autonomous platforms. Its Hoth subsidiary advances investigational therapeutic programs, while other company activities include licensed computing technologies and drone-related hardware, software, training and support. This gives Rocket One a diversified technology profile, with Hoth occupying a specialized biotechnology niche rather than serving as the group's sole operating focus.
Rocket One At A Glance
- Company: Rocket One Inc.
- Ticker: RKTO
- Home exchange: Nasdaq
- Clinical program: HT-001
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