Premier Research to support submission of an Expanded Access Program (EAP) application.
This move positions Hoth to offer compassionate access to HT-001 for cancer patients suffering from painful and debilitating skin toxicities caused by epidermal growth factor receptor (EGFR) inhibitor therapies—an area of high unmet medical need.
“We’re seeing encouraging signals from our open-label Phase 2a cohort and are taking bold steps to accelerate availability for patients in need,” said Robb Knie, Chief Executive Officer of Hoth Therapeutics. “This Expanded Access initiative not only reflects our dedication to patient care but also enhances HT-001’s clinical visibility and commercial potential.”
NEW YORK, June 11, 2025 /– Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company advancing breakthrough therapies for underserved conditions, today announced a major milestone in the development of its lead asset, HT-001, with the engagement of Premier Research to support submission of an Expanded Access Program (EAP) application. This move positions Hoth to offer compassionate access to HT-001 for cancer patients suffering from painful and debilitating skin toxicities caused by epidermal growth factor receptor (EGFR) inhibitor therapies—an area of high unmet medical need.
HT-001 has shown promising signs of clinical benefit in early evaluations, and now Hoth is preparing to make the investigational drug available to qualified patients outside of ongoing clinical trials. Expanded Access—often referred to as “compassionate use”—represents an important regulatory pathway that allows patients ineligible for traditional trials to gain access to experimental treatments when no approved alternatives exist.
“We’re seeing encouraging signals from our open-label Phase 2a cohort and are taking bold steps to accelerate availability for patients in need,” said Robb Knie, Chief Executive Officer of Hoth Therapeutics. “This Expanded Access initiative not only reflects our dedication to patient care but also enhances HT-001’s clinical visibility and commercial potential.”
The strategic move expands HT-001’s reach and reinforces Hoth’s long-term vision to be a leader in cancer supportive care. With a clearly defined regulatory pathway, a fast-growing addressable market, and no currently approved targeted treatment for EGFR-inhibitor-induced skin toxicities, HT-001 is uniquely positioned to capture attention from both the medical community and the investor marketplace.
Why It Matters for Investors
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High Unmet Need: Over 100,000 cancer patients annually receive EGFR inhibitors, with the majority experiencing skin toxicities that currently lack targeted treatments.
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Strong Market Potential: HT-001 targets a rapidly growing segment in oncology supportive care.
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Regulatory Momentum: Expanded Access status creates a faster route to commercialization and increases real-world data generation.
Investors and partners are encouraged to monitor updates closely as Hoth Therapeutics continues to advance HT-001 toward its next key inflection points.
For more information about HT-001, clinical trials, or Expanded Access eligibility, visit www.hoththerapeutics.com.
About Hoth Therapeutics, Inc.
Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options. To learn more, please visit https://ir.hoththerapeutics.com/ .