Hoth Therapeutics (NASDAQ: $HOTH), a clinical-stage biopharmaceutical working to develop innovative therapies, announced on Monday, March 10, 2025, that it planned to submit an Expanded Access application for HT-001.
Details Of The Application
HT-001 is a novel therapeutic candidate that Hoth Therapeutics aims to investigate for use in treating dermatological conditions arising from cancer therapy. It will be trialed in the alleviation of adverse dermatological effects that arise in patients undergoing epidermal growth factor receptor (EGFR) inhibitor treatments.
Thus far, clinical studies have shown positive progress, and Hoth Therapeutics aims to expand access outside of clinical trials, often called “compassionate use.”
Commenting on the announcement, Hoth Therapeutics CEO Robb Knie, said “Submitting an Expanded Access application is an important step in our commitment to ensuring patients who may benefit from HT-001 have the opportunity to receive this promising treatment.”
Addressing An Existing Gap
The application for compassionate use of HT-001 by Hoth Therapeutics is a major progression in the clinical development program. This topical treatment could help fill an important supportive care gap for patients undergoing treatment with EGFR inhibitors, who often experience dry skin, rashes, and inflammation that can prompt a reduction in dosages, or even discontinuations.
A grant from compassionate use by the FDA is often only given when preliminary evidence shows potential efficacy and safety. This could signal that Hoth’s ongoing clinical trials are delivering promising safety and efficacy numbers. However, it still must complete the full clinical trial process.
The timing of this application could suggest the company believes in the safety profile of their therapy and warrants wider access to patients as the clinical trials continue. For patients suffering from dermatological effects of EGFR-induced toxicity, this could be a useful alternative.
However, it is worth noting that the expanded access program serves a humanitarian purpose with no real commercial benefits. Nevertheless, the program could help to contribute important safety data.
Hoth Therapeutics Market Performance
Following the announcement of the expanded access program, HOTH shares closed 0.92% higher on March 10, 2025, at $1.1 per share. Year to date, the stock is up 47.06%, which could signal investor confidence in this clinical-stage biopharmaceutical firm.
Over the past six months, the stock is down 1.79%, while over the past year, the stock is down 15.38%. Meanwhile, the stock is up 26.44% in the past five days. Monday’s closing price is below its 50-day moving average of $1.18 but above its 200-day moving average of $0.95.
Is Hoth Therapeutics A Good Investment In 2025?
Hoth Therapeutics has marked a major milestone with the expanded access program for its HT-001 therapy. Its new target is an undressed market of cancer treatment side effects. With clinical trials showing positive progress, the new compassionate use program could further bolster data collection to improve its safety profile. While it has not yet received any FDA approval, and the drug is still in the clinical stage, the potential opportunity cannot be ignored. Consequently, adding HOTH to your portfolio could potentially yield some positive results in the medium term.
Click Here For Updates on HOTH – It’s FREE to Sign Up for Text Message Notifications!
Disclaimer: This website provides information about cryptocurrency and stock market investments. This website does not provide investment advice and should not be used as a replacement for investment advice from a qualified professional. This website is for educational and informational purposes only. The owner of this website is not a registered investment advisor and does not offer investment advice. You, the reader / viewer, bear responsibility for your own investment decisions and should seek the advice of a qualified securities professional before making any investment. We have been compensated fifteen thousand dollars electronically via bank wire by One Eyed Jack Enterprises LLC for an advertising / marketing campaign for Hoth Therapeutics, Inc. (NASDAQ: $HOTH) beginning on 3/13/2025 and ending on 3/18/2025. DEXWireNews may receive additional campaigns in the future by One Eyed Jack Enterprises LLC to distribute media for Hoth Therapeutics, Inc. (NASDAQ: $HOTH).
