Hoth Therapeutics, Inc. (HOTH) stock prices were up by 6.43% as of the market closing on May 21st, 2021, bringing the price per share up to USD$1.49 at the end of the trading day. Subsequent pre-market fluctuations saw the price fall by a marginal 2.68%, bringing it down to USD$1.45.
HOTH announced early in May that it intended to pursue the development of its proprietary HT-KIT mRNA Frame Shifting Therapeutic for various orphan diseases. A disease qualifies as an orphan disease if they are rare enough to affect less than 200,000 people within the United States. The HT-KIT is designed to target a shared cell signaling pathway and could have therapeutic potential for various diseases. Of the ailments potentially benefitting from HT-KIT are rare cancers such as aggressive systemic mastocytosis, mast cell leukemia, acute myeloid leukemia, and gastrointestinal stromal tumors.
Orphan Drug Designation
Treatments which focus on orphan diseases are eligible to apply for Orphan Drug Designation (ODD), which serves to facilitate the development of drugs for illnesses that don’t have the numerical scope of others. An ODD provides multiple benefits to the sponsor both during the development process and after approval. HOTH is actively pursuing an Orphan Drug Designation as a part of the development of its HT-KIT for the treatment of rare cancers.
Benefits of ODD
With an ODD, pharmaceutical companies are granted exclusive marketing and developmental rights, along with other benefits to recoup expenses incurred as a result of the research and development of the drug in question. As further incentive, a tax credit of 50% of the qualified costs of clinical drug testing is possible to be awarded upon approval of the drug being developed.
FDA’s ODD Provisions
The FDA offers regulatory streamlining and the provision of special assistance to companies working with an ODD, in addition to the exclusive rights and cost benefits. The FDA also provides protocol assistance, possibly lower wait times for drug approval, discounts on registration fees, and eligibility for market exclusivity after approval. Upon approval, an ODD could result in 7 years of exclusivity, and in the process of getting that approval, application fees for New Drug Applications and Biologics License Application are waived.
Future Outlook for HOTH
With resources being allocated towards an ODD designation, the development and commercialization of HT-KIT could prove significantly more lucrative than without such a designation. The company is keen to fast-track the process so it can allocate the resources from savings and recovery of costs back into the development of the company. Current and potential investors are hopeful for continued growth and sustained and significant increases in shareholder value.