Aptorum Group Limited (NASDAQ: APM) is engaged as a clinical-stage biopharmaceutical company, which is focused on the research, development and commercialization of novel treatments for unmet medical needs; particularly in oncology. Shares of the biopharma are surging 30% through early trading on Thursday, January 20, 2022. Over the past three months, Aptorum Group has seen average daily volume of 127,520 shares. However, volume of 72.83 million shares or dollar volume of around $119.44 million, has already exchanged hands through early trading on Thursday.
Shares of Aptorum Group are surging after the company announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company’s SACT-1 candidate, a repurposed small molecule compound for the treatment of Neuroblastoma. The company says they are planning to file an Investigational New Drug (IND) Application to begin Phase 1b/2a clinical trials this year.
SACT-1 is an orally-administered drug that has shown in preclinical studies to improve killing of tumor cells, as well as suppress MYCN expression. The drug candidate is meant to be used in combination with standard-of-care chemotherapy.
Mr. Darren Lui, President and Executive Director of Aptorum Group says, “The granting of orphan drug designation for SACT-1 for the treatment of neuroblastoma is another important step forward in the development of our drug candidate and reflects both the FDA’s and Aptorum’s commitment to addressing the unmet clinical needs of patients with neuroblastoma.” Further to our recently announced completion of Phase 1 clinical trial and patent grant for SACT-1, we are currently focusing on our IND preparation for entering into the exciting Phase 1b/2a clinical trials for SACT-1 in the United States.”
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