Highlights
- Aptorum Group has received FDA's Orphan Drug Designation for its SACT-1 drug.
- The Aptorum stock surged over 33% following the news.
- The company now plans to file an Investigational New Drug Application to start clinical trials of SACT-1.
Shares of biopharmaceutical company Aptorum Group Limited (NASDAQ:APM) jumped over 33% after it announced receiving the “Orphan Drug Designation” from the US Food and Drug Administration (FDA).
The UK-based company develops drugs for infectious diseases and oncology and neurology-related complications. On Thursday, the company said it received the Orphan Drug Designation for SACT-1, used in treating Neuroblastoma, from FDA.
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The company now plans to file an “investigational new drug application” to start its phase 1b/2a clinical trial for SACT-1 to test the drug’s efficacy in neuroblastoma patients this year.
SACT-1 is an orally administered small molecule drug for treating neuroblastoma. It is used in combination with standard-of-care chemotherapy.
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Aptorum Group (NASDAQ:APM) stock performance, financials
Its shares traded at US$1.63 at 10:47 am ET on January 20, up 33.61% from its previous close. The stock fell 29.07% in the past 30 days. Aptorum has a market cap of US$58.42 million.
Its trading volume on January 19 was 57,115. The APM stock saw the highest price of US$4.94 and the lowest price of US$1.19 in the last 52 weeks.
For the six months ended on June 30, 2021, the company reported a net loss of US$17.10 million or US$0.47 per share, compared to a loss of US$6.98 million, or US$0.21 per share in the same quarter of the previous year.
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Bottomline
Aptorum President and Executive Director Darren Lui said the Orphan Drug Designation would help the company provide unmet clinical needs of patients with neuroblastoma.