Shares of Antares Pharma Inc (NASDAQ:ATRS) climbed in premarket trade Monday after the US Food and Drug Administration (FDA) approved the specialty pharmaceutical company’s Xyosted injection to treat low testosterone levels in men.
The Ewing, New Jersey-based company’s once-weekly at-home testosterone replacement therapy for adult males, however, comes with a boxed warning flagging risks of rise in blood pressure that can cause major cardiovascular events.
The FDA had declined to approve the drug, Xyosted, in October last year, highlighting elevated blood pressure, depression and suicidal tendencies in patients.
Antares Pharma stock rose 6.9% to $3.59.
"Today's FDA approval of Xyosted is a significant milestone for Antares," said Antares Pharma CEO Robert F Apple. "Published data from the Xyosted phase three studies have shown our product to be easy to use and virtually pain-free while providing steady testosterone levels."
The CEO said the injection “significantly enhances” a testosterone deficient patient's option for treatment.
“We will now begin the process of onboarding sales representatives and expect to make Xyosted available to patients before the end of this year," said Apple.
Contact Uttara Choudhury at [email protected]