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Shares of Antares Pharma fly after FDA approves Xyosted injection to treat low testosterone in adult males

CEO Robert F Apple said the company would make Xyosted available to patients before the end of the year

A man sitting at a desk
Antares Pharma focuses on the development of drugs delivered through self-administered injections

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.

READ: Antares Pharma shares rally sparked by deal with Pfizer

"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]

Follow her on Twitter@UttaraProactive

Quick facts: Antares Pharma

Price: 2.6 USD

NASDAQ:ATRS
Market: NASDAQ
Market Cap: $430.46 m
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