Antares Pharma's Oral Testosterone Treatment Scores FDA Approval

  • Antares Pharma Inc ATRS has nabbed another FDA approval, and the Company's second involving testosterone.
  • The Company announced FDA approval for Tlando (testosterone undecanoate), an oral treatment for testosterone replacement therapy indicated for deficiency or absence of endogenous testosterone or hypogonadism.
  • The first time the Company got a testosterone product approved by the FDA was in 2018, when the FDA gave its OK to Xyosted, a subcutaneous auto-injector containing testosterone enanthate, designed to be a testosterone replacement therapy. 
  • The drug comes with a boxed warning of blood pressure increases and subsequent elevated risk for cardiovascular problems.
  • Antares CEO and president Robert Apple said that the Company had expanded its commercial side to 108 sales representatives and is looking forward to the drug's commercial launch in Q2 of 2022.
  • In October last year, Lipocine Inc LPCN announced an exclusive licensing agreement with Antares Pharma to commercialize Tlando in the U.S. 
  • Tlando is an oral testosterone product for testosterone replacement therapy in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone.
  • Price Action: LPCN shares are down 18.7% at $1.48, and ATRS shares are trading at $4.14 during the market session on the last check Tuesday.

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