- Antares Pharma (NASDAQ:ATRS) is up 1% premarket on the heels of its announcement that it expects to refile its U.S. marketing application next quarter for XYOSTED (testosterone enanthate) for the treatment of men with low testosterone. The company received a CRL in October 2017 in response to its initial application citing concerns that the product could cause a clinically meaningful increase in blood pressure and could be related to depression and suicidality.
- The company says it does not need to conduct additional clinical trials based on the information it received from a meeting with the FDA and the minutes from that meeting. It believes that a reanalysis of existing data, labeling and post-approval risk mitigation strategies will address the FDA's concerns.
- Previously: FDA rejects Antares Pharma's Xyosted marketing application (Oct. 23, 2017)
- Now read: AnaptysBio's lead candidate shows positive effect in mid-stage peanut allergy study; shares ahead 7% after hours
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