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ATRS: Xyosted Regulatory Update

03/27/2018
By John Vandermosten, CFA

NASDAQ:ATRS

Antares Pharma (NASDAQ:ATRS) held its Type A meeting with the FDA on February 21, 2018, that addressed the complete response letter (CRL) for Xyosted which was received October 20th last year. FDA-generated notes from Type A meetings are generally sent to the sponsor within 30 days of the meeting, and Antares issued a press release today which notified investors of the receipt of the notes and also outlined their contents.

Based on the content in the notes, Antares believes that they will not need to conduct any further clinical studies, but will need to provide additional analysis of the existing data. Additional work on product labeling and post-approval risk mitigation strategies are also required. Based on the company’s assessment, management believes they can address the discrepancies noted in the CRL and resubmit a response in the second quarter of 2018.

Thirty days following the CRL, the FDA will notify Antares whether or not the resubmission is a complete response and set a target action date. The target action date will be within six months of the resubmission.

This is good news for Antares as it sticks to the timeline we expect: the CRL delays approval by approximately one year. While there still may be a risk of FDA rejection, it is a positive that no new clinical studies are required. Based on the press release we maintain our forecast of first Xyosted sales in 2019, which allows a few months of preparation following a 4Q:18 anticipated approval. Our probability of approval (and NPV value adjustment) remains at 50% and there is no resulting change in target price.

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