ATRS Shares Rocked as FDA Finds Deficiencies in XYOSTED NDA October 13, 2017 - Baystreet.ca Companies always try and figure out the best time to release news, albeit positive or negative, with respect to market reaction. For bad news, a release after the market close is usually hoped to dampen the blow, but it generally doesn’t matter much. This is the case with Antares Pharma (NASDAQ: ATRS) on Friday following a 5 PM ET release of news on Thursday that the U.S. Food and Drug Administration has some issues with XYOSTED™ (testosterone enanthate), Antares’ injectable testosterone replacement therapy. The Ewing, New Jersey-based drug maker has a new drug application pending with the FDA for XYOSTED™ with a Prescription Drug User Fee Act (PDUFA) date of October 20, 2017. Staring down the FDA’s decision, shares of ATRS have been climbing, including hitting a nearly four-year high on Monday at $4.09, in part on the PDUFA date. Antares also said this week (to little fanfare) that it sold worldwide rights to its ZOMAJET™ needle-free auto injector device to Ferring Pharmaceuticals for up to $14.5 million. Shares are taking a beating in Friday morning trading following Thursday’s news that the FDA found deficiencies with the NDA for XYOSTED™ “that preclude the continuation of the discussion of labeling and postmarketing requirements/commitments at this time.” The government agency didn’t enlighten Antares as to what the deficiencies exactly were, leaving shareholders in the dark with a marketing decision for XYOSTED™ expected within a week. In September, Antares received labeling comments from the FDA, which it responded to promptly, a reply that the FDA doesn’t appear ready to address just yet, based upon the latest communication. While this could just be a mild hiccup on the path to commercialization, investors don’t like reading about “deficiencies” in a NDA review or speculating about any potential delays with said application. Showing the dissatisfaction, shares have been clubbed back to $2.30 in morning activity for a loss of 38.3% after touching $2.16, the lowest level for ATRS since February 8.
ATRS Shares Rocked as FDA Finds Deficiencies in XYOSTED NDA October 13, 2017 - Baystreet.ca Companies always try and figure out the best time to release news, albeit positive or negative, with respect to market reaction. For bad news, a release after the market close is usually hoped to dampen the blow, but it generally doesn’t matter much. This is the case with Antares Pharma (NASDAQ: ATRS) on Friday following a 5 PM ET release of news on Thursday that the U.S. Food and Drug Administration has some issues with XYOSTED™ (testosterone enanthate), Antares’ injectable testosterone replacement therapy. The Ewing, New Jersey-based drug maker has a new drug application pending with the FDA for XYOSTED™ with a Prescription Drug User Fee Act (PDUFA) date of October 20, 2017. Staring down the FDA’s decision, shares of ATRS have been climbing, including hitting a nearly four-year high on Monday at $4.09, in part on the PDUFA date. Antares also said this week (to little fanfare) that it sold worldwide rights to its ZOMAJET™ needle-free auto injector device to Ferring Pharmaceuticals for up to $14.5 million. Shares are taking a beating in Friday morning trading following Thursday’s news that the FDA found deficiencies with the NDA for XYOSTED™ “that preclude the continuation of the discussion of labeling and postmarketing requirements/commitments at this time.” The government agency didn’t enlighten Antares as to what the deficiencies exactly were, leaving shareholders in the dark with a marketing decision for XYOSTED™ expected within a week. In September, Antares received labeling comments from the FDA, which it responded to promptly, a reply that the FDA doesn’t appear ready to address just yet, based upon the latest communication. While this could just be a mild hiccup on the path to commercialization, investors don’t like reading about “deficiencies” in a NDA review or speculating about any potential delays with said application. Showing the dissatisfaction, shares have been clubbed back to $2.30 in morning activity for a loss of 38.3% after touching $2.16, the lowest level for ATRS since February 8.