AcelRx refiles U.S. marketing application for Dsuvia, action date Q4; shares up 10% premarket [Seeking Alpha]
AcelRx Pharmaceuticals, Inc. (ACRX)
Last acelrx pharmaceuticals, inc. earnings: 3/16 07:35 am
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AcelRx refiles U.S. marketing application for Dsuvia, action date Q4; shares up 10% premarketAcelRx Pharmaceuticals (NASDAQ:ACRX) is up10% premarket on light volume on the heels of itsannouncement that it has resubmitted its marketing application to the FDA seeking approval for pain med DSUVIA (sufentanil sublingual tablet, 30 mcg).The company expects a six-month review cycle so the outcome should be announced in Q4.The company received a CRL in October 2017 citing the need for additional data to assess the safety of the product at the maximum recommended dose and changes to the Directions for Use to ensure proper administration, validated via a human factors study.Previously:AcelRx completes the human factors study for DSUVIA; plans to resubmit NDA in Q2 (April 16)Previously:FDA rejects AcelRx Pharma's marketing application for pain med DSUVIA; shares down 45% premarket (Oct. 12, 2017)See all stocks on the move »Now read:Merck Tackles Front-Line Lung Cancer In Latest Trial Win »
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