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The FDA News That Put The Wind Beneath Egalet Stock's Wings
Wednesday, March 29, 2017 - 2:35pm | 320Amid a raging opioid epidemic, Egalet Corp (NASDAQ: EGLT) soared as high as 13 percent Wednesday after the U.S. Food and Drug Administration permitted it to distribute promotional material highlighting the abuse-deterrent properties of intranasal ARYMO ER. The detail is small but notable for Egalet...
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Egalet Says FDA Saw Unintended Consequence Of IV Abuse Potential With Endo's Opana ER
Thursday, March 16, 2017 - 9:07am | 491The U.S. Food and Drug Administration reached a conclusion this week concerning Endo International plc - Ordinary Shares (NASDAQ: ENDP)'s therapy Opana ER, which is intended to treat pain severe enough to require a daily, around-the-clock, long-term opioid treatment. An independent FDA panel...
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Exclusive: Egalet CEO Talks Drug Approvals, 21st Century Cures Act And Winning The War On Opioid Abuse
Thursday, January 19, 2017 - 9:37am | 1104Egalet Corp (NASDAQ: EGLT) was surely one of the most watched biotechs of the fourth quarter of 2016. After the company announced the Food and Drug Administration would miss its PDUFA decision date for Egalet’s opioid-based pain medication ARYMO ER, investors waited impatiently for news of a...
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Why Egalet Shares Are Plummeting After FDA Approval Of ARYMO ER
Tuesday, January 10, 2017 - 11:23am | 309After initially spiking as much as 20 percent on Monday following FDA approval of ARYMO ER, shares of Egalet Corp (NASDAQ: EGLT) are down more than 16.4 percent in early Tuesday trading. For traders wondering why Egalet shares are selling off after such good news, the devil is in the details....
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Egalet's FDA Approval May Have Triggered Major Short Squeeze
Monday, January 9, 2017 - 3:10pm | 271Egalet Corp (NASDAQ: EGLT) shares jumped as much as 17 percent on Monday before being halted following news that the FDA has approved ARYMO ER. In its JPMorgan Healthcare Conference presentation, the company said it plans to launch ARYMO ER starting in Q1 2017. The positive news and subsequent halt...
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FDA Has Approved Egalet's ARYMO ER
Monday, January 9, 2017 - 2:27pm | 212The U.S. Food and Drug Administration approved Egalet Corp (NASDAQ: EGLT)'s ARYMO ER on Monday to expand the industry for opioid-based pain-management treatments. The announcement bodes well for Egalet, the shares of which responded with a 17-percent jump. Trading was halted at 12:24.33 p.m....
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Egalet Reports Q3 Results, Offers ARYMO ER Updates
Friday, November 4, 2016 - 7:24am | 118Egalet Corp (NASDAQ: EGLT) lost $1.10 per share in its third quarter and missed estimates by $0.20 per share. Revenue of $4.7 million beat by $0.1 million. Company highlighted FDA Advisory Committee's recommended approval of ARYMO ER during the quarter. Company also highlighted...
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Why Egalet's FDA PDUFA Delay Is No Cause For Panic
Monday, October 17, 2016 - 1:20pm | 370Shares of Egalet Corp (NASDAQ: EGLT) traded lower by more than 5 percent Monday morning after a scheduled meeting with the U.S. Food and Drug Administration (FDA) to discuss its delayed ARYMO ER therapy. Egalet said in a press release that the FDA "has identified no particular issue with our...
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Exclusive: Egalet CFO Talks 'Hot Button' Rx Abuse-Deterrence, Pipeline And Multimillion-Dollar Financing
Friday, September 9, 2016 - 11:25am | 694Egalet Corp (NASDAQ: EGLT) is a U.S.-based specialty pharmaceutical company that focus on treatments for pain and other conditions. The company is developing two late-stage product candidates, ARYMO ER and Egalet-002 using Guardian Technology. Benzinga had the privilege of chatting with the company...