United Kingdom

Egalet Corp (EGLT.OQ)

EGLT.OQ on NASDAQ Stock Exchange Global Market

24 Nov 2017
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$0.12 (+11.88%)
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Latest Key Developments (Source: Significant Developments)

Egalet notified that FDA will not meet PDUFA goal data for ARYMO ER
Thursday, 13 Oct 2016 

Egalet Corp : Egalet notified that FDA will not meet PDUFA goal data for ARYMO ER . Egalet Corp -FDA will not meet previously announced October 14 Prescription Drug User Fee Act (PDUFA) date for ARYMO ER . Egalet - FDA has identified no particular issue with Co's application for ARYMO ER and it is working on product label . On ARYMO ER - FDA indicated that they need more time as they have done with other abuse-deterrent opioid NDA .Egalet Corp - FDA confirms no additional scientific information or data is needed for application for ARYMO ER.  Full Article

Egalet reports Q2 loss per share $0.97
Thursday, 4 Aug 2016 

Egalet : Q2 loss per share $0.97 . Q2 earnings per share view $-0.82 -- Thomson Reuters I/B/E/S . Deterrent arymo(tm) er (morphine sulfate) and reports second quarter 2016 financial results . Q2 revenue $3.5 million versus i/b/e/s view $3.8 million . FDA prescription drug user fee act (pdufa) goal date for a decision is october 14, 2016. .Committees voted that if approved arymo er should be labeled as an abuse-deterrent product by intravenous, nasal and oral routes of abuse.  Full Article

Egalet announces issuance of two new U.S. patents for Guardian Technology
Tuesday, 19 Jul 2016 

Egalet Corp : U.S. Patent number 9,358,295 covers through 2031 immediate-release formulations intended to be resistant to abuse by intake of alcohol . U.S. Patent number 9,375,428 covers through 2024 extended-release formulations of opioids .Egalet announces issuance of two new U.S. Patents for Guardian™ Technology.  Full Article

Egalet says FDA advisory committee meeting on August 4 for ARYMO™
Tuesday, 28 Jun 2016 

Egalet Corp : Egalet announces FDA advisory committee meeting will take place August 4, 2016 for lead abuse-deterrent candidate ARYMO™ ER (morphine sulfate) extended-release tablets .FDA prescription drug user fee act (pdufa) goal date for a decision is October 14, 2016.  Full Article

Egalet settles patent litigations with Purdue Pharma
Monday, 23 May 2016 

Egalet Corp : Settles patent litigations with Purdue Pharma . Settlement relates to alleged patent infringements against Egalet and product licensor Acura Pharmaceuticals for Oxaydo Tablets CII .Says there are no financial obligations to either party.  Full Article

Egalet Q1 loss per share $0.76
Tuesday, 10 May 2016 

Egalet Corp : Egalet reports first quarter 2016 financial results . Q1 loss per share $0.76 . Q1 revenue $2.7 million versus $805,000 . Q1 revenue view $3.5 million -- Thomson Reuters I/B/E/S .Q1 earnings per share view $-0.87 -- Thomson Reuters I/B/E/S.  Full Article

Egalet Corp submits New Drug Application to U.S. Food and Drug Administration for ARYMO ER Extended-Release Tablets
Tuesday, 15 Dec 2015 

Egalet Corp:Says it has submitted a new drug application (NDA) for ARYMO ER (morphine sulfate) extended-release tablets for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate.Submission is based on the pivotal pharmacokinetic studies that demonstrated bioequivalence of ARYMO ER 15 mg, 30 mg and 60 mg to equivalent doses of MS Contin.In addition, submission includes a comprehensive battery of abuse-deterrent studies (Category 1, 2 and 3) which were conducted to support abuse-deterrent label claims for intravenous injection, snorting and oral abuse.  Full Article

Egalet signs agreement with Teva Pharmaceutical Industries to commercialize SPRIX Nasal Spray in select geographies outside United States
Monday, 14 Dec 2015 

Egalet Corp:Announced collaboration agreement with Teva Pharmaceutical Industries Ltd.With this agreement, Egalet granted Teva exclusive marketing and commercialization rights to SPRIX Nasal Spray in Israel, Gaza and the West Bank. Teva.Under the terms of the agreement, Egalet will receive an undisclosed upfront payment, sales-based milestones and will share in the profits from net sales of SPRIX in these territories.  Full Article