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Egalet Corp (EGLT.OQ)

EGLT.OQ on NASDAQ Stock Exchange Global Market

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12 Dec 2017
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Latest Key Developments (Source: Significant Developments)

Egalet Corp's Phase 3 Study Of Egalet-002 In Patients With Moderate-To-Severe Chronic Low Back Pain Meets Primary Endpoint​
Tuesday, 28 Nov 2017 

Nov 28 (Reuters) - Egalet Corp ::EGALET ANNOUNCES POSITIVE TOP-LINE RESULTS FROM PHASE 3 STUDY EVALUATING EFFICACY AND SAFETY OF EGALET-002 IN PATIENTS WITH MODERATE-TO-SEVERE CHRONIC LOW BACK PAIN.EGALET CORP - ‍EGALET-002 WAS GENERALLY WELL-TOLERATED AND NO NEW SAFETY CONCERNS WERE IDENTIFIED IN STUDY​.EGALET CORP - ‍STUDY OF EGALET-002 MET ITS PRIMARY ENDPOINT​.  Full Article

Egalet Corp Says ‍Apotex Has Lost Right To Launch An Authorized Generic Version Of Sprix Nasal Spray​
Tuesday, 28 Nov 2017 

Nov 27 (Reuters) - Egalet Corp ::EGALET CORP - ‍COMPANY DID NOT RECEIVE ANY WRITTEN NOTIFICATION ON OR BEFORE NOTIFICATION DEADLINE FOR PRODUCT LAUNCH FROM APOTEX CORP & APOTEX INC​.EGALET CORP - ‍APOTEX HAS LOST RIGHT TO LAUNCH AN AUTHORIZED GENERIC VERSION OF SPRIX NASAL SPRAY​.EGALET CORP - ‍IF APOTEX IS ABLE TO SATISFY REQUIREMENTS FOR LAUNCHING AN UNAUTHORIZED GENERIC, IT WOULD BE PERMITTED TO DO SO IN SEPTEMBER 2018​.  Full Article

Egalet notified that FDA will not meet PDUFA goal data for ARYMO ER
Friday, 14 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
Friday, 5 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

BRIEF-Egalet Says Notified Verbally By CVS Caremark That Sprix Will No Longer Be On Formulary For A Portion Of Commercial Covered Lives Beginning 2018

* EGALET - NOTIFIED VERBALLY BY CVS CAREMARK THAT SPRIX WILL NO LONGER BE ON FORMULARY FOR A PORTION OF COMMERCIAL COVERED LIVES BEGINNING JAN 1, 2018