Stock Monitor: Champions Oncology Post Earnings Reporting

LONDON, UK / ACCESSWIRE / December 18, 2017 / Active-Investors issued a free report on Egalet Corp. (NASDAQ: EGLT), which is readily accessible upon registration at www.active-investors.com/registration-sg/?symbol=EGLT as the Company's latest news hit the wire. On December 15, 2017, the Company declared that the US Food and Drug Administration (FDA) has granted tentative approval for a new, expanded label for ARYMO ER (morphine sulfate) extended-release (ER) tablets C-II. The new labeling will include data from a Category 2/3 intranasal human abuse potential (HAP) study and an intranasal abuse-deterrent claim. The final approval is likely to be granted after the patent exclusivity granted to other Company expires on October 02, 2018. Sign up now for our free research reports at:

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Active-Investors.com is currently working on the research report for Champions Oncology, Inc. (NASDAQ: CSBR), which also belongs to the Healthcare sector as the Company Egalet. Do not miss out and become a member today for free to access this upcoming report at:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Egalet most recent news is on our radar and we have decided to include it on our blog post. Today's free coverage is available at:

www.active-investors.com/registration-sg/?symbol=EGLT

FDA issues tentative approval to the applicant if a generic drug product is ready for approval before the expiration of any patents or exclusivities accorded to the reference listed drug product.

Inclusion of Additional Abuse-deterrent Data is an Important Improvement for Chronic Pain Patients

Mark Strobeck, Ph.D., Chief Operating Officer of Egalet, stated that given that extended-release morphine is the most frequently prescribed ER opioid for individuals living with chronic pain and the majority of those prescriptions are in easy to abuse formulations, the Company believes that strengthening the ARYMO® ER label to include additional abuse-deterrent data is an important improvement for chronic pain patients and their communities.

FDA Approved ARYMO? ER Tablets C-II for Treatment of Chronic Pain in January

On January 09, 2017, FDA approved ARYMO? ER (morphine sulfate) extended-release tablets C-II, developed using Egalet's proprietary Guardian? Technology, for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

FDA Approvals to Opioid Analgesic in 2017

  • On January 17, 2017, FDA approved Vantrela® ER (hydrocodone bitartrate extended-release tablets), an extended-release (ER) opioid analgesic, becoming the ninth ER opioid analgesic to be approved with labeling describing the product's abuse-deterrent properties consistent with the FDA's 2015 guidance for industry, Abuse-Deterrent Opioids- Evaluation and Labeling.

  • On April 20, 2017, FDA approved RoxyBond (oxycodone hydrochloride). RoxyBond is the first immediate-release opioid analgesic approved with labeling describing its abuse-deterrent properties consistent with the FDA's 2015 Guidance for Industry.

About ARYMO® ER Extended-Release Tablets CII

ARYMO® ER (morphine sulfate) extended-release tablets CII is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, ARYMO® ER is reserved for use in patients for whom alternative treatment options are ineffective.

About Guardian? Technology

Guardian Technology, trademark of Egalet, has been used to develop abuse-deterrent forms of commonly abused prescription medications. Guardian Technology is a polymer matrix tablet technology that utilizes a novel application of the well-characterized manufacturing process of injection molding, resulting in tablets that are hard and difficult to manipulate for misuse and abuse. Tablets manufactured with Guardian Technology have been shown to have increased resistance to physical methods of manipulation, such as cutting, crushing, grinding or breaking, using a variety of mechanical and electrical tools. They are also resistant to chemical manipulation.

Stock Performance Snapshot

December 15, 2017 - At Friday's closing bell, Egalet's stock surged 20.79%, ending the trading session at $1.22.

Volume traded for the day: 19.32 million shares, which was above the 3-month average volume of 1.25 million shares.

Stock performance in the last month ? up 46.99%

After last Friday's close, Egalet's market cap was at $60.39 million.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 1.0% at the end of the session.

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