18:39 , Dec 22, 2017 |  BC Week In Review  |  Clinical News

FDA tentatively approves abuse deterrent claim for Egalet's Arymo ER

Egalet Corp. (NASDAQ:EGLT) said FDA granted tentative approval to an expanded label for Arymo ER morphine sulfate extended-release tablets to include data from a Category 2/3 intranasal human abuse potential study and an intranasal abuse...
22:39 , Apr 7, 2017 |  BioCentury  |  Finance

Fade to black

At the end of 2016, investors argued that equity values had nowhere to go but up. This proved to be the case in 1Q as all market cap bands finished in the black. Sector specialists,...
20:49 , Jan 20, 2017 |  BC Week In Review  |  Financial News

Egalet completes private placement of senior notes

On Jan. 18, pain and drug delivery company Egalet Corp. (NASDAQ:EGLT) raised $40 million in the second and final tranche of a senior secured notes offering to institutional investors, bringing the total raised to $80...
18:42 , Jan 11, 2017 |  BC Week In Review  |  Clinical News

Arymo ER regulatory update

FDA approved an NDA from Egalet for Arymo ER morphine sulfate extended-release tablets to manage pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. The company plans to...
00:30 , Jan 10, 2017 |  BC Extra  |  Company News

FDA approves Egalet's Arymo

FDA approved Arymo ER morphine sulfate extended-release from Egalet Corp. (NASDAQ:EGLT) to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The company expects to...
07:00 , Oct 24, 2016 |  BC Week In Review  |  Clinical News

Arymo ER morphine sulfate extended-release regulatory update

Egalet said it received notice from FDA that the agency would not meet the Oct. 14 PDUFA date for pain candidate Arymo ER morphine sulfate extended-release tablets, an abuse-deterrent morphine formulation. The company said FDA...
07:00 , Oct 3, 2016 |  BioCentury  |  Finance

ASH and others

Cancer and hematology companies are likely to garner the most headlines in 4Q16 thanks to ESMO in October and ASH in December, but some investors also are branching out to events that typically receive less...
07:00 , Sep 5, 2016 |  BC Week In Review  |  Financial News

Egalet completes private placement of senior notes

Egalet Corp. (NASDAQ:EGLT), Wayne, Pa.   Business: Drug delivery, Neurology, Cardiovascular   Date completed: 2016-09-01   Type: Private placement of senior notes   Raised: $40 million   Placement agent: Morgan Stanley   Investor: Institutional investors   Note: Egalet raised $40 million in...
07:00 , Aug 8, 2016 |  BC Week In Review  |  Clinical News

Arymo ER morphine sulfate extended-release regulatory update

FDA’s Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees voted 18-1 to recommend approval of Arymo ER morphine sulfate extended-release tablets from Egalet to manage pain severe enough to require...
07:00 , Aug 4, 2016 |  BC Extra  |  Company News

FDA panels back Egalet's Arymo

FDA's Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees voted 18-1 on Thursday to recommend approval of Arymo ER morphine sulfate extended-release from Egalet Corp. (NASDAQ:EGLT) to manage pain severe...