Alkermes Plc (ALKS.OQ)
21 Sep 2018
* ALKERMES ANNOUNCES FDA ACCEPTANCE FOR REVIEW OF NEW DRUG APPLICATION FOR ALKS 5461 FOR THE ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER
* ALKERMES PLC SAYS CHAIRMAN AND CEO RICHARD POPS' FY 2017 TOTAL COMPENSATION WAS $9.4 MLN VS $9.6 MLN IN FY 2016 - SEC FILING Source text: (https://bit.ly/2GPYT4o) Further company coverage:
* CEO SAYS "WE DON'T BELIEVE ANY ADDITIONAL CLINICAL TRIALS ARE NECESSARY" ON CONF CALL WHEN ASKED ABOUT FDA'S DECISION ON ITS DEPRESSION DRUG Further company coverage:
Alkermes Plc has been told to conduct more clinical trials of its experimental depression treatment after the U.S. Food and Drug Administration rejected its initial application for approval, citing a lack of evidence of its effectiveness.
* Shares fall as much as 22 percent (Adds comments from conference call; updates shares)
April 2 Alkermes Plc said on Monday the U.S. Food and Drug Administration rejected the application seeking approval for its experimental depression drug, citing insufficient evidence of effectiveness.
* ALKERMES RECEIVES REFUSAL TO FILE LETTER FROM FDA FOR ALKS 5461
* ALKERMES PLC SAYS ON MARCH 26, CO ,UNITS ENTERED AMENDMENT TO AMENDED & RESTATED CREDIT AGREEMENT, DATED AS OF SEPTEMBER 16, 2011 - SEC FILING
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