Alkermes Plc (ALKS.OQ)
21 Sep 2018
Recro Pharma's shares dropped more than 50 percent on Thursday after the U.S. Food and Drug Administration declined to approve the drugmaker's non-opioid shot IV meloxicam, saying the pain-relieving effect did not meet expectations.
* FDA says drug's pain-relieving effect did not meet expectations
* Q1 REVENUE $225.2 MILLION VERSUS I/B/E/S VIEW $219.3 MILLION
* 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
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