NEW YORK, NY / ACCESSWIRE / April 11, 2016 / This Market Exclusive report covers all major biotech news from last week as well as any major news expected this week on these companies.
Intercept Pharmaceuticals (NASDAQ:ICPT)
Gilead Sciences, Inc (NASDAQ:GILD)
Clovis Oncology, Inc. (NASDAQ:CLVS)
The first week of April 2016 in biotechnology saw three significant developments, two of which present buying opportunities. We’ll begin just two days before that, in the dead of night at 3:00am on March 30th.
Opko Health Inc
On March 30th, Opko Health Inc (NYSE:OPK) issued a press release stating that the FDA did not approve its flagship drug candidate, Rayaldee. Instead, it issued a Complete Response Letter, or CRL, citing problems at Opko’s contract manufacturer, Catalent Inc. (NASDAQ: CTLT)
This was a shocker to almost everyone at the time - everyone except the people at Catalent, who for obvious reasons could not disclose what was to come. On March 25th, four days before the expected PDUFA and FDA approval for Rayaldee, Catalent was hit with a Form 483, which is basically a piece of paper that details deficiencies in protocol and/or procedure at a contract manufacturing plant. Neither company has disclosed exactly what the deficiencies were, but we do know that Catalent will be addressing them by April 15th, after which Opko is hoping for an FDA response within 30 days.
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SOURCE: Market Exclusive
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