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News Breaks
May 2, 2014
06:11 EDTBMRNBioMarin says BMN 165-302 study to be available in Q4 of 2015
BioMarin announced last night that it intends to modify the entry criteria for the BMN 165-302 randomized discontinuation study. "The purpose of the eligibility modification is to leverage those patients who have relatively weaker immune reactions to PEG PAL, who therefore achieve Phe reductions faster, at relatively lower doses and with relatively fewer side effects. Under the revised entry criteria, patients will need to demonstrate a pre-specified reduction in blood Phe from PEG PAL during the BMN 165-301 feeder study prior to entering the BMN 165-302 RDT study," it stated. Based on the changed BMN 165-302 protocol, associated review of the proposed protocol and preliminary BMN 165-301 data with the FDA, and requirement for additional patients, the company now expects data from the enriched BMN 165-302 study to be available in Q4 of 2015.
News For BMRN From The Last 14 Days
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July 29, 2015
06:38 EDTBMRNBioMarin price target raised to $163 from $147 at Piper Jaffray
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July 21, 2015
07:59 EDTBMRNBioMarin gene therapy an overhang for Baxalta, says JPMorgan
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July 20, 2015
14:32 EDTBMRNFDA panel likely to review Sarepta, BioMarin drugs in November, TheStreet says
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11:03 EDTBMRNSarepta rises after Roth says added data can keep it ahead of BioMarin
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08:47 EDTBMRNBioMarin reports Abrazo Phase 2 trial met threshold for tumor reduction
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