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Fly News Breaks for May 20, 2019
NVS, BIIB, PTCT
May 20, 2019 | 15:22 EDT
RBC Capital analyst Brian Abrahams noted a new posting on ClinicalTrials.gov that he said "looks like" an expanded access program for Zolgensma that he believes could possibly offer some hints as to the potential label under discussion with the FDA. The most interesting parts are the inclusion criteria, which he thinks could "represent a middle ground" in terms of the breadth of label Novartis (NVS) could obtain for the drug. If the posting is predictive of Zolgensma's initial label, he said he would see it as an incremental positive for Biogen (BIIB), as it would potentially reduce the worst-case scenario of Zolgensma being approved with no age or weight restrictions. It would also be an incremental positive for PTC Therapeutics (PTCT), which Abrahams noted is looking to enter the space.