Look back at pharma news in the week to September 25, 2020

Last week’s regulatory news saw Bristol Myers Squibb reveal that the US Food and Drug Administration has accepted and granted priority review of its CAR-T cell therapy idecabtagene vicleucel (liso-cel), under development with bluebird bio, but the late decision date could have a serious impact on the contingent value rights (CVR) for Celgene’s former shareholders. Also, although the FDA agreed that Novartis’ intrathecal (IT) formulation of AVXS-101 has potential, the agency has called for a pivotal confirmatory study to support the regulatory submission. Additionally, US biotech Blueprint Medicines revealed on Friday that it has gained approval for its Ayvakyt (avapritinib) from the European Commission in the treatment of metastatic gastrointestinal tumorous (GIST) harboring the PDGFRA D842 mutation. On the research front, Roche and partner AC Immune posted top-line results for semorinemab in early Alzheimer’s, which failed key endpoints.

Bristol Myers CVR is worth $6.93

September 8 news came out that the Contingent Value Right or CVR associated with Bristol Myers Squibb's $74 billion acquisition of Celgene was down significantly in apparent reaction to management comments at a Citigroup conference revealing that the manufacturing plant for CAR T therapies has not yet been inspected by the FDA, noted Bram de Haas writing on the Seeking Alpha blog.