BeiGene and Mustang nail down special FDA status for top drugs; Roche bags added coverage for Hemlibra
→ BeiGene $BGNE is getting a boost in its drive to field a rival to Imbruvica. The FDA has offered an accelerated review to zanubrutinib, a BTK inhibitor that has posted positive results for mantle cell lymphoma. The PDUFA date lands on February 27, 2020. The drug scored breakthrough status at the beginning of the year.
→ BeiGene isn’t the only biopharma company to gain special regulatory status today. Mustang Bio $MBIO and St. Jude Children’s Research Hospital announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted Regenerative Medicine Advanced Therapy status.
→ Roche has been shaking up the hemophilia drug market with its blockbuster Hemlibra. And now the NHS in the UK is giving the pharma giant another leg up, adding coverage that will 2,000 more patients.