Biotech Stock Roundup: AMGN's Nuevolution Buyout, CELG, INCY Drugs' Label Expansion
Zacks Investment Research | May 28, 2019 10:22PM ET
It was a low-key week for the biotech sector. While Amgen (NASDAQ:AMGN) offered to buy a drug discovery platform biotech company, the FDA approved the label expansion of lead drugs of Celgene (NASDAQ:CELG) and Incyte (NASDAQ:INCY) .
Recap of the Week’s Top Stories:
Amgen to Acquire Drug Discovery Platform: Amgen announced that the FDA has approved a label expansion of its lead drug, Jakafi (ruxolitinib). Jakafi is now approved for the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients aged 12 years or older. The approval was based on encouraging data from REACH1, an open-label, single-arm, multicenter study of Jakafi in combination with corticosteroids in patients with steroid-refractory grade II-IV acute GVHD.
The FDA had earlier granted Breakthrough Therapy designation and Orphan Drug status to Jakafi for the treatment of patients with steroid-refractory acute GVHD. The supplemental New Drug Application (sNDA) was reviewed under the FDA’s Priority Review program. Per Incyte, this is the first and only FDA-approved treatment for the aforementioned indication. The approval comes as a sign of relief for investors as the FDA had earlier extended the review period of the sNDA. Jakafi is approved in the United States for the treatment of patients with polycythemia vera (“PV”), who have had an inadequate response to or are intolerant to hydroxyurea. The drug is also approved for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-PV MF and post-essential thrombocythemia MF.
FDA Nod for Label Expansion of Celgene’s Revlimid: Celgene announced that the FDA has approved a label expansion of lead drug, Revlimid. The drug has been approved in combination with a Rituxan product (R²) for the treatment of adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL). The approval was primarily based on results from the randomized, double-blind, phase III AUGMENT study, which evaluated the efficacy and safety of the R² combination versus rituximab plus placebo in patients with previously treated FL. The label expansion of the drug will further boost sales of the drug. A marketing authorization application for R2 is currently under review by the European Medicines Agency for the treatment of relapsed/refractory FL and MZL.
Celgene currently carries a Zacks Rank #2 (Buy). You can see
BioMarin’s Gene Therapy Meets Criteria in Phase III: BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) announced positive results from a late-stage study on investigational gene therapy, valoctocogene roxaparvovec. The candidate achieved pre-specified clinical criteria for regulatory review in the United States and Europe in adults suffering from severe hemophilia A. As of May 28, eight patients in the 20-patient cohort of the phase III GENEr8-1 study achieved Factor VIII levels of 40 international units per deciliter (IU/dL) or more at 23 to 26 weeks. Consequently, the pre-specified criterion for Factor VIII activity levels was met.
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