European Drug Regulator Recommends Approval Of GSK's Bone Marrow Cancer Med
Portfolio Pulse from Vandana Singh
The European Medicines Agency's CHMP has recommended approval of GSK plc's momelotinib for treating splenomegaly or symptoms in bone marrow cancer patients. The drug is for patients with myelofibrosis who are either Janus kinase inhibitor naïve or have been treated with ruxolitinib. The recommendation is based on data from the MOMENTUM study and SIMPLIFY-1 phase 3 trial. If approved, momelotinib, to be named Omjjara in the EU, would be the only medicine for myelofibrosis patients with moderate to severe anemia in the EU. GSK's stock saw a slight increase following the news.
November 13, 2023 | 4:44 pm
News sentiment analysis
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POSITIVE IMPACT
GSK's momelotinib received a positive opinion from the European Medicines Agency's CHMP for treating bone marrow cancer, potentially boosting its market presence in the EU.
The positive recommendation from the CHMP for momelotinib is likely to be viewed favorably by investors, as it opens the door for market approval in the EU. This could lead to increased sales and market share for GSK in the oncology segment, which is typically a high-margin area. The slight uptick in GSK's stock price following the announcement indicates a positive market reaction, although the impact may be moderate given that it is a recommendation and not final approval.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100