As discussed earlier, Novartis’s (NVS) operating revenue grew 4% year-over-year in the first quarter, to ~$12.7 billion from ~$11.5 billion. The chart below shows recent developments for Novartis.
- On May 30, the FDA accepted Novartis’s supplemental new drug application for the drug Promacta, and granted priority review designation to Promacta in combination with standard immunosuppressive therapy as a first-line treatment for severe aplastic anemia. Promacta is already approved for refractory severe aplastic anemia in patients who respond insufficiently to standard immunosuppressive therapy. Promacta is marketed as Revolade outside the United States.
- On May 24, the European Commission approved Zessly (infliximab), a biosimilar for the treatment of patients with rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, plaque psoriasis, and psoriatic arthritis.
- On May 17, the FDA approved the drug Aimovig (erenumab-aooe), co-developed with Amgen (AMGN) as a preventive treatment for migraines.
- On May 15, Novartis completed the acquisition of AveXis. The highlights of the deal are discussed in the next article.
- On May 11, the FDA approved Gilenya (fingolimod) for the treatment of children aged ten and above with relapsing forms of multiple sclerosis.
- On May 2, the FDA issued a complete response letter for Novartis’s rituximab biosimilar.
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