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TAK News
TAK Events
Protagonist Partners with Takeda to Launch MIMRYLO
Protagonist Therapeutics (PTGX) announced that Takeda (TAK) received U.S. Food and Drug Administration, FDA, approval for MIMRYLO, a subcutaneously delivered first-in-class hepcidin mimetic peptide for the treatment of erythrocytosis in adults with polycythemia vera. MIMRYLO will be commercialized by Takeda under the worldwide license and collaboration agreement entered into in 2024 between Protagonist and Takeda.
Takeda Receives FDA Approval for Mimrylo New Drug Application
Takeda announced U.S. FDA approval of the New Drug Application for Mimrylo for the treatment of erythrocytosis in adults with polycythemia vera, a blood cancer.
Novavax Secures Approval for Nuvaxovid Targeting SARS-CoV-2 XFG Variant
Novavax's (NVAX) partners have received approvals for the Nuvaxovid formulation to target the SARS-CoV-2 XFG variant for the 2026-2027 vaccination season in major markets including the U.S., European Union and Japan. These approvals position Novavax to continue earning royalties on net sales in these markets this season. Sanofi (SNY), Novavax's largest partner, leads Nuvaxovid commercial activities across most major markets and looks to be positioned for a robust 2026-2027 season, expanding the vaccine's commercial reach through broader activities in the U.S. and launches in Germany, Canada and other international markets from 2026 onward. Novavax is eligible to receive ongoing royalties from sales of the vaccine per their 2024 collaboration and license agreement. Takeda (TAK) commercializes Nuvaxovid in Japan. In the 2025-2026 season, Nuvaxovid was the second-most used COVID-19 vaccine in Japan, with delivery volumes and the number of sites receiving the vaccine increasing significantly year over year. Under the CLA terms announced in May 2025, Novavax earns annual milestones tied to regulatory approvals and royalties on net sales each season.
Takeda Receives Approval for Orzeyful for Adult Narcolepsy
Takeda announced that the Japanese Ministry of Health, Labour and Welfare, or MHLW, approved the use of Orzeyful for the treatment of narcolepsy type 1 in adults. Orzeyful is an oral orexin receptor 2 agonist and the only medicine indicated in Japan to treat the disease holistically rather than individual symptoms. The discovery of this new class of medicine originated in Takeda's laboratories in Japan. Takeda is proceeding with launch preparations and expects to make Orzeyful available as quickly as possible.
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