Roivant Sciences LtdROIV
▲ PositiveRegulationrelevance
FDA approval of Lisraya, the first oral dermatomyositis treatment, is a regulatory win for Roivant.
Impact on stocks 1
Biotech & Genomic Medicine▲ · 1 stocks
Roivant Sciences LtdTheme Impact 1
Off-coverage companies 1
Priovant TherapeuticsPrivate▲ Positive
Regulationrelevance
Partner Priovant Therapeutics shares in the FDA approval of Lisraya for dermatomyositis.
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Bristol Myers Sotyktu Shows Two-Year PsA Efficacy in POETYK Study
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Novo's Denecimig Wins CHMP Backing for Hemophilia A in EU
Novo Nordisk said the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion recommending approval of denecimig, also known as Mim8, for the treatment of hemophilia A, with or without inhibitors, in adults and children. Denecimig is a next-generation factor VIIIa mimetic bispecific antibody given subcutaneously as routine prophylaxis, with flexible dosing that includes once-monthly, every-two-week and weekly administration, and it is being developed as a prefilled pen. Novo expects to launch the drug in the first European countries in the fourth quarter of 2026 under the brand name Frehemgo, followed by a broader rollout across the European Union beginning in early 2027. The positive opinion is supported by data from the FRONTIER clinical program, which comprises five studies evaluating denecimig as a prophylactic treatment for hemophilia A across pediatric and adult populations, with or without inhibitors; in the FRONTIER 2 study denecimig significantly reduced annualized bleeding rates, results in children younger than 12 in FRONTIER 3 were consistent with those in adolescents and adults, and in FRONTIER 5 no new safety concerns were identified when participants switched directly from emicizumab to denecimig. The candidate is also under regulatory review in the United States for routine prophylaxis in adults and children with hemophilia A, with or without inhibitors, after Novo submitted a biologics license application to the FDA in September 2025. Novo already markets Alhemo for hemophilia A and B in patients with or without inhibitors.
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Trump to Announce Most Favored Nation Drug Pricing for Medicaid in All 50 States
President Trump will announce on Friday that Medicaid beneficiaries in all 50 states will receive Most Favored Nation pricing discounts on some prescription drugs. The White House Council of Economic Advisers projects the move will generate $27.6B in savings for state governments and $36.6B for the federal government over 10 years, according to Semafor, which broke the news. Trump is also scheduled to meet today with the governors of Arkansas, Mississippi, and South Dakota to discuss progress on lowering drug prices. Separately, an AARP Public Policy Institute report released in August found that applying MFN pricing to the top 10 drugs by Medicare Part D and Part B spending in 2025 would cut Medicare spending on those drugs from $273B to $76B between 2029 and 2033.