Roche

The FDA has initiated an accelerated review of Roche/Chugai’s drug Enspryng for the rare autoimmune disease MOGAD. The decision is based on the phase III Meteoroid study, in which Enspryng reduced relapse risk by 68% versus placebo and, at 48 weeks, 87% of patients on Enspryng were relapse-free versus 67% on placebo. The FDA aims to decide by January 10, 2027; the EMA is also reviewing the drug with an expected European Commission decision in the third quarter of 2027. Enspryng is already approved for the related condition neuromyelitis optica spectrum disorder in around 90 countries. » Mais em finanzen.net

Roche has acquired from Simcere Zaiming the exclusive worldwide development, manufacturing and commercialization rights to SIM0660, a trispecific antibody against B‑cell–mediated diseases. Simcere Zaiming will receive up to $1.53 billion, including an upfront payment of $75 million, plus tiered double‑digit royalties on future net sales. » Mais em finanzen.net

Roche has signed an exclusive license agreement for SIM0660 from Simcere and will pay an upfront $75 million; depending on development, milestone payments of up to $1.455 billion and tiered payments on future net sales are agreed. Separately, Roche is working with Treeline Biosciences on a combination study testing Treeline’s TLN‑121 together with Roche’s drugs glofitamab (Columvi) and mosunetuzumab (Lunsumio) in B‑cell lymphomas. Treeline will fund and run the phase‑1 study, with the combined use planned for Q4 2026; financial details were not disclosed. » Mais em finanzen.net