Shots:
The US FDA has accepted an NDA & granted priority review to fenebrutinib for RMS & PPMS based on P-III (FENhance 1 & 2) studies & the P-III (FENtrepid) trial, respectively
FENhance 1 & 2 showed fenebrutinib reduced relapses and active & chronic brain lesions vs teriflunomide, lowering ARR by 51.1% & 58.5%, respectively,…
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Atavistik Bio has entered into a strategic research collaboration with Roche to discover & develop novel small molecules against multiple targets for cardiovascular, renal, and metabolic (CVRM) diseases, using Atavistik’s AMPS platform
As per the deal, Atavistik Bio will be responsible for discovery & research activities for the collaboration targets, with Roche responsible for…
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Ionis & Roche have reported interim P-III (IMAgINATION) trial results assessing sefaxersen (QM, SC) in 459 adults with IgAN for 105wks., after which eligible pts may switch to open-label treatment
IMAgINATION met its 1EP, showing improvements in proteinuria reduction at 37wks., as measured by 24hr. UPCR; data to be presented in future & shared with…
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The EC has approved Susvimo (ranibizumab 100mg/mL solution for injection) for the treatment of neovascular age-related macular degeneration (nAMD), based on the 3 studies, P-III (Archway), P-II (LADDER) & open-label LTE study (Portal)
Archway showed Susvimo (refilled in Q6M) maintained vision improvements equivalent to ranibizumab (QM, IVT), with Portal showing maintenance of vision up…
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Dualitas has entered into a research collaboration & license agreement with Roche to advance novel bispecific antibodies for immunology & inflammation (I&I) diseases, using Dualitas' DualScreen Bispecific Discovery Engine
As per the deal, Dualitas will receive $36.5M upfront & additional research, development & commercial milestone payments, representing the total deal value of ~$1B, in addition…
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Roche has reported the P-III (CELESTIMO) trial assessing Lunsumio (mosunetuzumab) + lenalidomide vs MabThera + lenalidomide in pts with r/r follicular lymphoma who have received ≥1L of prior systemic therapy
Trial met its 1EP, showing a statistically significant & clinically meaningful improvement in PFS, while OS data remained immature at the interim analysis; the…
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Simcere Zaiming has entered into an exclusive global licensing agreement with Roche for the development & commercialization of SIM0660, a potential treatment of B-cell-mediated diseases
As per the deal, Roche will acquire exclusive global rights to develop, manufacture, & commercialize SIM0660 in exchange for ~$1.53B in total, incl. $75M in upfront, as well as…
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The US FDA has granted approval to expand the use of Pathway HER2 (4B5) & Ventana HER2 Dual ISH tests to identify HER2+ metastatic gastroesophageal adenocarcinoma (GEA), incl. gastric, GEJ & esophageal adenocarcinoma
The companion diagnostics can help identify pts who may be eligible for HER2-targeted treatment with two Ziihera (zanidatamab-hrii) regimens for 1L…
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The US FDA has granted clearance to Elecsys pTau217 to measure the phosphorylated Tau (pTau) 217 protein to help rule in or rule out Alzheimer’s-related amyloid pathology in people (≥55yrs.) with signs or complaints of cognitive decline
In adults aged 55+ with cognitive decline associated with Alzheimer’s disease, Elecsys pTau217 showed high agreement with…
Shots:
Nurix has enrolled the first patient in the global P-III (DAYBreak CLL-306) study assessing bexobrutideg in pts with r/r chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received a covalent BTK inhibitor
The trial, conducted under the collaboration between Nurix and Roche, is expected to enroll ~620 pts, where they will be randomized…

