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Atavistik Bio Inks ~$1.97B Partnership with Roche to Advance Allosteric Small Molecules for CVRM Diseases

Shots: 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 and Roche Report Interim P-III (IMAgINATION) Trial Data on Sefaxersen in IgA Nephropathy (IgAN)

Shots: 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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Roche

Roche Reports EC Approval of Susvimo to Treat nAMD

Shots: 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 Therapeutics and Roche Partner to Advance Novel Bispecific Antibodies for I&I Diseases in a ~$1B Deal

Shots: 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

Roche Reports the P-III (CELESTIMO) Trial Data on Lunsumio in Follicular Lymphoma

Shots: 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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Roche

Roche Reports FDA Approval of HER2 Companion Diagnostics for Gastroesophageal Cancer

Shots: 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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Roche

Roche’ Elecsys pTau217 Test Receives the US FDA Clearance to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology

Shots: 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…

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Nurix Therapeutics Enrolled First Patient in P-III (DAYBreak CLL-306) Trial of Bexobrutideg in R/R CLL/SLL

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…

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