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GSK

GSK’s Jemperli (Dostarlimab) Secures US FDA Priority Review for dMMR/MSI-H Locally Advanced Rectal Cancer

Shots: The US FDA has accepted the sBLA under Project Orbis & granted priority review to Jemperli in previously untreated stage II/III dMMR/MSI-H locally advanced rectal cancer (PDUFA: Feb 2027), with eligibility for an earlier decision through the NPV program sBLA was based on the global P-II (AZUR-1) trial assessing Jemperli (dostarlimab) monotx. (500mg, IV, Q3W…

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Relation and GSK Partner to Advance Drug Discovery

Shots: Relation has entered a strategic research collaboration with GSK to generate large-scale human cellular perturbation datasets to understand disease biology & discover novel therapeutic targets Relation will generate large-scale perturbation datasets using advanced human cellular disease models & experimental systems to develop, validate, & train foundation models, incl. MORGAN, to investigate disease biology &…

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GSK Reports the US FDA Approval of Jideytro for Previously Treated ROS1-Positive NSCLC

Shots: The US FDA has approved Jideytro (zidesamtinib) for the treatment of adults with locally advanced or metastatic ROS1-positive NSCLC who received a prior ROS1 kinase inhibitor Approval was based on the global P-I/II (ARROS-1) trial evaluating Jideytro in pts (n=117) with advanced or metastatic ROS1-positive NSCLC previously treated with a ROS1 inhibitor Trial showed meaningful & durable…

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GSK

GSK Reports P-II (AZUR-1) Trial Data on Jemperli for dMMR/MSI-H Locally Advanced Rectal Cancer

Shots: GSK has reported global P-II (AZUR-1) trial data assessing Jemperli (dostarlimab) (500mg, IV, Q3W for 9 cycles) in 154 pts with stage II/III mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer Trial met its 1EP, with a meaningful & sustained clinical complete response rate at 12mos. Interim AZUR-1 data will be shared with global…

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GSK & Spero Therapeutics Report the US FDA Approval of Utebzi for Complicated Urinary Tract Infections (cUTIs)

Shots: The US FDA has approved Utebzi (tebipenem pivoxil; 600mg, PO, Q6H) for the treatment of cUTIs incl. pyelonephritis, in adults who have limited or no alternative oral treatment options, with launch expected by the end of 2026 Approval was supported by the P-III (PIVOT-PO) trial demonstrating that Utebzi was non-inferior to IV imipenem-cilastatin in…

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GSK to Acquire Nuvalent for ~$10.6B

Shots: GSK has entered an agreement to acquire Nuvalent, accelerating its entry into lung cancer As per the deal, GSK will acquire Nuvalent through a tender offer of $124 per share in cash, valuing the company at ~$10.6B (£8.0B); net of acquired cash, GSK’s total investment is estimated at $9.4B (£7.1B). Closing is expected in…

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Engitix and GSK Partner on Human ECM Platform to Identify Liver Fibrosis Regression Targets

Shots: Engitix & GSK have entered a strategic research collaboration & option agreement to identify & validate novel therapeutic targets that drive liver fibrosis regression using Engitix’s human extracellular matrix (ECM) platform & multi-omics datasets As per the deal, Engitix will receive ~£44.5M (~$59.3M) upfront & near-term payments, along with ~£118M (~$157.3M) per target in…

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