Shots:
HUTCHMED has granted GSK worldwide rights to develop & commercialize HMPL-A830 (excl. Mainland China, Hong Kong, Macau and Taiwan), with clinical development initially focussing on colorectal, pancreatic & lung cancer indications
As per the deal, HUTCHMED will be responsible for the global P-I program, (expected to start in H2’26), while GSK subsidiary will handle…
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…
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 &…
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…
Shots:
The EMA has accepted a submission to update Bexsero’s label to incl. a single-dose booster for individuals (≥10yrs.) who were previously vaccinated with Bexsero
Submission was backed by a P-IIIb study showing that a single Bexsero booster dose effectively enhanced immune responses in individuals (10–20yrs.) who completed primary vaccination series during infancy; full data…
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…
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…
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…
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…
Shots:
GSK has reported data from the P-III (B-Well 1 & B-Well 2) trials assessing bepirovirsen vs PBO in nucleos(t)ide analogue-treated pts with CHB & baseline HBsAg ≤3000 IU/ml. Bepirovirsen is under regulatory review in the US, EU, China & Japan
Pooled data showed a 19% functional cure rate (1EP) in the overall population (233/1,220…

