HUTCHMED fanregratinib hits 42.5% ORR in pivotal ICC Phase II

HUTCHMED's FGFR2-targeted oral candidate met its primary endpoint in pretreated intrahepatic cholangiocarcinoma, supporting a China NMPA priority review NDA.
HUTCHMED's FGFR2-targeted oral candidate met its primary endpoint in pretreated intrahepatic cholangiocarcinoma, supporting a China NMPA priority review NDA.
Biologics

Phathom Pharmaceuticals completes enrolment in Phase 2 EoE trial

Phathom has fully enrolled 95 adults in its pHalcon-EoE-201 study of vonoprazan, with topline data expected in Q4 2026.
Phathom has fully enrolled 95 adults in its pHalcon-EoE-201 study of vonoprazan, with topline data expected in Q4 2026.
Bioprocessing

TISSIUM raises €60m to back COAPTIUM launch and pipeline growth

The Paris-based MedTech has combined a €30m Series D2 with a €30m EIB facility to fund US commercialisation of its FDA-cleared polymer repair
The Paris-based MedTech has combined a €30m Series D2 with a €30m EIB facility to fund US commercialisation of its FDA-cleared polymer repair
Biologics

Lilly's $7.8bn Centessa acquisition cleared by English High Court

Eli Lilly's scheme of arrangement to acquire OX2R-focused Centessa Pharmaceuticals has been sanctioned by the High Court, with closing expected on 24 June.
Eli Lilly's scheme of arrangement to acquire OX2R-focused Centessa Pharmaceuticals has been sanctioned by the High Court, with closing expected on 24 June.
Regulatory Science

Agomab aligns with FDA on Phase 2b NOV-ERA design for FSCD

Agomab Therapeutics has finalised the design of its NOV-ERA Phase 2b study, with first participants expected to be dosed in the second half of
Agomab Therapeutics has finalised the design of its NOV-ERA Phase 2b study, with first participants expected to be dosed in the second half of
Pharmaceuticals

Orion Pharma's ODM-212 wins EU Orphan Designation for mesothelioma

The Finnish pharma group's oral pan-TEAD inhibitor now holds Orphan Designation on both sides of the Atlantic as its Phase 2 TEADES trial
The Finnish pharma group's oral pan-TEAD inhibitor now holds Orphan Designation on both sides of the Atlantic as its Phase 2 TEADES trial
Biologics

Sanofi's Wayrilz wins Japan approval for immune thrombocytopenia

Japan's health ministry has approved rilzabrutinib for persistent or chronic ITP, backed by Phase 3 data showing a 23% durable platelet response versus zero
Japan's health ministry has approved rilzabrutinib for persistent or chronic ITP, backed by Phase 3 data showing a 23% durable platelet response versus zero
Biologics

Silexion secures BfArM approval for SIL204 Phase 2/3 LAPC trial

Germany's BfArM has cleared Silexion's siRNA candidate SIL204 for a Phase 2/3 trial in locally advanced pancreatic cancer, with first dosing expected
Germany's BfArM has cleared Silexion's siRNA candidate SIL204 for a Phase 2/3 trial in locally advanced pancreatic cancer, with first dosing expected
Biologics

Boehringer opens three Phase III trials in lung and NEC cancers

Boehringer Ingelheim has initiated three Phase III trials covering obrixtamig in SCLC and epNEC, and zongertinib in resectable HER2-mutant NSCLC.
Boehringer Ingelheim has initiated three Phase III trials covering obrixtamig in SCLC and epNEC, and zongertinib in resectable HER2-mutant NSCLC.
Regulatory Science

BridgeBio to present Phase 3 infigratinib achondroplasia data at ICCBH

BridgeBio will share primary Phase 3 PROPEL 3 results for oral infigratinib in children with achondroplasia at ICCBH 2026 in Montreal.
BridgeBio will share primary Phase 3 PROPEL 3 results for oral infigratinib in children with achondroplasia at ICCBH 2026 in Montreal.
Diagnostics
Genomics

A3P Biomedical's Stockholm3 outperforms PSA in 12,670-man study

Stockholm3 detected 90% of aggressive prostate cancers versus 52% for standard PSA testing in a large population-based screening trial published in Annals of Internal
Stockholm3 detected 90% of aggressive prostate cancers versus 52% for standard PSA testing in a large population-based screening trial published in Annals of Internal
Biologics

Sanofi wins EU approval for tolebrutinib in progressive MS

The European Commission has approved Cenrifki for non-relapsing secondary progressive MS, making it the first therapy to target disability progression in the indication.
The European Commission has approved Cenrifki for non-relapsing secondary progressive MS, making it the first therapy to target disability progression in the indication.
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