Clinical Trials

Regulatory Science

Elevar Therapeutics doses first patients in FGFR2 Phase 2 expansion

Elevar's ReFocus202 trial opens enrolment in non-CCA solid tumours, testing lirafugratinib across a broad range of FGFR2-altered cancers globally.
Elevar's ReFocus202 trial opens enrolment in non-CCA solid tumours, testing lirafugratinib across a broad range of FGFR2-altered cancers globally.

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.
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.
Genomics
Diagnostics
Bioinformatics

Bionano OGM studies at ESHG 2026 surge 67% year-on-year

Thirty-five studies featuring optical genome mapping appeared at ESHG 2026, up from 21 the prior year, spanning authors across 17 countries.
Thirty-five studies featuring optical genome mapping appeared at ESHG 2026, up from 21 the prior year, spanning authors across 17 countries.
Biologics
Regulatory Science

ENA Respiratory secures two US patents for TLR2 agonist COPD programme

USPTO notices of allowance extend INNA-051's potential US exclusivity to at least 2042, covering both composition of matter and rhinovirus-mediated COPD exacerbations.
USPTO notices of allowance extend INNA-051's potential US exclusivity to at least 2042, covering both composition of matter and rhinovirus-mediated COPD exacerbations.
Biologics

MoonLake's sonelokimab hits 67% HiSCR75 at one year in HS

Week 52 VELA data show sonelokimab outperforming competing IL-17 agents in hidradenitis suppurativa, with a BLA filing targeted for late September 2026.
Week 52 VELA data show sonelokimab outperforming competing IL-17 agents in hidradenitis suppurativa, with a BLA filing targeted for late September 2026.
Biologics

BioCardia targets Japan PMDA submission for CardiAMP by end of 2026

BioCardia plans to file CardiAMP Cell Therapy for approval in Japan by Q4 2026, targeting an initial patient subgroup of 20,000 ischemic heart failure
BioCardia plans to file CardiAMP Cell Therapy for approval in Japan by Q4 2026, targeting an initial patient subgroup of 20,000 ischemic heart failure
Biologics

CTD-ILD pipeline heats up as physicians seek disease modification

A Spherix Global Insights survey of 107 US specialists finds only 15% of CTD-ILD patients achieve drug-free remission, driving pipeline interest.
A Spherix Global Insights survey of 107 US specialists finds only 15% of CTD-ILD patients achieve drug-free remission, driving pipeline interest.
Biologics

Kither Biotech completes Phase 1 of inhaled peptide KIT2014 in COPD

The Turin-based biotech reported KIT2014 was safe and well tolerated at all doses, with no detectable systemic exposure, in 56 healthy participants.
The Turin-based biotech reported KIT2014 was safe and well tolerated at all doses, with no detectable systemic exposure, in 56 healthy participants.
Biologics

MAIA Biotechnology opens third US site for ateganosine Phase 2 trial

Winship Cancer Institute of Emory University joins THIO-101, evaluating ateganosine as a third-line NSCLC therapy in checkpoint-inhibitor-resistant patients.
Winship Cancer Institute of Emory University joins THIO-101, evaluating ateganosine as a third-line NSCLC therapy in checkpoint-inhibitor-resistant patients.
Regulatory Science

Nerandomilast modelling predicts multi-year survival gain in IPF

Boehringer Ingelheim survival models predict nerandomilast could more than double median IPF survival, based on Phase III FIBRONEER trial data.
Boehringer Ingelheim survival models predict nerandomilast could more than double median IPF survival, based on Phase III FIBRONEER trial data.
Biologics
Regulatory Science

Sanofi wins Japan approval for Sarclisa subcutaneous formulation

Japan's MHLW has approved isatuximab SC across multiple myeloma indications, with an on-body injector application still under regulatory review.
Japan's MHLW has approved isatuximab SC across multiple myeloma indications, with an on-body injector application still under regulatory review.
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