Immunology

Biologics
Regulatory Science

Leads Biolabs wins IND approval for Opamtistomig in metastatic CRC

China's NMPA cleared a Phase Ib/II trial of the PD-L1/4-1BB bispecific in MSS colorectal cancer, where checkpoint inhibitors have largely
China's NMPA cleared a Phase Ib/II trial of the PD-L1/4-1BB bispecific in MSS colorectal cancer, where checkpoint inhibitors have largely
Biologics

Tiziana sees neuroinflammation fall in third MSA patient on foralumab

PET imaging showed up to 34% reduction in brain inflammatory activity in a third MSA patient treated with intranasal foralumab, consistent with earlier results.
PET imaging showed up to 34% reduction in brain inflammatory activity in a third MSA patient treated with intranasal foralumab, consistent with earlier results.
Biologics

Novo Nordisk ZEUS trial fails to cut cardiovascular events

Ziltivekimab hit its biological targets in 6,300-patient Phase 3 ZEUS but did not reduce MACE versus placebo, triggering a Q3 impairment charge.
Ziltivekimab hit its biological targets in 6,300-patient Phase 3 ZEUS but did not reduce MACE versus placebo, triggering a Q3 impairment charge.
Biologics

Leads Biolabs completes enrolment in Phase II BTC study of opamtistomig

The Nanjing biotech has enrolled 70 patients in a Phase II trial of its PD-L1/4-1BB bispecific, with full data expected at ESMO
The Nanjing biotech has enrolled 70 patients in a Phase II trial of its PD-L1/4-1BB bispecific, with full data expected at ESMO
Biologics

Diakonos Oncology doses first patients in DOC1021 melanoma trial

The Houston biotech has initiated its Phase 1/2 DOC-RM study in refractory melanoma, with early safety results expected by end of 2026.
The Houston biotech has initiated its Phase 1/2 DOC-RM study in refractory melanoma, with early safety results expected by end of 2026.
Biologics

Annexon secures $200m credit facility from Oxford Finance

The Brisbane-based neuroinflammation biotech drew $50m at closing, with up to $150m more tied to milestones for vonaprument and tanruprubart.
The Brisbane-based neuroinflammation biotech drew $50m at closing, with up to $150m more tied to milestones for vonaprument and tanruprubart.
Biologics
Digital Health
Diagnostics

Clue data study links follicular-phase vaccination to more side effects

Research using Clue app data suggests menstrual cycle phase at vaccination may influence COVID-19 vaccine side effects and subsequent infection timing.
Research using Clue app data suggests menstrual cycle phase at vaccination may influence COVID-19 vaccine side effects and subsequent infection timing.
Biologics
Regulatory Science

Pfizer-BioNTech win EC nod for XFG-adapted COVID-19 vaccine

The European Commission has authorised the 2026-2027 COMIRNATY formula targeting the XFG variant of JN.1, covering all 27 EU member states plus Iceland
The European Commission has authorised the 2026-2027 COMIRNATY formula targeting the XFG variant of JN.1, covering all 27 EU member states plus Iceland
Biologics

BriaCell adds Sunnybrook to Phase 3 breast cancer trial

Sunnybrook's Odette Cancer Centre becomes BriaCell's first Canadian site for its pivotal Bria-IMT Phase 3 study in metastatic breast cancer.
Sunnybrook's Odette Cancer Centre becomes BriaCell's first Canadian site for its pivotal Bria-IMT Phase 3 study in metastatic breast cancer.
Biologics
Regulatory Science

DBV Technologies targets Q3 BLA filing for VIASKIN Peanut Patch

DBV Technologies expects to submit its peanut-patch BLA in Q3 2026, backed by $174.9m in cash and active FDA engagement.
DBV Technologies expects to submit its peanut-patch BLA in Q3 2026, backed by $174.9m in cash and active FDA engagement.
Biologics
Regulatory Science

Novartis Fabhalta wins FDA traditional approval in IgA nephropathy

Iptacopan slowed eGFR decline by 48% versus placebo over two years in the Phase III APPLAUSE-IgAN study, converting an accelerated approval granted in 2024.
Iptacopan slowed eGFR decline by 48% versus placebo over two years in the Phase III APPLAUSE-IgAN study, converting an accelerated approval granted in 2024.
Biologics

InnoCare TYK2 inhibitor soficitinib meets Phase II endpoint in vitiligo

InnoCare's oral TYK2 inhibitor soficitinib cut facial vitiligo scores by up to 41% versus 2.2% for placebo at Week 24.
InnoCare's oral TYK2 inhibitor soficitinib cut facial vitiligo scores by up to 41% versus 2.2% for placebo at Week 24.
Biologics

Grifols doses first patients in Phase 3 SIGMA and XPERT Ig trials

Grifols has initiated two Phase 3 trials seeking to broaden US label approvals for its GAMUNEX-C and XEMBIFY immunoglobulin therapies.
Grifols has initiated two Phase 3 trials seeking to broaden US label approvals for its GAMUNEX-C and XEMBIFY immunoglobulin therapies.
Biologics

Neutrolis publishes NEJM case report on NET-degrading SLE therapy

A single-patient compassionate-use case in NEJM shows NTR-441 rapidly cleared SLE symptoms caused by congenital DNASE1L3 deficiency.
A single-patient compassionate-use case in NEJM shows NTR-441 rapidly cleared SLE symptoms caused by congenital DNASE1L3 deficiency.
Biologics

InnoCare soficitinib meets Phase III endpoint in atopic dermatitis

InnoCare's oral TYK2 inhibitor soficitinib met its primary endpoint with statistical significance in a registrational Phase III atopic dermatitis trial.
InnoCare's oral TYK2 inhibitor soficitinib met its primary endpoint with statistical significance in a registrational Phase III atopic dermatitis trial.
Biologics

Spero Therapeutics raises $105m royalty financing to fund SP001 Phase 2

The Cambridge biotech is monetising Utebzi royalties via a KKR-backed deal to fund its anti-CD40L immunology candidate SP001.
The Cambridge biotech is monetising Utebzi royalties via a KKR-backed deal to fund its anti-CD40L immunology candidate SP001.
Biologics

Spero Therapeutics licenses anti-CD40L antibody SP001 from Innovent

Spero gains ex-China rights to a Phase 2-ready monoclonal antibody targeting autoimmune diseases, in a deal worth up to $1.1 billion.
Spero gains ex-China rights to a Phase 2-ready monoclonal antibody targeting autoimmune diseases, in a deal worth up to $1.1 billion.
Biologics

Immutep efti shows 30.9-month mOS in 1L NSCLC despite trial setback

Mature INSIGHT-003 data show efti plus pembrolizumab and chemotherapy achieved 30.9-month mOS in low PD-L1 first-line NSCLC patients.
Mature INSIGHT-003 data show efti plus pembrolizumab and chemotherapy achieved 30.9-month mOS in low PD-L1 first-line NSCLC patients.
Biologics

Anaveon promotes Laetitia Pouzol to Chief Scientific Officer

The Basel biotech has elevated its Head of Immunology to CSO, as ANV200 advances through IND-enabling studies toward clinical testing.
The Basel biotech has elevated its Head of Immunology to CSO, as ANV200 advances through IND-enabling studies toward clinical testing.
Biologics

Junshi Biosciences licenses IL-17A antibody roconkibart to Fosun Wanbang

Junshi Biosciences will receive RMB215m upfront plus milestones and royalties under a Greater China licensing deal for its anti-IL-17A antibody.
Junshi Biosciences will receive RMB215m upfront plus milestones and royalties under a Greater China licensing deal for its anti-IL-17A antibody.
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