Immunology

Biologics
Pharmaceuticals

First Tracks' ANB033 hits goals in coeliac gluten challenge

ANB033 significantly reduced intestinal damage and symptoms versus placebo in a Phase 1b gluten-challenge study, with a late-stage trial planned for 2027.
ANB033 significantly reduced intestinal damage and symptoms versus placebo in a Phase 1b gluten-challenge study, with a late-stage trial planned for 2027.
Biologics
Pharmaceuticals

InnoCare wins China IND approval for TL1A/IL-23p19 bispecific ICP-B161

InnoCare Pharma has received NMPA clearance to trial ICP-B161, a long-acting bispecific antibody targeting two key IBD pathways, in China.
InnoCare Pharma has received NMPA clearance to trial ICP-B161, a long-acting bispecific antibody targeting two key IBD pathways, in China.
Pharmaceuticals
Biologics

Alumis files NDA plan for envudeucitinib after Phase 3 psoriasis data

Alumis reported 54% complete skin clearance at 48 weeks in its ONWARD programme and plans to submit an NDA for envudeucitinib in Q4 2026.
Alumis reported 54% complete skin clearance at 48 weeks in its ONWARD programme and plans to submit an NDA for envudeucitinib in Q4 2026.
Pharmaceuticals
Biologics

Novartis wins FDA approval for Rhapsido in symptomatic dermographism

Remibrutinib becomes the first FDA-approved therapy for symptomatic dermographism, doubling Rhapsido's approved indications in chronic hives.
Remibrutinib becomes the first FDA-approved therapy for symptomatic dermographism, doubling Rhapsido's approved indications in chronic hives.
Biologics
Pharmaceuticals

argenx Phase 2 data back FB102 as first drug for celiac disease

argenx's CD122 inhibitor FB102 met its primary histological endpoint in a 126-patient Phase 2 gluten-challenge trial, with a Phase 3 programme now
argenx's CD122 inhibitor FB102 met its primary histological endpoint in a 126-patient Phase 2 gluten-challenge trial, with a Phase 3 programme now
Pharmaceuticals
Biologics

Rezera: ruvonoflast cuts inflammation added to semaglutide

Rezera's RESOLVE-2 Phase 2 trial showed ruvonoflast added significant hsCRP reductions to semaglutide therapy, with no new safety signals observed.
Rezera's RESOLVE-2 Phase 2 trial showed ruvonoflast added significant hsCRP reductions to semaglutide therapy, with no new safety signals observed.
Biologics
Pharmaceuticals

argenx halts Phase 3 UNITY trial of efgartigimod in Sjögren's disease

An independent data monitoring committee recommended stopping the UNITY study for futility after an interim analysis found it unlikely to meet its primary endpoint.
An independent data monitoring committee recommended stopping the UNITY study for futility after an interim analysis found it unlikely to meet its primary endpoint.
Cell & Gene Therapy
Biologics

CAR-T safety events dent rheumatologist confidence, Spherix finds

A Spherix Global Insights survey shows physician confidence in autologous CAR-T fell sharply after trial pauses at Novartis and Bristol Myers Squibb.
A Spherix Global Insights survey shows physician confidence in autologous CAR-T fell sharply after trial pauses at Novartis and Bristol Myers Squibb.
Cell & Gene Therapy
Biologics
Pharmaceuticals

MiNK Therapeutics to show iNKT cell data at SITC 2026

MiNK will present two posters at SITC covering checkpoint-resistant colorectal cancer and senescent tumour-cell clearance using its iNKT platform.
MiNK will present two posters at SITC covering checkpoint-resistant colorectal cancer and senescent tumour-cell clearance using its iNKT platform.
Biologics
Pharmaceuticals

Climb Bio to show Phase 2 budoprutug and CLYM116 data at ASN 2026

Climb Bio will present preliminary PrisMN Phase 2 data on budoprutug in membranous nephropathy at ASN Kidney Week in Denver this October.
Climb Bio will present preliminary PrisMN Phase 2 data on budoprutug in membranous nephropathy at ASN Kidney Week in Denver this October.
Cell & Gene Therapy
Biologics
Pharmaceuticals

Artiva to present AlloNK autoimmune data across 34 patients at ACR 2026

Artiva Biotherapeutics will present Phase 2a data for its NK cell therapy in refractory RA, Sjögren disease and systemic sclerosis at ACR Convergence in November.
Artiva Biotherapeutics will present Phase 2a data for its NK cell therapy in refractory RA, Sjögren disease and systemic sclerosis at ACR Convergence in November.
Pharmaceuticals
Biologics

Amplio Pharma Phase 1b data back NovoBioJect methotrexate booster

The Amsterdam biotech reported a 38% rise in active methotrexate inside immune cells, supporting a €10m Series A and a Phase 2a trial in 2027.
The Amsterdam biotech reported a 38% rise in active methotrexate inside immune cells, supporting a €10m Series A and a Phase 2a trial in 2027.
Biologics
Pharmaceuticals

Biogen litifilimab CLE data show durable skin clearance at 52 weeks

Phase 2 AMETHYST data show over a quarter of litifilimab-treated patients achieved clear or almost clear skin; Phase 3 results are due in H1
Phase 2 AMETHYST data show over a quarter of litifilimab-treated patients achieved clear or almost clear skin; Phase 3 results are due in H1
Biologics
Pharmaceuticals

Sanofi and Regeneron expand immunology alliance with $8bn deal

Four next-generation long-acting antibodies targeting IL-13, IL-4 and IL-4Rα join the partnership that produced Dupixent, with Regeneron receiving $1bn upfront.
Four next-generation long-acting antibodies targeting IL-13, IL-4 and IL-4Rα join the partnership that produced Dupixent, with Regeneron receiving $1bn upfront.
Biologics
Pharmaceuticals

Egle Therapeutics: EGL-003 Phase 1 shows clean safety, Treg lift

Egle's IL-2 agonist EGL-003 was well tolerated across four dose cohorts and produced selective Treg expansion, supporting a Q4 2026 atopic dermatitis
Egle's IL-2 agonist EGL-003 was well tolerated across four dose cohorts and produced selective Treg expansion, supporting a Q4 2026 atopic dermatitis
Biologics
Pharmaceuticals

ALX Oncology's evorpacept hits 63.6% ORR in HER2+ gastric subgroup

Phase 2 ASPEN-06 data published in Nature Medicine show evorpacept doubling response rates in CD47-high, HER2-retained gastric cancer patients.
Phase 2 ASPEN-06 data published in Nature Medicine show evorpacept doubling response rates in CD47-high, HER2-retained gastric cancer patients.
Pharmaceuticals
Biologics
Cell & Gene Therapy

C4 Therapeutics cemsidomide shows T-cell data at IMS 2026

Biomarker data from two trials support cemsidomide's T-cell activating mechanism, as the 75 µg dose combination with elranatamab clears safety review.
Biomarker data from two trials support cemsidomide's T-cell activating mechanism, as the 75 µg dose combination with elranatamab clears safety review.
Biologics
Pharmaceuticals

IMUNON reports 14.7-month OS gain from Phase 2 ovarian cancer trial

IMUNON's IMNN-001 showed a 14.7-month median overall survival advantage over standard care in a 112-patient Phase 2 study, as its
IMUNON's IMNN-001 showed a 14.7-month median overall survival advantage over standard care in a 112-patient Phase 2 study, as its
Pharmaceuticals
Biologics

Elicio Therapeutics AMPLIFY-7P data selected for ESMO 2026 oral slot

Phase 2 KRAS-targeting immunotherapy data will be presented at ESMO Congress in Madrid on 23 October, informing a refined Phase 3 strategy.
Phase 2 KRAS-targeting immunotherapy data will be presented at ESMO Congress in Madrid on 23 October, informing a refined Phase 3 strategy.
Biologics
Pharmaceuticals

Celldex barzolvolimab Phase 3 trials meet all endpoints in CSU

Both EMBARQ-CSU studies hit primary and key secondary endpoints, with complete response rates above 40% at 12 weeks; a BLA filing is planned for
Both EMBARQ-CSU studies hit primary and key secondary endpoints, with complete response rates above 40% at 12 weeks; a BLA filing is planned for
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