Immunology

Biologics
Pharmaceuticals

Eledon tegoprubart shows 13 mL/min eGFR edge over tacrolimus

Eledon's Phase 2 BESTOW extension data show tegoprubart maintained significantly better kidney function than tacrolimus at 24 months, with no rejections beyond six
Eledon's Phase 2 BESTOW extension data show tegoprubart maintained significantly better kidney function than tacrolimus at 24 months, with no rejections beyond six
Biologics
Pharmaceuticals

PDS Biotech's PDS0101 combo shows 39-month survival in HNSCC trial

VERSATILE-002 Phase 2 results, published in JAMA Oncology, showed 39.3 months median overall survival in HPV16-positive head and neck cancer, more than
VERSATILE-002 Phase 2 results, published in JAMA Oncology, showed 39.3 months median overall survival in HPV16-positive head and neck cancer, more than
Pharmaceuticals
Biologics

J&J wins EC approval for icotrokinra in plaque psoriasis

Johnson & Johnson's icotrokinra becomes the first targeted oral peptide to block the IL-23 receptor, approved for moderate-to-severe plaque psoriasis in Europe.
Johnson & Johnson's icotrokinra becomes the first targeted oral peptide to block the IL-23 receptor, approved for moderate-to-severe plaque psoriasis in Europe.
Cell & Gene Therapy
Biologics
Pharmaceuticals

Vironexis VNX-101 achieves MRD-negative responses in R/R ALL

All three antibody-naïve relapsed/refractory ALL patients in SENTRY-CD19 achieved durable MRD-negative complete responses after a single VNX-101 infusion.
All three antibody-naïve relapsed/refractory ALL patients in SENTRY-CD19 achieved durable MRD-negative complete responses after a single VNX-101 infusion.
Biologics
Pharmaceuticals

Cue Biopharma: CUE-221 beats placebo and omalizumab in CSU trial

CUE-221 met both primary and key secondary endpoints in a 145-patient Phase 2 study, with the 4 mg/kg dose outperforming omalizumab 12
CUE-221 met both primary and key secondary endpoints in a 145-patient Phase 2 study, with the 4 mg/kg dose outperforming omalizumab 12
Biologics
Pharmaceuticals

Tiziana Life Sciences signs KAIMRC MOU for RRMS combination trial

Tiziana will collaborate with Saudi Arabia's KAIMRC on a clinical trial combining intranasal foralumab with anti-CD20 therapy in poorly responding RRMS patients.
Tiziana will collaborate with Saudi Arabia's KAIMRC on a clinical trial combining intranasal foralumab with anti-CD20 therapy in poorly responding RRMS patients.
Biologics
Pharmaceuticals

Electra Therapeutics prices upsized $350m IPO on Nasdaq

The South San Francisco biotech will trade under "ETRA" after pricing 23.3 million shares at $15 each, with proceeds targeting its SIRP-targeting pipeline.
The South San Francisco biotech will trade under "ETRA" after pricing 23.3 million shares at $15 each, with proceeds targeting its SIRP-targeting pipeline.
Biologics
Pharmaceuticals

Novartis secukinumab gets positive CHMP opinion for PMR

The EMA's advisory committee has backed Cosentyx as the first IL-17A inhibitor for polymyalgia rheumatica in Europe, pending European Commission sign-off.
The EMA's advisory committee has backed Cosentyx as the first IL-17A inhibitor for polymyalgia rheumatica in Europe, pending European Commission sign-off.
Biologics
Pharmaceuticals

Connect Biopharma's rademikibart cuts asthma treatment failure by 66%

Phase 2 data show rademikibart reduced treatment failure and improved lung function in acute asthma, with COPD readout and FDA engagement planned.
Phase 2 data show rademikibart reduced treatment failure and improved lung function in acute asthma, with COPD readout and FDA engagement planned.
Biologics
Pharmaceuticals

Electra Therapeutics starts Phase 1 of SIRPγ antibody ELA822

Electra's second SIRP-targeted candidate enters the clinic targeting selective depletion of pathogenic T cells in chronic immune and inflammatory diseases.
Electra's second SIRP-targeted candidate enters the clinic targeting selective depletion of pathogenic T cells in chronic immune and inflammatory diseases.
Biologics
Pharmaceuticals
Medical Devices

Syncromune presents SYNC-T Phase 1 prostate data at CIRSE 2026

The Florida biotech reported an 87% overall response rate in a 15-patient Phase 1 study of its intratumoral immunotherapy platform in metastatic prostate cancer.
The Florida biotech reported an 87% overall response rate in a 15-patient Phase 1 study of its intratumoral immunotherapy platform in metastatic prostate cancer.
Pharmaceuticals
Biologics

Beeline Medicines' afimetoran meets Phase 2 primary endpoint in SLE

The Stamford biotech reported highly significant SRI-4 response rates versus placebo at Week 48, supporting pivotal development in systemic and cutaneous lupus.
The Stamford biotech reported highly significant SRI-4 response rates versus placebo at Week 48, supporting pivotal development in systemic and cutaneous lupus.
Biologics
Regulatory Science

Roche wins FDA Priority Review for Enspryng in MOGAD

The FDA has accepted Roche's sBLA for satralizumab in MOGAD, a CNS autoimmune disease with no approved treatments, with a decision due January 2027.
The FDA has accepted Roche's sBLA for satralizumab in MOGAD, a CNS autoimmune disease with no approved treatments, with a decision due January 2027.
Biologics
Pharmaceuticals

Solstice Oncology launches with $225m Series A for CTLA-4 antibody

The Boston immuno-oncology startup closed a $225m Series A to advance porustobart, a next-generation CTLA-4 antibody, in neoadjuvant colon cancer.
The Boston immuno-oncology startup closed a $225m Series A to advance porustobart, a next-generation CTLA-4 antibody, in neoadjuvant colon cancer.
Biologics
Pharmaceuticals

Spyre Therapeutics completes IBD proof-of-concept with SPY003 data

SPY003 met its primary endpoint in ulcerative colitis, giving Spyre positive Phase 2 monotherapy readouts for all three of its IBD combination components.
SPY003 met its primary endpoint in ulcerative colitis, giving Spyre positive Phase 2 monotherapy readouts for all three of its IBD combination components.
Biologics
Pharmaceuticals

Vor Bio completes UPSTREAM MG enrolment and launches oMG trial

Vor Bio has fully enrolled its global Phase 3 gMG study and will initiate a sister trial in ocular myasthenia gravis, with topline data expected
Vor Bio has fully enrolled its global Phase 3 gMG study and will initiate a sister trial in ocular myasthenia gravis, with topline data expected
Pharmaceuticals
Biologics
Regulatory Science

Monte Rosa pockets $50m milestone as Novartis starts MRT-6160 Phase 2

Novartis has dosed its first Sjögren's disease patient with MRT-6160, triggering a $50m payment to Monte Rosa under the pair's $2.1bn
Novartis has dosed its first Sjögren's disease patient with MRT-6160, triggering a $50m payment to Monte Rosa under the pair's $2.1bn
Diagnostics
Medical Devices
Biologics

Cytek Biosciences to showcase spectral cytometry at ESCCA and ICCS

Cytek will present Full Spectrum Profiling technology at two clinical cytometry conferences in September and October, with a focus on MRD monitoring.
Cytek will present Full Spectrum Profiling technology at two clinical cytometry conferences in September and October, with a focus on MRD monitoring.
Biologics
Pharmaceuticals

HCW Biologics wins patent allowance for HCW9302 in alopecia areata

The Florida biotech has secured a USPTO notice of allowance covering HCW9302 as an alopecia areata treatment, as Phase 1 data show early signs of
The Florida biotech has secured a USPTO notice of allowance covering HCW9302 as an alopecia areata treatment, as Phase 1 data show early signs of
Biologics
Pharmaceuticals

Climb Bio CLYM116 Phase 1 data back every-12-week dosing in IgAN

Phase 1 data show CLYM116 achieved near-complete APRIL suppression and a 29-day half-life, supporting quarterly dosing in IgA nephropathy.
Phase 1 data show CLYM116 achieved near-complete APRIL suppression and a 29-day half-life, supporting quarterly dosing in IgA nephropathy.
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