Immunology

Biologics
Cell & Gene Therapy

Transgene TG4050 sustains 100% disease-free survival at three years

All 16 TG4050-treated HNSCC patients remained relapse-free at 41 months' median follow-up, with full Phase 1 data now published in Nature Communications.
All 16 TG4050-treated HNSCC patients remained relapse-free at 41 months' median follow-up, with full Phase 1 data now published in Nature Communications.
Biologics
Pharmaceuticals

Teva's TEV-408 meets primary endpoint in celiac Phase 2a

Teva's anti-IL-15 antibody TEV-408 significantly reduced gluten-induced intestinal damage versus placebo in a 50-patient Phase 2a study.
Teva's anti-IL-15 antibody TEV-408 significantly reduced gluten-induced intestinal damage versus placebo in a 50-patient Phase 2a study.
Biologics
Pharmaceuticals

Attovia Therapeutics raises $332m IPO as itch drug shows Phase 1b signal

The San Carlos biotech reported preliminary proof of concept for ATTO-1310 in chronic pruritus and atopic dermatitis, with two Phase 2 studies planned for
The San Carlos biotech reported preliminary proof of concept for ATTO-1310 in chronic pruritus and atopic dermatitis, with two Phase 2 studies planned for
Biologics
Pharmaceuticals

Upstream Bio plans dual Phase 3 trials for verekitug in 2027

The Waltham biotech will start pivotal studies in severe asthma and CRSwNP in Q1 2027, targeting a quarterly 400 mg subcutaneous regimen.
The Waltham biotech will start pivotal studies in severe asthma and CRSwNP in Q1 2027, targeting a quarterly 400 mg subcutaneous regimen.
Biologics
Regulatory Science

Alvotech wins FDA review acceptance for AVT80 vedolizumab biosimilar

Alvotech's BLA for AVT80, a proposed interchangeable subcutaneous biosimilar to Entyvio, has been accepted for review by the FDA, completing its dual-presentation
Alvotech's BLA for AVT80, a proposed interchangeable subcutaneous biosimilar to Entyvio, has been accepted for review by the FDA, completing its dual-presentation
Biologics

Corvus Pharmaceuticals publishes Phase 1 soquelitinib data in Blood

Final Phase 1/1b data for the ITK inhibitor in T cell lymphoma show durable responses and support an ongoing Phase 3 trial in relapsed
Final Phase 1/1b data for the ITK inhibitor in T cell lymphoma show durable responses and support an ongoing Phase 3 trial in relapsed
Biologics

argenx acquires Forte Biosciences, adding anti-CD122 antibody

argenx has completed its takeover of Forte Biosciences, gaining FB102, an anti-CD122 antibody with clinical data in vitiligo and coeliac disease.
argenx has completed its takeover of Forte Biosciences, gaining FB102, an anti-CD122 antibody with clinical data in vitiligo and coeliac disease.
Biologics

Priovant wins FDA approval for brepocitinib in dermatomyositis

LISRAYA becomes the first targeted oral therapy approved for dermatomyositis, backed by Phase 3 data showing significant steroid-sparing and disease-activity benefits.
LISRAYA becomes the first targeted oral therapy approved for dermatomyositis, backed by Phase 3 data showing significant steroid-sparing and disease-activity benefits.
Biologics
Regulatory Science

Roivant's brepocitinib wins FDA approval for dermatomyositis

LISRAYA becomes the first targeted therapy approved for dermatomyositis, a rare autoimmune disease with few treatment advances in decades.
LISRAYA becomes the first targeted therapy approved for dermatomyositis, a rare autoimmune disease with few treatment advances in decades.
Biologics

Priovant's brepocitinib hits skin remission targets in Phase 3 DM trial

JAMA Dermatology publishes secondary endpoint data showing rapid, durable skin improvements for brepocitinib versus placebo in dermatomyositis.
JAMA Dermatology publishes secondary endpoint data showing rapid, durable skin improvements for brepocitinib versus placebo in dermatomyositis.
Biologics

Spyre Therapeutics' SPY072 misses RA monotherapy bar in SKYWAY Phase 2

SPY072 showed statistically significant benefits in rheumatoid arthritis but fell short of Spyre's internal threshold to advance it as a standalone therapy.
SPY072 showed statistically significant benefits in rheumatoid arthritis but fell short of Spyre's internal threshold to advance it as a standalone therapy.
Biologics

Apollo Therapeutics: Phase 1 pan-rhinovirus vaccine data positive

APL-10456 induced broad cross-reactive T cell responses against all three rhinovirus species in a 144-participant Phase 1 trial, with no serious adverse
APL-10456 induced broad cross-reactive T cell responses against all three rhinovirus species in a 144-participant Phase 1 trial, with no serious adverse
Biologics

Leads Biolabs' opamtistomig posts 65% ORR in Phase 2 NSCLC study

Updated data from over seven months of follow-up, including PFS rates, will be presented at WCLC on 14 September 2026.
Updated data from over seven months of follow-up, including PFS rates, will be presented at WCLC on 14 September 2026.
Biologics
Regulatory Science

FDA awards Orphan Drug status to Lakefront's gamgertamig in pemphigus

Lakefront Biotherapeutics gains a third FDA designation for gamgertamig, its BCMAxCD3 bispecific T cell engager, as pemphigus joins its autoimmune pipeline.
Lakefront Biotherapeutics gains a third FDA designation for gamgertamig, its BCMAxCD3 bispecific T cell engager, as pemphigus joins its autoimmune pipeline.
Biologics

AC Immune NLRP3 inhibitor clears Phase 1 with CSF penetration

ACI-19764 was safe and well tolerated across dose cohorts, with brain penetration confirmed and a therapeutic dose expected at 10mg once daily.
ACI-19764 was safe and well tolerated across dose cohorts, with brain penetration confirmed and a therapeutic dose expected at 10mg once daily.
Regulatory Science

Aclaris Therapeutics wins Fast Track tag for modzatinib in lichen planus

The FDA granted Fast Track Designation to modzatinib for moderate to severe lichen planus, a condition with no currently approved therapies.
The FDA granted Fast Track Designation to modzatinib for moderate to severe lichen planus, a condition with no currently approved therapies.
Biologics

Nurix earns $10m milestone as Sanofi starts STAT6 degrader Phase 1

Sanofi's first-in-human trial of oral STAT6 degrader SAR448272 triggers a milestone payment, bringing Nurix's total collaboration receipts to roughly $139m.
Sanofi's first-in-human trial of oral STAT6 degrader SAR448272 triggers a milestone payment, bringing Nurix's total collaboration receipts to roughly $139m.
Biologics

BriaCell wins FDA clearance for Bria-PROS+ prostate cancer study

BriaCell's next-generation personalised cell-based immunotherapy for prostate cancer can now enter a Phase 1/2a trial after receiving FDA IND clearance.
BriaCell's next-generation personalised cell-based immunotherapy for prostate cancer can now enter a Phase 1/2a trial after receiving FDA IND clearance.
Biologics

Dianthus Therapeutics reports 75% CIDP response rate and $1.2bn cash

Dianthus posted positive interim Phase 3 data for claseprubart in CIDP and unveiled a third pipeline asset, DNTH312, alongside Q2 2026 financials.
Dianthus posted positive interim Phase 3 data for claseprubart in CIDP and unveiled a third pipeline asset, DNTH312, alongside Q2 2026 financials.
Biologics
Regulatory Science

Oblenio Bio doses first patients in LBL-051 autoimmune Phase 1a trial

The tri-specific T-cell engager, licensed from Leads Biolabs, targets BCMA, CD19 and CD3 to drive a durable immune reset in refractory autoimmune disease.
The tri-specific T-cell engager, licensed from Leads Biolabs, targets BCMA, CD19 and CD3 to drive a durable immune reset in refractory autoimmune disease.
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