Disease

Biologics

Compass Therapeutics tovecimig data wins oral slot at ESMO 2026

Phase 2/3 COMPANION-002 biliary tract cancer results will be presented orally at ESMO in Madrid on 24 October 2026.
Phase 2/3 COMPANION-002 biliary tract cancer results will be presented orally at ESMO in Madrid on 24 October 2026.
The Biotech Times Editorial Team  · 
Biologics

Diagonal Therapeutics doses first patient in HHT antibody trial

The Watertown biotech has initiated its DIAMOND Phase 1/2 trial of DIAG723, a clustering agonist antibody targeting the ALK1 pathway in a rare vascular
The Watertown biotech has initiated its DIAMOND Phase 1/2 trial of DIAG723, a clustering agonist antibody targeting the ALK1 pathway in a rare vascular
The Biotech Times Editorial Team  · 
Regulatory Science

Adneuris licenses cebranopadol to Conba for Greater China pain market

Adneuris will receive $17.5m upfront and up to $100m in milestones as Conba gains rights to the dual-receptor pain candidate across Greater China.
Adneuris will receive $17.5m upfront and up to $100m in milestones as Conba gains rights to the dual-receptor pain candidate across Greater China.
The Biotech Times Editorial Team  · 
Biologics

Angelini Pharma completes $4.1bn Catalyst Pharmaceuticals buyout

The Italian pharma group has taken full ownership of Nasdaq-listed Catalyst, backed by €1bn each from Blackstone and CDP Equity.
The Italian pharma group has taken full ownership of Nasdaq-listed Catalyst, backed by €1bn each from Blackstone and CDP Equity.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
Biologics

Teva licenses Polpharma ocrelizumab biosimilar for global markets

Teva secures exclusive commercialisation rights to Polpharma Biologics' ocrelizumab biosimilar candidate across key markets including the US, EU and Brazil.
Teva secures exclusive commercialisation rights to Polpharma Biologics' ocrelizumab biosimilar candidate across key markets including the US, EU and Brazil.
The Biotech Times Editorial Team  · 
Diagnostics

Alpha Tau treats first immunocompromised cSCC patient in ADMIRE trial

Alpha Tau's ADMIRE study has dosed its first patient, targeting a population for whom standard checkpoint immunotherapy carries significant organ-rejection risk.
Alpha Tau's ADMIRE study has dosed its first patient, targeting a population for whom standard checkpoint immunotherapy carries significant organ-rejection risk.
The Biotech Times Editorial Team  · 
Biologics

Boehringer starts Phase II for triple receptor agonist BI 3034701

Boehringer Ingelheim has dosed first patients in a Phase II trial of BI 3034701, a GLP-1/GIP/NPY2 triple agonist targeting obesity.
Boehringer Ingelheim has dosed first patients in a Phase II trial of BI 3034701, a GLP-1/GIP/NPY2 triple agonist targeting obesity.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
Biologics

ENDURANCE trial: two-year lenalidomide matches lifelong therapy

A phase III NEJM study found two years of lenalidomide maintenance equals indefinite treatment for survival in standard-risk multiple myeloma patients.
A phase III NEJM study found two years of lenalidomide maintenance equals indefinite treatment for survival in standard-risk multiple myeloma patients.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
Diagnostics
Biologics

IGeneX single-step immunoblot nearly doubles early Lyme detection rate

A peer-reviewed study found IGeneX's FDA-cleared IB tests detected early Lyme disease in 58.3% of cases versus 30.0% with standard
A peer-reviewed study found IGeneX's FDA-cleared IB tests detected early Lyme disease in 58.3% of cases versus 30.0% with standard
The Biotech Times Editorial Team  · 
Biologics

Novo Nordisk wins EC approval for Wegovy pill as EU's first oral GLP-1

The European Commission has approved once-daily oral semaglutide 25 mg for weight management, making Wegovy the first GLP-1 pill available across all EU
The European Commission has approved once-daily oral semaglutide 25 mg for weight management, making Wegovy the first GLP-1 pill available across all EU
The Biotech Times Editorial Team  · 
Biologics

Rani Therapeutics RT-114 oral GLP-1/2 agonist tops subcutaneous exposure

Phase 1a data showed oral RT-114 achieved more than 150% bioavailability relative to a matched subcutaneous dose, with a mild adverse-event profile.
Phase 1a data showed oral RT-114 achieved more than 150% bioavailability relative to a matched subcutaneous dose, with a mild adverse-event profile.
The Biotech Times Editorial Team  · 
Bioinformatics

Sinopia Biosciences publishes PKA-II modulator data in Science TM

Sinopia's SB-0110 reduced levodopa-induced dyskinesia while boosting motor benefit in primate models, with first-in-human studies targeted for 2027.
Sinopia's SB-0110 reduced levodopa-induced dyskinesia while boosting motor benefit in primate models, with first-in-human studies targeted for 2027.
The Biotech Times Editorial Team  · 

Mobia Medical publishes two-year Vivistim VNS stroke trial data

Two-year follow-up from the VNS-REHAB trial shows durable upper-limb motor gains in 76% of participants, published in Neurology.
Two-year follow-up from the VNS-REHAB trial shows durable upper-limb motor gains in 76% of participants, published in Neurology.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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