Immunology

Regulatory Science

Agios licenses SYK inhibitor cevidoplenib from Oscotec in $1bn ITP deal

Agios will pay $25m upfront for global rights to cevidoplenib, a next-generation oral SYK inhibitor targeting immune thrombocytopenia, with Phase 3 planned for 2028.
Agios will pay $25m upfront for global rights to cevidoplenib, a next-generation oral SYK inhibitor targeting immune thrombocytopenia, with Phase 3 planned for 2028.
The Biotech Times Editorial Team  · 

Cullinan Therapeutics' CLN-978 shows remissions in SLE and RA at EULAR

Phase 1 data from 29 patients show deep B cell depletion and clinical remissions in refractory lupus and rheumatoid arthritis after a single dose.
Phase 1 data from 29 patients show deep B cell depletion and clinical remissions in refractory lupus and rheumatoid arthritis after a single dose.
The Biotech Times Editorial Team  · 
Regulatory Science

InnoCare orelabrutinib hits Phase IIb endpoints in SLE study

Orelabrutinib met primary and secondary endpoints in a 187-patient Phase IIb SLE trial, with 57% SRI-4 response versus 34% for placebo at week
Orelabrutinib met primary and secondary endpoints in a 187-patient Phase IIb SLE trial, with 57% SRI-4 response versus 34% for placebo at week
The Biotech Times Editorial Team  · 
Regulatory Science

Gilead and Lakefront close Ouro Medicines deal for $1.675bn

The acquisition adds gamgertamig, a BCMAxCD3 T cell engager, to Gilead's inflammation portfolio; registrational studies are expected as early as 2027.
The acquisition adds gamgertamig, a BCMAxCD3 T cell engager, to Gilead's inflammation portfolio; registrational studies are expected as early as 2027.
The Biotech Times Editorial Team  · 
Regulatory Science

Novartis Cosentyx Phase III PMR data published in NEJM

Phase III REPLENISH trial showed secukinumab achieved sustained remission in twice as many PMR patients as placebo at 52 weeks, with significant steroid sparing.
Phase III REPLENISH trial showed secukinumab achieved sustained remission in twice as many PMR patients as placebo at 52 weeks, with significant steroid sparing.
The Biotech Times Editorial Team  · 
Regulatory Science

J&J nipocalimab meets Phasea 2 primary endpoint in lupus study

Phase 2 JASMINE data show nipocalimab reduced SLE disease activity through 52 weeks, with stronger responses in autoantibody-positive patients.
Phase 2 JASMINE data show nipocalimab reduced SLE disease activity through 52 weeks, with stronger responses in autoantibody-positive patients.
The Biotech Times Editorial Team  · 
Regulatory Science

Vera Therapeutics aligns with FDA on earlier atacicept Phase 3 eGFR read

Vera Therapeutics has pulled forward its ORIGIN 3 eGFR analysis to Q3 2026, opening a path to full IgAN approval as early as 2027.
Vera Therapeutics has pulled forward its ORIGIN 3 eGFR analysis to Q3 2026, opening a path to full IgAN approval as early as 2027.
The Biotech Times Editorial Team  · 
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