Regulatory Science

Abivax Phase 3 data show obefazimod hits all UC endpoints

Both doses of Abivax's oral miR-124 enhancer achieved placebo-adjusted remission rates above 39% at 44 weeks, with an NDA filing planned for
Both doses of Abivax's oral miR-124 enhancer achieved placebo-adjusted remission rates above 39% at 44 weeks, with an NDA filing planned for
The Biotech Times Editorial Team  · 
Genomics

Artios doses first patient in Phase 2 POLKA trial of ART6043

Artios Pharma has started its randomised Phase 2 POLKA study of Pol-theta inhibitor ART6043 plus olaparib in gBRCA-mutated HER2-negative breast cancer.
Artios Pharma has started its randomised Phase 2 POLKA study of Pol-theta inhibitor ART6043 plus olaparib in gBRCA-mutated HER2-negative breast cancer.
The Biotech Times Editorial Team  · 
Diagnostics

BeyondSpring plinabulin triple shows durable NSCLC benefit

Phase 2 data presented at ASCO 2026 show a 58% two-year survival rate in metastatic NSCLC patients with acquired resistance to checkpoint inhibitors.
Phase 2 data presented at ASCO 2026 show a 58% two-year survival rate in metastatic NSCLC patients with acquired resistance to checkpoint inhibitors.
The Biotech Times Editorial Team  · 
Regulatory Science

Candel prostate therapy shows 30% DFS gain in Lancet Oncology

Candel Therapeutics' aglatimagene cut disease recurrence by 30% versus placebo in a 745-patient Phase 3 trial, with a BLA filing planned for Q4 2026.
Candel Therapeutics' aglatimagene cut disease recurrence by 30% versus placebo in a 745-patient Phase 3 trial, with a BLA filing planned for Q4 2026.
The Biotech Times Editorial Team  · 
Diagnostics
Genomics

Cardiff Oncology: onvansertib hits 72% ORR in RAS-mutated mCRC

Phase 2 CRDF-004 data presented at ASCO 2026 support a registrational Phase 3 trial after FDA End-of-Phase 2 alignment.
Phase 2 CRDF-004 data presented at ASCO 2026 support a registrational Phase 3 trial after FDA End-of-Phase 2 alignment.
The Biotech Times Editorial Team  · 
Diagnostics

CG Oncology: cretostimogene combo shows high CR in NMIBC

Phase 2 Cohort CX data show 92.3% complete response and no Grade 3 adverse events for cretostimogene plus gemcitabine in high-risk bladder cancer.
Phase 2 Cohort CX data show 92.3% complete response and no Grade 3 adverse events for cretostimogene plus gemcitabine in high-risk bladder cancer.
The Biotech Times Editorial Team  · 
Diagnostics
Regulatory Science

Disc Medicine RALLY-MF data show broad anemia responses in MF

Updated Phase 2 data for DISC-0974 show durable anemia responses across all patient subgroups, with an FDA end-of-phase meeting expected by year
Updated Phase 2 data for DISC-0974 show durable anemia responses across all patient subgroups, with an FDA end-of-phase meeting expected by year
The Biotech Times Editorial Team  · 
Biotech

JJP Biologics: nebaprubart shows early efficacy in rare LAD trial

Interim Phase 1b data show rapid blister reduction and dapsone tapering in Linear IgA Disease, supporting a rheumatoid arthritis trial in Q3 2026.
Interim Phase 1b data show rapid blister reduction and dapsone tapering in Linear IgA Disease, supporting a rheumatoid arthritis trial in Q3 2026.
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  · 
Genomics

Ziftomenib triplet shows 87% ORR in venetoclax-naive R/R AML

Blood publication of KOMET-007 data shows deep, durable responses for ziftomenib plus venetoclax/azacitidine in NPM1-mutated relapsed/refractory AML.
Blood publication of KOMET-007 data shows deep, durable responses for ziftomenib plus venetoclax/azacitidine in NPM1-mutated relapsed/refractory AML.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biotech

Legend Biotech reports 100% ORR in Phase 1 in vivo CAR-T NHL trial

LB2501, a single-infusion in vivo CAR-T candidate, achieved 100% objective response in six relapsed/refractory NHL patients with no dose-limiting toxicities.
LB2501, a single-infusion in vivo CAR-T candidate, achieved 100% objective response in six relapsed/refractory NHL patients with no dose-limiting toxicities.
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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