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  · 
Regulatory Science

Amplia launches Phase 2b narmafotinib trial in pancreatic cancer

Amplia Therapeutics is initiating a daily-dosing Phase 2b study of its FAK inhibitor narmafotinib in advanced pancreatic cancer, with enrolment due by Q4 2026.
Amplia Therapeutics is initiating a daily-dosing Phase 2b study of its FAK inhibitor narmafotinib in advanced pancreatic cancer, with enrolment due by Q4 2026.
The Biotech Times Editorial Team  · 
Diagnostics
Digital Health
Regulatory Science

ESO EMS Index: one in five patients accounts for 44% of 911 calls

ESO's 2026 EMS Index, drawing on 17.3 million records, reveals repeat callers and persistent obstetric care gaps as key system pressures.
ESO's 2026 EMS Index, drawing on 17.3 million records, reveals repeat callers and persistent obstetric care gaps as key system pressures.
The Biotech Times Editorial Team  · 
Biotech

Actuate Therapeutics names Martin Huber to board of directors

The NASDAQ-listed oncology biotech has appointed the former Mersana Therapeutics CEO as an independent director to support elraglusib's path to registration studies.
The NASDAQ-listed oncology biotech has appointed the former Mersana Therapeutics CEO as an independent director to support elraglusib's path to registration studies.
The Biotech Times Editorial Team  · 
Regulatory Science

Alpha Tau to present Alpha DaRT plus pembrolizumab data at AHNS 2026

Alpha Tau Medical's combination therapy abstract has been selected for podium presentation at the AHNS International Conference on Head and Neck Cancer in July.
Alpha Tau Medical's combination therapy abstract has been selected for podium presentation at the AHNS International Conference on Head and Neck Cancer in July.
The Biotech Times Editorial Team  · 
Bioinformatics
Diagnostics
Digital Health

Alzai Health files IPO prospectus on TSXV to raise up to C$4m

The Toronto-based AI Alzheimer's screening company plans to list on the TSX Venture Exchange in May, raising up to C$4 million at
The Toronto-based AI Alzheimer's screening company plans to list on the TSX Venture Exchange in May, raising up to C$4 million at
The Biotech Times Editorial Team  · 
Digital Health

Amazon One Medical GLP-1 programme launch reshapes weight-loss market

Amazon's integrated GLP-1 programme combines One Medical clinical care, Amazon Pharmacy, and same-day delivery, but cash-pay and new patients face notable
Amazon's integrated GLP-1 programme combines One Medical clinical care, Amazon Pharmacy, and same-day delivery, but cash-pay and new patients face notable
The Biotech Times Editorial Team  · 
Bioprocessing
Synthetic Biology
Biotech

AMG Critical Materials beats Q1 2026 guidance on vanadium strength

AMG Critical Materials posted $44m adjusted EBITDA in Q1 2026, ahead of guidance, driven by vanadium gains and the AURA acquisition.
AMG Critical Materials posted $44m adjusted EBITDA in Q1 2026, ahead of guidance, driven by vanadium gains and the AURA acquisition.
The Biotech Times Editorial Team  · 
Medical Devices

Anika Therapeutics posts 13% revenue rise as margins recover sharply

The Bedford-based orthopaedic biotech grew Q1 2026 revenue to $29.6m and lifted gross margin eight points to 64%, driven by its Integrity regenerative
The Bedford-based orthopaedic biotech grew Q1 2026 revenue to $29.6m and lifted gross margin eight points to 64%, driven by its Integrity regenerative
The Biotech Times Editorial Team  · 
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