Genomics

Genomics

Biogen's salanersen wins FDA Breakthrough Therapy tag for SMA

The designation is backed by Phase 1b data showing motor function gains in children who had a suboptimal response to prior gene therapy.
The designation is backed by Phase 1b data showing motor function gains in children who had a suboptimal response to prior gene therapy.
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  · 
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  · 
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  · 
Pharmaceuticals
Genomics

Madrigal Pharmaceuticals posts $311m Rezdiffra Q1 sales, up 127%

Madrigal's MASH therapy Rezdiffra has crossed blockbuster sales thresholds as the company expands its pipeline with a licensed siRNA targeting PNPLA3.
Madrigal's MASH therapy Rezdiffra has crossed blockbuster sales thresholds as the company expands its pipeline with a licensed siRNA targeting PNPLA3.
The Biotech Times Editorial Team  · 
Genomics
Biotech

Madrigal licenses Arrowhead's PNPLA3 siRNA for $1bn in MASH push

Madrigal Pharmaceuticals has licensed ARO-PNPLA3 from Arrowhead, targeting a common genetic driver of MASH prevalent in Hispanic patients.
Madrigal Pharmaceuticals has licensed ARO-PNPLA3 from Arrowhead, targeting a common genetic driver of MASH prevalent in Hispanic patients.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics

Annovis Bio publishes Phase 2/3 buntanetap Alzheimer's data in Nature

Peer-reviewed results show buntanetap improved cognition in pTau217-positive early AD patients, with biomarker reductions suggesting potential disease-modifying activity.
Peer-reviewed results show buntanetap improved cognition in pTau217-positive early AD patients, with biomarker reductions suggesting potential disease-modifying activity.
The Biotech Times Editorial Team  · 
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