Pharmaceuticals
Biologics

Assembly Bio reports Phase 1a safety win for NTCP inhibitor ABI-6250

Phase 1a data showed ABI-6250 was well tolerated with no serious adverse events, paving the way for Phase 2 trials in HDV and cholestatic
Phase 1a data showed ABI-6250 was well tolerated with no serious adverse events, paving the way for Phase 2 trials in HDV and cholestatic
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Regulatory Science

Capricor DMD cell therapy data show 76% upper limb decline slowdown

HOPE-3 open-label extension data for Deramiocel are now before the FDA ahead of a 22 November PDUFA date for Duchenne muscular dystrophy.
HOPE-3 open-label extension data for Deramiocel are now before the FDA ahead of a 22 November PDUFA date for Duchenne muscular dystrophy.
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

OnCusp CUSP06 hits 62% response rate in resistant ovarian cancer

Phase 1b data for the CDH6-directed ADC showed a 62% ORR at the 4.0 mg/kg dose, with activity retained in patients previously
Phase 1b data for the CDH6-directed ADC showed a 62% ORR at the 4.0 mg/kg dose, with activity retained in patients previously
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Epcoritamab plus R-CHOP cuts DLBCL progression risk by 51% in Phase 3

Genmab and AbbVie say their EPCORE DLBCL-2 trial is the first Phase 3 bispecific study to hit a PFS endpoint in frontline diffuse large
Genmab and AbbVie say their EPCORE DLBCL-2 trial is the first Phase 3 bispecific study to hit a PFS endpoint in frontline diffuse large
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics

BridgeBio BBP-418 shows cardiac biomarker normalisation in LGMD2I/R9

New Phase 3 FORTIFY data show BBP-418 restored cardiac markers to normal in 100% of eligible patients, with FDA priority review decision due 27
New Phase 3 FORTIFY data show BBP-418 restored cardiac markers to normal in 100% of eligible patients, with FDA priority review decision due 27
The Biotech Times Editorial Team  · 
Biologics
Pharmaceuticals

Alector licenses AL050 GCase therapy to Genentech for $1.27bn

Alector receives $100m upfront and up to $1.17bn in milestones from Genentech for its brain-penetrant GCase enzyme replacement therapy in Parkinson's disease.
Alector receives $100m upfront and up to $1.17bn in milestones from Genentech for its brain-penetrant GCase enzyme replacement therapy in Parkinson's disease.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Medical Devices

Harrow closes $30m TYRVAYA acquisition from Viatris

Harrow has acquired worldwide rights to the FDA-approved nasal spray for dry eye disease, expecting the product to generate over $30m in 2027 revenue.
Harrow has acquired worldwide rights to the FDA-approved nasal spray for dry eye disease, expecting the product to generate over $30m in 2027 revenue.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Diagnostics

vTv Therapeutics completes Phase 3 enrolment for cadisegliatin

The North Carolina biotech has fully enrolled 166 patients in its CATT1 study, with topline results expected mid-2027.
The North Carolina biotech has fully enrolled 166 patients in its CATT1 study, with topline results expected mid-2027.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Genomics
Biologics

Prime Medicine doses first patient in PM577a Wilson disease trial

Prime Medicine has dosed the first patient with its in vivo Prime Editing therapy PM577a, marking the first clinical study of the technology in liver
Prime Medicine has dosed the first patient with its in vivo Prime Editing therapy PM577a, marking the first clinical study of the technology in liver
The Biotech Times Editorial Team  · 
Pharmaceuticals

Revolution Medicines starts Phase 3 RAS G12D PDAC doublet trial

Revolution Medicines has dosed first patients in RASolute 309, a Phase 3 study pitting its RAS inhibitor doublet against standard chemotherapy in metastatic pancreatic
Revolution Medicines has dosed first patients in RASolute 309, a Phase 3 study pitting its RAS inhibitor doublet against standard chemotherapy in metastatic pancreatic
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Vaxcyte VAX-31 meets all primary endpoints in pivotal Phase 3 trial

The 31-valent pneumococcal conjugate vaccine candidate beat noninferiority thresholds against Prevnar 20 and Capvaxive across all prespecified endpoints in 4,047 adults.
The 31-valent pneumococcal conjugate vaccine candidate beat noninferiority thresholds against Prevnar 20 and Capvaxive across all prespecified endpoints in 4,047 adults.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics

Immix Biopharma prices $125m share offering to fund NXC-201

The Los Angeles CAR-T company raised $125m at $11.00 per share, with J.P. Morgan sole book-runner and backing from Wellington and
The Los Angeles CAR-T company raised $125m at $11.00 per share, with J.P. Morgan sole book-runner and backing from Wellington and
The Biotech Times Editorial Team  · 
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