Biologics

AC Immune ACI-24 shows dose-response in Phase 1b/2 Alzheimer's trial

Interim 12-month data from the ABATE trial show ACI-24 is well tolerated with antibody responses at all dose levels in prodromal Alzheimer's
Interim 12-month data from the ABATE trial show ACI-24 is well tolerated with antibody responses at all dose levels in prodromal Alzheimer's
The Biotech Times Editorial Team  · 
Biologics

4DMT completes 4FRONT-2 Phase 3 enrolment four months ahead of schedule

4D Molecular Therapeutics has finished global enrolment for its wet AMD gene therapy trial, with topline 52-week data expected in the second half of
4D Molecular Therapeutics has finished global enrolment for its wet AMD gene therapy trial, with topline 52-week data expected in the second half of
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Sanofi's Nexviazyme hits all endpoints in infantile Pompe phase 3

Baby-COMET data showed avalglucosidase alfa kept treated infants alive and ventilator-free at 52 weeks, supporting a US label extension filing in H2 2026.
Baby-COMET data showed avalglucosidase alfa kept treated infants alive and ventilator-free at 52 weeks, supporting a US label extension filing in H2 2026.
The Biotech Times Editorial Team  · 
Biologics

Candel Therapeutics opens Phase 3 AURORA trial for CAN-2409 in NSCLC

Candel has activated the first site in its 150-site pivotal AURORA trial, testing viral immunotherapy aglatimagene against docetaxel in ICI-refractory lung cancer.
Candel has activated the first site in its 150-site pivotal AURORA trial, testing viral immunotherapy aglatimagene against docetaxel in ICI-refractory lung cancer.
The Biotech Times Editorial Team  · 
Biologics

Abivax ABTECT Part 2 data back obefazimod NDA submission in UC

Phase 3 maintenance data show obefazimod rescued remission in refractory ulcerative colitis patients, with an NDA filing planned for Q4 2026.
Phase 3 maintenance data show obefazimod rescued remission in refractory ulcerative colitis patients, with an NDA filing planned for Q4 2026.
The Biotech Times Editorial Team  · 
Biologics

Lycia Therapeutics raises $75m Series D for LYTAC pipeline

The oversubscribed round, co-led by Janus Henderson and Balyasny, funds two autoimmune degrader candidates toward Phase 1 proof-of-concept.
The oversubscribed round, co-led by Janus Henderson and Balyasny, funds two autoimmune degrader candidates toward Phase 1 proof-of-concept.
The Biotech Times Editorial Team  · 

LENZ Therapeutics signs fifth ex-US VIZZ deal with Arrotex

LENZ Therapeutics has licensed VIZZ to Australia's largest pharma distributor, marking its fifth international partnership for the FDA-approved presbyopia eye drop.
LENZ Therapeutics has licensed VIZZ to Australia's largest pharma distributor, marking its fifth international partnership for the FDA-approved presbyopia eye drop.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Capricor's DMD cell therapy Deramiocel heads to FDA advisory panel

The FDA's CTGTAC will review Capricor's BLA for Deramiocel on 29 July, ahead of an August 2026 PDUFA action date.
The FDA's CTGTAC will review Capricor's BLA for Deramiocel on 29 July, ahead of an August 2026 PDUFA action date.
The Biotech Times Editorial Team  · 
Genomics
Regulatory Science

Taysha Gene Therapies presents TSHA-102 Rett data at IRSF 2026

Taysha will share Phase 1/2 REVEAL trial results and natural history data supporting its pivotal study design for TSHA-102 in Rett syndrome.
Taysha will share Phase 1/2 REVEAL trial results and natural history data supporting its pivotal study design for TSHA-102 in Rett syndrome.
The Biotech Times Editorial Team  · 
Biologics

Atea Pharmaceuticals completes enrolment in Phase 3 C-FORWARD HCV trial

Atea has fully enrolled its 880-patient global HCV trial, with topline data from the head-to-head DAA study expected around year-end 2026.
Atea has fully enrolled its 880-patient global HCV trial, with topline data from the head-to-head DAA study expected around year-end 2026.
The Biotech Times Editorial Team  · 
Biologics

J&J's teclistamab plus daratumumab gets CHMP backing for myeloma

The EMA advisory committee has recommended expanding teclistamab's label to cover second-line relapsed/refractory myeloma, backed by Phase 3 overall survival data.
The EMA advisory committee has recommended expanding teclistamab's label to cover second-line relapsed/refractory myeloma, backed by Phase 3 overall survival data.
The Biotech Times Editorial Team  · 
Digital Health

Arab Therapy signs MOU with King Abdulaziz University on mental health

The Riyadh-based digital mental health platform will embed psychological support services, joint research, and staff training across the Jeddah campus.
The Riyadh-based digital mental health platform will embed psychological support services, joint research, and staff training across the Jeddah campus.
The Biotech Times Editorial Team  · 
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