Disease

FocalTherics launches endometriosis HIFU programme in Europe

FocalTherics has treated initial patients at Toulouse University Hospital using its Focal One Robotic HIFU system for deep infiltrating endometriosis.
FocalTherics has treated initial patients at Toulouse University Hospital using its Focal One Robotic HIFU system for deep infiltrating endometriosis.
Genomics

Oryzon Genomics raises €12m and secures €25m COFIDES commitment

The Barcelona epigenetics biotech priced 4.4 million new shares at €2.70 each and secured a €25m anchor commitment from Spain's Social Impact
The Barcelona epigenetics biotech priced 4.4 million new shares at €2.70 each and secured a €25m anchor commitment from Spain's Social Impact
Biologics

Kyowa Kirin mogamulizumab data show survival gains in rare CTCL

Two indirect treatment comparison analyses link mogamulizumab to significantly lower mortality risk in relapsed mycosis fungoides and Sézary syndrome.
Two indirect treatment comparison analyses link mogamulizumab to significantly lower mortality risk in relapsed mycosis fungoides and Sézary syndrome.
Biologics

Revolution Medicines: zoldonrasib combos active in RAS G12D PDAC

Phase 1/2 data presented at ESMO GI show response rates above 60% for zoldonrasib combinations, supporting two planned Phase 3 trials in pancreatic cancer.
Phase 1/2 data presented at ESMO GI show response rates above 60% for zoldonrasib combinations, supporting two planned Phase 3 trials in pancreatic cancer.
Diagnostics
Genomics

Myriad Genetics Prolaris meta-analysis backs prostate cancer staging

A pooled analysis of 8,478 patients shows Myriad's Prolaris Biopsy Test adds prognostic value beyond standard clinical risk tools in localised prostate cancer.
A pooled analysis of 8,478 patients shows Myriad's Prolaris Biopsy Test adds prognostic value beyond standard clinical risk tools in localised prostate cancer.
Biologics

Tenax Therapeutics to present LEVEL Phase 3 data at ESC 2026

Topline results from the PH-HFpEF trial of oral levosimendan are expected in August, ahead of a late-breaking session at ESC Congress in Munich.
Topline results from the PH-HFpEF trial of oral levosimendan are expected in August, ahead of a late-breaking session at ESC Congress in Munich.
Biologics

Vect-Horus and Servier tie up on CNS oligonucleotide delivery

The Marseille biotech will use its VECTrans platform to ferry Servier's oligonucleotides across the blood-brain barrier for rare neurological disorders.
The Marseille biotech will use its VECTrans platform to ferry Servier's oligonucleotides across the blood-brain barrier for rare neurological disorders.
Digital Health

Vibrant Gastro capsule used in JAMA Psychiatry gut-brain study

UCLA researchers used Vibrant's ingestible vibrating capsule to study gut-brain signalling as a predictor of relapse risk in anorexia nervosa recovery.
UCLA researchers used Vibrant's ingestible vibrating capsule to study gut-brain signalling as a predictor of relapse risk in anorexia nervosa recovery.
Biologics

Xeltis passes 50% enrollment in US pivotal trial for aXess graft

The Netherlands-based medtech has enrolled over 70 patients across 20 US sites for its bioabsorbable hemodialysis vascular access device.
The Netherlands-based medtech has enrolled over 70 patients across 20 US sites for its bioabsorbable hemodialysis vascular access device.
Biologics

Abivax prices upsized $800M ADS offering to fund obefazimod launch

The Paris-listed biotech upsized its US public offering from $600M to $800M, extending its cash runway to Q2 2029 ahead of a potential obefazimod
The Paris-listed biotech upsized its US public offering from $600M to $800M, extending its cash runway to Q2 2029 ahead of a potential obefazimod
Biologics

Ipsen to acquire Memo Therapeutics for up to EUR 700m

Ipsen is buying Swiss biotech Memo Therapeutics to gain potravitug, a Phase II monoclonal antibody targeting BK polyomavirus in kidney transplant recipients.
Ipsen is buying Swiss biotech Memo Therapeutics to gain potravitug, a Phase II monoclonal antibody targeting BK polyomavirus in kidney transplant recipients.

JenaValve presents LVAD and pacemaker data for Trilogy TAVR system

New York Valves 2026 featured two late-breaking Trilogy datasets, including early outcomes in LVAD patients with aortic regurgitation showing 7.3% one-year mortality.
New York Valves 2026 featured two late-breaking Trilogy datasets, including early outcomes in LVAD patients with aortic regurgitation showing 7.3% one-year mortality.
Biologics

Truveta study finds 16% of adalimumab biosimilar switchers revert

Real-world data from 67,594 US patients shows biosimilar adoption peaked after formulary changes, but switch-back rates highlight gaps in patient support.
Real-world data from 67,594 US patients shows biosimilar adoption peaked after formulary changes, but switch-back rates highlight gaps in patient support.
Biologics
Regulatory Science

Novartis wins EC approval for Itvisma in broader SMA population

The European Commission has approved Itvisma as the first gene replacement therapy for SMA patients aged two and older, including teens and adults.
The European Commission has approved Itvisma as the first gene replacement therapy for SMA patients aged two and older, including teens and adults.
Biologics
Regulatory Science

PolarityBio files BLA for SkinTE in diabetic foot ulcers

PolarityBio has submitted a BLA to the FDA for SkinTE, an autologous skin therapy backed by RMAT and Breakthrough Therapy designations.
PolarityBio has submitted a BLA to the FDA for SkinTE, an autologous skin therapy backed by RMAT and Breakthrough Therapy designations.
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
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.
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
Biologics

Ascendis TransCon CNP sustains leg alignment gains at two years

Week 104 data from the ApproaCH trial show tibial-femoral angle continued improving in children with achondroplasia, with greater gains in those with preexisting leg
Week 104 data from the ApproaCH trial show tibial-femoral angle continued improving in children with achondroplasia, with greater gains in those with preexisting leg
Biologics
Regulatory Science

Roche's Enspryng wins FDA Priority Review for thyroid eye disease

The FDA has accepted Roche's sBLA for satralizumab in TED, with a decision expected by 15 October 2026 based on Phase 3 SatraGO data.
The FDA has accepted Roche's sBLA for satralizumab in TED, with a decision expected by 15 October 2026 based on Phase 3 SatraGO data.
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