Disease

Diagnostics
Genomics
Regulatory Science

Mdxhealth GPS-ProMPT study published in European Urology Oncology

The peer-reviewed Oxford study of 409 men over six years underpins the GPS-ProtecT randomised controlled trial of mdxhealth's 17-gene prostate assay.
The peer-reviewed Oxford study of 409 men over six years underpins the GPS-ProtecT randomised controlled trial of mdxhealth's 17-gene prostate assay.
Biologics

Moleculin's Annamycin hits 3x control CR rate in R/R AML interim

Interim MIRACLE trial data showed Annamycin complete remission rates up to 43% versus 12% for control in relapsed or refractory AML patients.
Interim MIRACLE trial data showed Annamycin complete remission rates up to 43% versus 12% for control in relapsed or refractory AML patients.
Biologics

Kyowa Kirin PROSPER data show mogamulizumab eases CTCL symptoms

Real-world study in 73 patients found clinically meaningful skin symptom improvements from week 4, sustained through 48 weeks of follow-up.
Real-world study in 73 patients found clinically meaningful skin symptom improvements from week 4, sustained through 48 weeks of follow-up.
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.
Regulatory Science

Serenity Medical wins FDA Breakthrough Device tag for tinnitus stent

The Shepherd Stent System targets venous sinus stenosis in severe pulsatile tinnitus, a condition linked to depression and elevated suicide risk.
The Shepherd Stent System targets venous sinus stenosis in severe pulsatile tinnitus, a condition linked to depression and elevated suicide risk.
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.
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.
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.
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.
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.
Biologics

Absci reports clean Phase 1 safety data for anti-PRLR antibody ABS-201

Absci's AI-designed hair-loss antibody showed no serious adverse events across four SAD cohorts and a half-life of at least 65 days.
Absci's AI-designed hair-loss antibody showed no serious adverse events across four SAD cohorts and a half-life of at least 65 days.
Biologics

AnaCardio Phase 1b/2a heart failure data published in The Lancet

AC01, an oral ghrelin mimetic, showed haemodynamic gains and no serious adverse events in 58 HFrEF patients, supporting a Phase 2b trial.
AC01, an oral ghrelin mimetic, showed haemodynamic gains and no serious adverse events in 58 HFrEF patients, supporting a Phase 2b trial.
Biologics

Applied Biologics submits CAMPX Trial abstract to SAWC Fall 2026

Updated data from the 222-patient RCT showed XWRAP nearly doubled complete wound closure rates versus standard of care alone at 12 weeks.
Updated data from the 222-patient RCT showed XWRAP nearly doubled complete wound closure rates versus standard of care alone at 12 weeks.
Regulatory Science

Chiesi and Arbor win EU orphan designation for ABO-101 in PH1

The European Commission has granted orphan drug designation to ABO-101, a CRISPR-based gene editing therapy for primary hyperoxaluria type 1.
The European Commission has granted orphan drug designation to ABO-101, a CRISPR-based gene editing therapy for primary hyperoxaluria type 1.
Regulatory Science

EMBARC and Insmed to run 3,000-patient brensocatib study

The pan-European research network intends to test whether brensocatib can modify bronchiectasis disease course over three years in six countries.
The pan-European research network intends to test whether brensocatib can modify bronchiectasis disease course over three years in six countries.
Biologics
Regulatory Science

INmune Bio wins MHRA PIP approval for Ebstrocel in RDEB

The MHRA cleared INmune Bio's paediatric investigation plan in under three months, keeping the company's 2026 UK marketing authorisation application on track.
The MHRA cleared INmune Bio's paediatric investigation plan in under three months, keeping the company's 2026 UK marketing authorisation application on track.
Biologics

Phathom Pharmaceuticals completes enrolment in Phase 2 EoE trial

Phathom has fully enrolled 95 adults in its pHalcon-EoE-201 study of vonoprazan, with topline data expected in Q4 2026.
Phathom has fully enrolled 95 adults in its pHalcon-EoE-201 study of vonoprazan, with topline data expected in Q4 2026.
Biologics

Lilly's $7.8bn Centessa acquisition cleared by English High Court

Eli Lilly's scheme of arrangement to acquire OX2R-focused Centessa Pharmaceuticals has been sanctioned by the High Court, with closing expected on 24 June.
Eli Lilly's scheme of arrangement to acquire OX2R-focused Centessa Pharmaceuticals has been sanctioned by the High Court, with closing expected on 24 June.
Regulatory Science

Agomab aligns with FDA on Phase 2b NOV-ERA design for FSCD

Agomab Therapeutics has finalised the design of its NOV-ERA Phase 2b study, with first participants expected to be dosed in the second half of
Agomab Therapeutics has finalised the design of its NOV-ERA Phase 2b study, with first participants expected to be dosed in the second half of
Pharmaceuticals

Orion Pharma's ODM-212 wins EU Orphan Designation for mesothelioma

The Finnish pharma group's oral pan-TEAD inhibitor now holds Orphan Designation on both sides of the Atlantic as its Phase 2 TEADES trial
The Finnish pharma group's oral pan-TEAD inhibitor now holds Orphan Designation on both sides of the Atlantic as its Phase 2 TEADES trial
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