Disease

Pharmaceuticals
Biologics

Zealand Pharma's petrelintide hits Phase 2 weight and glycaemic goals

Petrelintide cut body weight by up to 9.2% versus 2.0% on placebo in the ZUPREME-2 trial, with near-placebo gastrointestinal discontinuation rates.
Petrelintide cut body weight by up to 9.2% versus 2.0% on placebo in the ZUPREME-2 trial, with near-placebo gastrointestinal discontinuation rates.
Pharmaceuticals
Genomics

BridgeBio to present CALIBRATE Phase 3 encaleret data at ASBMR 2026

BridgeBio will share 24-week Phase 3 CALIBRATE trial data on encaleret in ADH1, covering bone turnover and patient-reported outcomes, at ASBMR in Boston.
BridgeBio will share 24-week Phase 3 CALIBRATE trial data on encaleret in ADH1, covering bone turnover and patient-reported outcomes, at ASBMR in Boston.
Pharmaceuticals
Biologics

Jupiter Neurosciences doses first patient in Phase 2a Parkinson's trial

Jupiter Neurosciences has begun dosing in the RESET trial of JOTROL in Parkinson's disease while simultaneously exploring a sale or licensing of its assets.
Jupiter Neurosciences has begun dosing in the RESET trial of JOTROL in Parkinson's disease while simultaneously exploring a sale or licensing of its assets.
Pharmaceuticals
Biologics

RougeTx launches with $58m Series A to target HHT bleeding disorder

The Leiden spin-out is advancing RTX-001, a once-daily oral pericyte-targeting candidate, toward first-in-human trials in a condition with no
The Leiden spin-out is advancing RTX-001, a once-daily oral pericyte-targeting candidate, toward first-in-human trials in a condition with no
Cell & Gene Therapy
Genomics

AAVantgarde sees early efficacy signals in dual-AAV eye therapy

AAVantgarde Bio presented Phase 1/2 data showing visual function gains in Usher syndrome and strong preclinical support for its Stargardt programme at EURetina 2026.
AAVantgarde Bio presented Phase 1/2 data showing visual function gains in Usher syndrome and strong preclinical support for its Stargardt programme at EURetina 2026.
Cell & Gene Therapy
Biologics

CAR-T safety events dent rheumatologist confidence, Spherix finds

A Spherix Global Insights survey shows physician confidence in autologous CAR-T fell sharply after trial pauses at Novartis and Bristol Myers Squibb.
A Spherix Global Insights survey shows physician confidence in autologous CAR-T fell sharply after trial pauses at Novartis and Bristol Myers Squibb.
Cell & Gene Therapy
Biologics
Bioprocessing

Avaí Bio and Austrianova confirm Klotho secretion in encapsulated cells

Joint venture Klothonova has shown GMP-banked Klotho-producing cells remain viable and secrete therapeutic protein inside Cell-in-a-Box capsules.
Joint venture Klothonova has shown GMP-banked Klotho-producing cells remain viable and secrete therapeutic protein inside Cell-in-a-Box capsules.
Medical Devices
Biologics

Cuprina to acquire seven-clinic Singapore healthcare group for S$4m

Nasdaq-listed Cuprina is buying East Coast Podiatry and Orchard Clinic to integrate clinical delivery with its wound-care and collagen technologies.
Nasdaq-listed Cuprina is buying East Coast Podiatry and Orchard Clinic to integrate clinical delivery with its wound-care and collagen technologies.
Cell & Gene Therapy

Ernexa Therapeutics names Spiegel to board ahead of ERNA-101 IND

Ernexa Therapeutics has appointed oncology veteran Robert Spiegel to its board as it targets a Q4 2026 IND filing for its lead iMSC cell therapy.
Ernexa Therapeutics has appointed oncology veteran Robert Spiegel to its board as it targets a Q4 2026 IND filing for its lead iMSC cell therapy.
Biologics
Pharmaceuticals

Climb Bio to show Phase 2 budoprutug and CLYM116 data at ASN 2026

Climb Bio will present preliminary PrisMN Phase 2 data on budoprutug in membranous nephropathy at ASN Kidney Week in Denver this October.
Climb Bio will present preliminary PrisMN Phase 2 data on budoprutug in membranous nephropathy at ASN Kidney Week in Denver this October.
Pharmaceuticals
Biologics

Gain Therapeutics: rexaceract holds motor scores stable at 12 months

Phase 1b open-label extension data show no clinically meaningful motor progression in 12 Parkinson's patients after a full year of daily oral rexaceract.
Phase 1b open-label extension data show no clinically meaningful motor progression in 12 Parkinson's patients after a full year of daily oral rexaceract.
Biologics
Pharmaceuticals

Genmab's Rina-S hits 46% response rate in PROC trial

Phase 2 data show Rina-S achieved a 45.9% objective response rate and 12.1-month median duration of response in heavily pretreated platinum
Phase 2 data show Rina-S achieved a 45.9% objective response rate and 12.1-month median duration of response in heavily pretreated platinum
Medical Devices
Regulatory Science

Inspire Medical wins new CPT codes for its Inspire V device

New Category I CPT codes covering Inspire V's single-lead hypoglossal nerve stimulator are set to take effect on 1 January 2028.
New Category I CPT codes covering Inspire V's single-lead hypoglossal nerve stimulator are set to take effect on 1 January 2028.
Pharmaceuticals
Regulatory Science

Liquidia loses patent ruling on YUTREPIA PH-ILD indication

A Delaware district court found two claims of United Therapeutics' '327 patent valid and infringed, putting YUTREPIA's PH-ILD label at risk.
A Delaware district court found two claims of United Therapeutics' '327 patent valid and infringed, putting YUTREPIA's PH-ILD label at risk.
Biologics
Regulatory Science

Novo Nordisk's denecimig BLA delayed by manufacturing site remediation

The FDA has extended its review of denecimig for haemophilia A due to facility remediation issues, with no new decision timeline given.
The FDA has extended its review of denecimig for haemophilia A due to facility remediation issues, with no new decision timeline given.
Pharmaceuticals
Biologics

Amplio Pharma Phase 1b data back NovoBioJect methotrexate booster

The Amsterdam biotech reported a 38% rise in active methotrexate inside immune cells, supporting a €10m Series A and a Phase 2a trial in 2027.
The Amsterdam biotech reported a 38% rise in active methotrexate inside immune cells, supporting a €10m Series A and a Phase 2a trial in 2027.
Cell & Gene Therapy
Biologics
Pharmaceuticals

Artiva to present AlloNK autoimmune data across 34 patients at ACR 2026

Artiva Biotherapeutics will present Phase 2a data for its NK cell therapy in refractory RA, Sjögren disease and systemic sclerosis at ACR Convergence in November.
Artiva Biotherapeutics will present Phase 2a data for its NK cell therapy in refractory RA, Sjögren disease and systemic sclerosis at ACR Convergence in November.
Biologics
Pharmaceuticals

Biogen litifilimab CLE data show durable skin clearance at 52 weeks

Phase 2 AMETHYST data show over a quarter of litifilimab-treated patients achieved clear or almost clear skin; Phase 3 results are due in H1
Phase 2 AMETHYST data show over a quarter of litifilimab-treated patients achieved clear or almost clear skin; Phase 3 results are due in H1
Cell & Gene Therapy
Biologics

Century Therapeutics' CNTY-813 hits IND-readiness milestones at EASD

Nonclinical data for the iPSC-derived islet therapy showed consistent manufacturing and durable glycaemic control, with an IND filing due in Q4 2026.
Nonclinical data for the iPSC-derived islet therapy showed consistent manufacturing and durable glycaemic control, with an IND filing due in Q4 2026.
Pharmaceuticals
Regulatory Science

EMA validates Biosplice's lorecivivint application for knee OA

The EMA has begun its centralised review of lorecivivint, a small-molecule CLK/DYRK inhibitor Biosplice positions as a potential first disease-modifying therapy for
The EMA has begun its centralised review of lorecivivint, a small-molecule CLK/DYRK inhibitor Biosplice positions as a potential first disease-modifying therapy for
Subscribe to Disease