Clinical Trials

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

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

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

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 oversubscribed round, co-led by Janus Henderson and Balyasny, funds two autoimmune degrader candidates toward Phase 1 proof-of-concept.

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 FDA's CTGTAC will review Capricor's BLA for Deramiocel on 29 July, ahead of an August 2026 PDUFA action date.

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

Taysha will share Phase 1/2 REVEAL trial results and natural history data supporting its pivotal study design for TSHA-102 in Rett syndrome.

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.

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

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

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

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

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

Elevar's ReFocus202 trial opens enrolment in non-CCA solid tumours, testing lirafugratinib across a broad range of FGFR2-altered cancers globally.

HUTCHMED's FGFR2-targeted oral candidate met its primary endpoint in pretreated intrahepatic cholangiocarcinoma, supporting a China NMPA priority review NDA.

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

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