
Mirum Pharmaceuticals meets Phase 3 hepatitis delta trial endpoint
Weekly brelovitug achieved a 59 per cent combined response, and Mirum plans an FDA filing in the first half of 2027.

Weekly brelovitug achieved a 59 per cent combined response, and Mirum plans an FDA filing in the first half of 2027.

Eight participants completed the placebo-controlled cohort; extension data are expected in January 2027 while a partial FDA hold remains.

The 86 per cent brain-response rate came from seven evaluable patients; lower-dose safety data are required before Phase 3.



New Phase 1/2 data cover durability across three autoimmune diseases and safety in 71 patients treated after preconditioning.
At week 16, 58 per cent achieved the main joint response versus 41 per cent on placebo; the oral drug is not approved for psoriatic arthritis.
MRI-measured muscle fat fraction replaces dynamometry in the 53-boy Duchenne study, with placebo-controlled data expected in Q1 2027.
Armenia's conditional authorizations cover previously treated metastatic colorectal cancer; existing financing supports operations into 2027.
The 353-patient VOCAL study tested three-times-weekly vadadustat, a regimen that remains investigational despite Vafseo's daily-use approval.
Collection succeeded in 94.7 per cent of patients, but the retrospective analysis measures feasibility rather than comparative cancer outcomes.
Sensitivity was slightly lower than standard ECGs; a U.S. pivotal study is planned for the first quarter of 2027.
The agency cited mouse toxicity and inadequate data for pediatric enrollment; the company is awaiting its full clinical hold letter.
The agency set a May 1, 2027 action target for AMT-130 and is tentatively planning an advisory committee meeting.
The combination beat pembrolizumab alone on survival and tumour response in first-line PD-L1-positive head-and-neck cancer.
A planned 72-participant study will test four subcutaneous doses, with safety and tolerability assessed over 48 weeks.
The 523-patient study met its progression-free survival endpoint, but Pfizer withheld the comparative effect size and a filing date.
A pooled analysis of 139 treated adults showed sustained filtration gains, but long-term follow-up had no continuing placebo comparison.
Class C certification supports continued EU access beyond the 2028 transition deadline and covers the quality management system.
Four of 16 evaluable patients responded to lorigerlimab as the company enrols a lower-dose cohort after significant treatment-related toxicity.
RESOLVE will test symptom recovery and hospitalization in high-risk adults, starting with at least 200 patients in its Phase 2b portion.
The 541-patient DYNASTY-Breast02 trial met its primary endpoint, but the partners say potential patient benefit is limited.
Ivonescimab plus chemotherapy extended median survival to 14.9 months in a China-only study, with a separate U.S. trial planned.
Pumitamig plus docetaxel showed early activity after immunotherapy and chemotherapy, but the Phase 2 study had no control arm.
Severe or worse treatment-related adverse events affected 72.1 per cent across expansion cohorts; FDA talks are planned for 2027.
The single-arm analysis includes unconfirmed responses and supports two enrolling Phase 3 trials; median response duration was not disclosed.
The uncontrolled first-line analyses support continued development, with randomized SUNRAY-01 results expected in the first half of 2027.
Five of 13 patients reached immunologic remission at 12 weeks, while higher-dose cohorts and longer follow-up will guide development.
Genmab will conduct the Phase 1/2 study, while Incyte will co-fund it and supply its KRAS G12D inhibitor; a start date was not disclosed.
A 401-infant presentation compared immune responses and safety with Prevnar 20; the company has not dated its pediatric Phase 3 readout.
An independent board will review ReMEDy2 in Q1 2027 and may resize the study to as many as 728 participants or stop it for futility.
The hepatitis B developer can pursue further United States testing, but has not disclosed a new trial design or start date.
A 131-patient registry analysis found higher graft risk, while a separate randomized trial reported 49% fewer kidney biopsies.
A 1,859-patient pivotal trial will compare the resorbable implant with Xience, with primary completion estimated for June 2029.
The 24-week injection course targets eligible adults without cirrhosis, with boxed liver and platelet warnings.
Confirmed disability progression affected 11.7 per cent with continuous treatment versus 17.4 per cent after an initial comparator.
The placebo-controlled study tests two doses of NBI-'567 over 12 weeks, with primary completion estimated for May 2028.
The 183-patient APOLLO study met both primary endpoints, with an FDA resubmission planned by the end of 2026.
The Vanderbilt development partnership will pair CT imaging with blood biomarkers, with initial performance data due Dec. 3.