Clinical Trials

Biologics

Grifols doses first patients in Phase 3 SIGMA and XPERT Ig trials

Grifols has initiated two Phase 3 trials seeking to broaden US label approvals for its GAMUNEX-C and XEMBIFY immunoglobulin therapies.
Grifols has initiated two Phase 3 trials seeking to broaden US label approvals for its GAMUNEX-C and XEMBIFY immunoglobulin therapies.
Biologics

InnoCare TYK2 inhibitor soficitinib meets Phase II endpoint in vitiligo

InnoCare's oral TYK2 inhibitor soficitinib cut facial vitiligo scores by up to 41% versus 2.2% for placebo at Week 24.
InnoCare's oral TYK2 inhibitor soficitinib cut facial vitiligo scores by up to 41% versus 2.2% for placebo at Week 24.
Biologics
Regulatory Science

Novartis Fabhalta wins FDA traditional approval in IgA nephropathy

Iptacopan slowed eGFR decline by 48% versus placebo over two years in the Phase III APPLAUSE-IgAN study, converting an accelerated approval granted in 2024.
Iptacopan slowed eGFR decline by 48% versus placebo over two years in the Phase III APPLAUSE-IgAN study, converting an accelerated approval granted in 2024.

RapidPulse closes $48m Series B to advance TURBO stroke trial

The Miami medtech secured an oversubscribed round co-led by Medtronic to fund its IDE study of pulsed aspiration thrombectomy and pursue FDA clearance.
The Miami medtech secured an oversubscribed round co-led by Medtronic to fund its IDE study of pulsed aspiration thrombectomy and pursue FDA clearance.
Biologics

Allogene ALLO-316 achieves 31% response rate in solid tumour Phase 1

Full TRAVERSE Phase 1 data, published in JCO, show durable remissions in CD70-high metastatic renal cell carcinoma with a single allogeneic CAR T infusion.
Full TRAVERSE Phase 1 data, published in JCO, show durable remissions in CD70-high metastatic renal cell carcinoma with a single allogeneic CAR T infusion.
Diagnostics

Alpha Tau treats first immunocompromised cSCC patient in ADMIRE trial

Alpha Tau's ADMIRE study has dosed its first patient, targeting a population for whom standard checkpoint immunotherapy carries significant organ-rejection risk.
Alpha Tau's ADMIRE study has dosed its first patient, targeting a population for whom standard checkpoint immunotherapy carries significant organ-rejection risk.
Biologics

Boehringer starts Phase II for triple receptor agonist BI 3034701

Boehringer Ingelheim has dosed first patients in a Phase II trial of BI 3034701, a GLP-1/GIP/NPY2 triple agonist targeting obesity.
Boehringer Ingelheim has dosed first patients in a Phase II trial of BI 3034701, a GLP-1/GIP/NPY2 triple agonist targeting obesity.
Biologics

Cellectar publishes Phase 1 iopofosine I 131 data in multiple myeloma

Phase 1 results in 31 heavily pretreated patients showed a 30% response rate at higher doses and a manageable hematologic safety profile.
Phase 1 results in 31 heavily pretreated patients showed a 30% response rate at higher doses and a manageable hematologic safety profile.
Biologics

InnoCare soficitinib meets Phase III endpoint in atopic dermatitis

InnoCare's oral TYK2 inhibitor soficitinib met its primary endpoint with statistical significance in a registrational Phase III atopic dermatitis trial.
InnoCare's oral TYK2 inhibitor soficitinib met its primary endpoint with statistical significance in a registrational Phase III atopic dermatitis trial.
Biologics

ENDURANCE trial: two-year lenalidomide matches lifelong therapy

A phase III NEJM study found two years of lenalidomide maintenance equals indefinite treatment for survival in standard-risk multiple myeloma patients.
A phase III NEJM study found two years of lenalidomide maintenance equals indefinite treatment for survival in standard-risk multiple myeloma patients.
Biologics

Neutrolis publishes NEJM case report on NET-degrading SLE therapy

A single-patient compassionate-use case in NEJM shows NTR-441 rapidly cleared SLE symptoms caused by congenital DNASE1L3 deficiency.
A single-patient compassionate-use case in NEJM shows NTR-441 rapidly cleared SLE symptoms caused by congenital DNASE1L3 deficiency.
Biologics

Novo Nordisk wins EC approval for Wegovy pill as EU's first oral GLP-1

The European Commission has approved once-daily oral semaglutide 25 mg for weight management, making Wegovy the first GLP-1 pill available across all EU
The European Commission has approved once-daily oral semaglutide 25 mg for weight management, making Wegovy the first GLP-1 pill available across all EU
Biologics

Rani Therapeutics RT-114 oral GLP-1/2 agonist tops subcutaneous exposure

Phase 1a data showed oral RT-114 achieved more than 150% bioavailability relative to a matched subcutaneous dose, with a mild adverse-event profile.
Phase 1a data showed oral RT-114 achieved more than 150% bioavailability relative to a matched subcutaneous dose, with a mild adverse-event profile.
Bioinformatics

Sinopia Biosciences publishes PKA-II modulator data in Science TM

Sinopia's SB-0110 reduced levodopa-induced dyskinesia while boosting motor benefit in primate models, with first-in-human studies targeted for 2027.
Sinopia's SB-0110 reduced levodopa-induced dyskinesia while boosting motor benefit in primate models, with first-in-human studies targeted for 2027.
Digital Health
Diagnostics

RWS launches integrated eCOA linguistic validation service

RWS has combined COA licensing, translation, linguistic validation and rater training under one programme team to cut delays in global clinical trials.
RWS has combined COA licensing, translation, linguistic validation and rater training under one programme team to cut delays in global clinical trials.
Diagnostics
Digital Health

Brain & Performance Centre signs MOU with UAE Athletic Commission

The DP World-owned brain health facility will offer optional neurological assessments to professional boxers competing in sanctioned UAE events.
The DP World-owned brain health facility will offer optional neurological assessments to professional boxers competing in sanctioned UAE events.
Biologics

InnoCare's orelabrutinib cuts CLL/SLL progression risk by 68% in Phase 3

Phase 3 data published in STTT show orelabrutinib delivered a hazard ratio of 0.32 versus chemoimmunotherapy in treatment-naive CLL/SLL patients.
Phase 3 data published in STTT show orelabrutinib delivered a hazard ratio of 0.32 versus chemoimmunotherapy in treatment-naive CLL/SLL patients.

Mobia Medical publishes two-year Vivistim VNS stroke trial data

Two-year follow-up from the VNS-REHAB trial shows durable upper-limb motor gains in 76% of participants, published in Neurology.
Two-year follow-up from the VNS-REHAB trial shows durable upper-limb motor gains in 76% of participants, published in Neurology.

ORIC Pharmaceuticals starts Phase 3 Himalayas-1 trial in mCRPC

ORIC has dosed first patients in its 600-person global Phase 3 trial of rinzimetostat plus darolutamide, backed by a supply deal with Bayer.
ORIC has dosed first patients in its 600-person global Phase 3 trial of rinzimetostat plus darolutamide, backed by a supply deal with Bayer.
Biologics

Spero Therapeutics licenses anti-CD40L antibody SP001 from Innovent

Spero gains ex-China rights to a Phase 2-ready monoclonal antibody targeting autoimmune diseases, in a deal worth up to $1.1 billion.
Spero gains ex-China rights to a Phase 2-ready monoclonal antibody targeting autoimmune diseases, in a deal worth up to $1.1 billion.
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