Clinical Trials

Biologics

Dianthus Therapeutics reports 75% CIDP response rate and $1.2bn cash

Dianthus posted positive interim Phase 3 data for claseprubart in CIDP and unveiled a third pipeline asset, DNTH312, alongside Q2 2026 financials.
Dianthus posted positive interim Phase 3 data for claseprubart in CIDP and unveiled a third pipeline asset, DNTH312, alongside Q2 2026 financials.
Biologics
Regulatory Science

Oblenio Bio doses first patients in LBL-051 autoimmune Phase 1a trial

The tri-specific T-cell engager, licensed from Leads Biolabs, targets BCMA, CD19 and CD3 to drive a durable immune reset in refractory autoimmune disease.
The tri-specific T-cell engager, licensed from Leads Biolabs, targets BCMA, CD19 and CD3 to drive a durable immune reset in refractory autoimmune disease.
Diagnostics

Molecure KITE trial clears interim review with no protocol changes

An IDMC review of 30 patients found sufficient probability of hitting the primary endpoint, letting the Phase II sarcoidosis study proceed unchanged.
An IDMC review of 30 patients found sufficient probability of hitting the primary endpoint, letting the Phase II sarcoidosis study proceed unchanged.
Biologics

Novo Nordisk raises 2026 guidance as Wegovy pill tops 5m prescriptions

Novo Nordisk lifted its full-year outlook after adjusted Q2 operating profit rose 11% at CER, driven by accelerating GLP-1 volumes and Wegovy pill
Novo Nordisk lifted its full-year outlook after adjusted Q2 operating profit rose 11% at CER, driven by accelerating GLP-1 volumes and Wegovy pill
Biologics

Rein Therapeutics publishes LTI-03 IPF data in Nature Communications

Peer-reviewed first-in-human data show inhaled LTI-03 reduced five fibrosis and inflammation markers in IPF patients after just 14 days.
Peer-reviewed first-in-human data show inhaled LTI-03 reduced five fibrosis and inflammation markers in IPF patients after just 14 days.
Biologics

Syndax posts $73m Q2 revenue as both approved drugs top $200m run rate

Syndax Pharmaceuticals reported 92% year-on-year revenue growth in Q2 2026, with revumenib and axatilimab each annualising above $200m.
Syndax Pharmaceuticals reported 92% year-on-year revenue growth in Q2 2026, with revumenib and axatilimab each annualising above $200m.
Biologics

AIM ImmunoTech reaches last-dose milestone early in DURIPANC trial

The Florida biotech said its Phase 2 pancreatic cancer study has dosed its final patient ahead of schedule, with topline data expected in Q1 2027.
The Florida biotech said its Phase 2 pancreatic cancer study has dosed its final patient ahead of schedule, with topline data expected in Q1 2027.
Biologics

Akebia starts Phase 2 basket trial of complement inhibitor ebribafusp

Akebia Therapeutics has dosed first patients in a 30-person Phase 2 study of ebribafusp across three rare complement-mediated kidney diseases, with data expected
Akebia Therapeutics has dosed first patients in a 30-person Phase 2 study of ebribafusp across three rare complement-mediated kidney diseases, with data expected
Biologics

Nurix and Roche enrol first patient in Phase 3 bexobrutideg CLL trial

The DAYBreak CLL-306 study will pit the BTK degrader against pirtobrutinib in around 620 relapsed/refractory CLL patients.
The DAYBreak CLL-306 study will pit the BTK degrader against pirtobrutinib in around 620 relapsed/refractory CLL patients.
Biologics
Regulatory Science

Sanofi's MenQuadfi wins EU approval for infants from six weeks

The European Commission has expanded MenQuadfi's indication to cover infants from six weeks, extending protection against four meningococcal serogroups.
The European Commission has expanded MenQuadfi's indication to cover infants from six weeks, extending protection against four meningococcal serogroups.
Biotech

Clearmind reports clean CMND-100 safety data across dose escalation

Clearmind Medicine completed all four ascending-dose cohorts of its Phase I/II AUD trial with no serious adverse events recorded.
Clearmind Medicine completed all four ascending-dose cohorts of its Phase I/II AUD trial with no serious adverse events recorded.
Biologics

DBV Technologies raises $50m via ATM programme with RA Capital

The French peanut-allergy biotech sold 3.66 million new ADSs at $13.67 each to RA Capital, diluting existing shareholders by approximately 5.82%.
The French peanut-allergy biotech sold 3.66 million new ADSs at $13.67 each to RA Capital, diluting existing shareholders by approximately 5.82%.
Biologics

EPO upholds SOT201 patent for SOTIO's PD-1 immunocytokine

SOTIO Biotech's IL-15 immunocytokine patent survived a Sanofi-led appeal, reinforcing IP around a Phase 1 programme showing objective responses in heavily pre
SOTIO Biotech's IL-15 immunocytokine patent survived a Sanofi-led appeal, reinforcing IP around a Phase 1 programme showing objective responses in heavily pre
Biologics
Regulatory Science

Leads Biolabs wins IND approval for Opamtistomig in metastatic CRC

China's NMPA cleared a Phase Ib/II trial of the PD-L1/4-1BB bispecific in MSS colorectal cancer, where checkpoint inhibitors have largely
China's NMPA cleared a Phase Ib/II trial of the PD-L1/4-1BB bispecific in MSS colorectal cancer, where checkpoint inhibitors have largely
Genomics

Medicus Pharma wins UAE IND nod for genomics-guided endometriosis trial

Medicus Pharma has received UAE DOH authorisation to begin PRECISION-E2, a Phase 2a genomics-integrated study of Teverelix in 84 women with endometriosis.
Medicus Pharma has received UAE DOH authorisation to begin PRECISION-E2, a Phase 2a genomics-integrated study of Teverelix in 84 women with endometriosis.
Diagnostics

MMI wins FDA clearance to expand REMIND Alzheimer's robot surgery study

MMI's IDE supplement approval lets the REMIND study enrol up to 15 patients, testing robotic microsurgery to restore lymphatic drainage in Alzheimer's disease.
MMI's IDE supplement approval lets the REMIND study enrol up to 15 patients, testing robotic microsurgery to restore lymphatic drainage in Alzheimer's disease.
Regulatory Science

UroGen secures US patent protecting ZUSDURI to July 2044

UroGen Pharma has received a USPTO Notice of Allowance covering its RTGel-based mitomycin treatment for recurrent bladder cancer, extending exclusivity to 2044.
UroGen Pharma has received a USPTO Notice of Allowance covering its RTGel-based mitomycin treatment for recurrent bladder cancer, extending exclusivity to 2044.

Aprea Therapeutics expands APR-1051 trial to ten sites ahead of Q4 data

Aprea is scaling ACESOT-1051 enrollment to up to ten patients a month and adding combination arms in head and neck cancer and colorectal cancer.
Aprea is scaling ACESOT-1051 enrollment to up to ten patients a month and adding combination arms in head and neck cancer and colorectal cancer.
Diagnostics
Genomics

BioNexus advances VitaGuard MRD rollout across Southeast Asia

BioNexus Gene Lab Corp. is targeting 2026 deployment of its VitaGuard liquid-biopsy platform in Malaysia and Singapore after a technical visit to its Chinese
BioNexus Gene Lab Corp. is targeting 2026 deployment of its VitaGuard liquid-biopsy platform in Malaysia and Singapore after a technical visit to its Chinese
Regulatory Science

MIRA Pharmaceuticals advances MIRA-55 and SKNY-1 toward IND studies

MIRA Pharmaceuticals has completed exploratory toxicology dosing in rats and dogs for both its pain and obesity candidates, bringing them closer to formal IND-enabling
MIRA Pharmaceuticals has completed exploratory toxicology dosing in rats and dogs for both its pain and obesity candidates, bringing them closer to formal IND-enabling
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