Clinical Trials

Pharmaceuticals

Novo Nordisk wins MHRA approval for oral Wegovy semaglutide pill

The UK becomes the first European country to approve a once-daily GLP-1 weight-loss tablet, based on Phase 3 data showing ~14% weight
The UK becomes the first European country to approve a once-daily GLP-1 weight-loss tablet, based on Phase 3 data showing ~14% weight
Bioinformatics

Nurix BTK degrader bexobrutideg shows 92.9% ORR in second-line CLL

Updated Phase 1a/b data presented at EHA 2026 show durable responses and a clean safety profile across heavily pretreated CLL patients.
Updated Phase 1a/b data presented at EHA 2026 show durable responses and a clean safety profile across heavily pretreated CLL patients.
Bioinformatics

Syndax SAVE trial data published in JCO showing 88% ORR

Phase 1/2 SAVE data show revumenib plus decitabine/cedazuridine and venetoclax achieved 88% ORR in heavily pretreated AML patients.
Phase 1/2 SAVE data show revumenib plus decitabine/cedazuridine and venetoclax achieved 88% ORR in heavily pretreated AML patients.
Cell & Gene Therapy

Cartesian licenses mRNA payload to WestGene for in vivo CAR-T

Cartesian Therapeutics and WestGene Biopharma will combine mRNA CAR-T payloads with targeted LNPs to run a Phase 1 MG trial from late 2026.
Cartesian Therapeutics and WestGene Biopharma will combine mRNA CAR-T payloads with targeted LNPs to run a Phase 1 MG trial from late 2026.
Genomics

CONNECTA Therapeutics starts Phase IIa trial of CTH120 in fragile X

The Barcelona biotech has dosed its first participants in a 30-patient study of TrkB modulator CTH120, the only compound in late-stage development for
The Barcelona biotech has dosed its first participants in a 30-patient study of TrkB modulator CTH120, the only compound in late-stage development for
Cell & Gene Therapy

Cullinan Therapeutics reports remissions in SLE and RA with CD19 TCE

Phase 1 data for CLN-978 and velinotamig show clinical remissions and complete renal responses in heavily pre-treated autoimmune patients.
Phase 1 data for CLN-978 and velinotamig show clinical remissions and complete renal responses in heavily pre-treated autoimmune patients.
Regulatory Science
Biotech

Humacyte ATEV beats AV fistula on catheter-free days in Phase 3

Humacyte's bioengineered vessel delivered 91 more catheter-free days than standard-of-care AV fistula in female dialysis patients, triggering a supplemental BLA filing.
Humacyte's bioengineered vessel delivered 91 more catheter-free days than standard-of-care AV fistula in female dialysis patients, triggering a supplemental BLA filing.
Biotech

Linnaeus Therapeutics' LNS8801 selected for NIA lifespan testing

The GPER agonist joins the NIA's Interventions Testing Programme, complementing a separate $22m ARPA-H contract to evaluate healthspan preservation.
The GPER agonist joins the NIA's Interventions Testing Programme, complementing a separate $22m ARPA-H contract to evaluate healthspan preservation.
Regulatory Science

Optimi Health ships psilocybin to UK for Phase 2 clinical trial

The Canadian GMP manufacturer completed its first UK psilocybin export, supplying 5mg capsules and biomass under Health Canada and UK Home Office authorisations.
The Canadian GMP manufacturer completed its first UK psilocybin export, supplying 5mg capsules and biomass under Health Canada and UK Home Office authorisations.
Regulatory Science

Rafael Holdings completes Phase 3 enrolment for NPC drug Trappsol Cyclo

Rafael Holdings has reached last-patient-last-visit in its 94-patient TransportNPC trial, with topline data and an NDA submission both expected in H2
Rafael Holdings has reached last-patient-last-visit in its 94-patient TransportNPC trial, with topline data and an NDA submission both expected in H2
Biotech

Tectonic Therapeutic completes APEX Phase 2 enrolment for TX45

The Watertown biotech enrolled 191 patients across 14 countries; topline results for the PH-HFpEF candidate are expected in early Q1 2027.
The Watertown biotech enrolled 191 patients across 14 countries; topline results for the PH-HFpEF candidate are expected in early Q1 2027.
Regulatory Science

Teva closes $700m Emalex buy to add ecopipam for Tourette syndrome

Teva paid $700 million upfront for Emalex Biosciences, acquiring a Phase 3-complete D1 antagonist with an NDA filing expected in the second half of
Teva paid $700 million upfront for Emalex Biosciences, acquiring a Phase 3-complete D1 antagonist with an NDA filing expected in the second half of
Cell & Gene Therapy

Actuate Therapeutics' elraglusib enters BEACON2 neuroblastoma trial

Elraglusib will be assessed alongside dinutuximab beta and chemotherapy in relapsed and refractory paediatric neuroblastoma across up to 60 international sites.
Elraglusib will be assessed alongside dinutuximab beta and chemotherapy in relapsed and refractory paediatric neuroblastoma across up to 60 international sites.
Regulatory Science

Alterity Therapeutics wins FDA alignment on ATH434 Phase 3 MSA trial

Alterity's End-of-Phase 2 meeting secured FDA agreement on trial design, dosing, and endpoints for its pivotal ATH434 programme in multiple system atrophy.
Alterity's End-of-Phase 2 meeting secured FDA agreement on trial design, dosing, and endpoints for its pivotal ATH434 programme in multiple system atrophy.
Biotech

Atavistik Bio wins FDA IND clearance and Fast Track tag for ATV-1601

The Cambridge biotech can now advance directly into a randomised Phase 1/2 study of its oral AKT1 inhibitor in hereditary haemorrhagic telangiectasia.
The Cambridge biotech can now advance directly into a randomised Phase 1/2 study of its oral AKT1 inhibitor in hereditary haemorrhagic telangiectasia.
Cell & Gene Therapy
Regulatory Science

Cellectis wins FDA RMAT designation for allogeneic CAR-T lasme-cel

The Paris-based biotech secured RMAT status for its CD22-targeting off-the-shelf CAR-T candidate in relapsed or refractory B-cell acute lymphoblastic
The Paris-based biotech secured RMAT status for its CD22-targeting off-the-shelf CAR-T candidate in relapsed or refractory B-cell acute lymphoblastic
Diagnostics
Digital Health

Ceribell Clarity AI links seizure burden to neurological outcomes

A peer-reviewed study in Critical Care Medicine found Ceribell's AI algorithm associates high seizure burden with a 3.4-fold rise in death
A peer-reviewed study in Critical Care Medicine found Ceribell's AI algorithm associates high seizure burden with a 3.4-fold rise in death
Pharmaceuticals

Chiesi wins Health Canada priority review for FILSUVEZ in EB

Health Canada has accepted Chiesi's birch triterpenes gel for priority review, potentially making it the first therapy approved for EB wounds in Canada.
Health Canada has accepted Chiesi's birch triterpenes gel for priority review, potentially making it the first therapy approved for EB wounds in Canada.
Regulatory Science

Disc Medicine aligns with FDA on bitopertin CRL response path

Disc Medicine said a Type A FDA meeting confirmed the Phase 3 APOLLO study could support a traditional approval for bitopertin in EPP, with data
Disc Medicine said a Type A FDA meeting confirmed the Phase 3 APOLLO study could support a traditional approval for bitopertin in EPP, with data
Pharmaceuticals

Imviva Biotech wins FDA IND clearance for dual-target allogeneic CAR-T

CTA313 targets CD19 and BCMA in a Phase 1b basket trial spanning lupus, progressive MS, and autoimmune encephalitis.
CTA313 targets CD19 and BCMA in a Phase 1b basket trial spanning lupus, progressive MS, and autoimmune encephalitis.
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