Clinical Trials

Biologics

VarmX enrols first patient in Phase 3 trial of FXa reversal agent

VarmX has begun enrolling patients in EquilibriX-S, its pivotal Phase 3 study of VMX-C001 for urgent surgery in patients on Factor Xa inhibitors.
VarmX has begun enrolling patients in EquilibriX-S, its pivotal Phase 3 study of VMX-C001 for urgent surgery in patients on Factor Xa inhibitors.
Regulatory Science

Ambros and Werewolf merge to advance neridronate in CRPS-1

The all-stock deal, backed by a $150m oversubscribed private placement, creates a Nasdaq-listed company targeting the first FDA-approved therapy for CRPS-1.
The all-stock deal, backed by a $150m oversubscribed private placement, creates a Nasdaq-listed company targeting the first FDA-approved therapy for CRPS-1.
Digital Health
Regulatory Science

TrueProfile.io and MediLearning partner to expand GCC healthcare CPD

DataFlow's TrueProfile.io will list 70-plus DHA-accredited CPD/CME courses for verified healthcare professionals across six GCC countries.
DataFlow's TrueProfile.io will list 70-plus DHA-accredited CPD/CME courses for verified healthcare professionals across six GCC countries.
Biologics

MiNK Therapeutics reports Day 28 survival data from agenT-797 Phase 2

Early observations from MiNK's randomised Phase 2 in severe hypoxemic pneumonia showed treated patients alive, afebrile and off ventilator support at Day 28.
Early observations from MiNK's randomised Phase 2 in severe hypoxemic pneumonia showed treated patients alive, afebrile and off ventilator support at Day 28.

Pacira publishes two-year Phase 1 data for PCRX-201 in knee OA

Pacira BioSciences' intra-articular gene therapy showed durable tolerability and exploratory pain improvements over two years in moderate-to-severe knee osteoarthritis.
Pacira BioSciences' intra-articular gene therapy showed durable tolerability and exploratory pain improvements over two years in moderate-to-severe knee osteoarthritis.
Diagnostics

Zentalis plots DENALI Part 2 readout in 1H 2027 as cash thins

Zentalis said FDA alignment on its accelerated approval strategy for azenosertib in Cyclin E1-positive ovarian cancer keeps a 2027 filing pathway open.
Zentalis said FDA alignment on its accelerated approval strategy for azenosertib in Cyclin E1-positive ovarian cancer keeps a 2027 filing pathway open.

Amplia signs Lilly deal to test FAK inhibitor in KRAS G12C lung cancer

Amplia Therapeutics will combine narmafotinib with Lilly's olomorasib in a Phase 1b/2b NSCLC trial starting late 2026, targeting KRAS G12C resistance.
Amplia Therapeutics will combine narmafotinib with Lilly's olomorasib in a Phase 1b/2b NSCLC trial starting late 2026, targeting KRAS G12C resistance.
Biologics

Entera Bio raises $275m to fund EB613 oral osteoporosis Phase 3

The Tel Aviv-listed biotech secured an oversubscribed PIPE to take its oral PTH(1-34) tablet through a registrational trial and NDA submission.
The Tel Aviv-listed biotech secured an oversubscribed PIPE to take its oral PTH(1-34) tablet through a registrational trial and NDA submission.
Biologics

Gyre Therapeutics affirms $100m+ guidance after Cullgen deal closes

Gyre posted Q2 revenue of $29.1m and reaffirmed full-year guidance of up to $111m as its Cullgen acquisition added a protein-degrader pipeline.
Gyre posted Q2 revenue of $29.1m and reaffirmed full-year guidance of up to $111m as its Cullgen acquisition added a protein-degrader pipeline.
Biologics
Regulatory Science

Bavarian Nordic wins EC approval of mpox vaccine for young children

IMVANEX is now authorised in the EU for children aged 2 to 11, backed by Phase 2 data showing non-inferior immune responses versus adults.
IMVANEX is now authorised in the EU for children aged 2 to 11, backed by Phase 2 data showing non-inferior immune responses versus adults.
Biologics
Regulatory Science

CG Oncology awaits PIVOT-006 Phase 3 data as BLA filing nears

CG Oncology says PIVOT-006 has accrued most target events, with topline data imminent and a BLA submission for bladder cancer due in Q4 2026.
CG Oncology says PIVOT-006 has accrued most target events, with topline data imminent and a BLA submission for bladder cancer due in Q4 2026.
Diagnostics

Clearmind DSMB clears CMND-100 to advance into AUD patients

Clearmind Medicine's Phase I/II trial of CMND-100 can progress to patient cohorts after its safety board unanimously approved advancement following a clean
Clearmind Medicine's Phase I/II trial of CMND-100 can progress to patient cohorts after its safety board unanimously approved advancement following a clean
Biologics

CurePSP's PSP Trial Platform enrols first participant

The $75.4m NIA-funded platform trial will test multiple PSP drugs simultaneously at 50 US sites, enrolling 440 participants over two years.
The $75.4m NIA-funded platform trial will test multiple PSP drugs simultaneously at 50 US sites, enrolling 440 participants over two years.
Diagnostics
Regulatory Science

Spectral Medical's PMX enters FDA substantive review for septic shock

The Toronto-listed theranostic company said 12-month Tigris trial data showed a 13.9% absolute mortality reduction versus standard care.
The Toronto-listed theranostic company said 12-month Tigris trial data showed a 13.9% absolute mortality reduction versus standard care.
Diagnostics

Tarsus Pharmaceuticals closes oversubscribed $125m PIPE financing

The Irvine-based eye care biotech raised the funds alongside a pending acquisition of Alkeus Pharmaceuticals, with Bain Capital Life Sciences among participating
The Irvine-based eye care biotech raised the funds alongside a pending acquisition of Alkeus Pharmaceuticals, with Bain Capital Life Sciences among participating
Biologics

PSP Trial Platform enrols first participant in multi-drug study

The UCSF-led platform trial, backed by $75.4m in NIH funding, will test multiple drugs simultaneously across 50 sites in the US.
The UCSF-led platform trial, backed by $75.4m in NIH funding, will test multiple drugs simultaneously across 50 sites in the US.
Regulatory Science

Aclaris Therapeutics wins Fast Track tag for modzatinib in lichen planus

The FDA granted Fast Track Designation to modzatinib for moderate to severe lichen planus, a condition with no currently approved therapies.
The FDA granted Fast Track Designation to modzatinib for moderate to severe lichen planus, a condition with no currently approved therapies.
Biologics
Regulatory Science

Artiva Biotherapeutics initiates Phase 3 RA trial after RMAT designation

Artiva's AlloNK NK cell therapy secured FDA RMAT designation for refractory RA as it launches a 150-patient Phase 3 trial backed by $349m
Artiva's AlloNK NK cell therapy secured FDA RMAT designation for refractory RA as it launches a 150-patient Phase 3 trial backed by $349m
Biologics

Ascendis reports durable growth data from COACH and ApproaCH trials

Ascendis Pharma's combination therapy hit the 97th percentile for growth velocity at Week 78, while YUVIWEL surpassed 170 patient enrolments in the U.S.
Ascendis Pharma's combination therapy hit the 97th percentile for growth velocity at Week 78, while YUVIWEL surpassed 170 patient enrolments in the U.S.
Biologics
Regulatory Science

Pharvaris AAE-C1INH burden study published in Frontiers Immunology

Pharvaris published the first qualitative disease-burden study in AAE-C1INH, informing endpoint selection for its ongoing Phase 3 CREAATE trial of deucrictibant.
Pharvaris published the first qualitative disease-burden study in AAE-C1INH, informing endpoint selection for its ongoing Phase 3 CREAATE trial of deucrictibant.
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