Digital Health

Carvolix secures €30m debt financing from Claret Capital Partners

The French medtech firm will use the growth loan to commercialise TAVIpilot, its FDA-cleared AI-guided software for transcatheter aortic valve procedures.
The French medtech firm will use the growth loan to commercialise TAVIpilot, its FDA-cleared AI-guided software for transcatheter aortic valve procedures.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
Digital Health

Magnendo wins up to $32m ARPA-H grant for autonomous stroke robot

The MIT spinout will use five-year federal funding to develop a magnetic robotic navigation platform for autonomous endovascular thrombectomy.
The MIT spinout will use five-year federal funding to develop a magnetic robotic navigation platform for autonomous endovascular thrombectomy.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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.
The Biotech Times Editorial Team  · 
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