Clinical Trials

Biologics

NewAmsterdam Pharma to present obicetrapib Alzheimer's data at AAIC 2026

NewAmsterdam Pharma will share four BROADWAY-derived analyses at AAIC 2026, including biomarker data suggesting obicetrapib may slow Alzheimer's pathology.
NewAmsterdam Pharma will share four BROADWAY-derived analyses at AAIC 2026, including biomarker data suggesting obicetrapib may slow Alzheimer's pathology.
Diagnostics
Biotech

Urteste wins USPTO patent for urine-based Panuri pancreatic cancer test

The Polish diagnostics company secured US patent protection for its non-invasive Panuri test as a European clinical trial enrols its first participants.
The Polish diagnostics company secured US patent protection for its non-invasive Panuri test as a European clinical trial enrols its first participants.
Biologics
Bioprocessing

VERAXA Biotech taps ATUM to develop cell lines for BiTAC-TCE programme

VERAXA has engaged ATUM's Leap-In Transposase technology to generate stable clonal cell lines for its lead conditional T-cell engager candidate ahead of
VERAXA has engaged ATUM's Leap-In Transposase technology to generate stable clonal cell lines for its lead conditional T-cell engager candidate ahead of
Regulatory Science

CervoMed secures US patent on neflamapimod for pure DLB to 2042

CervoMed has received a USPTO notice of allowance for a patent covering neflamapimod in pure dementia with Lewy bodies, extending protection into 2042.
CervoMed has received a USPTO notice of allowance for a patent covering neflamapimod in pure dementia with Lewy bodies, extending protection into 2042.
Genomics

Oryzon Genomics raises €12m and secures €25m COFIDES commitment

The Barcelona epigenetics biotech priced 4.4 million new shares at €2.70 each and secured a €25m anchor commitment from Spain's Social Impact
The Barcelona epigenetics biotech priced 4.4 million new shares at €2.70 each and secured a €25m anchor commitment from Spain's Social Impact
Biologics

Kyowa Kirin mogamulizumab data show survival gains in rare CTCL

Two indirect treatment comparison analyses link mogamulizumab to significantly lower mortality risk in relapsed mycosis fungoides and Sézary syndrome.
Two indirect treatment comparison analyses link mogamulizumab to significantly lower mortality risk in relapsed mycosis fungoides and Sézary syndrome.
Biologics

Revolution Medicines: zoldonrasib combos active in RAS G12D PDAC

Phase 1/2 data presented at ESMO GI show response rates above 60% for zoldonrasib combinations, supporting two planned Phase 3 trials in pancreatic cancer.
Phase 1/2 data presented at ESMO GI show response rates above 60% for zoldonrasib combinations, supporting two planned Phase 3 trials in pancreatic cancer.
Biotech

BellaSeno pivotal trial enrols 30 women for absorbable breast scaffold

The Leipzig-based regenerative medtech firm reports 83% mean breast volume retention and zero scaffold-related complications in its first-in-human safety cohort.
The Leipzig-based regenerative medtech firm reports 83% mean breast volume retention and zero scaffold-related complications in its first-in-human safety cohort.
Biologics

Tenax Therapeutics to present LEVEL Phase 3 data at ESC 2026

Topline results from the PH-HFpEF trial of oral levosimendan are expected in August, ahead of a late-breaking session at ESC Congress in Munich.
Topline results from the PH-HFpEF trial of oral levosimendan are expected in August, ahead of a late-breaking session at ESC Congress in Munich.
Biologics

Xeltis passes 50% enrollment in US pivotal trial for aXess graft

The Netherlands-based medtech has enrolled over 70 patients across 20 US sites for its bioabsorbable hemodialysis vascular access device.
The Netherlands-based medtech has enrolled over 70 patients across 20 US sites for its bioabsorbable hemodialysis vascular access device.
Biologics

Abivax prices upsized $800M ADS offering to fund obefazimod launch

The Paris-listed biotech upsized its US public offering from $600M to $800M, extending its cash runway to Q2 2029 ahead of a potential obefazimod
The Paris-listed biotech upsized its US public offering from $600M to $800M, extending its cash runway to Q2 2029 ahead of a potential obefazimod
Genomics

Roche divarasib beats first-gen KRAS G12C drugs in Phase III NSCLC trial

Roche's Krascendo 1 study showed divarasib improved both progression-free and overall survival versus sotorasib or adagrasib in previously treated KRAS G12C lung cancer
Roche's Krascendo 1 study showed divarasib improved both progression-free and overall survival versus sotorasib or adagrasib in previously treated KRAS G12C lung cancer
Biologics
Diagnostics

Telix wins FDA alignment to open ProstACT Global Phase 3 in US

Telix Pharmaceuticals secured FDA agreement on protocol and statistics for Part 2 of its lutetium-177 rosopatamab Phase 3 trial in metastatic prostate cancer.
Telix Pharmaceuticals secured FDA agreement on protocol and statistics for Part 2 of its lutetium-177 rosopatamab Phase 3 trial in metastatic prostate cancer.
Biologics

Ipsen to acquire Memo Therapeutics for up to EUR 700m

Ipsen is buying Swiss biotech Memo Therapeutics to gain potravitug, a Phase II monoclonal antibody targeting BK polyomavirus in kidney transplant recipients.
Ipsen is buying Swiss biotech Memo Therapeutics to gain potravitug, a Phase II monoclonal antibody targeting BK polyomavirus in kidney transplant recipients.

JenaValve presents LVAD and pacemaker data for Trilogy TAVR system

New York Valves 2026 featured two late-breaking Trilogy datasets, including early outcomes in LVAD patients with aortic regurgitation showing 7.3% one-year mortality.
New York Valves 2026 featured two late-breaking Trilogy datasets, including early outcomes in LVAD patients with aortic regurgitation showing 7.3% one-year mortality.
Biologics

Nicox partner Kowa files NDA for NCX 470 glaucoma eye drop

Kowa's US NDA submission for the nitric oxide-donating bimatoprost drop triggers a €3m milestone and targets FDA approval by mid-2027.
Kowa's US NDA submission for the nitric oxide-donating bimatoprost drop triggers a €3m milestone and targets FDA approval by mid-2027.
Biologics
Regulatory Science

Novartis wins EC approval for Itvisma in broader SMA population

The European Commission has approved Itvisma as the first gene replacement therapy for SMA patients aged two and older, including teens and adults.
The European Commission has approved Itvisma as the first gene replacement therapy for SMA patients aged two and older, including teens and adults.
Biologics
Regulatory Science

PolarityBio files BLA for SkinTE in diabetic foot ulcers

PolarityBio has submitted a BLA to the FDA for SkinTE, an autologous skin therapy backed by RMAT and Breakthrough Therapy designations.
PolarityBio has submitted a BLA to the FDA for SkinTE, an autologous skin therapy backed by RMAT and Breakthrough Therapy designations.
Biologics

4DMT completes 4FRONT-2 Phase 3 enrolment four months ahead of schedule

4D Molecular Therapeutics has finished global enrolment for its wet AMD gene therapy trial, with topline 52-week data expected in the second half of
4D Molecular Therapeutics has finished global enrolment for its wet AMD gene therapy trial, with topline 52-week data expected in the second half of
Biologics

Abivax ABTECT Part 2 data back obefazimod NDA submission in UC

Phase 3 maintenance data show obefazimod rescued remission in refractory ulcerative colitis patients, with an NDA filing planned for Q4 2026.
Phase 3 maintenance data show obefazimod rescued remission in refractory ulcerative colitis patients, with an NDA filing planned for Q4 2026.
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