Pharmaceuticals

Pharmaceuticals
Biologics

Newron completes ENIGMA-TRS 1 screening with 12-week data due Q1 2027

Newron Pharmaceuticals has finished screening for its 600-patient Phase 3 trial of evenamide in treatment-resistant schizophrenia, with topline results expected early
Newron Pharmaceuticals has finished screening for its 600-patient Phase 3 trial of evenamide in treatment-resistant schizophrenia, with topline results expected early
Pharmaceuticals
Bioprocessing
Biologics

WuXi TIDES maps the path for oligonucleotides beyond the liver

WuXi AppTec argues that extrahepatic oligonucleotide delivery requires tissue-specific strategies, not a single universal technology.
WuXi AppTec argues that extrahepatic oligonucleotide delivery requires tissue-specific strategies, not a single universal technology.
Pharmaceuticals
Medical Devices
Diagnostics

PRF Technologies clears IND for OcuRing-K Phase II cataract trial

The Israel-based dual-business company reported FDA IND clearance for its intraocular drug-delivery ring and positive preclinical data for its non-opioid pain
The Israel-based dual-business company reported FDA IND clearance for its intraocular drug-delivery ring and positive preclinical data for its non-opioid pain
Pharmaceuticals
Genomics

Stoke and Biogen present 4-year zorevunersen data at EEC

Four-year open-label extension data showed durable seizure reductions and cognitive gains in Dravet syndrome; Phase 3 readout is expected in Q3 2027.
Four-year open-label extension data showed durable seizure reductions and cognitive gains in Dravet syndrome; Phase 3 readout is expected in Q3 2027.
Pharmaceuticals
Biologics

Tangram Therapeutics advances TGM-312 into MASH patient cohorts

The London RNAi biotech said its siRNA candidate cleared a safety review in healthy volunteers and now enters multiple ascending dose testing in MASH patients.
The London RNAi biotech said its siRNA candidate cleared a safety review in healthy volunteers and now enters multiple ascending dose testing in MASH patients.
Biologics
Pharmaceuticals

Attovia Therapeutics raises $332m IPO as itch drug shows Phase 1b signal

The San Carlos biotech reported preliminary proof of concept for ATTO-1310 in chronic pruritus and atopic dermatitis, with two Phase 2 studies planned for
The San Carlos biotech reported preliminary proof of concept for ATTO-1310 in chronic pruritus and atopic dermatitis, with two Phase 2 studies planned for
Biologics
Pharmaceuticals

HUTCHMED licenses KRAS-EGFR conjugate HMPL-A830 to GSK for $1.3bn

GSK gains worldwide rights outside Greater China to HMPL-A830, a novel antibody-targeted therapy conjugate, with $110m upfront and up to $1.295bn in
GSK gains worldwide rights outside Greater China to HMPL-A830, a novel antibody-targeted therapy conjugate, with $110m upfront and up to $1.295bn in
Pharmaceuticals
Regulatory Science

Inventiva completes patient visits in NATiV3 MASH Phase 3 trial

Topline results for lanifibranor's pivotal 1,009-patient trial are expected in Q4 2026, with regulatory submission targeted for H1 2027 if data are
Topline results for lanifibranor's pivotal 1,009-patient trial are expected in Q4 2026, with regulatory submission targeted for H1 2027 if data are
Biologics
Pharmaceuticals

Lecanemab subcutaneous autoinjector approved in China for early AD

China's NMPA has approved Eisai and Biogen's once-weekly lecanemab SC formulation for early Alzheimer's, making China the second market globally to
China's NMPA has approved Eisai and Biogen's once-weekly lecanemab SC formulation for early Alzheimer's, making China the second market globally to
Biologics
Pharmaceuticals

Teva's TEV-408 meets primary endpoint in celiac Phase 2a

Teva's anti-IL-15 antibody TEV-408 significantly reduced gluten-induced intestinal damage versus placebo in a 50-patient Phase 2a study.
Teva's anti-IL-15 antibody TEV-408 significantly reduced gluten-induced intestinal damage versus placebo in a 50-patient Phase 2a study.
Pharmaceuticals
Genomics

Ultragenyx Phase 3 Aspire trial fails in Angelman syndrome

Ultragenyx's apazunersen missed both its primary and key secondary endpoints in the Phase 3 Aspire study, leaving Angelman syndrome without an approved treatment.
Ultragenyx's apazunersen missed both its primary and key secondary endpoints in the Phase 3 Aspire study, leaving Angelman syndrome without an approved treatment.
Pharmaceuticals
Diagnostics

BioVie completes treatment phase of bezisterim Long COVID trial

BioVie says its ADDRESS-LC Phase 2 trial of bezisterim has finished dosing, with topline results expected before end of September 2026.
BioVie says its ADDRESS-LC Phase 2 trial of bezisterim has finished dosing, with topline results expected before end of September 2026.
Pharmaceuticals
Biologics

Boehringer Ingelheim launches SCOVELLA for equine laminitis in GB

Velagliflozin oral solution becomes the first licensed therapy for insulin dysregulation in horses, targeting the primary driver of laminitis.
Velagliflozin oral solution becomes the first licensed therapy for insulin dysregulation in horses, targeting the primary driver of laminitis.
Diagnostics
Pharmaceuticals
Biologics

Juniper's JBS-003 wins FDA Breakthrough Therapy Designation

The FDA granted Breakthrough Therapy Designation to JBS-003, a hypoxia tracer designed to halve radiation doses in HPV-positive head and neck cancer.
The FDA granted Breakthrough Therapy Designation to JBS-003, a hypoxia tracer designed to halve radiation doses in HPV-positive head and neck cancer.
Diagnostics
Genomics
Pharmaceuticals

Kala Bio signs LOI to distribute Virotek ophthalmic genetic tests

Kala Bio will market Virotek's CLIA-registered ophthalmology genetic screening programme across U.S. eye care practices, targeting a definitive deal within 30 days.
Kala Bio will market Virotek's CLIA-registered ophthalmology genetic screening programme across U.S. eye care practices, targeting a definitive deal within 30 days.
Pharmaceuticals
Biologics

Kyntra Bio cuts royalty obligation by $60m in balance sheet overhaul

Kyntra Bio has amended its royalty financing deal to reduce maximum aggregate payments from $125m to $65m, extending its cash runway into Q4 2027.
Kyntra Bio has amended its royalty financing deal to reduce maximum aggregate payments from $125m to $65m, extending its cash runway into Q4 2027.
Pharmaceuticals
Biologics

Novartis remibrutinib meets Phase III endpoints in relapsing MS

The REMODEL-1/-2 trials showed remibrutinib significantly reduced relapse rates versus teriflunomide, with disability progression benefits and no liver safety signal.
The REMODEL-1/-2 trials showed remibrutinib significantly reduced relapse rates versus teriflunomide, with disability progression benefits and no liver safety signal.
Diagnostics
Pharmaceuticals

Telix completes BiPASS enrolment and aligns with FDA on NDA path

Telix has finished enrolling 350 patients in its Phase 3 pre-biopsy PSMA-PET study and confirmed an NDA pathway with the FDA that could
Telix has finished enrolling 350 patients in its Phase 3 pre-biopsy PSMA-PET study and confirmed an NDA pathway with the FDA that could
Biologics
Pharmaceuticals

Upstream Bio plans dual Phase 3 trials for verekitug in 2027

The Waltham biotech will start pivotal studies in severe asthma and CRSwNP in Q1 2027, targeting a quarterly 400 mg subcutaneous regimen.
The Waltham biotech will start pivotal studies in severe asthma and CRSwNP in Q1 2027, targeting a quarterly 400 mg subcutaneous regimen.
Pharmaceuticals

Orion Pharma's ODM-212 wins EU Orphan Designation for mesothelioma

The Finnish pharma group's oral pan-TEAD inhibitor now holds Orphan Designation on both sides of the Atlantic as its Phase 2 TEADES trial
The Finnish pharma group's oral pan-TEAD inhibitor now holds Orphan Designation on both sides of the Atlantic as its Phase 2 TEADES trial
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