Clinical - REDFILED

PDSB

PDS (PDSB) BIOTECH Phase 2 Data Published in JAMA Oncology With 39.3-Month Survival

VERSATILE-002 results for PDS0101 plus pembrolizumab show 39.3 months median overall survival in checkpoint-inhibitor-naive HPV16-positive head and neck cancer.

Tegoprubart is being developed to prevent rejection in kidney transplant recipients.

ELDN

ELEDON (ELDN) Reports 24-Month Phase 2 Kidney Data and Wins FDA Fast Track

Tegoprubart kept kidney function about 13 mL/min/1.73 m² above tacrolimus at month 24, as Eledon prepares to start its Phase 3 LEGACY trial in Q4.

Viking Therapeutics is developing VK2735 in both injectable and oral formulations for obesity.

VKTX

VIKING THERAPEUTICS (VKTX) Says VK2735 Holds Weight Loss on Monthly Dosing

Maintenance study shows patients kept up to 97% of weight loss on every-other-week dosing and up to 90% on monthly dosing, with GI side effects near placebo.

Chronic spontaneous urticaria causes recurring hives and itching.

CLDX

CELLDEX (CLDX) Phase 3 Trials of Barzolvolimab Hit All Endpoints in Hives

Both EMBARQ-CSU studies met primary and all key secondary endpoints, with complete response rates above 42% at week 12; BLA planned for 2027.

Barzolvolimab is being developed for chronic spontaneous urticaria, a condition marked by persistent hives and itch.

CLDX

CELLDEX (CLDX) Phase 3 Trials of Barzolvolimab Hit All Endpoints in Hives

Both EMBARQ-CSU studies met their primary and all key secondary endpoints, with complete response rates above 42% at 12 weeks; BLA planned for 2027.

PDSB

PDS BIOTECHNOLOGY (PDSB) Refocuses on IL-12 Asset After Nant Capital Financing

Corporate deck filed with the SEC shows a 71.4% six-month response rate for PDS0301 in liver-metastatic colorectal cancer and a new board seat for Patrick Soon-Shiong.

CagriSema is Novo Nordisk's investigational once-weekly combination therapy for obesity and type 2 diabetes.

NVO

NOVO (NVO) NORDISK's Cagrisema Beats Tirzepatide On Weight Loss In Trial

Phase 3 data show Novo's investigational CagriSema outperformed Eli Lilly's tirzepatide on weight loss in diabetes patients and beat placebo in obesity.

TEVA

TEVA Posts New SOLARIS Data on Monthly Olanzapine Shot Ahead of FDA Call

Post hoc analysis shows 56% of patients on TEV-'749 reached stabilization, with a PDUFA decision due in the fourth quarter of 2026.

Research into hypertrophic cardiomyopathy focuses on how the heart muscle thickens.

BMY

BRISTOL-MYERS SQUIBB (BMY) Halts Phase 3 Mavacamten Trial for Lack of Efficacy

The company terminated its Phase 3 study of mavacamten in non-obstructive hypertrophic cardiomyopathy after the drug failed to show short-term efficacy.

Artelo tested ART27.13 in the diet-induced obesity mouse model used across the industry.

ARTL

ARTELO BIOSCIENCES (ARTL) Says ART27.13 Matched Semaglutide in Obese Mice

Nonclinical study showed roughly 20% weight loss on Artelo's oral cannabinoid agonist alone and about 40% when combined with semaglutide.

Ivonescimab is being studied as a first-line treatment for advanced non-small cell lung cancer.

SMMT

SUMMIT Partner Akeso Reports 8.2-Month Survival Edge Over Keytruda

Ivonescimab cut the risk of death 27% versus pembrolizumab in Akeso's Chinese Phase III HARMONi-2 trial, with median overall survival of 30.8 months.

Gotistobart is being developed for patients with squamous non-small cell lung cancer.

BNTX

BIONTECH Says Gotistobart Nearly Doubled Survival in Lung Cancer Trial

BioNTech and partner OncoC4 report first median overall survival data from stage 1 of the Phase 3 PRESERVE-003 trial in squamous NSCLC.