Final Analysis

Galectin Therapeutics Reports the Positive Outcome of the Fifth Data and Safety Monitoring Board Meeting for NAVIGATE Phase 2b/3 Study of Belapectin in Patients with Cirrhotic Portal Hypertension Caused by Metabolic Dysfunction-Associated SteatoHepatitis

Retrieved on: 
Tuesday, April 9, 2024
Data monitoring committee, Cirrhosis, Metabolism, Disease, Risk, Patient, Hope, MASH, Final Analysis, Therapy, GALT, Safety, DSMB, Interim, Plasma protein binding, Esophageal varices, Liver, Pharmaceutical industry

The objective of this fifth DSMB meeting was to further review the emerging tolerance and safety profiles of belapectin.

Key Points: 
  • The objective of this fifth DSMB meeting was to further review the emerging tolerance and safety profiles of belapectin.
  • Based on its deliberation, which included an unblinded review of the data collected thus far, the DSMB concluded that NAVIGATE can continue as designed, without modifications.
  • The Phase 2b/3 NAVIGATE study is a global, seamless, adaptive, randomized, placebo-controlled, double-blind trial.
  • Enrolled patients have been randomized to receive every two weeks a blinded infusion of belapectin at 2 mg/kg/LBM or 4 mg/kg/LBM or placebo.

EQS-News: MorphoSys to Share New Data on Pelabresib and Monjuvi® (tafasitamab-cxix) in 14 Presentations at the American Society of Hematology Annual Meeting

Retrieved on: 
Monday, November 7, 2022
Constellation, FC, Cyclophosphamide, Adult, Bruise, CD19, Flushing, PFS, Dor, ADCC, Fever, Rituximab, Partnership, CD20, RCHOP, Sheraton New Orleans, ADCP, Food, CST, Final Analysis, ASCT, ASH, Rash, BET, Safety, Lenalidomide, Chills, Blinded, Prednisone, TD, JAK, Gene, Cancer, Pharmacokinetics, PET, ORR, Progression-free survival, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Ruxolitinib, Headache, Lymphoid leukemia, Immunotherapy, Arm, Vincristine, Incyte, Apoptosis, Death, Bleeding, Doxorubicin, GLA, Pharmaceutical industry, Medical imaging, Vaccine, Patient, DLBCL, Infection, Tafasitamab, MorphoSys, Primary myelofibrosis

As a global commercial-stage biopharmaceutical company, we use groundbreaking science and technologies to discover, develop, and deliver innovative cancer medicines to patients.

Key Points: 
  • As a global commercial-stage biopharmaceutical company, we use groundbreaking science and technologies to discover, develop, and deliver innovative cancer medicines to patients.
  • Pelabresib is being investigated as a treatment for myelofibrosis and has not yet been evaluated or approved by any regulatory authorities.
  • MANIFEST (NCT02158858) is an open-label Phase 2 clinical trial of pelabresib in patients with myelofibrosis.
  • Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose.

Atea Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Monday, August 8, 2022
High-risk pregnancy, Public health, GLOBE, Death, NS5A, Clinical trial, Research, Patient, Hospital, Final Analysis, Viral load, Atea, Development, Food, Combination therapy, Income, Omicron, Merck, Fever Dream, DENV, Safety, Doctor of Philosophy, Nasdaq, Pharmacokinetics, Alpha, European Medicines Agency, Protease, COVID-19, Virology, Vaccine, Infection, Immunodeficiency, RZR, Delta, Cash, Food and Drug Administration, Severe acute respiratory syndrome coronavirus 2, HCV, EMA, Dengue fever, FDA, BID, Ritonavir, Founder, Emergency Task Force (Toronto Police Service), Therapy, Income tax, Dengue virus, Personal income in the United States, Administration, Adult, Pharmaceutical industry, Life insurance, Vitro

New antivirals with improved profiles are urgently needed, said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals.

Key Points: 
  • New antivirals with improved profiles are urgently needed, said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals.
  • For dengue, we are currently enrolling two proof-of-concept trials for AT-752 and expect initial results in late 2022.
  • Operational planning for this trial is currently underway with the goal of initiation during the fourth quarter of 2022.
  • Results from the human challenge trial and initial results from the DEFEND-2 study are expected in the fourth quarter of 2022.