CLINICAL TRIALS, STUDIES, REGISTRIES, DATA

"It is encouraging to see positive initial safety results in various combination studies of ORSERDU, along with promising preliminary efficacy data in these trials," said Hope Rugo, MD, professor of medicine, Division of Hematology and Oncology at the University of California San Francisco Helen Diller Family Comprehensive Cancer Center. "We look forward to learning more about ORSERDU's role in combination settings and its potential across the spectrum of metastatic breast cancer."

“The completion of the APEX-AV Study represents an important milestone in the catheter-directed therapies CDT space for the treatment of pulmonary embolism. I sincerely thank all the investigators for their commitment and dedication,” said William Brent Keeling, MD, Associate Professor of Surgery, Department of Surgery, at the Emory University School of Medicine, and Immediate Past President, The PERT Consortium™.

Innovent Biologics and Synaffix: Under the terms of the expanded agreement, Innovent will be responsible for the research, development, manufacturing and commercialization of new ADC candidates. Synaffix is eligible to receive an upfront payment plus potentialmilestone payments and royalties on commercial sales for each licensed target.

Data from clinical studies of STK-001 demonstrated clinical benefit for patients ages 2 to 18 years old, including reductions in seizures and improvements in cognition and behavior that support the potential for disease modificatio. Analysis of 72 patients treated in STK-001 clinical trials suggests that higher STK-001 drug exposure in brain leads to greater seizure reductions. Two-year data from the longest prospective natural history study of Dravet syndrome showed that, on average, patients experienced no meaningful improvement in convulsive seizure frequency and exhibited widening gaps in cognition and behavior despite treatment with the best available anti-seizure medicines.

"Exact Sciences is looking forward to presenting new evidence at SABCS that adds important perspectives to treating breast cancer patients and showing that some patients may be able to de-escalate treatments and still have positive outcomes," said Dr. Rick Baehner, Chief Medical Officer, Precision Oncology, Exact Sciences. "Every year, we build upon the precedent set by the Oncotype DX Breast Recurrence Score® test and its prognostic and predictive abilities to determine the chemotherapy benefit for specific breast cancer patients. We are pleased to see authorities expanding access to this test as we continue to develop key evidence in collaboration with some of the world's most prestigious, breast cancer-focused organizations."

Clozapine has been established as the most effective antipsychotic medication for treatment-resistant schizophrenia. However, it is significantly underutilized mainly due to the risk of developing agranulocytosis and the need to frequently monitor the absolute neutrophil count (ANC).

The findings suggest that the novel, non-invasive genomic test can help physicians guide next steps for these patients, enabling them to potentially avoid unnecessary invasive procedures or accelerate time to appropriate treatment.

“These study results are highly encouraging especially given the short treatment duration of 10 days with BX004,” said Jonathan Solomon, Chief Executive Officer of BiomX. “In Part 2 of the study, BX004 showed clinically meaningful improvement in pulmonary function compared to placebo, as measured by relative FEV11 improvement (5.67% at Day 17, 1 week after end of treatment) and Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain (8.87 points at Day 17) in a predefined subgroup of patients with reduced lung function.”  

Importantly, the study reported no serious treatment-related adverse events from any of the 109 patients treated with InGeneron’s Transpose® RT cell therapy system.