Statistically Significantly Positive 1-Year EFS, OS, and Safety Clinical Data Updates for OST-HER2 in osteosarcoma patients
“The feedback received from FDA regarding the use of external control comparators in settings where placebo-controlled randomization trials are not feasible increases the avenues available for OST-HER to gain Accelerated Approval,” said Paul Romness, Chairman & CEO of OS Therapies. “We have now responded to the follow-up questions from our recent positive Type D Meeting with FDA positioning us to soon be granted an End of Phase 2 meeting. We were also very pleased with the reception the presentation received from the osteosarcoma community.”
Share:
More News
“The positive outcome of our pre-IND interactions with the FDA reinforces the development pathway for MaaT034 and supports its continued advancement toward the clinic. It also represents an important step in MaaT Pharma’s expansion into immuno-oncology, highlighting the broader potential of our first in class co-cultivated microbiome donor-independent platform across
“Patients with metastatic RAS G12D non-squamous NSCLC, occurring in approximately 4% of cases, represent an underserved population, with no approved targeted treatment options. Initial clinical data evaluating zoldonrasib in combination with standard of care pembrolizumab and platinum doublet chemotherapy in patients with previously untreated metastatic RAS G12D non-squamous NSCLC showed
“At Georgiamune, we are focused on uncovering novel mechanisms that control immune-cell function and translating that biology into first-in-class medicines across autoimmune disease and oncology,” said Samir N. Khleif, M.D., Founder and Chief Executive Officer of Georgiamune. “GIM-621 is one of multiple programs to emerge from that work, alongside three
“Our team’s outstanding execution has enabled us to rapidly advance three programs into the clinic in 2026 and make significant progress in developing next-generation IO, ADC and combination therapies. Together with our partner, Kelun-Biotech, we have achieved seven IND clearances to date, and by mid-2027, we expect more than 2,000