Orphan Drug Designation Granted by the FDA for NXP800 for the Treatment of ARID1a-deficient Ovarian, Fallopian Tube, and Primary Peritoneal Cancers
Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, “We are very pleased to have received this designation from the FDA for NXP800. The prevalence of ovarian cancer, which is comprised of ovarian, fallopian tube and primary peritoneal cancers, exceeds the 200,000 patient threshold below which drugs may be eligible to receive Orphan Drug Designation in the United States and in ovarian cancer it has been uncommon to receive this designation for the treatment of a subset of the disease. We therefore believe that this Orphan Drug Designation granted by the FDA for NXP800 for the treatment of a subset of ovarian cancer, specifically for patients with an ARID1a deficiency, provides further validation for NXP800’s mechanism of action and the target patient population in our ongoing Phase 1b clinical trial in patients with platinum resistant, ARID1a-mutated ovarian cancer. We expect to provide a data update from this study this coming fall.”
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