Gradalis Secures FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Vigil® (Gemogenovatucel-T) for Advanced Ovarian Cancer
“The RMAT designation for Vigil highlights the transformative capacity of our unique immunotherapy to benefit women battling advanced ovarian cancer,” said David Shanahan, CEO of Gradalis. “This important recognition affirms that Vigil has the potential to extend patient survival and may offer a safer, more precise therapeutic approach to a population in urgent need of innovative solutions. We continue to advance our Vigil development efforts as we work to bring this investigational therapy to patients as rapidly as possible.”
Share:
More News
Pnina Fishman, CSO & Chairperson of Can-Fite BioPharma, commented: “We are pleased to offer this compassionate use program with Namodenoson for eligible patient in the US to address the unmet medical needs for pancreatic cancer. Initiating this program is another milestone achieved for Namodenoson, and concurrently to our ongoing Phase
“We are deeply disappointed by these results from our Phase 1 trial. Despite continuing to demonstrate differentiated safety as a more combinable ADC, updated efficacy data suggest that treatment with EO-3021 does not meet our bar for success and is insufficient to provide patients a competitive benefit-risk profile compared to
Søren Bregenholt, CEO of Alligator, commented: “The FDA’s recognition of HLX22/AC101’s potential with Orphan Drug Designation is a notable recognition. While Alligator’s is not directly involved in the development of HLX22/AC101, we continue to follow its progress as it potentially represents future income to Alligator.”
“At Servier, we are dedicated to transforming patient care in areas with significant unmet needs. Our partnership to develop BDTX-4933 is an important opportunity in targeted cancer therapies, as we believe we can serve more people by helping the right patients find the right treatment, at the right time,” said
