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.”
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“The designation reinforces the significant unmet need for effective treatment options for patients with advanced breast cancer,” said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto Biosciences. “We are committed to advancing highly selective therapies designed to expand treatment options for patients with difficult to treat cancers.”
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