AUTX-703 Granted Fast Track Designation by the FDA for R/R AML
“We are gratified by the FDA’s recognition of AUTX-703’s potential as an important, novel treatment option for relapsed or refractory AML patients, a community that remains in desperate need of new therapies,” said Kate Yen, Ph.D., Founder and Chief Executive Officer of Auron. “The FDA Fast Track Designation underscores the urgent need for innovative treatments for these patients and this milestone comes at a pivotal moment as we prepare to advance AUTX-703 into the clinic. Our team is energized by the potential to bring a first-in-class therapy to patients who have limited effective options today, while simultaneously exploring the broader applications of KAT2A/B modulation.”
Share:
More News
“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.”
“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.