R289 Granted Fast Track Designation by the FDA for Lower-Risk MDS
“We are pleased that R289 has been granted Fast Track designation, which underscores the significant unmet need for patients with transfusion dependent lower-risk MDS,” said Raul Rodriguez, Rigel’s president and CEO. “By targeting inflammatory signaling, we believe that R289 has the potential to meaningfully improve the lives of those living with this disease.”
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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.”
“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.