FDA grants Orphan Drug Designation for AJ1-11095 for the Treatment of Myelofibrosis
“Orphan Drug Designation is an important milestone in our clinical development of AJ1-11095 for the treatment of myelofibrosis,” said David Steensma, MD, FACP, Chief Medical Officer of Ajax. “This designation reinforces the compelling need for effective new treatment options for patients suffering from myelofibrosis, and supports our continued efforts to advance AJ1-11095 to address the unmet need for patients who would benefit from improved treatment efficacy, or who have not responded to existing therapies.”
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.