Tempest Receives Orphan Drug Designation from the EMA for Amezalpat for the Treatment of Patients with HCC
“We’re incredibly pleased to receive Orphan Drug Designation from the EMA, building on the momentum of regulatory support we’ve already received from the FDA,” said Stephen Brady, president and chief executive officer of Tempest. “These designations reflect the significant unmet need in liver cancer and reinforce our belief in the potential of amezalpat to make a meaningful difference for patients and families affected by this devastating disease.”
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.