FDA Grants Fast Track Designation to DPTX3186 for the Treatment of Gastric Cancer
“Fast Track designation reflects a recognition of the promise that our condensate modulators may hold to address serious diseases through a new biological lens,” said Ameet Nathwani, MD, Chief Executive Officer of Dewpoint Therapeutics. “It also provides an important regulatory framework that can help us advance DPTX3186 more efficiently, maximizing the speed and impact with which we can deliver novel therapies to patients in diseases with high unmet need.”
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.