BridgeBio Announces Infigratinib Is the First Ever Investigational Therapeutic Option for Achondroplasia to Be Awarded Breakthrough Therapy Designation by the FDA

Breakthrough Therapy Designation was granted based on preliminary clinical evidence from the PROPEL 2 clinical trial, meeting the FDA’s requirement of potentially demonstrating substantial improvement in efficacy over available therapies on clinically significant endpoint(s) - BridgeBio will leverage the benefits of Breakthrough Therapy Designation to expedite the development and regulatory review of infigratinib in the United States and if approved, infigratinib could be the first-in-class oral therapeut ...