Exicure Inc. (XCUR) Granted Orphan Drug Designation by the U.S. Food and Drug Administration for Cavrotolimod
Get Alerts XCUR Hot Sheet
Join SI Premium – FREE
Exicure, Inc. (NASDAQ: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA™) technology, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its clinical product candidate, cavrotolimod (AST-008), for the treatment of patients with Merkel cell carcinoma (MCC).
“We are excited to have been granted Orphan Drug Designation by the FDA for cavrotolimod for MCC,” said Dr. Douglas Feltner, Chief Medical Officer of Exicure. “This designation marks significant progress toward our goal of fulfilling the unmet medical need and finding a treatment for Merkel cell carcinoma patients.”
Exicure previously announced that the FDA granted two Fast Track designations for cavrotolimod (AST-008) for MCC and cutaneous squamous cell carcinoma (CSCC), both in the advanced/metastatic setting after progression on anti-PD-1/PD-L1 antibodies.
About Orphan Drug Designation
Orphan Drug Designation is a designation granted by the FDA which provides orphan status to drugs or biologics which are intended to treat rare diseases or disorders that affect fewer than 200,000 people in the United States. This designation provides the sponsor of the drug certain incentives, including tax credits for qualified clinical trials and fee waivers. Orphan Drug Designation confers eligibility for seven years of market exclusivity to an orphan drug post-approval, subject to a receipt by the FDA of marketing approval.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Mainz Biomed (MYNZ) Reports Positive Topline Results from Pooled Study Evaluating Novel mRNA Biomarkers and Proprietary AI Algorithm
- Aligos Therapeutics Inc. (ALGS) Presents Positive Data from the ALG-097558 Phase 1 Study
- Central Securities (CET) Releases Report to Stockholders
Create E-mail Alert Related Categories
Corporate News, FDA, Management CommentsRelated Entities
FDASign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!