Algernon Pharmaceuticals (CSE: AGN) recently made a big step in the advancement of its IPF treatment, Ifenprodil. On September 19, the company filed a request for Orphan Drug Designation with the USDA.
Supporting the development and evaluation of new treatments for rare diseases through orphan designation is a priority for the U.S. FDA and other jurisdictions (Europe) that have similar orphan programs. Orphan designation qualifies sponsors for incentives including tax credits for qualified clinical trials, exemption from user fees, and a potential seven years of market exclusivity after approval.
In addition to this, Algernon also recently received a $450K cash refund from its clinical research work in Australia. Algernon tries to conduct as much of its clinical research in Australia as possible because of the 43.5% refundable R&D tax credit program. To date, the company has received refunds exceeding $3 million from its Australian programs.
AGN.c is currently trading at $4.3, valued at $10.14 million.
https://ceo.ca/@GlobeNewswire/algernon-pharmaceuticals-files-for-orphan-designation