Health and Healthcare

Protagonist Therapeutics Wins FDA Fast Track

Chris Lange

Published: September 27, 2018 10:15 am

Last Updated: January 11, 2020 5:14 pm

Protagonist Therapeutics Inc. (NASDAQ: PTGX) shares made a solid gain on Thursday after the company announced a key update from the U.S. Food and Drug Administration (FDA).

Specifically, the FDA has granted Fast Track designation to therapeutic candidate PTG-300 for the treatment of chronic anemia due to ineffective erythropoiesis in patients with beta-thalassemia. PTG-300 is an injectable hepcidin mimetic that had previously been granted Orphan Drug Designation by the FDA for beta-thalassemia, a rare disease characterized by iron overload.

The FDA Fast Track program is designed to facilitate the development and expedite the review of new therapeutics that are intended to treat serious conditions and that demonstrate the potential to address unmet medical needs. Drugs that receive this designation benefit from more frequent interactions and meetings with the FDA and potential pathways for expedited approval.

Dinesh V. Patel, Ph.D., Protagonist president and CEO, commented:

We are pleased to have received Fast Track designation for PTG-300 as recognition of its potential in beta-thalassemia, our initial area of focus and a rare disease with unmet medical need. We remain on track to initiate a Phase 2 clinical trial in beta-thalassemia patients by the end of the year. The Phase 2 trial incorporates an open label trial design with objective endpoints that will enable us to assess the performance of PTG-300 in an accurate and timely manner. In addition, the therapeutic mechanism of PTG-300 suggests potential for future development in the treatment of a broad range of blood disorders, including hereditary hemochromatosis and rare diseases such as polycythemia vera and myelodysplastic syndrome.

Shares of Protagonist were last seen up 15% at $10.24, with a consensus analyst price target of $16.67 and a 52-week range of $5.50 to $23.97.