- The US Food and Drug Administration has granted Radiopharm Theranostics’ (RAD) DUNP19 technology rare pediatric disease designation
- The designation is used as an incentive for companies to develop drugs for the treatment of rare diseases that affect children
- Moreover, it comes with a priority review voucher (PRV) that can be used to expedite FDA approval or sold and transferred to other companies
- According to Radiopharm, recent PRVs have sold for upwards of $160 million
- Radiopharm shares were up 12.12 per cent and trading at 18.5 cents at 3:04 pm AEST
Radiopharm Theranostics (RAD) has been granted rare pediatric disease designation (RPD) by the US Food and Drug Administration (FDA) for its DUNP19 technology.
The company’s product is designed to treat bone cancer in children, and the designation means Radiopharm will receive a priority review voucher (PRV), which can be used to expedite approval of the technology.
The voucher can also be sold or transferred to other companies. According to Radiopharm, recent PRVs have been sold in the price range of US105 million to US$110 million (A$156 million to AU $164 million).
This latest FDA designation follows RAD’s Orphan Drug Designation for DUNP19 on September 9 — another status offered by the FDA to incentivise the development of treatments for rare diseases.
“This is again excellent recognition of the work to date by Dr David Ulmert and his team and the potential for DUNP19 to make a significant difference to young patients in need,” Radiopharm CEO and Managing Director Riccardo Canevari said.
“The RPD and associated PRV can be incredibly valuable, and we look forward to progressing the DUNP19 program and eventually taking advantage of this.”
DUNP19 is an antibody developed to treat LRRC15 expression, which is produced by cancerous cells and the surrounding tumour microenvironment but not by healthy tissue.
The company is using DUNP19 to treat bone cancer osteosarcoma, which primarily affects children and young adults, and has one of the highest expressions of LRRC15 in aggressive cases.
Radiopharm shares are up 12.12 per cent and trading at 18.5 cents at 3:04 pm AEST.