AUST Business today:
NOXOPHARM SURGES AFTER FDA GREEN LIGHT
Cameron England
Noxopharm shares surged as much as 150 per cent on Wednesday after the US Food and Drug Administration granted orphan drug status to its pancreatic cancer drug candidate.
The company’s drug candidate, CRO-67, is still in the preclinical stage.
The orphan drug designation will grant it benefits including tax credits for qualified clinical trials, exemption from FDA application fees and a potential seven years of market exclusivity after approval.
“CRO-67’s designation as an orphan drug supports the company’s development plan for the asset, and its future commercial value, as Noxopharm continues to build the data package that will be required for regulatory progression,’’ the company said.
“The designation comes shortly after further encouraging CRO-67 data was presented at the American Association of Cancer Research Special Conference on Pancreatic Cancer.
“The disease is set to become the second leading cause of cancer-related deaths in the US by 2040, and has a very poor five-year survival rate of about 9 per cent from the time of diagnosis.
Noxopharm chief executive Gisela Mautner said it was a significant milestone in the development of the drug. “In addition to financial benefits, the orphan drug designation will also strengthen our commercial position in a market that has seen very few new treatments over recent decades,” Dr Mautner said.
“Our pancreatic cancer program is a high priority, and we are committed to progressing its development as quickly as possible. Further studies are in the works, as are investigations into dosing and formulation.”
Noxopharm shares closed up 61.3 per cent at 10c each, after trading as high as 16.5c. The stock traded at 3.8c a week ago.
NOX Price at posting:
10.0¢ Sentiment: Hold Disclosure: Held
