It has been a stunning start to the day for ASX healthcare stock Noxopharm Ltd (ASX: NOX).
In morning trade, the biotech company's shares are up 166% to 16.5 cents.
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Why is this ASX healthcare stock rocketing?
Investors have been scrambling to buy the company's shares this morning after its CRO-67 preclinical drug candidate for the treatment of pancreatic cancer was given a major boost from the US Food and Drug Administration (FDA).
According to the release, the FDA has granted orphan drug designation (ODD) status to CRO-67.
The FDA grants ODDs for drugs that are designed to prevent, diagnose, or treat rare diseases or conditions. The designation comes with various benefits that include tax credits for qualified clinical trials, exemption from FDA application fees, and potential seven years of market exclusivity after approval.
The company notes that the designation comes shortly after further encouraging CRO-67 data was presented at the American Association of Cancer Research Special Conference on Pancreatic Cancer.
It also highlights that 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% from the time of diagnosis.
And while it is important to note that this is not FDA approval, it's hard to deny that it isn't a big step in the right direction for the ASX healthcare stock.
Management notes that 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.
'A significant milestone'
Noxopharm's CEO, Dr Gisela Mautner, was very pleased with the news. Dr Mautner said:
For CRO-67 to achieve an ODD is a significant milestone in the development of the drug. In addition to financial benefits, the ODD will also strengthen our commercial position in a market that has seen very few new treatments over recent decades. 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.
