Shield Therapeutics PLC (AIM:STX, OTCQX:SHIEF) said KYE Pharmaceuticals, its licensing partner in Canada, has made a new drug submission for iron deficiency treatment Accrufer.
The regulator is expected to complete its review by the middle of next year.
The green light for the product, which is already on sale in the US, UK and EU, would trigger a £250,000 milestone payment from KYE.
A further £600,000 would be due after hitting specific sales targets, while Shield will receive double-digit royalties on those sales.