The company is now eligible for several development incentives, including tax credits and reduced filing fees for clinical trials carried out in the US.
If FDA approves SOR-C13 for commercialization, it could qualify for seven years of marketing exclusivity in the US.
Soricimed Biopharma president and CEO Paul Gunn said: "Receiving orphan drug status is significant.
"It is an important regulatory milestone, offering special incentives to Soricimed through the development stage of SOR-C13."
SOR-C13 binds with high selectivity and affinity to TRPV6, a calcium channel that is highly elevated in prostate, breast, lung and ovarian cancer and is correlated with poor outcomes.
TRPV6-mediated Ca2+ entry maintains a high tumour proliferation rate, increases tumour cell survival and consolidates mechanisms that combat cell destruction.
By binding to TRPV6, SOR-C13 ceases cancer cells of calcium that is required for cell growth and division.
Soricimed claims that SOR-C13 is the first drug candidate targeting TRPV6 to have entered clinical development anywhere in the world.
Last month, Soricimed unveiled positive top-line results in phase 1 trial of SOR-C13 in subjects with advanced solid tumour cancers.
Preliminary data indicated safety and tolerability in phase I subjects and potential activity was demonstrated with 54% of subjects achieving stable disease.
Image: Ovarian cancer results in abnormal cells that have the ability to invade or spread to other parts of the body. Photo: courtesy of Nephron.