The actively traded, small-cap biotech said after the close Tuesday that the FDA granted Orphan Drug Designation to Nerlynx for the treatment of breast cancer patients with brain metastases.
Nerlynx is indicated as an adjuvant therapy for adult patients with early-stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy.
The drug, Puma's first and only commercial product, fetched revenue of $53.8 million in the second quarter of 2019, up about 6% year-over-year.
Despite the prevalence of several treatment options for HER2-positive breast cancer, brain metastases offer a significant clinical challenge, invariably leading to morbidity and mortality, Puma said.
"The blood-tumor penetrability of NERLYNX represents a potential treatment option for these underserved patients," CEO Alan Auerbach said in a statement.
Orphan Drug Designation
ODD is accorded to investigational drugs developed to treat, prevent or diagnose rare medical diseases affecting fewer than 200,000 individuals in the U.S.
This special status vests several advantages such as granting the sponsor of the drug several key benefits and incentives, including grant funding for clinical trial, tax credits, user fee waivers and the potential for a seven-year period of marketing exclusivity.
Puma shares were down 3.16% at $10.10 at the time of publication Wednesday.
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