Spectrum Pharmaceuticals (SPPI) - Get Spectrum Pharmaceuticals, Inc. Report, which focuses on cancer drugs, jumped on Thursday after it said the Food and Drug Administration approved fast-track status for one of its treatments.
That’s poziotinib, used to fight non-small-cell lung cancer in previously treated patients with HER2 exon 20 mutations.
The Henderson, Nevada, company plans to submit a new-drug application for poziotinib later this year.
“There are currently no approved therapies to treat patients with HER2 exon 20 mutations,” said Joe Turgeon, chief executive of Spectrum Pharmaceuticals.
Fast track is "designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need," the FDA says on its website.
Spectrum recently traded at $3.72, up 13%. The shares have fallen 22% over the past three months amid uncertainty over its drug pipeline.
But Spectrum shares jumped late last year, after the company announced positive data from the Phase 2 trial of poziotinib in July.
In other pharmaceutical news Thursday, AstraZeneca AZN shares fell, after Norway followed Denmark in suspending use of the AstraZeneca/Oxford COVID vaccine amid reports that some people taking the treatment suffered severe blood clots.
“Vaccination with the AstraZeneca vaccine is put on hold for Norway,” Norway’s National Institute of Public Health wrote on Twitter. As for Denmark, its Health and Medicines Authority suspended the vaccine for two weeks.
“We need to clarify this before we can continue to use the vaccine from AstraZeneca,” Søren Brostrøm, director of the National Board of Health, said in a statement.
AstraZeneca American depositary receipts recently traded at $49, down 1.6%. The shares are off 8% over the past six months.