Spectrum Pharma Shares Tumble as FDA Turns Away Rolontis Application

By Colin Kellaher

Shares of Spectrum Pharmaceuticals Inc. fell nearly 30% on Friday after the U.S. Food and Drug Administration rejected its application for a drug targeting a side effect of some cancer treatments.

Spectrum said the FDA, in a complete response letter, cited manufacturing deficiencies related to the manufacturing of Rolontis and indicated that it will need to reinspect the drug's manufacturing plant in South Korea.

An FDA complete response letter indicates that the agency won't approve an application in its current form.

Spectrum is seeking FDA approval of Rolontis for the treatment of neutropenia, an abnormally low count of a type of white blood cell, in patients receiving myelosuppressive anticancer drugs.

The FDA had been scheduled to act on Spectrum's application for Rolontis by last October, but the inspection of the South Korea plant was delayed until this year by travel restrictions related to the coronavirus pandemic.

The Henderson, Nev., biopharmaceutical company said it is seeking further clarification on the manufacturing issues from the FDA, and that it plans to meet with the agency as soon as possible.

Spectrum shares were recently down 28% to $2.34 after hitting a 52-week low of $2.27 earlier in the session.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

08-06-21 1040ET