Verastem Shares Gain Pre-Bell as FDA Grants Orphan Drug Status to Rare Cancer Drug

Verastem (VSTM) shares were higher over 4% in recent pre-market trade after saying the U.S. Food and Drug Administration has granted orphan drug status to its VS-5584 drug to treat mesothelioma, an aggressive form of cancer that occurs in the thin layer of tissue that covers the lungs and other organs. VSTM is trading in the lower half of the 52-week range between $6.78 and $16.60.

“This is an important regulatory milestone for Verastem and, together with our European orphan medicinal product designation, will facilitate our global development of VS-5584 to help improve the available treatment options for patients suffering from this highly aggressive cancer,” CEO Robert Forrester said in a statement. “We look forward to taking full advantage of the opportunities that orphan designation allows in order to bring this potential new treatment option to patients as rapidly as possible.”

The orphan drug status is granted to drugs that are meant to treat a rare disease or condition, which is generally a disease that affects fewer than 200,000 individuals in the country. If approved, the designation gives the drug certain benefits, including seven years of U.S. market exclusivity in the specified indications if the sponsor complies with certain FDA requirements.