Clovis Jumps as Cancer Drug Gets Priority for FDA Reviewby
Clovis Oncology Inc. shares soared after the U.S. Food and Drug Administration granted a faster review process to the company’s experimental ovarian cancer drug rucaparib.
The FDA scheduled a decision to be made on the drug by Feb. 23, 2017, the Boulder, Colorado-based company said Tuesday in a statement. Rucaparib was designated a breakthrough therapy by the FDA in April 2015. The FDA gives that designation to drugs that may bring substantial improvement over available treatments and is intended to speed up the process of development and review.
The shares rose 29 percent to $23.40 at 3:41 p.m. in New York trading, after jumping as much as 38 percent, the biggest intraday move since June 2013.
Rucaparib is Clovis’s only drug in clinical trials. In June, U.S. regulators didn’t approve its experimental lung-cancer drug rociletinib, leading Clovis to stop enrollment in those trials and cut staff. Rucaparib inhibits a protein called PARP, which is involved in DNA repair. In theory, by disrupting cancer cells’ ability to repair themselves, the drug can slow the uncontrolled growth and replication of cells that are the hallmark of cancer.
Medivation Inc., a maker of cancer drugs that agreed Monday to be acquired by Pfizer Inc. for $14 billion, also is developing a PARP inhibitor. The purchase raised hopes that other developers of PARP inhibitors also would be acquired, pushing Clovis’s shares up by 4.9 percent on Monday.