Clovis Oncology (CLVS) shares shot up more than 30 percent today after the U.S. Food and Drug Administration accepted the company’s New Drug Application (NDA) for accelerated approval of rucaparib, an anti-cancer agent.
Clovis was also granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of February 23, 2017.
Rucaparib is a PARP inhibitor, a new type of medicine that blocks a particular enzyme that’s used by our cells to repair DNA so that tumors can’t survive. This is the same drug that Pfizer sold the rights to in 2011, and has since picked up a competing drug in its $14 billion Medivation acquisition. Rucaparib was designated a breakthrough therapy by the FDA in April 2015.
Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing anti-cancer agents in the United States, Europe and other international markets. The company is developing approximately three product candidates: Rociletinib, Rucaparib and Lucitanib. Rociletinib is an oral epidermal growth factor receptor (EGFR), mutant-selective covalent inhibitor that is under review with the United States and European regulatory authorities for the treatment of non-small cell lung cancer (NSCLC) in patients with activating EGFR mutations, as well as the resistance mutation, T790M. Rucaparib is an oral inhibitor of poly (ADP-ribose) polymerase (PARP) that is in advanced clinical development for the treatment of ovarian cancer. Lucitanib is an oral inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1-3 (VEGFR1-3) and platelet-derived growth factor receptors alpha and beta (PDGFR a/b).
CLVS stock looks headed for a gap fill at the $35 level. The stock crashed from $100 last November when discrepancies concerning the effectiveness of rociletinib — an anti-lung cancer drug that is one of the core products at Clovis — led the Food and Drug Administration to request more clinical information regarding the overall therapy.
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