The FDA granted accelerated approval to Pfizer's Selzentry tablets for HIV based on 24-week data. The drug is the first in a class (called CCR5 antagonists) that stop the R5 virus on the outside surface of cells before it enters, rather than fighting the virus inside as do all other classes of oral HIV medicines, according the company.
"The approval of Selzentry for treatment-experienced patients is a significant breakthrough, and we continue its development in a spectrum of other patients living with HIV/AIDS," said Joseph Feczko, Pfizer's chief medical officer. Selzentry is expected to be available in the U.S. by the middle of September. The company recently received a positive opinion from the Committee for Medicinal Products for Human Use in the EU, and plans to commercialize it as Celsentri outside of the U.S. The stock was up 54 cents, or 2.3%, at $24.05.
Vertex Pharmaceuticals (VRTX - Get Report) gained $2.92, or 8.8%, to $36.14 after analysts at Leerink Swann & Co. issued a note indicating a favorable outlook for interim data from the PROVE-1 study of Telaprevir in Hepatitis C patients. The analysts also said that management comments suggest the key clinical data from PROVE-1 will be presented at the American Association for the Study of Liver Diseases meeting in November and not the Interscience Conference on Antimicrobial Agents and Chemotherapy in September.