Iovance Biotherapeutics up after skin cancer therapy receives FDA nod

Iovance Biotherapeutics

20/02/2024 10:18

** Iovance Biotherapeutics's shares  IOVA.O  rise 40.3% to
$12.85 - among the top pct. gainers across US stock exchanges
premarket
    ** US FDA late on Friday granted an accelerated approval for
IOVA's cell therapy for adult patients with advanced melanoma
    ** Lifileucel, branded as Amtagvi, became the first such
treatment to be approved for the deadliest form of skin cancer
    ** The accelerated approval of Amtagvi is based on safety
and effectiveness data froms a global study of 73 patients
    ** Amtagvi will be sold in the U.S. at a list price of
$515,000 per patient
    ** The therapy's label comes with a boxed warning for
treatment-related mortality, prolonged severe cytopenia, severe
infection, and cardiopulmonary and renal impairment
    ** The Amtagvi approval is not only a landmark,
first-in-technology approval, but a nice relief given the
prolonged regulatory process - Brokerage TD Cowen
    ** Up to Friday's close, stock had risen ~31% in the last 12
months

 (Reporting by Khushi Mandowara in Bengaluru)
 ((Khushi.Mandowara@thomsonreuters.com;))