On the regulatory front, the big news last week was Gilead Sciences’ newly-acquired Kite Pharma gaining US Food and Drug Administration approval for its Yescarta, the second CAR-T therapy to be cleared for marketing in the USA. Also, there was Aerie getting a favorable FDA advisory panel vote on its Rhopressa. Attracting attentions elsewhere, Celgene had a big disappointment with its Crohn’s disease candidate mongersen, French firm Exelixis’ liver cancer drug cabozantinib; invalidation of Allergan’s ophthalmic product Restasis patents; and better-than expected financials from Johnson & Johnson.
FDA approval of Gilead CAR-T therapy will move the needle
On Wednesday, Gilead Science announced that it had received FDA approval for its CAR-T therapy Yescarta (axi-cel). Terry Christomalis who runs the Biotech Analysis Central pharmaceutical investment research service on Seeking Alpha Marketplace, noted that this approval comes just six weeks after Gilead shelled out $11 billion to buy Kite Pharma. Gilead wasted no time to acquire Kite, and even bought it at a 29% premium at $180 per share. This move came on the heels of Gilead feeling pressure to put its cash to good use. Especially, since its Hepatitis C franchise has been diminishing for quite some time now.
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