The FDA has requested an additional clinical trial to support the efficacy of Esbriet in IPF patients.
But unfortunately on Tuesday 05:16 pm InterMune (ITMN) fails to win FDA approval for a lung treatment that analysts estimated would bring in more than $1B in annual sales. Outside advisers to the FDA had recommended approval of the drug in March. Shares -80.7% AH. (PR)

This FDA action just wiped out about $2 billion in investor market cap, and just delayed the time of this drug if it will be approved. As noted above, shares closed down 5.4% at $45.44, but now the stock is down 80% at $9.00 in the after-hours session.

InterMune intends to meet with the FDA as soon as possible to explore the best ways to address the points raised by the Agency and to discuss pathways to approval.




Tags; itmn, intermune, vvus, pfe