It’s been a long time in the coming, but Mannkind (MNKD) is finally going to get a second chance to win the FDA’s approval for its inhaled insulin, Afrezza.
The story is too long to tell in all its glory. The short version is, Afrezza was considered to be all but approved back in 2011, as the efficacy numbers were solid. Even the FDA insider who had a history of front-running the agency’s approvals had his long position in MNKD stock in place. Then at the 11th hour, a hedge fund manager known for shorting biotech stocks in front of PDUFA dates made a relatively unusual (and considerably suspicious) decision to send a letter to several FDA chiefs explaining they had a duty to reject the drug. Sure enough, the drug was rejected. Plenty of people were shocked, but none so much as the people at Mannkind.
In any case, Mannkind humored the FDA and repeated the Phase 3 niceties, pretty much coming up with the same good results the second time around. We’ll find out if the FDA has the stomach to rear-end Mannkind again when Afrezza is up for approval on April 15.
As of this writing, James Brumley did not hold a position in any of the aforementioned securities.