The only certainty for MannKind (MNKD) is uncertainty now that the FDA has delayed an expected January 16 regulatory decision on its inhaled insulin product, Afrezza, formerly known as Afresa.
MannKind announced on January 8 that the FDA would not be able to meet the PDUFA deadline for the decision because the regulator had not completed the inspection of the manufacturing facilities of NV Organon, a Merck & Co (MRK) subsidiary that is supplying insulin to the company. With no news on when the product's review will conclude, the already volatile shares will continue to provide investors with a roller coaster ride.
Whilst a definitive decision was on the drug was not necessarily expected by January 16 (MannKind holding its breath over Afresa approval, January 5, 2010) , the announcement, with no clear signal on when the FDA will make up its mind, saw the stock slip slightly in after-hours trading from $8.05 after market close on January 8. In early trading today, MannKind shares were at $7.84, not a huge decline, reflecting the fact that the delay stems from the regulator missing a deadline rather than heightened concerns over approvability.
The market has been deeply divided over Afrezza, mindful of the withdrawal of Exubera from the market in 2007.
Supporters insist Afrezza is superior to Exubera, and expect a a positive decision from FDA and a successful partnership with a major pharmaceutical company. However, many investors remain sceptical, as reflected by the fact that 27% of MannKind's free-floating shares were held in short interest positions as of December 15, according to NASDAQ, suggesting a lot of people are betting the stock is heading for a fall.