After-hours today MannKind Corp. got a verbal “yes” from the FDA on their inhaled diabetes treatment, Afrezza. FDA approved advisors voted positively for the MNKD drug. Afrezza received a 13 to 1 vote for the drug to be used to treat Type 1 diabetes; and 14 to 0 for Type 2 diabetes. The FDA staff did note that Afrezza may affect lung function. After 7 years and 2 rejections, MNKD are almost at the answer they are looking for. If MannKind Corp. gets the official approval from the FDA, “Afrezza may generate $583 million in 2018”-Bloomberg The FDA is expected to decide by April 15th if they will be clearing the drug for sale.
What does this mean for MNKD? After 2 distinct “No’s”, the FDA has lined Afrezza up for an official approval. This clearance would allow MNKD to increase their revenue by $500 million, and increase their total revenue towards the $3 billion that their competitor Novolog (injected insulin) did last year. The stock closed Monday at $4.02 per share and after-hours Tuesday surpassed the $9 per share mark, an increase greater than double. The pending April 15th clearance would make that number play around the $15 per share mark, which would almost be 4 times Monday’s price. Keep a close eye on MNKD, there is definitely a lot of money to be made here.