MannKind Corporation (NASDAQ:MNKD) ended up more than 10% on Wednesday, after the biotech announced positive results for two phase 3 trials testing its inhaled insulin Afrezza.
Apparently, I had a little more confidence that the trials would be positive than the average investor did. A 10% increase — that’s a $220 million increase in value — surprises me. I figured, after the monster run the stock has been on, we might see a sell-the-news event, given how widely expected the results were.
Maybe if the data was unanimously positive. But it wasn’t.
For instance, type 1 diabetics in the Afrezza group failed to hit the key target A1c levels, a long-term measure of blood sugar levels. Doctors like to see patients get their A1c levels below 7%, but the portion of the patients who reached the target was higher in the group taking Novo Nordisk A/S (ADR) (NYSE:NVO)‘s injected insulin Novolog than the Afrezza group. The proportion getting under 6.5% also favored the Novolog group.
The number of severe hypoglycemia events, extremely low blood sugar, in type 1 diabetics was lower in the Afrezza group than those taking Novolog, but it wasn’t statistically significant, so MannKind Corporation (NASDAQ:MNKD) won’t be able to tout it as an advantage.
In type 2 diabetics, Afrezza caused more hypoglycemic events than the placebo, which isn’t all that surprising, but will clearly be a factor for whether doctors are willing to prescribe it earlier in the disease progression than they would Novolog or Eli Lilly & Co. (NYSE:LLY)‘s injected insulin Humalog.
Patients taking placebo also lost more weight than the group taking Afrezza. Again it’s a comparison to placebo, so Afrezza might be able to compete with Novolog and Humalog — which tend to cause weight gain anyway — but the data might not be convincing enough to justify the early use of Afrezza.
Afrezza will still be approved, though
The main thing the Food and Drug Administration will look at is the primary endpoints. For both studies, Afrezza met the primary endpoints.
For type 1 diabetics, the second-generation Dreamboat was just as good as Novolog at reducing A1c. And when the Dreamboat was compared with the first-generation MedTone device, the devices affected patients’ ability to breathe at a comparable level.