Westlake Village biotech company Mannkind received approval to update the prescribing information for its inhalable insulin product, Afrezza, making it easier to market to customers.
The new label information clarifies starting and adjusting mealtime dosages, as well as initial and peak effects, and helps the company avoid confusing language, CEO Michael Castagna said in a conference call Oct. 2. The change took about two and a half years for the company to accomplish, he added.
The company also exchanged 1.3 million of its shares for 100 percent of the outstanding Series A and Series B stock purchase warrants, Chief Financial Officer Steven Binder said on the call. The exchange freed up 8.4 million shares of common stock, bringing Mannkind up to 22 million shares available for future financing activities.
A pediatric trial for Afrezza began Sept. 29, Castagna said, and the company is laying out plans to launch the product in Europe, among other international deals. The U.S. Food and Drug Administration also approved a glucose monitoring system that doesn’t require a blood sample earlier in the week, potentially opening up the market to Type 2 diabetes customers, he said.
Currently around half of the company’s customers are Type 1, despite Type 2 being much more prevalent.
Shares for the company ended Oct. 2 at $2.34, up 7.8 percent.
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