FDA Panel’s Surprising Approval of Afrezza Sends MNKD Stock Soaring
by Burke Speaker | April 2, 2014 9:25 am
An FDA advisory panel has voted in favor of using Mannkind Corp’s (MNKD[1]) new drug inhalant for the treatment of diabetes, which sent MNKD stock skyrocketing.
[2]While the FDA does not have the follow the recommendation from the panel, the company — and Wall Street — are viewing the news as one step closer to drug approval.
Shares more than doubled in after-hours trading Tuesday. MNKD stock is up 89% pre-market.
Via Businessweek[3]:
Food and Drug Administration advisers voted 13-1 and 14-0 yesterday that the drug, Afrezza, should be approved for Type 1 and Type 2 diabetes, respectively.
“We are pleased with the advisory committee’s approval recommendation in support of Afrezza, and we appreciate the thoroughness of their review,” said Alfred Mann, the company’s CEO. “Diabetes is a major health problem in the United States, and we are committed to bring Afrezza to the many patients who might benefit from this novel product.”
But there are still potential complications for Mannkind’s new drug.
Last month, an FDA report pointed out that the medicine may be related to decreased lung function. It also noted data was missing from a study of the Type 1 Diabetes patients.
At the same time, the advisory panel’s backing is being seen as a huge win — considering who makes up the panel (via SeekingAlpha[4]):
… keep in mind that according to MannKind, these committee members will selflessly be voting against their own material interests on Tuesday afternoon. This because Afrezza’s lesser risk of hypoglycemic events and weight-neutrality will keep patients in the care of general practitioners longer, without requiring them to switch over to the care of specialists, as they now tend to do.
MannKind Corporation is a development-stage biopharmaceutical company that develops drugs and products for diseases such as diabetes and cancer.
- MNKD: http://studio-5.financialcontent.com/investplace/quote?Symbol=MNKD
- [Image]: https://investorplace.com/wp-content/uploads/2014/04/mannkind-mnkd-stock.jpg
- Businessweek: http://www.businessweek.com/news/2014-04-01/mannkind-wins-u-dot-s-dot-panel-backing-for-inhaled-insulin-afrezza
- via SeekingAlpha: http://seekingalpha.com/article/2117903-mannkinds-latest-critic-the-fda-has-joined-the-chorus-of-missing-data-concerns
Source URL: https://investorplace.com/2014/04/fda-approval-afrezza-mnkd-stock/