S&P 500
7,582.20
+0.03%
Dow Jones
51,018.80
+0.58%
Nasdaq 100
30,344.40
+0.25%
Russell 2000
2,916.31
-0.54%
FTSE 100
10,378.60
-0.32%
Nikkei 225
66,231.90
+0.67%

Health and Healthcare

MannKind’s Afrezza Inhaled Insulin Drug Gets FDA Approval

Photo of Paul Ausick
By Paul Ausick Updated Published
This post may contain links from our sponsors and affiliates, and Flywheel Publishing may receive compensation for actions taken through them.

biotech

Thinkstock
The U.S. Food and Drug Administration (FDA) late Friday afternoon announced that it has approved Afrezza, a rapid-acting, inhaled insulin power that improves glycemic control in adults with diabetes. The FDA estimates that 25.8 million Americans have diabetes.

The drug is manufactured by MannKind Corp. (NASDAQ: MNKD) and has had its ups and downs in the approval process. In early April the FDA said it would delay its decision for 3 months and MannKind’s stock lost 11%, dropping to around $6.15.

That FDA decision followed by one week the revelation that regulators had voted nearly unanimously to approve the drug for both Type 1 and Type 2 diabetes. That news sent the stock up 80% to around $7.25.

In the announcement an FDA official noted:

Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin. Today’s approval broadens the options available for delivering mealtime insulin in the overall management of patients with diabetes who require it to control blood sugar levels.

The FDA also noted that Afrezza is not a substitute for long-acting insulin, and must be used in combination with long-acting insulin in patients with type 1 diabetes. The drug is not recommended for the treatment of diabetic ketoacidosis, or in patients who smoke.

The news has sent MannKind’s shares up 2.9% in after-hours trading to $10.29 in a 52-week range of $3.80 to $11.11. It appears that investors had already priced the good news into the stock.

ALSO READ: America’s Most Profitable Products

DISCLOSURE:
INVESTMENTS ARE NOT FDIC INSURED • ARE NOT BANK GUARANTEED • MAY LOSE VALUE Brokerage and Active investing products offered through SoFi Securities LLC, member FINRA(www.finra.org)/SIPC(www.sipc.org). Advisory services are offered by SoFi Wealth LLC, an SEC-registered investment adviser. Information about SoFi Wealth’s advisory operations, services, and fees is set forth in SoFi Wealth’s current Form ADV Part 2 (Brochure), a copy of which is available upon request and at www.adviserinfo.sec.gov. Probability of Member receiving $1,000 is a probability of 0.026%; If you don’t make a selection in 30 days, you’ll no longer qualify for the promo. Customer must fund their account with a minimum of $50.00 to qualify. Other fees, such as exchange fees, may apply. Please view our fee disclosure to view a full listing of fees. Investing in alternative investments and/or strategies may not be suitable for all investors and involves unique risks, including the risk of loss. An investor should consider their individual circumstances and any investment information, such as a prospectus, prior to investing. Interval Funds are illiquid instruments, the ability to trade on your timeline may be restricted. Brokerage and Active investing products offered through SoFi Securities LLC, Member FINRA(www.finra.org) /SIPC(www.sipc.org). There are limitations with fractional shares to consider before investing. During market hours fractional share orders are transmitted immediately in the order received. There may be system delays from receipt of your order until execution and market conditions may adversely impact execution prices. Outside of market hours orders are received on a not held basis and will be aggregated for each security then executed in the morning trade window of the next business day at market open. Share will be delivered at an average price received for executing the securities through a single batched order. Fractional shares may not be transferred to another firm. Fractional shares will be sold when a transfer or closure request is initiated. Please consider that selling securities is a taxable event. Options involve risks, including substantial risk of loss and the possibility an investor may lose the entire investment Before trading options please review the Characteristics and Risks of Standardized Options  Investing in an Initial Public Offering (IPO) involves substantial risk, including the risk of loss. Further, there are a variety of risk factors to consider when investing in an IPO, including but not limited to, unproven management, significant debt, and lack of operating history. For a comprehensive discussion of these risks please refer to SoFi Securities’ IPO Risk Disclosure Statement This should not be considered a recommendation to participate in IPOs and investors should carefully read the offering prospectus to determine whether an offering is consistent with their investment objectives, risk tolerance, and financial situation. New offerings generally have high demand and there are a limited number of shares available for distribution to participants. Many customers may not be allocated shares and share allocations may be significantly smaller than the shares requested in the customer’s initial offer (Indication of Interest). For more information on the allocation process please visit IPO Allocation.
Follow 24/7 Wall St. on Google
Photo of Paul Ausick
About the Author Paul Ausick →

Paul Ausick has been writing for 247Wallst.com for more than a decade. He has written extensively on investing in the energy, defense, and technology sectors. In a previous life, he wrote technical documentation and managed a marketing communications group in Silicon Valley.

He has a bachelor's degree in English from the University of Chicago and now lives in Montana, where he fishes for trout in the summer and stays inside during the winter.

Continue Reading

Paul Ausick |

Vindication for MannKind on FDA Approval

After markets closed last Friday, MannKind announced that the FDA had approved Afrezza, a rapid-acting, inhaled insulin powder that improves…

Jon C. Ogg |

Vindication for MannKind With FDA Panel Backing

ThinkstockMannKind Corp. (NASDAQ: MNKD)had been trading as though the stock was bracing for an U.S. Food and Drug Administration (FDA)…

Jon C. Ogg |

Can MannKind Shares Double Again on FDA Approval? (Final)

MannKind has a serious victory within its grasp. The company has struggled to get its Afrezza inhalable insulin to market…

Jon C. Ogg |

The MannKind Lifeline Lights Up

MannKind is just about a month away from the FDA decision on Afrezza as the first inhalable insulin treatment for…

Jon C. Ogg |

Is Inhalable Insulin Assured To Be Approved By The FDA?

ThinkstockIf you have followed the diabetes drug market for very long, chances are high that you have run across the…

Jon C. Ogg |

FDA Keeps Driving Up Future Cost of Inhalable Insulin

While the FDA has been far from a friend to MannKind over the past few years, the latest FDA panel…

FDA Diabetes Treatment Vote to Determine the Fate of Lexicon Therapeutics?
Chris Lange |

FDA Diabetes Treatment Vote to Determine the Fate of Lexicon Therapeutics?

Lexicon shares fell on Friday after the FDA voted to approve the firm’s type 1 diabetes treatment. Although the result…

Why RBC Is Now So Negative Against MannKind
Jon C. Ogg |

Why RBC Is Now So Negative Against MannKind

RBC Capital Markets downgraded MannKind on Wednesday to Underperform from a Market Perform, with a price target of a mere…

Are All Insulin Pens Created Equal?
Steven M. Peters |

Are All Insulin Pens Created Equal?

Nine percent of Americans, about 30 million people, have diabetes, according to the Centers for Disease Control and Prevention. About…

Top Gaining Stocks

Dell Technologies
DELL • Vol: 42,366,555
NetApp
NTAP • Vol: 15,911,807
ServiceNow
NOW • Vol: 68,243,561
IBM
IBM • Vol: 28,527,546
Hewlett Packard Enterprise
HPE • Vol: 86,996,387

Top Losing Stocks

Coterra Energy
CTRA • Vol: 73,319,495
Clorox
CLX • Vol: 4,744,001
ResMed
RMD • Vol: 3,526,686
Intel
INTC • Vol: 191,680,425
Skyworks Solutions
SWKS • Vol: 5,407,806