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MNKD
MannKind Corporation - NASDAQ

4/24/2014, 10:12 AM ET
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PRO Articles
There are 6 articles on this stock available only to PRO subscribers.
Other Articles
  • The Stalled State Of MannKind
    Scrying Biotech Fri, Apr. 11 76 Comments

    Summary

    • The FDA has postponed MannKind's Afrezza PDUFA date until July 15, 2014.
    • While regulatory assent seems likely, questions abound as to what form that approval will take.
    • MannKind stock peaked in the wee hours of pre-market trading the day following a near unanimous adcom victory, but might not equal that fondly remembered price for years to come.
    • Though talk of a buyout, or commercial partnership may satisfy the need to divert focus from the harsh reality of the present moment, neither is likely to occur soon.
  • Why I Believe MannKind Shares Will Rise Significantly Upon FDA Approval Of Afrezza
    Think Long Term Thu, Apr. 10 40 Comments

    Summary

    • The company received an overwhelming FDA Advisory Panel Recommendation on April 1, 2014.
    • Current market sales of injected insulin have reached $35 billion globally and are expected to reach $58 billion.
    • The current stock price isn't pricing in potential approval by FDA, nor future Technosphere platform opportunities with only two major players in the insulin market.
    • An FDA denial would obliterate the share price.
  • The 27-1 AdCom Votes Have So Many Positive Implications For MannKind
    George Rho Mon, Apr. 7 65 Comments

    Summary

    • The AdCom recommendations make the FDA's approval of Afrezza a near certainty.
    • MannKind stockholders should be able to sleep far more soundly.
    • The just-announced delay in the FDA decision is clearly aggravating but of little long-term concern.
    • The company's steady progression towards commercial prosperity continues unabated.
  • If MannKind Keeps Pulling Back, It's A Buying Opportunity
    Quoth the Raven Mon, Apr. 7 30 Comments

    Summary

    • MannKind found enormous success last week when its drug Afrezza received a 13-1 ADCOM vote "for".
    • PDUFA date moved to July.
    • Ultimately, the company's plan to monetize the drug could result in growth for investors from this point on.
  • Over 91% Chance Of Approval For MannKind And Durata Therapeutics
    Tri Duong Mon, Apr. 7 52 Comments

    Summary

    • Statistics showed MannKind and Durata have over 91% chance of FDA approval.
    • There are high correlation between percentage of yes votes in Advisory Committees to final approval by the Food and Drug Administration.
    • Investigating into reasons for rejection showed only careless mistakes by drug companies.
  • Will The Third Time Be A Charm For MannKind? Leading Fund Managers Definitely Think So
    GuruFundPicks Sun, Apr. 6 158 Comments

    Summary

    • Positive recommendation on Tuesday from FDA's Endocrinologic and Metabolic Advisory Committee means almost certain approval of Afrezza by the PDUFA date of April 15th.
    • Leading fund managers have been aggressively buying Mannkind, doubling their position in the last few quarters, with recent purchases near current prices, and at almost 200% above year-ago levels.
    • Given that leading fund managers saw value near current prices, even before the FDA Committee's recommendation, the risk-to-reward is even more favorable now.
    • Biotech correction gives investors a unique opportunity to still buy Mannkind at attractive levels, before prices most likely go up in the days leading to the PDUFA deadline.
  • How MannKind Shows Depth Of The Diabetes Market
    Tedra DeSue Thu, Apr. 3 117 Comments

    Summary

    • In terms of expense, treating diabetes is on the top ten list in the U.S.
    • Small cap companies like MannKind stand to gain significantly from their diabetes drug products.
    • Big Pharma companies gain by replenishing their product lines that were depleted due to the "patent cliff.".
  • Reconciling Rival Views Of Afrezza, And How To Play The Post-AdCom Surge
    Jeff Eiseman Wed, Apr. 2 90 Comments

    Summary

    • I review how the ground has shifted since the release of the FDA briefing document.
    • I explain my investment strategy in the light of MannKind’s shares highly predictable volatility.
    • I contrast two rival views of Afrezza: one highly favorable vs. one that Afrezza has limited value.
    • I list one set of conditions under which the highly favorable view is probably valid, and another under which the rival view is probably valid.
  • MannKind's FDA Win Is A Short Seller Massacre
    Quoth the Raven Wed, Apr. 2 31 Comments

    Summary

    • MannKind receives positive vote of 13-1 at FDA's ADCOM for Afrezza.
    • Stock is already trading up over 100% this morning.
    • Due to bearish sentiment and massive short interest, stock could easily blow through 52 week highs today.
  • History Shows MannKind Has A Near Certain Chance Of Approval
    Tri Duong Wed, Apr. 2 114 Comments

    Summary

    • Probability of any drug that went through an Advisory Committee to get Food and Drug Administration approval is very favorable.
    • Endocrinologic and Metabolic Drugs with an overwhelming number of "yes" votes from an Advisory Committee is near certain.
    • Afrezza could be the first drug to be denied with near perfect votes from the Advisory Committee.
  • MannKind - A Trail Of Failure Leading To Success
    Tri Duong Tue, Apr. 1 123 Comments

    Summary

    • MNKD's first two Complete Response Letters were for the same mistakes.
    • I believe Afrezza will be approved, because it's safe and has met all primary endpoints.
    • Black Swans don't exist in the in the FDA.
    • A different proposed dosing regimen is a concern.
  • MannKind's Latest Critic: The FDA Has Joined The Chorus Of Missing Data Concerns
    Scrying Biotech Mon, Mar. 31 178 Comments

    Summary

    • The historical foundation of the Afrezza application is made up of multiple identified deficiencies.
    • Missing data is now a black box concern of the FDA as well.
    • The seal of MannKind's fate will be broken on Tuesday, April 1, 2014.
  • What The FDA Document Says About Afrezza: Implications For FDA Approval
    Jeff Eiseman Fri, Mar. 28 205 Comments

    Summary

    • The 249-page FDA document released this morning has been distorted by early press releases.
    • If Afrezza is not approved, the reason won’t be because of findings related to safety.
    • The FDA may not approve Afrezza for Type 1 at this time, but I believe that it will do so eventually.
    • I predict that the FDA will approve Afrezza for Type 2 with a favorable label.
  • MannKind And Afrezza's NDA Evaluation: What Is The Real Justification For The Advisory Committee?
    Greg Johnstone Thu, Mar. 27 173 Comments

    Summary

    • “Diabetes Mellitus” the disease - it's very complicated. Some implications of the disease on body systems and hence, treatment-related risks.
    • Negative patient realities associated with daily subcutaneous injection of insulin, which impact patient compliance and hence, justify the need for a better diabetes management option.
    • Challenges associated with inhalable drug administration, including Afrezza (dry powder) insulin, which could impact NDA decision and patient compliance.
    • The role and rationale for an “Advisory Committee (AD-COM)” in the NDA process.
  • Fear, Greed, And Prudent Risks: A Clarion Call To The Keepers Of The MannKind Flame
    Jeff Eiseman Mon, Mar. 24 112 Comments

    Summary

    • I quickly review why investors fear that MNKD will not thrive.
    • I explain why many MannKind believers allow their fear and temptations to override their best judgments.
    • I encourage believers to allow the results of their due diligence to override their fears.
  • MLV Sees A Good Chance Of FDA Approval For MannKind's Afrezza And 60% Upside
    Ben Yoffe Tue, Mar. 18 59 Comments

    Summary

    • In this interview, MLV's Dr. Graig Suvannavejh discusses his views on the future of MannKind as it gets closer to the upcoming AdCom and PDUFA for Afrezza.
    • Dr. Suvannavejh believes Afrezza has 90% chance of a positive FDA AdCom outcome.
    • Additionally, we discuss current investor concerns, including; the regulatory outlook and commercial concerns.
  • MannKind: The Gambler's Creed - Let It Ride
    Scrying Biotech Fri, Mar. 14 162 Comments

    Summary

    • In my previous article, we examined the obstacles to approval that Mannkind faces at its upcoming FDA advisory committee meeting by expanding our definition of what an adcom is.
    • In this article, we'll suss out the risks for long-term investors that attend to holding through this or any other high-profile event in the absence of using options.
    • Are adcoms really approved 82% of the time as MannKind's fervent supporters suggest? I'll demonstrate why it's better to read a document with quiet discernment than with partisan zeal.
    • And finally, we'll address the role that bloggers play in clarifying important issues surrounding investment in the sector, especially as this applies to binary events and to adcoms in particular.
  • What Can The Deerfield Conversion Tell Us About MannKind Going Into ADCOM?
    Black Gold Thu, Mar. 13 118 Comments

    Summary

    • Deerfield debt-to-equity conversion is not necessarily a positive.
    • Scheduling of an ADCOM is not a positive event for the stock.
    • Release of briefing documents at the end of March is the next big catalyst.
    • Absent any ADCOM black swans, Afrezza will ultimately be approved by the FDA.
  • MannKind: Follow The Smart Money
    George Rho Mon, Mar. 10 219 Comments

    Summary

    • Time runs out for short sellers in 21 days.
    • Attempts to drive down the price of MNKD stock will likely intensify in the lead up to April Fool's day.
    • A favorable outcome at the Advisory Committee meeting is highly likely.
  • How Will Subconscious Issues Influence FDA AdCom Voting On Afrezza?
    Jeff Eiseman Thu, Mar. 6 112 Comments

    Summary

    • In a recent SA article, Michael Webb claimed that the subconscious of FDA AdCom panel members reviewing MannKind’s Afrezza could lead to it being rejected.
    • I analyze the psychological premises underlying his arguments and partially agree with him.
    • I introduce additional information about how the subconscious works and conclude that Webb is only right under certain conditions.
    • After examining the conditions that prevail at FDA panels, I show why the decision will be based on the questions FDA asked and the evidence presented.
    • After briefly reviewing the questions and the evidence, I conclude that Afrezza will be approved and become a commercial success.
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Company Description

MannKind Corporation is a development stage company engaged in the discovery, development, and commercialization of therapeutic products for diseases such as diabetes.

Sector: Healthcare
Industry: Biotechnology
Country: United States