MNKD MannKind Corporation

4.03
+0.04  (+1%)
Previous Close 3.99
Open 3.99
52 Week Low 1.52
52 Week High 6.25
Market Cap $1,004,104,137
Shares 249,157,354
Float 244,923,158
Enterprise Value $1,080,959,151
Volume 3,807,069
Av. Daily Volume 3,497,556
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Upcoming Catalysts

Drug Stage Catalyst Date
TYVASO (treprostinil) DPI
Pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease (PH-ILD) (WHO Group 3)
PDUFA priority review
PDUFA priority review
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Drug Pipeline

Drug Stage Notes
AFREZZA
Type 1/2 diabetes
Approved
Approved
Approved June 27, 2014.

Latest News

  1. RADNOR, Pa., Aug. 4, 2021 /PRNewswire/ -- NRx Pharmaceuticals (NRx) (NASDAQ:NRXP) announced today it has signed an agreement with MannKind Corporation to develop a dry powder formulation of ZYESAMI (aviptadil), a synthetic form of human Vasoactive Intestinal Peptide (VIP), produced by the body to help protect cells against inflammatory conditions. Development will be based on MannKind's proven Technosphere® platform, that is the basis of the US Food and Drug Administration (FDA) -approved Afrezza® inhaled insulin product.

    NRx Pharmaceuticals Partners with MannKind Corporation to Further Develop Inhalable Formulation of ZYESAMI™

    In June 2020, FDA awarded a Fast Track Designation to NRx for the use of aviptadil for the treatment of Acute Lung Injury/Acute Respiratory Distress Syndrome associated with COVID-19. The investigational drug has demonstrated a greater than 2-fold increased odds of survival at 60 days in a phase 2b/3 clinical trial, and demonstrated significantly reduced IL-6 cytokine formation (commonly known as cytokine storm) compared to placebo. Both intravenous and inhaled formulations of ZYESAMI™ are in phase 3 clinical trials funded by the US National Institutes of Health, the Biomedical Advanced Research Development Authority (BARDA), and by NRx.

    Although Vasoactive Intestinal Peptide (VIP) was discovered in 1970, NRx was the first to formulate aviptadil (the synthetic form of VIP) for  human intravenous and inhaled use under the "Good Manufacturing Practices" (GMP) standards required by FDA and other regulators in 2020. The stable, sterile liquid formulation of ZYESAMI™ developed by NRx is suitable for emergency use and stockpiling purposes. With clinical effects of aviptadil now emerging in clinical trials, NRx is broadening its focus to develop a simple, room-temperature inhaled delivery system that is convenient for patients and is already proven in commercial manufacture. Senior FDA officials and others have emphasized the need to develop inhaled drugs to treat COVID and other acute lung disorders in order to increase patient convenience and move treatment from the ICU to the outpatient setting.

    "As we continue to identify the beneficial effects of VIP in treating various respiratory disorders, development of a convenient dosing method that offers multi-year stability at room temperature is key to meeting the needs of patients." said Prof Jonathan Javitt, MD, MPH, CEO and Chairman of NRx (see concept image). "I had the privilege of working closely with Dr. Alfred Mann, on the refinement and regulatory approval of MannKind's Technosphere platform and have long admired its simplicity and elegance. On many occasions he and I discussed his vision to extend Technosphere beyond insulin to solve the unique stability and administration challenges of peptide-based drugs. I am personally delighted to be partnering once again with MannKind and bringing Dr. Mann's vision to life."  

    "We are looking forward to the collaboration with NRx and looking for an avenue to marry the benefits of our Technosphere technology with ZYESAMI," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "Our focus is to continue to explore ways that our Technosphere technology can deliver unique compounds in a targeted and convenient manner for patients with serious lung diseases."

    About NRx Pharmaceuticals

    NRx Pharmaceuticals (NASDAQ:NRXP) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. In July 2021, NRx was awarded an exclusive worldwide license to develop and commercialize the BriLife (VSV-ΔG) COVID-19 vaccine developed by the Israel Institute of Biological Research.

    NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits, and been appointed to advisory roles in four US Presidential administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra-rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. Afrezza is also available by prescription in Brazil, where it is commercialized by the Company's partner, Biomm SA. MannKind was established in 1991, and is headquartered in Westlake Village, Calif., with a manufacturing and R&D facility based in Danbury, Conn. The Company also employs field sales and medical representatives across the U.S.  Please visit mannkindcorp.com to learn more.

    Cautionary Note Regarding Forward-Looking Statements

    This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company's management. 

    The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above. 

    For MannKind:

    For NRx:

    Christie Iacangelo, Corporate Communications

    Jack Hirschfield, Head of External Affairs

    (818) 292-3500

    (512) 674-5163

    Email:  

    Email:





    Rose Alinaya, Investor Relations

    John Mulally, Investor Relations

    (818) 661-5000

    (617) 429-3548

    Email:  

    Email:

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-partners-with-mannkind-corporation-to-develop-zyesami-aviptadil-inhaler-for-respiratory-conditions-301348051.html

    SOURCE NRx Pharmaceuticals

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  2. WESTLAKE VILLAGE, Calif., Aug. 4, 2021 /PRNewswire/ -- MannKind Corporation (NASDAQ:MNKD) has partnered with NRx Pharmaceuticals (NASDAQ:NRXP) (NRx) to evaluate the feasibility of formulating a dry powder formulation of ZYESAMI (aviptadil), a synthetic form of human Vasoactive Intestinal Peptide (VIP) – an endogenous substance produced by the body that helps protect cells against inflammatory conditions.  An intravenous formulation of ZYESAMI is currently in clinical trials, having been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of Critical COVID-19 with Respiratory Failure.

    "We continue to explore ways that our Technosphere technology can deliver unique compounds in a targeted and convenient manner for patients with serious lung diseases," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "The novel coronavirus continues to be a factor around the world, and we are just beginning to bear witness to its long-term effects on the lungs."

    Rapid recovery from Critical COVID-19 with Respiratory Failure has been reported in patients treated with open label VIP under a Phase 2b/3 clinical trial and in an FDA Expanded Access Program. Emerging data indicates that VIP binds uniquely to receptors on Alveolar Type II cells preventing cell death, stopping replication of the coronavirus in the Type II cells and upregulating the production of surfactant – the loss of which is increasingly implicated in COVID-19 respiratory failure.

    "As we continue to identify beneficial effects of VIP in treating various respiratory disorders, development of a convenient dosing method that offers stability at room temperature is key to long term success," said Prof Jonathan Javitt, MD, MPH, CEO and Chairman of the Board, of NRx. "We are pleased to be working with MannKind to develop an inhaled form of ZYESAMI which may offer patients an easier and more therapeutic option."

    MannKind will begin exploring formulation potential at its research and manufacturing facility located in Danbury, Conn., which features a full range of development and manufacturing capabilities, including analytical, chemical, formulation, filling and packaging. It has sufficient filling capacity to produce more than 300 million cartridges of inhaled drug annually.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra-rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. Afrezza is also available by prescription in Brazil, where it is commercialized by the Company's partner, Biomm SA. MannKind was established in 1991, and is headquartered in Westlake Village, Calif., with a manufacturing and R&D facility based in Danbury, Conn. The Company also employs field sales and medical representatives across the U.S.  Please visit mannkindcorp.com to learn more.

    Forward-looking Statements

    This press release contains forward-looking statements that involve risks and uncertainties. Words such as "plans," "expects," "intend," "will," "targeted," "potential" and similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements regarding the potential to create a dry powder formulation of a new compound and to treat certain diseases. Such forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that continued testing of product candidates may not yield successful results.  These and other risks are detailed in MannKind's filings with the Securities and Exchange Commission ("SEC"), including under the heading "Risk Factors" in MannKind's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, filed with the SEC on May 12, 2021. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

    ZYESAMI is a trademark of NRx Pharmaceuticals, Inc.

    AFREZZA and TECHNOSPHERE are registered trademarks of MannKind Corporation.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/mannkind-partners-with-nrx-pharmaceuticals-to-explore-a-dry-powder-formulation-of-zyesami-aviptadil-based-on-the-technosphere-platform-301347875.html

    SOURCE MannKind Corporation

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  3. WESTLAKE VILLAGE, Calif., Aug. 04, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) will release its 2021 second quarter financial results and its management will host a conference call to discuss the financial results and corporate updates at 5:00 PM (Eastern Time) on Wednesday, August 11, 2021.

    Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven B. Binder.

    Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at https://investors.mannkindcorp.com/events-and-presentations Events & Presentations.  A replay will also be available on MannKind's website for 14 days.

    About MannKind Corporation
    MannKind…

    WESTLAKE VILLAGE, Calif., Aug. 04, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) will release its 2021 second quarter financial results and its management will host a conference call to discuss the financial results and corporate updates at 5:00 PM (Eastern Time) on Wednesday, August 11, 2021.

    Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven B. Binder.

    Those interested in listening to the conference call live via the Internet may do so by visiting the Company's website at https://investors.mannkindcorp.com/events-and-presentations Events & Presentations.  A replay will also be available on MannKind's website for 14 days.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra-rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. Afrezza is also available by prescription in Brazil where it is commercialized by the Company's partner Biomm SA. MannKind was established in 1991, and is headquartered in Westlake Village, Calif., with a manufacturing and R&D facility in Danbury, Conn. The Company also employs field sales and medical representatives across the U.S. Please visit www.mannkindcorp.com to learn more.

    MANNKIND CONTACT:

    Rose Alinaya, Investor Relations

    Phone: (818) 661-5000

    Email:



    Primary Logo

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  4. WESTLAKE VILLAGE, Calif., Aug. 03, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, announced today that its Chief Executive Officer, Michael Castagna, PharmD, will participate in a Fireside Chat in the BTIG Virtual Biotechnology Conference 2021 on Tuesday, August 10, 2021 at 12:30 PM (ET).

    BTIG hosted events are intended for prospective and existing BTIG clients only. To listen to the live event, please contact your BTIG representative with interest.

    About MannKind Corporation
    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic…

    WESTLAKE VILLAGE, Calif., Aug. 03, 2021 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, announced today that its Chief Executive Officer, Michael Castagna, PharmD, will participate in a Fireside Chat in the BTIG Virtual Biotechnology Conference 2021 on Tuesday, August 10, 2021 at 12:30 PM (ET).

    BTIG hosted events are intended for prospective and existing BTIG clients only. To listen to the live event, please contact your BTIG representative with interest.

    About MannKind Corporation

    MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra-rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. Afrezza is also available by prescription in Brazil where it is commercialized by the Company's partner Biomm SA. MannKind was established in 1991, and is headquartered in Westlake Village, Calif., with a manufacturing and R&D facility in Danbury, Conn. The Company also employs field sales and medical representatives across the U.S. Please visit www.mannkindcorp.com to learn more.

    MANNKIND CONTACT:

    Rose Alinaya, Investor Relations

    Phone: (818) 661-5000

    Email:



    Primary Logo

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  5. WESTLAKE VILLAGE, Calif., July 29, 2021 /PRNewswire/ -- MannKind Corporation (NASDAQ:MNKD) will team up with NTT INDYCAR SERIES driver Conor Daly, who is living with Type 1 diabetes (T1D) for a one-of-a-kind experience with local youth and families as part of Music City Grand Prix week. Daly will share his personal story of being diagnosed with diabetes as a teen and how he does not let it keep him from living life without limits. The former karting champion will also provide some karting tips and then race go-karts to identify the Fastest 6.

    Daly was first diagnosed with diabetes at the age of 14, and today is the only known U.S. professional racing driver who competes full-time while living with T1D. He is entered in the Music City Grand Prix with the No. 20 U.S. Air Force Chevrolet competing for Ed Carpenter Racing.

    DATE/TIMES:    

    WEDNESDAY, AUGUST 4, 2021

    10:00 a.m.1:00 p.m.

    LOCATION:     

    Music City Indoor Karting

    404 Davidson Street (Nashville)

    VISUALS/SOUND: 

    • Tweens/teens hear Conor Daly's diabetes story and how he doesn't let it slow him down
    • 20 young racing fans receive karting tips from kart champion Conor Daly
    • Music City Grand Prix driver Conor Daly racing go-karts with youth for Fastest 6
    • Jeff Hitchcock, Founder and President of Children with Diabetes

    BACKGROUND: Like many professional racers, Daly started regularly competing in karting at the age of 10.  Four years later, he encountered a hurdle when he found himself heading to the hospital, having lost weight and possessing an insatiable thirst for water. Instead of racing that day, he found himself at the hospital and received a diagnosis of Type 1 diabetes. While a surprise, it did not slow him down as Daly was behind the wheel less than a week later and went on to take home the 2006 World Karting Association Grand Nationals title. He progressed to car racing in 2007, and has continued to thrive in the sport he loves – finding success in both the U.S. and international open-wheel ladder systems. Daly has competed in over 70 Indy car races over the last seven years.

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/indycar-driver-conor-daly-to-share-his-personal-diabetes-story-and-race-go-karts-with-local-youth-on-wednesday-august-4th-301344360.html

    SOURCE MannKind Corporation

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