MannKind Corp. (MNKD)

[TheFinalCD]

$MNKD 4.65 NEWS

MannKind Announces New Clinical Data From Inhale-3 Study to be Presented by Dr. Irl B. Hirsch at ATTD on March 8 $MNKD https://t.co/R2cKawGGUI

— Health Stocks News (@health_stocks) March 5, 2024

[kugel]

well just got 6000 more shares thanks

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MannKind Corp. said Tuesday it has entered a royalty agreement with Sagard Healthcare under which the latter will receive 1% of royalty sales of Tyvaso DPI inhalation powder for up to $200 million. United Therapeutics Corp. licensed Tyvaso DPI from MannKind in 2018 and started to market it in June 2022 as a treatment for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease following U.S. FDA approval. Under the terms of that deal, MannKind is entitled to a 10% royalty on sales of the treatment. Under its new agreement, Sagard will be entitled to royalty payments equal to 1% of net sales of Tyvaso DPI that are made between Oct. 1, 2023 and Dec. 31, 2042. MannKind will receive a $150 million upfront payment and $50 million if sales equal or exceed $1.9 billion by end-December 2026. If that milestone is not achieved, MannKind will get $45 million if the sales equal or exceed $2.3 billion by Sept. 30 of 2027. If neither milestone is achieved, MannKind will not receive the milestone payment and Sagard will not get any of the royalties payable in respect of sales that exceed $3.5 billion in any calendar year. MannKind’s stock fell 1% premarket and is down 31% over the last 12 months, while the S&P 500 has gained 24%.”

[kugel]

oh wow

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“On June 26, 2023, MannKind Corporation (the “Company”) was informed that the contract manufacturer responsible for the production of clofazimine inhalation solution, the investigational product being developed by the Company as MNKD-101, experienced a fire in its manufacturing facility in Germany. As a result of this incident, the Company estimates that production of clinical supplies of MNKD-101 will be delayed by 3-6 months, which has the potential to impact the initiation of a Phase 2/3 clinical study of MNKD-101 planned for later in 2023. The Company is evaluating several mitigation strategies and will update the projected timing for this clinical study at a later date.”

Hopefully the clofazimine supply chain has some other nodes available outside of Germany.
https://investors.mannkindcorp.com/node/19231/html

[chrismiss_everyday]

https://imgur.com/a/lTiTEU4

“MannKind Corporation Common Stock is estimated to report earnings on 08/08/2023. The upcoming earnings date is derived from an algorithm based on a company's historical reporting dates. Our vendor, Zacks Investment Research, might revise this date in the future, once the company announces the actual earnings date.”

[Profit]

This is looking real sweet with solid growth and profit coming soon!

[chrismiss_everyday]

https://investors.mannkindcorp.com/node/19221/pdf

[chrismiss_everyday]

Considering the move into India with Cipla, and the addition of yet another highly qualified team member, it’s looking like some very good years ahead for MannKind.

https://investors.mannkindcorp.com/news-releases/news-release-details/dr-burkhard-blank-joins-mannkind-executive-vice-president

[chrismiss_everyday]

https://investors.mannkindcorp.com/news-releases/news-release-details/correction-mannkind-corporation-reports-2023-first-quarter

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 09, 2023 (GLOBE NEWSWIRE) -- In a release issued under the same headline earlier today by MannKind Corporation (Nasdaq: MKND), please note in the second table, titled "CONDENSED CONSOLIDATED BALANCE SHEETS", the right column header was incorrectly labeled as "March 31, 2022", when it should be labeled "December 31, 2022". The corrected release follows:

1Q 2023 Total Revenues of $41 million; +239% vs. 1Q 2022
1Q 2023 Revenues associated with Tyvaso DPI of $23 million
1Q 2023 Loss from operations decreased 72% vs. 1Q 2022 to $6 million
$167 million of Cash, Cash Equivalents and Investments at March 31, 2023
MannKind Corporation (Nasdaq: MNKD) today reported financial results for the quarter ended March 31, 2023.

“Demand for Tyvaso DPI® has been very strong, which resulted in $23 million in revenues in the first quarter of 2023,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “I'm excited about our inhaled platform and orphan lung pipeline as we get ready to launch our Phase 2/3 inhaled clofazimine trial for patients in the second half of 2023.”

[chrismiss_everyday]

https://www.insideprecisionmedicine.com/topics/patient-care/therapeutics/respiratory-drugs/new-nanoparticles-carrying-mrna-can-perform-in-lung-gene-editing

Get a lungful of this!

[Profit]

Still long and strong

[chrismiss_everyday]

https://www.nasdaq.com/articles/blackrock-updates-holdings-in-mannkind-mnkd

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https://www.fool.com/earnings/call-transcripts/2022/11/08/mannkind-corporation-mnkd-q3-2022-earnings-call-tr/

[chrismiss_everyday]

Well…plenty of other good things on the way!

Clofazimine, sold under the brand name Lamprene, is a medication used together with rifampicin and dapsone to treat leprosy. It is specifically used for multibacillary leprosy and erythema nodosum leprosum.

Nintedanib, sold under the brand names Ofev and Vargatef, is an oral medication used for the treatment of idiopathic pulmonary fibrosis and along with other medications for some types of non-small-cell lung cancer.

Dornase alfa is used to reduce the number of lung infections and to improve lung function in patients with cystic fibrosis.

Transforming growth factor-beta (TGFß) is a secreted cytokine, which intricately controls a plethora of physiological and pathological processes during development and carcinogenesis. TGFß exerts antiproliferative effects and functions as a tumor suppressor during early stages of tumorigenesis, whereas at later stages it functions as a tumor promoter aiding in metastatic progression through an autocrine TGFß loop. Intricate knowledge of TGFß signaling and its regulation are still evolving. In this review, we make an attempt to showcase the associated enigma of TGFß signaling in its dual functional role as tumor suppressor and metastatic promoter during early and late stages of carcinogenesis, respectively.

[chrismiss_everyday]

Technosphere® Insulin (TI) peaked 30 minutes faster and significantly reduced postprandial glucose excursions (PPGE) at 60 minutes compared to subcutaneous insulins

The Afrezza with Basal Combination (ABC) Study demonstrated similar glucose control between the three treatment groups; data to be presented and published in 2023

[chrismiss_everyday]

Pretty good news!

“MannKind and United Therapeutics both surge the most in a year after the FDA approved their Tyvaso DPI product for lung disease.”

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“Chief Executive Officer, Michael Castagna, PharmD, will ring the opening bell at the Nasdaq stock exchange on Monday, May 23, 2022 at 9:30 am ET at the Nasdaq MarketSite at Times Square.”

Will this also be a day of significant announcement(s)? ??

[chrismiss_everyday]

https://www.go-vgo.com/

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https://www.healio.com/news/pulmonology/20220413/transition-to-dry-powder-inhaled-treprostinil-safe-tolerable-for-patients-with-pah

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“The FDA is expected to complete its review of the pending NDA for Tyvaso DPI in May 2022.”

Would approval be a jolt to the heart?

[TheFinalCD]

https://ih.advfn.com/stock-market/NASDAQ/mannkind-MNKD/stock-news/86432282/mannkind-corporation-to-hold-2021-third-quarter-fi

[terragord7]

Just realized they had a sales leaseback on the plant in Danbury CT for 100M and it closed in September 2021. Honestly, do not like it too much. That is poor man financing.

[criqsus]

good info

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Improved Bioavailability with Dry Powder Cannabidiol Inhalation: A Phase 1 Clinical Study

https://www.jpharmsci.org/article/S0022-3549(21)00413-5/pdf

[criqsus]

I came across this stock on seeking alpha. I really look forward to getting paid by this one in my bday in October. GLTA here, Go Mannkind.

[Profit]

Its happening!

[bakersson]

MNKD partners with NRx Pharmaceuticals

https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-partners-nrx-pharmaceuticals-explore-dry-powder

MannKind Partners With NRx Pharmaceuticals To Explore A Dry Powder Formulation Of ZYESAMI™ (aviptadil) Based On The Technosphere® Platform
08/04/21
PDF Version
NRx was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for ZYESAMI™ (aviptadil) for the treatment of Critical COVID-19 with respiratory failure; currently in clinical trials
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

For MannKind: Christie Iacangelo, Corporate Communications, [phone]Email: [e-mail]; Rose Alinaya, Investor Relations, [phone], Email: [e-mail]; For NRx: Jack Hirschfield, Head of External Affairs, [phone], Email: [e-mail]; John Mulally, Investor Relations, [phone], Email: [e-mail]

[Profit]

"October"

[STOCKSEEK]

Agreed!!!

[harry crumb]

Nothing but buying! Patience longs, we will have a big winner here soon enough $$$$

[harry crumb]

Great news, look for this to get back to 7+ area in due time. $$$

[AlphaStockNews]

$MNKD is screaming for the top after news broke that Medicare patients will have expanded access to Afrezza. https://cnafinance.com/mannkind-mnkd-stock-rokets-on-afrezza-access/

[Profit]

UTHR clearing the road.
Lets Go!

[AlphaStockNews]

$MNKD is screaming for the top in the premarket after announcing that its collaboration with United led to an NDA acceptance by the FDA. https://cnafinance.com/mannkind-mnkd-stock-heads-up-on-nda-acceptance/

[kugel]

are there any boards that have new up dates and information.

[harry crumb]

They could be landing more use for afrezza with latest studies. This may be a trigger to add in the event things pick up here. $$$

[Profit]

Lets Go!

[chrismiss_everyday]

Easier to read this way...

https://www.sec.gov/edgar/search/#/ciks=0000899460&entityName=MANNKIND%2520CORP%2520(MNKD)%2520(CIK%25200000899460)

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“Tired of Pricks?”

https://finance.yahoo.com/news/mannkind-announces-partnership-type-1-130000665.html

Tired of the same old FUD and bash crowd, but there might be a receptive IndyCar audience willing to give Afrezza a try instead of continued injections.

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MC- "And we're looking forward to hopefully having an acceptance from the FDA with ILD later this quarter in approval by year end. On the pipeline side, we completed our first toxicology studies for clofazimine, which is MNKD-101."

Looks like leprosy and tuberculosis treatment potential?

"Clofazimine is a highly lipophilic antimicrobial riminophenazine dye used in combination with other agents, such as dapsone, for the treatment of leprosy. It was originally described in 1957 and was the prototypical riminophenazine dye - a bright-red dye that, in its clinical use, results in long-lasting discoloration of the skin and bodily fluids.2 Although it carries in vitro activity against other mycobacterium, such as Mycobacterium tuberculosis, it is generally considered an ineffective treatment in comparison to classic tuberculosis treatments such as rifampicin and isoniazid."

[harry crumb]

Great report an the stock is red! This schmo joe b.... era is gonna wreck havoc on the stock market

[bakersson]

I wonder if Tyvaso would help in post covid symptoms.

[Quaaflac]

April 01 press release:
https://ir.unither.com/news/press-releases/press-release-details/2021/United-Therapeutics-Announces-FDA-Approval-and-Launch-of-Tyvaso-for-the-Treatment-of-Pulmonary-Hypertension-Associated-with-Interstitial-Lung-Disease/default.aspx

[SidVicious]

How is Afrezza doing? Have they grown prescriptions or is it still in the dumpster?

[chrismiss_everyday]

Buying time is here.

At least the timing is good.

"Our Technosphere platform we expect additional opportunities with partners as we're working on 10 different molecules here, some for Mannkind, some for partners, but we expect continued opportunities on Technosphere platform in the coming years."

Plus the FDA feedback. Type I & II pediatric approval would be a coup.

[Quaaflac]

CEO acquiring more stock...hmmm

[chrismiss_everyday]

I don't mind sale prices...

...when the payoff will be pediatric approval and a host of other developments.

[harry crumb]

Typical day trader reaction, this will rebound an opportunity to add

[harry crumb]

All bio company's do this, typical to have dilution, in mnkd's situation, they are in much better shape now than before, pipeline looking promising, an afrezza sales picking up, large pharma funds investing for growth, target prices on pps are very reachable. Long play with mnkd. $$$