MannKind Corporation (MNKD)

Afrezza HCP INHALE Phase 3 Data 🫁🏆

https://afrezzahcp.com/inhale-3-data/

Afrezza HCP INHALE Phase 3 Data 🫁🏆

https://afrezzahcp.com/inhale-3-data/

https://mannkindcorp.com/inhale1/

https://finance.yahoo.com/news/mannkind-highlight-data-recent-pediatric-200500642.html

“ Inhalable insulin is a powdered form of insulin, delivered with an inhaler into the lungs where it is absorbed. In general inhaled insulins have been more rapidly absorbed than subcutaneous injected insulin, with faster peak concentration in serum and more rapid metabolism. Exubera, developed by Inhale Therapeutics, became the first inhaled insulin product to be marketed, in 2006 by Pfizer, but poor sales led Pfizer to withdraw it in 2007. Afrezza, a monomeric inhaled, ultra rapid-acting insulin developed by Mannkind, was approved by the FDA in 2014 and is the only inhaled insulin commercialized at the moment.”

Also… Inhaled Clofazimine: https://pmc.ncbi.nlm.nih.gov/articles/PMC9933692/

🫁 All that surface area = maximum efficacy for inhaled medications. 🏆

When it runs eventually it will be aggressive. 

https://www.marketbeat.com/earnings/reports/2025-5-8-mannkind-co-stock/

https://fintel.io/news/mizuho-initiates-coverage-of-mannkind-mnkd-with-outperform-recommendation-525

Baffling to belive with the recent price dip that Big Pharma isn't "kicking mannkind's door down" with take over offers...
Here's hoping

https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-teams-juncos-hollinger-racing-jhr-driver-conor-daly

https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-showcases-efficacy-safety-and-mealtime-control-data

*Five presentations affirm positive outcomes utilizing inhaled insulin
*An sNDA filing for Afrezza in pediatric population anticipated in 2025
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., March 10, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and delivery devices for patients with endocrine and orphan lung diseases, will showcase data from recent studies of inhaled insulin across five presentations at the 18th International Conference on Advanced Technologies and Treatments for Diabetes to be held March 19-22 in Amsterdam.

“Data from both the INHALE-1 pediatric and INHALE-3 adult studies continue to drive groundbreaking conversations around inhaled insulin,” said Dr. Kevin Kaiserman, Senior Vice President, Therapeutic Area Head, Endocrine Diseases for MannKind Corporation. "Afrezza continues to be an important treatment option for adults living with diabetes, including those utilizing MDI and AID, and we look forward to the study investigators’ presentations at the ATTD meeting.”

The following oral presentations are on the scientific program at ATTD 2025 to be held virtually and at the RAI Amsterdam Convention Center:

What’s New in Pulmonary Inhaled Insulin?
Thursday, March 20, 2025 – 4:40 PM (CET) in Hall I
Presenter: Dr. Irl B. Hirsch

Inhaled Insulin in Pediatrics (INHALE-1 Peds Study)
Thursday, March 20, 2025 – 4:40 PM (CET) in Hall I
Presenter: Dr. Michael J. Haller

Sustained Benefit from Use of Inhaled Insulin in the INHALE-3 Extension Study
Saturday, March 22, 2025 – 11:05 AM (CET) at Station 4
Presenter: Dr. Grazia Aleppo

Post-Prandial Glucose Excursion with Inhaled Insulin in Youth Compared with Adults with Type 1 Diabetes (INHALE-1 Peds Study)
Saturday, March 22, 2025 – 11:30 AM (CET) in Hall D2
Presenter: Dr. Michael J. Haller

Comparison of a Regimen of Inhaled Technosphere Insulin Plus Insulin Degludec Versus Usual Care in Adults with Type 1 Diabetes
Saturday, March 22, 2025 – 11:30 AM (CET) in Hall D2
Presenter: Dr. Anastasios Manessis

In addition to the planned presentations, MannKind will host booth #40 in the exhibit hall (Hall I) throughout ATTD. Members of MannKind’s Clinical Education Team will be available for scientific exchange in the medical section of the booth.

For more information about ATTD programming, and/or to register to attend the conference (virtual or in person), please visit: https://attd.kenes.com/register/.

About the INHALE-1 Pediatric Study
INHALE-1 is a Phase 3, randomized controlled trial in children and teenagers aged 4-17 with type 1 or type 2 diabetes to evaluate the efficacy and safety of inhaled insulin in combination with basal insulin versus multiple daily injections of rapid acting insulin in combination with basal insulin. The 26-week, open-label clinical trial randomized 230 pediatric subjects to one of two groups: Afrezza or multiple daily injections (MDI) of rapid acting insulin analog (RAA) in combination with basal insulin. The primary endpoint was a non-inferior change in HbA1c levels after 26 weeks. A 26-week extension phase in which all remaining MDI patients switched to Afrezza is still ongoing. Six-month results were announced by MannKind in December 2024, and 12-month findings are expected mid-year 2025.

About the INHALE-3 Study (Adults)
The INHALE-3 study was a 17-week, randomized controlled trial with a 13-week extension conducted across 19 U.S. sites. The study, which enrolled 141 patients (123 randomized), assigned participants over 18 years of age with T1D who are using MDI, an automated insulin delivery system, or a pump without automation to either continue their standard of care or initiate an insulin regimen of a daily basal injection plus Afrezza for boluses (mealtime and corrections). Subjects utilizing Afrezza (inhaled insulin) received a higher initial conversion dose than in the current U.S. product label. Both arms utilized continuous glucose monitoring to assess glucose control.

The randomized control trial (RCT) included an inhaled insulin group that began with 62 subjects at randomization and 57 at 17 weeks; the usual care group consisted of 61subjects at randomization and 58 at 17 weeks. The 17-week results shared that the study met its primary efficacy endpoint of a non-inferior change in HbA1c between baseline and week 17 compared to the usual care group. At 17 weeks, those who utilized Afrezza (plus basal insulin) continued with it through the extension phase, and those who were on usual care switched over to Afrezza to week 30. The extension phase started with 45 subjects from the inhaled insulin group and 43 completed the extension; the usual care-to-Afrezza group started with 49 in the extension, with 42 completing. There was no control group in the extension phase. A1c levels were obtained at baseline, 17 and 30-weeks. The 30-week results from the study expanded upon the positive 17-week data and showed that more people living with T1D were able to reach target A1c levels when they remain on Afrezza (plus basal insulin) or switch to Afrezza from usual care.

About Afrezza
Afrezza (insulin human) Inhalation Powder is a rapid-acting inhaled human insulin indicated to improve glycemic control in adults with diabetes mellitus.

Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis or in patients that smoke or have recently stopped smoking.

Friday night (on this side of the planet) cheers 🍷 to all of us who still feel the debt reduction may signal buyout...

I hope so...

"Prost" & may the remainder of 2025 belong to us  

Sale. Adding time.

Nice earnings report. Will add more tomorrow. 🍷

Just mentioned on Making Money with Charles Payne. I bought a few.

MNKD reports 2/21

Some may say, we are either on a one way, doomed space voyage to the planet Jupiter or we're going to be sittin' and shitin' in Tall Cotton.
Me, I'm partial to the soft, Egyptian stuff and believe that's were we're headed! 

Come on Mike, only Love but package MNKD up and sell to highest Big Pharma Bider!

Hoping that's why you buried the debt!

♾️ T

Come on Mike and Martine

Love U both but if a big buyout's coming (UTHR and Big Pharma splitting up MNKD), let's get our game on and let er rip!

Over a million share buy block today at $6.60. Very Bullish. 

Happy trading. 

Long time Mannkinder here...

Hard to believe with their recent debt reduction, this isn't a major take out targer for Big Pharma...

Time will tell

BUY rating on technicals issued on Friday 

Mannkind, my kind of stock, news out boys

https://finance.yahoo.com/news/mannkind-corporation-announces-exchange-convertible-120000933.html


-T

https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-six-month-results-phase-3-inhale-1-pediatric

https://investors.mannkindcorp.com/node/20181/pdf

👍 https://investors.mannkindcorp.com/news-releases/news-release-details/cdsco-approves-afrezzar-insulin-human-inhalation-powder-india

Come on Big Pharma...

You have to realize the untapped potential of techno-sphere as a delivery system

Swoop in amd snatch this company up for $40 + a share (pennies on future dollars for you)

https://investors.mannkindcorp.com/node/20136/html

UBS Global Healthcare Conference
11/12/24 at 1:15 PM EST

MNKD, 10Q 11/7

MNKD, new 52 week high

https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-corporation-hold-2024-third-quarter-financial-results

MNKD anew 52 week high

This company with their Techno Shere delivery system is low hanging fruit that Big Pharma should be all over...

Come on, ruin Mike and Martine's (like both but Mike will make bank and Martine's had her chances to buybout mnkd) perfect party and someone take this out at $40+ a share....

Up and to the right Mannkind looking better than ever. Lets Go!

May Mannkind be taken out at $35 a share but some out of the blue, no one saw it coming, Big Pharma conglomerate...

And hoping it won't screw UTHR up too much but Martine has had her chances here...

Martine & UTHR should “pony up” & purchase Mannkind before an unknown entity moves in & potentially ruins United’s perfect party

30-week results from the Phase 4 INHALE-3 study expand upon the positive 17-week data presented earlier this year at the American Diabetes Association’s 84th Scientific Sessions

Switching to, or remaining on Afrezza allowed twice as many people to get to goal during the extension phase

https://investors.mannkindcorp.com/news-releases/news-release-details/more-adults-type-1-diabetes-achieved-a1c-goal

https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-clearance-pmda-initiate-phase-3-clinical

MNKD under $7

Under $5 is a joke . Worth so much more considering its value to diabetics.

https://learnaboutntm.com/

https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-launches-educational-website-raise-awareness-ntm-lung

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., July 30, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), announced today that it will report its second quarter 2024 financial results before the market opens on Wednesday, August 7, 2024. A press release detailing the quarterly results will be issued the same day approximately one hour prior to the webcast.

MannKind will host a webcast beginning at 9:00 a.m. Eastern Time for investors, media, and the general public. Participating in the conference call from MannKind will be Chief Executive Officer Michael Castagna, PharmD, and Chief Financial Officer Chris Prentiss. The webcast will be accessible via a link on MannKind’s website at https://investors.mannkindcorp.com/events-and-presentations. A replay will also be available in the same location within 24 hours following the call and be accessible for approximately 90 days.

https://investors.mannkindcorp.com/news-releases/news-release-details/inhale-3-study-reveals-positive-readout-head-head-comparison

MannKind to Establish Boston-Area Research & Development Foothold and Expand Portfolio of Dry Powder Inhalation Technology in Transaction With Pulmatrix

05/29/24

Immediate opportunity to increase capacity for formulation and early asset development in upgraded Boston area R&D space
Non-cash deal includes royalty-free iSPERSE™ technology license in exchange for access to MannKind’s Cricket® inhaler
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 29, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that it has agreed to in-license iSPERSE™ technology from Pulmatrix for certain indications in exchange for an out-license of MannKind’s Cricket® inhaler to Pulmatrix for inhaled delivery of dihydroergotamine (DHE) for migraine treatment. The two companies also agreed that Pulmatrix will transfer its Bedford, Mass. R&D facility to MannKind, along with all leasehold improvements, laboratory equipment and other related personal property used in the laboratory in non-cash transaction.

“We are delighted to grow our Boston-area presence as we continue to progress our pipeline efforts, and in particular, our expanding orphan lung programs,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “We have formulated two FDA-approved products utilizing our proven Technosphere® dry powder technology, and this agreement affords us access to another option for future development opportunities.”

“Our Technosphere technology, which is a unique carrier-based, dry powder inhalation platform used in tandem with our proprietary inhaler, provides deep and effective penetration of lung tissue that is well suited for many active ingredients,” said Dr. Burkhard Blank, Executive Vice President, Research & Development and Chief Medical Officer of MannKind Corporation. “However, for some drug candidates, such as Clofazimine, that may require a significantly higher drug payload, the iSPERSE formulation technology may be better suited for developing viable powders.”

The royalty-free licensing structure will allow MannKind to have exclusive use of the iSPERSE technology for clofazimine, NTM, and insulin, and non-exclusive use for endocrine diseases and interstitial lung diseases (ILD) including idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis (PFF) and other related lung diseases. In exchange, Pulmatrix will receive a royalty-free, exclusive license to MannKind’s single-use Cricket inhalation device for inhaled delivery of DHE in any formulation and non-exclusive use for neurological diseases.

MannKind expects to consolidate its Boston presence by transitioning its Marlborough staff into the newly renovated, fully outfitted R&D facility in Bedford. To maintain continuity of iSPERSE platform knowledge, MannKind plans to hire some members of current Pulmatrix R&D staff.

The agreement is anticipated to close in July 2024.

06/05/24

17-week endpoint results comparing Afrezza® head-to-head with multiple daily injections (MDI) and insulin pumps

INHALE-3 Study Protocol Chair Dr. Irl. B. Hirsh joined by investigational team to deliver presentation moderated by Jaeb Center founder Dr. Roy W. Beck

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., June 05, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced that the 17-week endpoint results from the INHALE-3 study will be presented during a 90-minute symposium and livestream on Saturday, June 22, at the American Diabetes Association’s (ADA) 84th Scientific Sessions. The presentation will be delivered by INHALE-3 Study Protocol Chair Dr. Irl B. Hirsh and the investigational team and will be moderated by Jaeb Center founder Dr. Roy W. Beck.

“We are excited for the first read-out of results from the largest post-market clinical trial MannKind has conducted with Afrezza in the last 10 years,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “The results will speak to the common question about Afrezza: ‘How does inhaled insulin fare when compared head-to-head with usual care?’ The full 30-week results of INHALE-3 will be available later this year.”

Title:
The Efficacy and Safety of Inhaled Insulin Used with Insulin Degludec Compared with Automated Insulin Delivery or Multiple Daily Injections in Adults with Type 1 Diabetes
Date: Saturday, June 22, 2024
Times: 8:00-9:30 AM (ET) with topics/presenters to include:

Inhaled Insulin’s History and Study Rationale – Dr. Halis Akturk

Study Methods & Participant Baseline Characteristics – Dr. Yogish Kudva

Study Results I: Comparison of Inhaled Insulin vs. Rapid Acting Analogue Insulin in Users of AID or

MDI During Standardized In-Clinic Meal Challenge –Dr. Ruth S. Weinstock

Study Results II: Primary Efficacy, Safety, and Quality of Life Outcomes – Dr. Carol J. Levy

Study Results III: Effect of Inhaled Insulin-Degludec Compared with AID and in Subgroups According

to Participant Characteristics – Dr. Grazia Aleppo

Critique of Study Design and Results – by Dr. Irl B. Hirsch

Use of Afrezza in Clinical Practice – by Dr. Thomas Blevins

Question and Answer Session – Moderated by Dr. Roy W. Beck
Location: W320 Chapin Theatre at the Orange County Convention Center (+livestream)
Livestream:
Please refer to https://professional.diabetes.org/scientific-sessions for access details

MannKind will host booth# 1307 in the Exhibit Hall throughout the Scientific Sessions as well. Members of MannKind’s Clinical Education Team will be available for scientific exchange in the medical section of the booth.

https://investors.mannkindcorp.com/news-releases/news-release-details/inhale-3-study-results-be-presented-during-90-minute-symposium

MNKD under $5

https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-proceed-phase-1-nintedanib-dpi-mnkd-201-study-pulmonary

https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-ind-clearance-us-fda-start-phase-3-study

$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— Life Science Report (@lifesciencerpt) March 5, 2024

well just got 6000 more shares thanks