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MNKD, new 52 week high
MNKD anew 52 week high
Up and to the right Mannkind looking better than ever. Lets Go!
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
MNKD under $7
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.
MNKD under $5
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%.”
This is looking real sweet with solid growth and profit coming soon!
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
Still long and strong
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