chrismiss_everyday
3 일 전
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.
St. Sauvage
1 월 전
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
chrismiss_everyday
7 월 전
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.
chrismiss_everyday
9 월 전
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.
chrismiss_everyday
9 월 전
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.
chrismiss_everyday
1 년 전
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%.”
chrismiss_everyday
2 년 전
“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
2 년 전
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.”
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