chrismiss_everyday
4 months ago
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
6 months ago
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
6 months ago
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
11 months ago
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
1 year ago
“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 years ago
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
2 years ago
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.
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