Latest news with #MannKind


Time of India
26-06-2025
- Health
- Time of India
Inhaled insulin as good as injection for children at mealtime
London: Children with diabetes who inhaled their mealtime doses of insulin did just as well as those who injected insulin under the skin, researchers reported at the American Diabetes Association scientific meeting in Chicago. To regulate their blood sugar, patients with type 1 diabetes usually require an injection of a long-acting basal insulin once a day, plus additional injections of rapid-acting insulins at mealtimes. MannKind's inhaled insulin Afrezza is approved for use by adults but not yet for children, which prompted the study. The 230 children with type 1 diabetes, ages 4 to 17, who participated in the trial received either Afrezza at mealtimes, or their usual mealtime injections of insulin, for 26 weeks. Everyone continued to receive their basal insulin injections. Control of hemoglobin A1c, a marker of blood sugar control over the past several months, was comparable with the inhaled insulin and the injected insulin, the researchers found. Inhaled insulin was also associated with less weight gain and slightly higher child and parent preference scores. The inhaled formula did not have any adverse effects on patients' lungs, the researchers reported. "Inhaled insulin is the fastest acting insulin available and is a valuable alternative to injected analogue insulin," study leader Dr. Michael Haller of the University of Florida said in a statement. "Afrezza should be available as an option to all children and adults with type 1 diabetes." ONCE-WEEKLY INSULIN PROMISING FOR TYPE 2 DIABETES Eli Lilly's experimental once-weekly insulin efsitora was comparable to daily insulins in nearly a thousand adults with type 2 diabetes in three late-stage trials, researchers reported at the ADA meeting. The trials, which were designed to study patients at different stages of insulin use, each found efsitora to be just as effective as daily insulins for bringing HbA1c levels - a common measure of blood sugar over time - under control. "Once-weekly efsitora may offer a significant advancement for people with type 2 diabetes who need insulin by eliminating over 300 injections per year," Lilly's senior vice president of product development, Jeff Emmick, said in a statement. One trial, reported in The New England Journal of Medicine, involved patients with type 2 diabetes who were using insulin for the first time. A second trial in patients who had been using daily basal insulin degludec and a third trial in those who had been taking basal insulin glargine plus extra mealtime insulin doses were both reported in The Lancet. Efsitora "has the potential to facilitate and simplify insulin therapy , reducing the hesitation often associated with starting insulin to treat type 2 diabetes," Dr. Julio Rosenstock of University of Texas Southwestern Medical Center, who led one of the studies, said in a statement. People newly diagnosed with type 2 diabetes usually start treatment with oral medications, but roughly one-third of them will need to use insulin within 8 years of their diagnosis, according to an editorial in The Lancet. GENETICALLY ENGINEERED SKIN GRAFTS TREAT BLISTERING DISEASE Long-lasting wounds from a painful genetic skin disease can be healed with skin grafts genetically engineered from a patient's own cells, researchers reported in The Lancet. In severe dystrophic epidermolysis bullosa , or EB, the skin is so fragile the slightest touch - even from clothing - causes blistering and wounds, eventually leading to large, open lesions that never heal. "With our novel gene therapy technique, we successfully treated the hardest-to-heal wounds, which were usually also the most painful ones for these patients," study leader Dr. Jean Tang of Lucile Packard Children's Hospital Stanford in Palo Alto, California said in a statement. Severe dystrophic EB is caused by a defect in the gene for collagen VII, a protein that normally holds the skin together. As a result, the layers of the skin separate in response to even slight friction. To create the personalized skin grafts, doctors take a small biopsy sample of the patient's un-wounded skin and introduce a corrected version of the collagen VII gene to the skin cells. These cells are then grown into sheets of healthy skin. For the late-stage study, 11 patients with recessive dystrophic EB had a total of 43 wounds treated with grafts. For each treated wound, the researchers also identified a comparable "control" wound on the same patient that was managed with traditional measures. Six months later, 81% of treated wounds were at least half healed, compared with 16% of control wounds. Roughly two-thirds of treated wounds were at least three-quarters healed, compared with 7% of control wounds, and 16% of treated wounds had completely healed, compared with none of the control wounds. In addition, grafted areas had less pain, itching and blistering. The same research team had previously developed a gene therapy gel for treating smaller EB wounds. "I hope that if these patients are diagnosed as infants and start the gene therapy gel, maybe they won't develop big wounds," Tang said. "But if the gels don't work and a wound does expand, the skin graft therapy is the right treatment. The life arc of their disease will, I hope, be modified, with less suffering." An editorial published with the study notes that EB patients who participated in early-stage trials of the skin grafts still had decreased blistering and wounding, pain, and itch at grafted sites five years later. In April, the U.S. Food and Drug Administration granted Abeona Therapeutics approval for the skin grafts as an EB therapy. (To receive the full newsletter in your inbox for free sign up here)


Reuters
25-06-2025
- Health
- Reuters
Health Rounds: Inhaled insulin as good as injection for children at mealtime
June 25 (Reuters) - (This is an excerpt of the Health Rounds newsletter, where we present latest medical studies on Tuesdays and Thursdays. To receive the full newsletter in your inbox for free sign up here.) Children with diabetes who inhaled their mealtime doses of insulin did just as well as those who injected insulin under the skin, researchers reported at the American Diabetes Association, opens new tab scientific meeting in Chicago. To regulate their blood sugar, patients with type 1 diabetes usually require an injection of a long-acting basal insulin once a day, plus additional injections of rapid-acting insulins at mealtimes. MannKind's (MNKD.O), opens new tab inhaled insulin Afrezza is approved for use by adults but not yet for children, which prompted the study. The 230 children with type 1 diabetes, ages 4 to 17, who participated in the trial received either Afrezza at mealtimes, or their usual mealtime injections of insulin, for 26 weeks. Everyone continued to receive their basal insulin injections. Control of hemoglobin A1c, a marker of blood sugar control over the past several months, was comparable with the inhaled insulin and the injected insulin, the researchers found. Inhaled insulin was also associated with less weight gain and slightly higher child and parent preference scores. The inhaled formula did not have any adverse effects on patients' lungs, the researchers reported. 'Inhaled insulin is the fastest acting insulin available and is a valuable alternative to injected analogue insulin,' study leader Dr. Michael Haller of the University of Florida said in a statement. 'Afrezza should be available as an option to all children and adults with type 1 diabetes.' ONCE-WEEKLY INSULIN PROMISING FOR TYPE 2 DIABETES Eli Lilly's (LLY.N), opens new tab experimental once-weekly insulin efsitora was comparable to daily insulins in nearly a thousand adults with type 2 diabetes in three late-stage trials, researchers reported at the ADA meeting. The trials, which were designed to study patients at different stages of insulin use, each found efsitora to be just as effective as daily insulins for bringing HbA1c levels - a common measure of blood sugar over time - under control. 'Once-weekly efsitora may offer a significant advancement for people with type 2 diabetes who need insulin by eliminating over 300 injections per year," Lilly's senior vice president of product development, Jeff Emmick, said in a statement. One trial, reported in The New England Journal of Medicine, opens new tab, involved patients with type 2 diabetes who were using insulin for the first time. A second trial, opens new tab in patients who had been using daily basal insulin degludec and a third trial, opens new tab in those who had been taking basal insulin glargine plus extra mealtime insulin doses were both reported in The Lancet. Efsitora 'has the potential to facilitate and simplify insulin therapy, reducing the hesitation often associated with starting insulin to treat type 2 diabetes," Dr. Julio Rosenstock of University of Texas Southwestern Medical Center, who led one of the studies, said in a statement. People newly diagnosed with type 2 diabetes usually start treatment with oral medications, but roughly one-third of them will need to use insulin within 8 years of their diagnosis, according to an editorial, opens new tab in The Lancet. Long-lasting wounds from a painful genetic skin disease can be healed with skin grafts genetically engineered from a patient's own cells, researchers reported in The Lancet, opens new tab. In severe dystrophic epidermolysis bullosa, or EB, the skin is so fragile the slightest touch – even from clothing - causes blistering and wounds, eventually leading to large, open lesions that never heal. 'With our novel gene therapy technique, we successfully treated the hardest-to-heal wounds, which were usually also the most painful ones for these patients,' study leader Dr. Jean Tang of Lucile Packard Children's Hospital Stanford in Palo Alto, California said in a statement. Severe dystrophic EB is caused by a defect in the gene for collagen VII, a protein that normally holds the skin together. As a result, the layers of the skin separate in response to even slight friction. To create the personalized skin grafts, doctors take a small biopsy sample of the patient's un-wounded skin and introduce a corrected version of the collagen VII gene to the skin cells. These cells are then grown into sheets of healthy skin. For the late-stage study, 11 patients with recessive dystrophic EB had a total of 43 wounds treated with grafts. For each treated wound, the researchers also identified a comparable "control" wound on the same patient that was managed with traditional measures. Six months later, 81% of treated wounds were at least half healed, compared with 16% of control wounds. Roughly two-thirds of treated wounds were at least three-quarters healed, compared with 7% of control wounds, and 16% of treated wounds had completely healed, compared with none of the control wounds. In addition, grafted areas had less pain, itching and blistering. The same research team had previously developed a gene therapy gel for treating smaller EB wounds. 'I hope that if these patients are diagnosed as infants and start the gene therapy gel, maybe they won't develop big wounds,' Tang said. 'But if the gels don't work and a wound does expand, the skin graft therapy is the right treatment. The life arc of their disease will, I hope, be modified, with less suffering.' An editorial published with the study notes that EB patients who participated in early-stage trials of the skin grafts still had decreased blistering and wounding, pain, and itch at grafted sites five years later. In April, the U.S. Food and Drug Administration granted Abeona Therapeutics (ABEO.O), opens new tab approval for the skin grafts as an EB therapy. (To receive the full newsletter in your inbox for free sign up here)
Yahoo
23-06-2025
- Business
- Yahoo
MannKind (MNKD) Presents Pediatric Insulin Trial Data
MannKind Corporation (NASDAQ:MNKD) is one of the 11 Best US Stocks to Invest in Under $5. MannKind Corporation (NASDAQ:MNKD) reported that it will present its inhaled insulin product at the American Diabetes Association's 85th Scientific Sessions, which is taking place from June 20 to June 23 in Chicago. During a 'Future Ready' symposium, Dr. Michael J. Haller, Professor and Chief of Pediatric Endocrinology at the University of Florida, will share results from the randomized period of the INHALE-1 clinical trial. Dr. Haller also serves as the Chair for MannKind Corporation's (NASDAQ:MNKD) Phase 3 INHALE-1 study of Afrezza, an inhaled insulin powder, in children and adolescents between 4 and 17 years old. A close-up of a doctor's hand pressing on an inhaler, conveying the effect of the company's therapeutic products. MannKind Corporation (NASDAQ:MNKD) aims to release the topline results from the full pediatric study with safety extension in the second quarter of 2025. The company also expects to submit a Supplemental Biologics License Application in mid-2025 for a possible pediatric indication for Afrezza. MannKind Corporation (NASDAQ:MNKD) is a biopharmaceutical company focused on developing and commercializing innovative inhaled therapeutic products and devices for those living with endocrine and orphan lung diseases. While we acknowledge the potential of MNKD as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 11 Stocks That Will Bounce Back According To Analysts and 11 Best Stocks Under $15 to Buy According to Hedge Funds. Disclosure: None.
Yahoo
10-06-2025
- Health
- Yahoo
MannKind to Highlight Data from Recent Pediatric and Adult Studies of Inhaled Insulin (Afrezza®) at American Diabetes Association's 85th Scientific Sessions in Chicago, June 20-23
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., June 09, 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 inhaled insulin at the American Diabetes Association's (ADA) 85th Scientific Sessions from June 20-23 in Chicago. Dr. Michael J. Haller, Professor and Chief of Pediatric Endocrinology at the University of Florida, will present the results from the randomized period of the INHALE-1 clinical trial during a 'Future Ready' symposium. Dr. Haller is the Chair for MannKind's Phase 3 INHALE-1 study of Afrezza (insulin human) Inhalation Powder in children and adolescents (aged 4-17 years of age). The presentation/posters planned at ADA's 85th Scientific Sessions regarding the most recent advances in inhaled insulin treatment include: Symposium – Future Ready – Breakthrough in Pediatric Type 1 Diabetes Care Sunday, June 22 – 1:30 to 3:00 p.m. (Central) in Room W 181(A-C)Dr. Michael J. Haller will present: From Discovery to Treatment – Latest Updates on Inhaled Insulin Treatment Patient Reported Outcomes with Use of Inhaled Technosphere Insulin (T1) (Board 827)Saturday, June 21, 2025 – 12:30 to 1:30 p.m. (Central) Presenter: Dr. Peter Calhoun Efficacy and Safety of Prandial Technosphere Inhaled Insulin (Afrezza) Compared with Placebo in Adult Individuals with T2DM – Results from a Phase III Clinical Trial from India (Board No. 833)Saturday, June 21, 2025 – 12:30 to 1:30 p.m. (Central) Presenter: Dr. K M Prasanna Kumar Additionally, MannKind will host booth #1617 in the Exhibit Hall throughout the ADA's Scientific Sessions. Members of MannKind's Medical Education Team will be available for scientific exchange in the medical section of the booth. For more information about ADA's Scientific Sessions programming, and/or to register to attend the conference, please visit: MannKind expects to issue the topline results from the full study pediatric data set with safety extension in 2Q 2025 and anticipates submitting a Supplemental Biologics License Application in mid-2025 for a potential pediatric indication for Afrezza. About MannKindMannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life. Please visit to learn more, and follow us on LinkedIn, Facebook, X or Instagram. Forward-Looking StatementsThis press release contains forward-looking statements about a planned release of scientific data and a potential sBLA submission for Afrezza that involves risks and uncertainties. Words such as 'believes', 'anticipates', 'plans', 'expects', 'intends', 'will', 'goal', 'potential' and similar expressions are intended to identify forward-looking statements. These 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 issues that develop in the preparation of data releases and filings may subject us to unanticipated delays as well as other risks detailed in MannKind's filings with the Securities and Exchange Commission, including under the 'Risk Factors' heading of its Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. 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. AFREZZA and MANNKIND are registered trademarks of MannKind Corporation. CONTACT: MannKind Contacts: Media Relations Christie Iacangelo, (818) 292-3500 Email: media@ Investor Relations Ana Kapor, (818) 661-5000 Email: ir@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
09-06-2025
- Health
- Yahoo
MannKind to Highlight Data from Recent Pediatric and Adult Studies of Inhaled Insulin (Afrezza®) at American Diabetes Association's 85th Scientific Sessions in Chicago, June 20-23
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., June 09, 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 inhaled insulin at the American Diabetes Association's (ADA) 85th Scientific Sessions from June 20-23 in Chicago. Dr. Michael J. Haller, Professor and Chief of Pediatric Endocrinology at the University of Florida, will present the results from the randomized period of the INHALE-1 clinical trial during a 'Future Ready' symposium. Dr. Haller is the Chair for MannKind's Phase 3 INHALE-1 study of Afrezza (insulin human) Inhalation Powder in children and adolescents (aged 4-17 years of age). The presentation/posters planned at ADA's 85th Scientific Sessions regarding the most recent advances in inhaled insulin treatment include: Symposium – Future Ready – Breakthrough in Pediatric Type 1 Diabetes Care Sunday, June 22 – 1:30 to 3:00 p.m. (Central) in Room W 181(A-C)Dr. Michael J. Haller will present: From Discovery to Treatment – Latest Updates on Inhaled Insulin Treatment Patient Reported Outcomes with Use of Inhaled Technosphere Insulin (T1) (Board 827)Saturday, June 21, 2025 – 12:30 to 1:30 p.m. (Central) Presenter: Dr. Peter Calhoun Efficacy and Safety of Prandial Technosphere Inhaled Insulin (Afrezza) Compared with Placebo in Adult Individuals with T2DM – Results from a Phase III Clinical Trial from India (Board No. 833)Saturday, June 21, 2025 – 12:30 to 1:30 p.m. (Central) Presenter: Dr. K M Prasanna Kumar Additionally, MannKind will host booth #1617 in the Exhibit Hall throughout the ADA's Scientific Sessions. Members of MannKind's Medical Education Team will be available for scientific exchange in the medical section of the booth. For more information about ADA's Scientific Sessions programming, and/or to register to attend the conference, please visit: MannKind expects to issue the topline results from the full study pediatric data set with safety extension in 2Q 2025 and anticipates submitting a Supplemental Biologics License Application in mid-2025 for a potential pediatric indication for Afrezza. About MannKindMannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life. Please visit to learn more, and follow us on LinkedIn, Facebook, X or Instagram. Forward-Looking StatementsThis press release contains forward-looking statements about a planned release of scientific data and a potential sBLA submission for Afrezza that involves risks and uncertainties. Words such as 'believes', 'anticipates', 'plans', 'expects', 'intends', 'will', 'goal', 'potential' and similar expressions are intended to identify forward-looking statements. These 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 issues that develop in the preparation of data releases and filings may subject us to unanticipated delays as well as other risks detailed in MannKind's filings with the Securities and Exchange Commission, including under the 'Risk Factors' heading of its Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. 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. AFREZZA and MANNKIND are registered trademarks of MannKind Corporation. CONTACT: MannKind Contacts: Media Relations Christie Iacangelo, (818) 292-3500 Email: media@ Investor Relations Ana Kapor, (818) 661-5000 Email: ir@ in to access your portfolio