Lexicon Pharmaceuticals Aktie WKN: 936717 ISIN: US5288721047 Symbol: LXRX Typ: Aktie (Seite 7)
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ISIN: US5288723027 · WKN: A14SSK · Symbol: LXRX
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Aktie bei $3.41 :-( - alle small Biotechs gedumpt
https://www.lexpharma.com/media-center/news/797-lexicon-phar…
https://www.lexpharma.com/media-center/news/797-lexicon-phar…
Jetzt 💰
https://finance.yahoo.com/news/lexicon-submits-drug-applicat…
Lexicon Submits New Drug Application for Sotagliflozin for the Treatment of Heart Failure in Adults With Type 2 Diabetes
Lexicon Pharmaceuticals, Inc.
Thu, December 30, 2021, 10:05 PM·4 min read
In this article:
THE WOODLANDS, Texas, Dec. 30, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of sotagliflozin to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure irrespective of left ventricular ejection fraction. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.
“The submission of the NDA for sotagliflozin brings us one step closer to the possibility of bringing this innovative new investigational treatment to those who are suffering from heart failure and living with type 2 diabetes on a daily basis,” said Lonnel Coats, Lexicon’s chief executive officer. “We look forward to working closely with the FDA during the review process.”
The NDA submission is supported by the results from the Phase 3 SOLOIST clinical study in patients with type 2 diabetes who had recently been hospitalized for worsening heart failure and the Phase 3 SCORED clinical study in patients with type 2 diabetes, chronic kidney disease and risks for cardiovascular disease.
About the SOLOIST and SCORED Studies
SOLOIST was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 1,222 patients with type 2 diabetes who had recently been hospitalized for worsening heart failure. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo.
SCORED was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 10,584 patients with type 2 diabetes, chronic kidney disease with eGFR of 25 to 60 ml per minute per 1.73 m2 of body-surface area, and risks for cardiovascular disease. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo.
Both SOLOIST and SCORED achieved their respective primary endpoints, with overall tolerability similar to placebo across both trials. Results from both studies were presented at the Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions 2020 and simultaneously published in The New England Journal of Medicine (NEJM) in two separate articles titled: “Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure” and “Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease.”
https://finance.yahoo.com/news/lexicon-submits-drug-applicat…
Lexicon Submits New Drug Application for Sotagliflozin for the Treatment of Heart Failure in Adults With Type 2 Diabetes
Lexicon Pharmaceuticals, Inc.
Thu, December 30, 2021, 10:05 PM·4 min read
In this article:
THE WOODLANDS, Texas, Dec. 30, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of sotagliflozin to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure irrespective of left ventricular ejection fraction. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.
“The submission of the NDA for sotagliflozin brings us one step closer to the possibility of bringing this innovative new investigational treatment to those who are suffering from heart failure and living with type 2 diabetes on a daily basis,” said Lonnel Coats, Lexicon’s chief executive officer. “We look forward to working closely with the FDA during the review process.”
The NDA submission is supported by the results from the Phase 3 SOLOIST clinical study in patients with type 2 diabetes who had recently been hospitalized for worsening heart failure and the Phase 3 SCORED clinical study in patients with type 2 diabetes, chronic kidney disease and risks for cardiovascular disease.
About the SOLOIST and SCORED Studies
SOLOIST was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 1,222 patients with type 2 diabetes who had recently been hospitalized for worsening heart failure. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo.
SCORED was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 10,584 patients with type 2 diabetes, chronic kidney disease with eGFR of 25 to 60 ml per minute per 1.73 m2 of body-surface area, and risks for cardiovascular disease. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo.
Both SOLOIST and SCORED achieved their respective primary endpoints, with overall tolerability similar to placebo across both trials. Results from both studies were presented at the Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions 2020 and simultaneously published in The New England Journal of Medicine (NEJM) in two separate articles titled: “Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure” and “Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease.”
Antwort auf Beitrag Nr.: 70.300.418 von Charly_2 am 22.12.21 18:18:54Blockbuster!
Schreiben - Lexicon muss daraus Antrag für neues Medikament (gegen Herzinfarkt) stellen, das ist alleine in den USA ein Multi Billionen USD Markt
https://downloads.regulations.gov/FDA-2021-N-0208-0081/attac…
https://downloads.regulations.gov/FDA-2021-N-0208-0081/attac…
Ab Stocktwits
Just listen to Lionel’s pitch in London with the exception of marketing and sales tidbits is the same speech he gave in July at the second quarter CC.
The Wall Street guys at this convention don’t give a flying fuck about HFHF, inhibitors and type one and type two diabetes they want to know when it’s going to be approved when they’re going to start making money and how much money they’re going to make no wonder this stock has flatlined. Tomorrow I’m gonna buy some more and continue to do so every week-because it’s one of the most undervalued stocks in the NASDAQ even at a bankruptcy garage sale it’s Gene technology research is worth $6 a share! I believe the only risk is losing your sanity.
Kurs aktuell $4.96 - aufstocken angesagt!
Just listen to Lionel’s pitch in London with the exception of marketing and sales tidbits is the same speech he gave in July at the second quarter CC.
The Wall Street guys at this convention don’t give a flying fuck about HFHF, inhibitors and type one and type two diabetes they want to know when it’s going to be approved when they’re going to start making money and how much money they’re going to make no wonder this stock has flatlined. Tomorrow I’m gonna buy some more and continue to do so every week-because it’s one of the most undervalued stocks in the NASDAQ even at a bankruptcy garage sale it’s Gene technology research is worth $6 a share! I believe the only risk is losing your sanity.
Kurs aktuell $4.96 - aufstocken angesagt!
Trading Spotlight
Antwort auf Beitrag Nr.: 69.915.815 von Charly_2 am 14.11.21 23:16:01Lexicon’s Sotagliflozin Demonstrates Benefits in Heart Failure and Blood Glucose Control Across the Full Range of Kidney Function in New Analysis of Clinical Data
November 14, 2021 08:35 ET
| Source: Lexicon Pharmaceuticals, Inc.
Post hoc analysis of pooled clinical data from the SOLOIST and SCORED trials supporting benefit of sotagliflozin presented at the virtual American Heart Association Scientific Sessions 2021, including:
Sotaglifozin significantly reduced total cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure across the full range of kidney function studied.
Sotaglifozin also significantly reduced hemoglobin A1c, a goal of diabetes management, across the full range of kidney function studied, including individuals with moderate-to-severe chronic kidney disease.
THE WOODLANDS, Texas, Nov. 14, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that a new analysis evaluating the clinical benefit of Lexicon’s investigational drug, sotagliflozin, in heart failure and blood glucose control across the full range of kidney function was presented at the virtual American Heart Association Scientific Sessions 2021.
The new analysis was presented by the study chair for the SOLOIST and SCORED trials, Deepak L. Bhatt, M.D., M.P.H., executive director of Interventional Cardiovascular Programs at Brigham and Women's Hospital, and professor of medicine at Harvard Medical School. The presentation, broadcast at 8:24 a.m. ET today and entitled, “Cardiovascular Benefits of Sodium Glucose Cotransporter-1/2 Inhibition with Sotagliflozin Across Baseline Kidney Function,” can be downloaded from the AHA website.
Heart and kidney disease are often interconnected, with chronic kidney disease considered to be an independent risk factor for heart failure and cardiovascular disease.i It is estimated that around half of patients with type 2 diabetes have chronic kidney disease.ii
“In this new analysis of pooled clinical data from the SOLOIST and SCORED trials, sotagliflozin consistently reduced total cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure across the full range of kidney function,” said Dr. Bhatt. “Sotagliflozin, with its dual mechanism of SGLT1 and SGLT2 inhibition, also significantly reduced hemoglobin A1c across the full range of kidney function studied, including patients with severe renal impairment or an estimated glomerular filtration rate between 25 and 30 ml/min/1.73m2, with a magnitude of effect that has not been reported in studies of selective SGLT2 inhibitors.”
The pooled analysis of clinical data from the SOLOIST and SCORED trials involved a total of 11,806 patients with diabetes and heart failure or cardiovascular risk factors.
“This continued research provides further evidence of the rapid, robust and broad benefits observed in the SOLOIST and SCORED studies of sotagliflozin in heart failure,” said Lexicon senior vice president and chief medical officer Craig B. Granowitz, M.D., Ph.D. “We believe these results will strengthen the new drug application we plan on filing with the U.S. Food and Drug Administration around year-end. If approved, we believe sotagliflozin has the potential to become an important new therapeutic option for heart failure in patients with type 2 diabetes. With its unique dual SGLT1 and SGLT2 inhibition, sotagliflozin continues to show benefits we believe to be differentiating for a broad range of patients suffering from heart failure or at a higher risk for heart failure.”
About the SOLOIST and SCORED Studies
SOLOIST was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 1,222 patients with type 2 diabetes who had recently been hospitalized for worsening heart failure. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo.
SCORED was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 10,584 patients with type 2 diabetes, chronic kidney disease with eGFR of 25 to 60 ml per minute per 1.73 m2 of body-surface area, and risks for cardiovascular disease. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo.
Both SOLOIST and SCORED achieved their respective primary endpoints, with overall tolerability similar to placebo across both trials. Results from both studies were presented at the Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions 2020 and simultaneously published in The New England Journal of Medicine (NEJM) in two separate articles titled: “Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure” and “Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease.”
About Sotagliflozin
Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Sotagliflozin is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy, but has not yet been commercially launched
November 14, 2021 08:35 ET
| Source: Lexicon Pharmaceuticals, Inc.
Post hoc analysis of pooled clinical data from the SOLOIST and SCORED trials supporting benefit of sotagliflozin presented at the virtual American Heart Association Scientific Sessions 2021, including:
Sotaglifozin significantly reduced total cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure across the full range of kidney function studied.
Sotaglifozin also significantly reduced hemoglobin A1c, a goal of diabetes management, across the full range of kidney function studied, including individuals with moderate-to-severe chronic kidney disease.
THE WOODLANDS, Texas, Nov. 14, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that a new analysis evaluating the clinical benefit of Lexicon’s investigational drug, sotagliflozin, in heart failure and blood glucose control across the full range of kidney function was presented at the virtual American Heart Association Scientific Sessions 2021.
The new analysis was presented by the study chair for the SOLOIST and SCORED trials, Deepak L. Bhatt, M.D., M.P.H., executive director of Interventional Cardiovascular Programs at Brigham and Women's Hospital, and professor of medicine at Harvard Medical School. The presentation, broadcast at 8:24 a.m. ET today and entitled, “Cardiovascular Benefits of Sodium Glucose Cotransporter-1/2 Inhibition with Sotagliflozin Across Baseline Kidney Function,” can be downloaded from the AHA website.
Heart and kidney disease are often interconnected, with chronic kidney disease considered to be an independent risk factor for heart failure and cardiovascular disease.i It is estimated that around half of patients with type 2 diabetes have chronic kidney disease.ii
“In this new analysis of pooled clinical data from the SOLOIST and SCORED trials, sotagliflozin consistently reduced total cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure across the full range of kidney function,” said Dr. Bhatt. “Sotagliflozin, with its dual mechanism of SGLT1 and SGLT2 inhibition, also significantly reduced hemoglobin A1c across the full range of kidney function studied, including patients with severe renal impairment or an estimated glomerular filtration rate between 25 and 30 ml/min/1.73m2, with a magnitude of effect that has not been reported in studies of selective SGLT2 inhibitors.”
The pooled analysis of clinical data from the SOLOIST and SCORED trials involved a total of 11,806 patients with diabetes and heart failure or cardiovascular risk factors.
“This continued research provides further evidence of the rapid, robust and broad benefits observed in the SOLOIST and SCORED studies of sotagliflozin in heart failure,” said Lexicon senior vice president and chief medical officer Craig B. Granowitz, M.D., Ph.D. “We believe these results will strengthen the new drug application we plan on filing with the U.S. Food and Drug Administration around year-end. If approved, we believe sotagliflozin has the potential to become an important new therapeutic option for heart failure in patients with type 2 diabetes. With its unique dual SGLT1 and SGLT2 inhibition, sotagliflozin continues to show benefits we believe to be differentiating for a broad range of patients suffering from heart failure or at a higher risk for heart failure.”
About the SOLOIST and SCORED Studies
SOLOIST was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 1,222 patients with type 2 diabetes who had recently been hospitalized for worsening heart failure. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo.
SCORED was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 10,584 patients with type 2 diabetes, chronic kidney disease with eGFR of 25 to 60 ml per minute per 1.73 m2 of body-surface area, and risks for cardiovascular disease. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo.
Both SOLOIST and SCORED achieved their respective primary endpoints, with overall tolerability similar to placebo across both trials. Results from both studies were presented at the Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions 2020 and simultaneously published in The New England Journal of Medicine (NEJM) in two separate articles titled: “Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure” and “Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease.”
About Sotagliflozin
Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Sotagliflozin is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy, but has not yet been commercially launched
Ich hasse Charts 
da sie stets nur eine aktuelle Situation aufzeigen, rückwärtsgewandt :-)
https://realmoney.thestreet.com/investing/take-a-pass-on-lex…
da sie stets nur eine aktuelle Situation aufzeigen, rückwärtsgewandt :-)https://realmoney.thestreet.com/investing/take-a-pass-on-lex…
https://www.practicalcardiology.com/view/the-future-of-sotag…
Deepak Bhatt, MD, discusses a presentation he gave at ESC Congress 2021 on SGLT2, 1/2 inhibition and reflects on the potential for sotagliflozin to receive approval from the FDA based on data from SOLOIST-WHF and SCORED.
Although SGLT2 inhibitors have put the ‘flozins’ at centerstage at recent cardiology conferences, a unique newcomer to the group has been making waves since a pair of phase 3 trials were presented at the American Heart Association 2020 Annual Meeting.
A dual SGLT1/2 inhibitor, sotagliflozin made a splash in late 2020 with the SOLOIST-WHF and SCORED trials, which demonstrated the agent provided meaningful benefit in patients with diabetes and chronic kidney disease or heart failure. Despite impressive data from its phase 3 program, sotagliflozin has no existing FDA indications, unlike other SGLT2 inhibitors.
The subject of SLGT1/2 inhibition and its effect on cardiovascular and kidney endpoints was the subject of a late-breaking presentation led by principal investigator of the SOLOIST-WHF and SCORED trials Deepak Bhatt, MD, MPH, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital, at the European Society of Cardiology (ESC) Congress 2021. With an interest in learning more about sotagliflozin and its potential for receiving an FDA indication in the future, we reached to Bhatt for more perspective and that conversation is the subject of this ESC Congress 2021 House Call.
Deepak Bhatt, MD, discusses a presentation he gave at ESC Congress 2021 on SGLT2, 1/2 inhibition and reflects on the potential for sotagliflozin to receive approval from the FDA based on data from SOLOIST-WHF and SCORED.
Although SGLT2 inhibitors have put the ‘flozins’ at centerstage at recent cardiology conferences, a unique newcomer to the group has been making waves since a pair of phase 3 trials were presented at the American Heart Association 2020 Annual Meeting.
A dual SGLT1/2 inhibitor, sotagliflozin made a splash in late 2020 with the SOLOIST-WHF and SCORED trials, which demonstrated the agent provided meaningful benefit in patients with diabetes and chronic kidney disease or heart failure. Despite impressive data from its phase 3 program, sotagliflozin has no existing FDA indications, unlike other SGLT2 inhibitors.
The subject of SLGT1/2 inhibition and its effect on cardiovascular and kidney endpoints was the subject of a late-breaking presentation led by principal investigator of the SOLOIST-WHF and SCORED trials Deepak Bhatt, MD, MPH, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital, at the European Society of Cardiology (ESC) Congress 2021. With an interest in learning more about sotagliflozin and its potential for receiving an FDA indication in the future, we reached to Bhatt for more perspective and that conversation is the subject of this ESC Congress 2021 House Call.
Antwort auf Beitrag Nr.: 69.186.360 von Charly_2 am 30.08.21 14:08:34Amis sind arme Luschen, dumpen den Kurs um günstigst an Aktien zu kommen, über 5 Mio Aktien über den Tisch, krasse Bande! 🙈
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