Lexicon Pharmaceuticals Aktie WKN: 936717 ISIN: US5288721047 Symbol: LXRX Typ: Aktie (Seite 13)
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Antwort auf Beitrag Nr.: 59.965.684 von bernie55 am 26.02.19 12:53:10Sanofi : CHMP recommends ZynquistaTM (sotagliflozin) for the treatment of adults with type 1 diabetes
The CHMP recommended approval of sotagliflozin in the European Union (EU) in both a 200-mg and 400-mg dose for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes (T1D) mellitus with a body mass index >= 27 kg/m2, who have failed to achieve adequate glycemic control despite optimal insulin therapy.
Sotagliflozin is an investigational oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2).1 SGLT1 is responsible for glucose absorption in the gastrointestinal tract,2 and SGLT2 is responsible for glucose reabsorption by the kidney.3
The CHMP opinion is based on evidence including data from the inTandem clinical trial program, which included three Phase 3 clinical trials assessing the safety and efficacy of sotagliflozin in approximately 3,000 adults with inadequately controlled T1D. These three trials demonstrated that treatment with sotagliflozin, when given to adults with inadequately controlled T1D as an oral adjunct to insulin, resulted in consistent, significant reductions from baseline at 24 weeks in average blood sugar (HbA1c), body weight, systolic blood pressure and a significant improvement of time in target blood sugar range, versus insulin alone, at both 200-mg and 400-mg doses.4-7
The European Commission is expected to make a final decision on the Marketing Authorization Application for sotagliflozin in the EU in the coming months.
https://finance.yahoo.com/news/sanofi-chmp-recommends-zynqui…l
The CHMP recommended approval of sotagliflozin in the European Union (EU) in both a 200-mg and 400-mg dose for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes (T1D) mellitus with a body mass index >= 27 kg/m2, who have failed to achieve adequate glycemic control despite optimal insulin therapy.
Sotagliflozin is an investigational oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2).1 SGLT1 is responsible for glucose absorption in the gastrointestinal tract,2 and SGLT2 is responsible for glucose reabsorption by the kidney.3
The CHMP opinion is based on evidence including data from the inTandem clinical trial program, which included three Phase 3 clinical trials assessing the safety and efficacy of sotagliflozin in approximately 3,000 adults with inadequately controlled T1D. These three trials demonstrated that treatment with sotagliflozin, when given to adults with inadequately controlled T1D as an oral adjunct to insulin, resulted in consistent, significant reductions from baseline at 24 weeks in average blood sugar (HbA1c), body weight, systolic blood pressure and a significant improvement of time in target blood sugar range, versus insulin alone, at both 200-mg and 400-mg doses.4-7
The European Commission is expected to make a final decision on the Marketing Authorization Application for sotagliflozin in the EU in the coming months.
https://finance.yahoo.com/news/sanofi-chmp-recommends-zynqui…l
EMA - CHMP entscheidet in den nächsten Tagen über Sotagliflozin ( 25.02.-28.02.)
3.1.8. sotagliflozin - EMEA/H/C/004889
indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1
diabetes mellitus.
Scope: Opinion
Action: For adoption
List of Outstanding Issues adopted on 31.01.2019, 15.11.2018. List of Questions adopted on
26.07.2018.
https://www.ema.europa.eu/documents/agenda/agenda-chmp-agend…
3.1.8. sotagliflozin - EMEA/H/C/004889
indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1
diabetes mellitus.
Scope: Opinion
Action: For adoption
List of Outstanding Issues adopted on 31.01.2019, 15.11.2018. List of Questions adopted on
26.07.2018.
https://www.ema.europa.eu/documents/agenda/agenda-chmp-agend…
F.D.A. Panel Splits on Whether to Approve New Diabetes Drug
The advisory committee voted 8-8 on approving the drug, to be called Zynquista, which would be the first oral medication for people with Type 1 diabetes.
Jan. 17, 2019
An advisory panel for the Food and Drug Administration split evenly on Thursday over whether the agency should approve the first oral medication to treat Type 1 diabetes.
The committee voted 8-8, leaving it up to the agency to decide by the end of March whether the drug, sotagliflozin, should reach the market.
The drug, which is used along with insulin, is being developed by the drug makers Sanofi and Lexicon Pharmaceuticals, who plan to sell it under the brand name Zynquista. It carries a higher risk for developing diabetic ketoacidosis, a life-threatening complication that happens when the body doesn’t get enough insulin, which led some of the reviewers to vote against it.
The companies said they would continue work with the F.D.A. throughout the review process.
The drug is a once-daily pill designed to help people manage their blood sugar levels. In Type 1 diabetes — also known as juvenile diabetes because it is often diagnosed in childhood — the body does not produce insulin, so people with the disease must monitor their blood sugar and take insulin. But relying on external insulin can lead the body’s blood sugar levels to rise and fall, which is uncomfortable and can lead to health problems.
Like some other recently approved drugs for people with Type 2 diabetes — including Invokana and Jardiance — this one causes the body to excrete more blood sugar into the urine.
The drug’s approval would be based on the results of three clinical trials involving about 3,000 people. The trials found that the drug helped patients manage their blood sugar levels and brought other benefits, such as lower blood pressure and some weight loss.
But among patients who were given the drug, there were 56 cases of diabetic ketoacidosis in 1,748 patients, or 3.2 percent. In patients who took the placebo, by contrast, there were 5 cases out of 1,229 patients, or 0.4 percent.
Diabetic ketoacidosis, which is always a risk for people with Type 1 diabetes, can result in serious hospitalization or death. Several panel members said they worried the risk could be even higher in the real world, outside the confines of a clinical trial.
“I didn’t think it was ready for prime time,” said Dr. Jack A. Yanovski, of the National Institutes of Health, who voted against it. “The degree of benefit is small enough that it’s not clear that it could overwhelm the increased risk for very serious complications.”
But others said patients with Type 1 diabetes needed new treatments. Several patients who had received the drug in the clinical trial testified at the meeting, saying it had improved their quality of life. “It’s a step in the right direction,” said Susan Lellock, the panel’s patient representative, who voted in favor of approval. “With guidance, they need this. They need it desperately.”
Several panel members, including those who voted both for and against its approval, said the F.D.A. should require the drug makers to sell the drug under a strict plan for how patients should be monitored and educated about the risks of taking the drug.
Although the vast majority of Americans with diabetes have Type 2 diabetes, about 1.25 million people in the United States have Type 1, and an estimated 40,000 people each year will be diagnosed with it, according to the American Diabetes Association.
Diabetes drugs have come under a different kind of scrutiny because of the price of insulin, which has skyrocketed in recent years and led some patients to cut back on using it. Sanofi declined to comment on the potential price of Zynquista if it is approved.
Sheila Kaplan contributed reporting.
https://www.nytimes.com/2019/01/17/health/fda-diabetes-drug-…
The advisory committee voted 8-8 on approving the drug, to be called Zynquista, which would be the first oral medication for people with Type 1 diabetes.
Jan. 17, 2019
An advisory panel for the Food and Drug Administration split evenly on Thursday over whether the agency should approve the first oral medication to treat Type 1 diabetes.
The committee voted 8-8, leaving it up to the agency to decide by the end of March whether the drug, sotagliflozin, should reach the market.
The drug, which is used along with insulin, is being developed by the drug makers Sanofi and Lexicon Pharmaceuticals, who plan to sell it under the brand name Zynquista. It carries a higher risk for developing diabetic ketoacidosis, a life-threatening complication that happens when the body doesn’t get enough insulin, which led some of the reviewers to vote against it.
The companies said they would continue work with the F.D.A. throughout the review process.
The drug is a once-daily pill designed to help people manage their blood sugar levels. In Type 1 diabetes — also known as juvenile diabetes because it is often diagnosed in childhood — the body does not produce insulin, so people with the disease must monitor their blood sugar and take insulin. But relying on external insulin can lead the body’s blood sugar levels to rise and fall, which is uncomfortable and can lead to health problems.
Like some other recently approved drugs for people with Type 2 diabetes — including Invokana and Jardiance — this one causes the body to excrete more blood sugar into the urine.
The drug’s approval would be based on the results of three clinical trials involving about 3,000 people. The trials found that the drug helped patients manage their blood sugar levels and brought other benefits, such as lower blood pressure and some weight loss.
But among patients who were given the drug, there were 56 cases of diabetic ketoacidosis in 1,748 patients, or 3.2 percent. In patients who took the placebo, by contrast, there were 5 cases out of 1,229 patients, or 0.4 percent.
Diabetic ketoacidosis, which is always a risk for people with Type 1 diabetes, can result in serious hospitalization or death. Several panel members said they worried the risk could be even higher in the real world, outside the confines of a clinical trial.
“I didn’t think it was ready for prime time,” said Dr. Jack A. Yanovski, of the National Institutes of Health, who voted against it. “The degree of benefit is small enough that it’s not clear that it could overwhelm the increased risk for very serious complications.”
But others said patients with Type 1 diabetes needed new treatments. Several patients who had received the drug in the clinical trial testified at the meeting, saying it had improved their quality of life. “It’s a step in the right direction,” said Susan Lellock, the panel’s patient representative, who voted in favor of approval. “With guidance, they need this. They need it desperately.”
Several panel members, including those who voted both for and against its approval, said the F.D.A. should require the drug makers to sell the drug under a strict plan for how patients should be monitored and educated about the risks of taking the drug.
Although the vast majority of Americans with diabetes have Type 2 diabetes, about 1.25 million people in the United States have Type 1, and an estimated 40,000 people each year will be diagnosed with it, according to the American Diabetes Association.
Diabetes drugs have come under a different kind of scrutiny because of the price of insulin, which has skyrocketed in recent years and led some patients to cut back on using it. Sanofi declined to comment on the potential price of Zynquista if it is approved.
Sheila Kaplan contributed reporting.
https://www.nytimes.com/2019/01/17/health/fda-diabetes-drug-…
Antwort auf Beitrag Nr.: 59.645.450 von bernie55 am 16.01.19 16:59:37Endocrinologic and Metabolic Drugs Advisory Committee Meeting Set for January 17, 2019
8 - YES ---- 8 - NO
8 - YES ---- 8 - NO
Endocrinologic and Metabolic Drugs Advisory Committee Meeting Set for January 17, 2019
The Woodlands, TX – November 29, 2018 - Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) plans to review Lexicon collaborator Sanofi’s New Drug Application (NDA) for sotagliflozin, an investigational oral treatment for adults with type 1 diabetes, on January 17, 2019.
The FDA accepted the NDA for sotagliflozin on May 22, 2018. The NDA included data from the inTandem clinical trial program, which includes three Phase 3 clinical trials assessing the safety and efficacy of sotagliflozin in approximately 3,000 adults with inadequately controlled type 1 diabetes.
The target date for an FDA action regarding sotagliflozin under the Prescription Drug User Fee Act (PDUFA) is anticipated to be March 22, 2019.
http://www.lexpharma.com/media-center/news/691-fda-advisory-…
https://www.fda.gov/AdvisoryCommittees/Calendar/ucm627271.ht…
The Woodlands, TX – November 29, 2018 - Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) plans to review Lexicon collaborator Sanofi’s New Drug Application (NDA) for sotagliflozin, an investigational oral treatment for adults with type 1 diabetes, on January 17, 2019.
The FDA accepted the NDA for sotagliflozin on May 22, 2018. The NDA included data from the inTandem clinical trial program, which includes three Phase 3 clinical trials assessing the safety and efficacy of sotagliflozin in approximately 3,000 adults with inadequately controlled type 1 diabetes.
The target date for an FDA action regarding sotagliflozin under the Prescription Drug User Fee Act (PDUFA) is anticipated to be March 22, 2019.
http://www.lexpharma.com/media-center/news/691-fda-advisory-…
https://www.fda.gov/AdvisoryCommittees/Calendar/ucm627271.ht…
Trading Spotlight
Lexicon Pharmaceuticals to Present at Upcoming Investor Conference
GlobeNewswire•December 21, 2018
THE WOODLANDS, Texas, Dec. 21, 2018 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (LXRX) today announced that Lonnel Coats, President and Chief Executive Officer, will present at the following conference:
37th Annual J.P. Morgan Healthcare Conference on Tuesday, January 8, 2019 at 12:00 p.m. PST in San Francisco, CA.
A live audio webcast for this conference will be available in the “Investors” section of the Lexicon website at www.lexpharma.com/.
An archived version of the webcast will be available on the website for two weeks.
https://finance.yahoo.com/news/lexicon-pharmaceuticals-prese…" target="_blank" rel="nofollow ugc noopener">
https://finance.yahoo.com/news/lexicon-pharmaceuticals-prese…
GlobeNewswire•December 21, 2018
THE WOODLANDS, Texas, Dec. 21, 2018 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (LXRX) today announced that Lonnel Coats, President and Chief Executive Officer, will present at the following conference:
37th Annual J.P. Morgan Healthcare Conference on Tuesday, January 8, 2019 at 12:00 p.m. PST in San Francisco, CA.
A live audio webcast for this conference will be available in the “Investors” section of the Lexicon website at www.lexpharma.com/.
An archived version of the webcast will be available on the website for two weeks.
https://finance.yahoo.com/news/lexicon-pharmaceuticals-prese…" target="_blank" rel="nofollow ugc noopener">
https://finance.yahoo.com/news/lexicon-pharmaceuticals-prese…
Lexicon Pharmaceuticals to Present at Upcoming Investor Conference
August 30, 2018 07:00 ET
THE WOODLANDS, Texas, Aug. 30, 2018 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc.(Nasdaq:LXRX) today announced that Jeffrey L. Wade, J.D., Executive Vice President, Corporate and Administrative Affairs and Chief Financial Officer, will present at the following conference:
Bank of America Merrill Lynch 2018 Global Healthcare Conference on Thursday, September 13, 2018 at 4:30 p.m. BST (10:30 a.m. CDT) in London.
A live audio webcast for this conference will be available in the “Investors” section of the Lexicon website at www.lexpharma.com. An archived version of the webcast will be available on the website for two weeks
http://globenewswire.com/news-release/2018/08/30/1563223/0/e…
August 30, 2018 07:00 ET
THE WOODLANDS, Texas, Aug. 30, 2018 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc.(Nasdaq:LXRX) today announced that Jeffrey L. Wade, J.D., Executive Vice President, Corporate and Administrative Affairs and Chief Financial Officer, will present at the following conference:
Bank of America Merrill Lynch 2018 Global Healthcare Conference on Thursday, September 13, 2018 at 4:30 p.m. BST (10:30 a.m. CDT) in London.
A live audio webcast for this conference will be available in the “Investors” section of the Lexicon website at www.lexpharma.com. An archived version of the webcast will be available on the website for two weeks
http://globenewswire.com/news-release/2018/08/30/1563223/0/e…
Lexicon Pharmaceuticals to Present at Upcoming Investor Conference
GlobeNewswire•August 22, 2018
THE WOODLANDS, Texas, Aug. 22, 2018 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (LXRX) today announced that Lonnel Coats, President and Chief Executive Officer, will present at the following conference:
Wells Fargo Securities Healthcare Conference on Wednesday, September 5, 2018 at 8:40 a.m. EDT in Boston, MA.
A live audio webcast for this conference will be available in the “Investors” section of the Lexicon website at www.lexpharma.com. An archived version of the webcast will be available on the website for two weeks.
https://finance.yahoo.com/news/lexicon-pharmaceuticals-prese…
GlobeNewswire•August 22, 2018
THE WOODLANDS, Texas, Aug. 22, 2018 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (LXRX) today announced that Lonnel Coats, President and Chief Executive Officer, will present at the following conference:
Wells Fargo Securities Healthcare Conference on Wednesday, September 5, 2018 at 8:40 a.m. EDT in Boston, MA.
A live audio webcast for this conference will be available in the “Investors” section of the Lexicon website at www.lexpharma.com. An archived version of the webcast will be available on the website for two weeks.
https://finance.yahoo.com/news/lexicon-pharmaceuticals-prese…
Antwort auf Beitrag Nr.: 58.009.450 von bernie55 am 18.06.18 14:57:12Lexicon Pharmaceuticals Announces Positive 52-Week Results From Sotagliflozin inTandem1 Study Presented at ADA 2018 and Published in Diabetes Care
GlobeNewswire•June 24, 2018
These results presented today provide evidence for the long-term efficacy and safety of sotagliflozin and highlight the need for new treatment options for people living with type 1 diabetes,” said lead study investigator Dr. John Buse, MD, PhD, director of the Diabetes Center, director of the NC Translational and Clinical Sciences Institute, and executive associate dean for clinical research at the University of North Carolina School of Medicine in Chapel Hill. “Most patients do not reach their treatment goals on insulin alone and management of disease burden remains challenging. If approved, sotagliflozin, in combination with insulin, may be an important treatment option for patients with type 1 diabetes.”
“We are extremely pleased to see that the clinical effects of sotagliflozin on blood sugar and weight for adults with type 1 diabetes were sustained through one year of treatment,” said Pablo Lapuerta, MD, executive vice president and chief medical officer of Lexicon. “Importantly, sotagliflozin, in combination with insulin, helped patients achieve their target glucose levels while also experiencing a lower incidence of severe hypoglycemia. There remains a need for oral therapeutic agents used in conjunction with insulin to improve the treatment options for people with type 1 diabetes and we believe sotagliflozin can potentially meet this need.”
https://finance.yahoo.com/news/lexicon-pharmaceuticals-annou…
GlobeNewswire•June 24, 2018
These results presented today provide evidence for the long-term efficacy and safety of sotagliflozin and highlight the need for new treatment options for people living with type 1 diabetes,” said lead study investigator Dr. John Buse, MD, PhD, director of the Diabetes Center, director of the NC Translational and Clinical Sciences Institute, and executive associate dean for clinical research at the University of North Carolina School of Medicine in Chapel Hill. “Most patients do not reach their treatment goals on insulin alone and management of disease burden remains challenging. If approved, sotagliflozin, in combination with insulin, may be an important treatment option for patients with type 1 diabetes.”
“We are extremely pleased to see that the clinical effects of sotagliflozin on blood sugar and weight for adults with type 1 diabetes were sustained through one year of treatment,” said Pablo Lapuerta, MD, executive vice president and chief medical officer of Lexicon. “Importantly, sotagliflozin, in combination with insulin, helped patients achieve their target glucose levels while also experiencing a lower incidence of severe hypoglycemia. There remains a need for oral therapeutic agents used in conjunction with insulin to improve the treatment options for people with type 1 diabetes and we believe sotagliflozin can potentially meet this need.”
https://finance.yahoo.com/news/lexicon-pharmaceuticals-annou…
Antwort auf Beitrag Nr.: 58.023.820 von butcherfriend am 20.06.18 09:31:32
..auf dem Weg zu höheren Kursen ?
Lexicon Pharmaceuticals, Inc. (LXRX): Bullish Rating Reiterated
JUN 18, 2018 | 1:23PM | BY STOCKNEWS.COM STAFF
LXRX – Wedbush reiterates Buy rating, $42 PT.
This price target represents a 225.33% upside over the stock’s previous closing price of $12.91.
Update: As of Jun. 20, 2018, this bullish analyst call has returned 6.04%.
https://stocknews.com/news/lxrx-wedbush-reiterates-buy-ratin…
Zitat von butcherfriend: Sieht auch Charttechnisch excellent aus - könnte ein Ausbruch bis 25 Dollar werden....
..auf dem Weg zu höheren Kursen ?
Lexicon Pharmaceuticals, Inc. (LXRX): Bullish Rating Reiterated
JUN 18, 2018 | 1:23PM | BY STOCKNEWS.COM STAFF
LXRX – Wedbush reiterates Buy rating, $42 PT.
This price target represents a 225.33% upside over the stock’s previous closing price of $12.91.
Update: As of Jun. 20, 2018, this bullish analyst call has returned 6.04%.
https://stocknews.com/news/lxrx-wedbush-reiterates-buy-ratin…
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