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Lexicon Pharmaceuticals Aktie WKN: 936717 ISIN: US5288721047 Symbol: LXRX Typ: Aktie (Seite 10)

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    26.03.18 14:00:10
    Beitrag Nr. 17 ()
    Lexicon Pharmaceuticals Announces Regulatory Submissions for Sotagliflozin to Treat Adults With Type 1 Diabetes

    GlobeNewswire•March 26, 2018

    - New Drug Application Submitted to U.S. Food and Drug Administration

    - Marketing Authorization Application Submitted to European Medicines Agency

    THE WOODLANDS, Texas, March 26, 2018 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (LXRX), today announced that its collaborator, Sanofi, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, for use in combination with insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.

    “The NDA and MAA submissions for sotagliflozin represent important milestones for Lexicon and for people in the United States and Europe who are living with the challenges of type 1 diabetes,” said Pablo Lapuerta, M.D., executive vice president and chief medical officer. “These filings highlight our strong investment in internally discovered therapies and are a culmination of the largest Phase 3 program for an oral anti-diabetic agent ever conducted in type 1 diabetes, in the broadest range of patients, resulting in the most comprehensive efficacy and safety database. I am extremely proud of our team members who have worked tirelessly to achieve this step towards bringing this important potential therapy to patients with type 1 diabetes.”

    “With approximately three-quarters of adult patients in the U.S. with type 1 diabetes not reaching their A1C goals, sotagliflozin would represent an important advance in managing these patients,” said Anne Peters, M.D., Professor of Medicine at the Keck School of Medicine of USC, Director of the USC Clinical Diabetes Programs and Chairman of the Sotagliflozin Type 1 Diabetes Steering Committee. “It potentially will be the first oral agent in the U.S. to be used in combination with insulin to improve glycemic control and patient outcomes.”


    https://finance.yahoo.com/news/lexicon-pharmaceuticals-annou…
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    30.01.18 11:09:28
    Beitrag Nr. 16 ()
    3 Fastest-Growing Diabetes Stocks of 2018 -- According to Wall Street
    Keith Speights, The Motley Fool
    Motley Fool - January 21, 2018

    Diabetes ranks as one of the top healthcare issues in the United States. Between 1990 and 2010, the number of Americans with diabetes tripled. By 2030, it's projected that nearly 55 million Americans will have diabetes -- a 54% increase from 2015.

    With such a dire need, you'd think lots of companies would be developing products to help manage and treat diabetes. And you'd be right. The diabetes market has grown significantly and should continue to grow well into the future.


    Lexicon Pharmaceuticals

    Lexicon Pharmaceuticals stock could more than double if Wall Street analysts' price targets aren't too far off. If that happens, it would be a night-and-day difference between 2018 and 2017, when Lexicon stock plunged nearly 29%.
    The company won FDA approval in February 2017 for its first commercial product, Xermelo, in treating carcinoid syndrome diarrhea. However, Lexicon's lead pipeline candidate, sotagliflozin, is an oral SGLT1/SGLT2 inhibitor for treating treatment of type 1 and type 2 diabetes.

    Lexicon and its partner, Sanofi (NYSE: SNY), expect to submit for approval of sotagliflozin in the U.S. and Europe for treating type 1 diabetes in the first half of 2018. The two companies have already announced positive results from a couple of late-stage studies. Late-stage studies for type 2 diabetes are also now under way. The earliest of these studies should wrap up in 2019. 

    If sotagliflozin wins approval, market research firm EvaluatePharma projects the drug could reach sales of nearly $1.2 billion by 2022. However, potential approval probably won't come until 2019.

    Wall Street could be right on the price target for Lexicon, but the timing might be a little off.

    https://finance.yahoo.com/news/3-fastest-growing-diabetes-st…
    Avatar
    27.09.17 14:49:34
    Beitrag Nr. 15 ()
    LEXICON PHARMACEUTICALS INITIATES PATIENT DOSING IN A PHASE 1 STUDY OF LX9211

    The Woodlands, Texas, September 27, 2017 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the company has initiated dosing in a Phase 1 study of LX9211, an orally-administered small molecule for the treatment of neuropathic pain. LX9211 is a selective inhibitor of AAK1 (adapter-associated kinase), which in preclinical studies demonstrated significant reduction in pain response in a series of pain models and was well-tolerated at and above efficacious doses in animals.

    “The successful filing of the IND followed by initiation of the first-in-human clinical study for LX9211 are significant milestones for the company as these events validate our robust preclinical results and bring us closer to demonstrating clinical proof-of-concept for LX9211 in patients with neuropathic pain,” said Praveen Tyle, Ph.D., Lexicon’s executive vice president, research and development. “Based on animal data, LX9211 has the potential to significantly reduce pain response while offering a novel therapeutic approach to neuropathic pain through inhibition of AAK1. We look forward to producing important early data to guide our future development plans.”

    The Phase 1 double-blind, placebo-controlled, single ascending dose study for LX9211 is designed to assess the safety, tolerability and pharmacokinetics of LX9211 across nine oral escalating dose levels (5 mg to 300 mg) in healthy volunteers.

    http://www.lexpharma.com/media-center/news/653-lexicon-pharm…
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    23.09.17 00:40:39
    Beitrag Nr. 14 ()
    tja, nach 10 Jahren immer noch 50 % Minus, wird wohl auch die nächsten 10 Jahre so bleiben
    Avatar
    19.09.17 23:39:17
    Beitrag Nr. 13 ()
    European Commission Approves XERMELO® (Telotristat Ethyl) For The Treatment Of Carcinoid Syndrome Diarrhea In Combination With Somatostatin Analog Therapy

    PR NewswireSeptember 19, 2017

    First-in-Class Oral Tryptophan Hydroxylase Inhibitor that Sustains Improvement of Carcinoid Syndrome Diarrhea in Adults Inadequately Controlled by Somatostatin Analogs

    THE WOODLANDS, Texas, Sept. 19, 2017 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc.(LXRX), announced today that the European Commission has approved XERMELO®(telotristat ethyl) 250 mg as a first and only orally administered therapy for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.

    This approval allows for the marketing of XERMELO by Lexicon's collaborator, Ipsen, in the above indication in all 28 member states of the European Union,Norway and Iceland.

    Carcinoid syndrome is a rare and debilitating condition that affects people with metastatic neuroendocrine tumors (mNETs). XERMELO targets the overproduction of serotonin inside mNET cells, providing a new treatment option for patients suffering from carcinoid syndrome diarrhea.

    https://finance.yahoo.com/news/european-commission-approves-…
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    14.09.17 16:58:04
    Beitrag Nr. 12 ()
    Antwort auf Beitrag Nr.: 55.703.889 von bernie55 am 09.09.17 12:01:39Ein Experte hat wohl eine andere Meinung zu Sotaglifloxin....
    ....ein Grund für das aktuelle "Extrem-Down"....
    :confused:

    Article. by Satish K. Garg, MD*
    The addition of sotagliflozin to existing insulin regimens improved glycemic control and led to reductions in the total, bolus and basal doses of insulin,” the researchers wrote. “A decrease in insulin dose may be a risk factor for diabetic ketoacidosis.

    In an accompanying editorial, David M. Nathan, MD, of the Diabetes Center at Massachusetts General Hospital and Harvard Medical School, wrote that the benefit of reducing HbA1c in people with type 1 diabetes may not outweigh the increased risk for diabetic ketoacidosis observed with sotagliflozin
    .
    In addition, he wrote, “further development of automated insulin delivery systems is likely to make adjunctive drug therapies for type 1 diabetes unnecessary.


    https://finance.yahoo.com/quote/LXRX/community?p=LXRX
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    09.09.17 12:01:39
    Beitrag Nr. 11 ()
    Lexicon Pharmaceuticals Reports Positive Pooled Continuous Glucose Monitoring Data From Pivotal Phase 3 inTandem1 And inTandem2 Studies Of Sotagliflozin

    PR Newswire September 8, 2017 Comment

    - Patients on sotagliflozin 200 mg spent 1.3 hours longer in target glucose range per day than placebo

    - Patients on sotagliflozin 400 mg spent 2.8 hours longer in target glucose range per day than placebo

    THE WOODLANDS, Texas, Sept. 8, 2017 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (LXRX) today announced positive pooled continuous glucose monitoring (CGM) data from the pivotal Phase 3 inTandem1 and inTandem2 studies of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor. At Week 24, patients treated with 200 mg and 400 mg doses of sotagliflozin spent a 5.4% and 11.7% greater proportion of the day, respectively, in the target glucose range of 70-180 mg/dL than those taking placebo, which translated into an additional 1.3 hours and 2.8 hours in a 24-hour period, respectively. These results were statistically significant (p=0.026 and p<0.001, respectively) and clinically meaningful for both doses of sotagliflozin.

    "We are very pleased with today's results, which have important implications for the clinical management of glycemic control in patients with type 1 diabetes," said Paul Strumph, M.D., Lexicon's vice president of clinical research and development who leads the development program for sotagliflozin and has been living with type 1 diabetes for more than 50 years. "Every 1% increase in time in target glucose range of 70-180 mg/dL corresponds to up to 15 minutes a day not spent in hypo- or hyperglycemia. We believe that these highly favorable results represent an important key indicator of glucose control in addition to A1C reduction, and will be highly meaningful for patients as they seek to maintain glucose control throughout each day."

    https://finance.yahoo.com/news/lexicon-pharmaceuticals-repor…
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    05.09.17 14:55:16
    Beitrag Nr. 10 ()
    Lexicon Pharmaceuticals to Present New Clinical Data at the European Association for the Study of Diabetes 53rd Annual Meeting

    News Provided by PR Newswire 2017-09-05


    THE WOODLANDS, Texas, Sept. 5, 2017 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that new clinical data for sotagliflozin will be presented at the upcoming European Association for the Study of Diabetes (EASD) 53rd annual meeting (September 11-15, Lisbon, Portugal). The four accepted abstracts, including two oral presentations, reflect Lexicon's efforts to improve current approaches to the clinical management of type 1 diabetes.

    Lexicon will share new efficacy and safety data for its investigational drug, sotagliflozin, including two oral presentations on pivotal data from the Phase 3 inTandem2 study and additional data from the JDRF study and two posters from the Phase 3 in Tandem1 and Phase 2 dose-ranging studies. In addition, the sotagliflozin clinical program will be highlighted in a symposium.

    Presentation Details (all times local)

    Wednesday, September 13, 8:30am-10:00am, Symposium
    "An Emerging and Innovative Therapeutic Approach in Types 1 Diabetes with Dual SGLT1 and SGLT2 Inhibition: the Sotagliflozin Clinical Program
    "
    Wednesday, September 13, 1:15pm-2:15pm, poster presentations
    "A 12-Week Dose-Ranging Study of Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, as Adjunct Therapy to Insulin in Type 1 Diabetes" (#884)
    "24–Week Efficacy and Safety of Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, as Adjunct Therapy to Insulin in Type 1 Diabetes" (inTandem1) (#885)

    Thursday, September 14, 2:30pm-4:00pm, oral presentations
    3:30pm: "24–Week Efficacy and Safety of Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, as Adjunct Therapy to Insulin in Type 1 Diabetes" (inTandem2) (#185)

    3:45pm: "Efficacy and Safety of Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, as Adjunct Therapy to Insulin in Young Adults with Poorly Controlled Type 1 Diabetes" (JDRF Study) (#186)

    http://crweworld.com/article/news-provided-by-pr-newswire/13…
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    01.08.17 16:27:41
    Beitrag Nr. 9 ()
    Lexicon Pharmaceuticals Reports Second Quarter 2017 Financial Results And Provides A Business Update
    Tue August 1, 2017 7:00 AM|PR Newswire|About: LXRX

    EPS of $-0.33 beats by $0.11 | Revenue of $12.05M (- 40.0% Y/Y) misses by $-6.29M

    Conference Call and Webcast Today at 8:00 am EDT / 7:00 am CDT
    PR Newswire

    THE WOODLANDS, Texas, Aug. 1, 2017 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (LXRX) (Nasdaq: LXRX), today reported financial results for the three months ended June 30, 2017 and provided an overview of key milestones for the company's commercial product, XERMELO®, and its pipeline drug candidates.

    "I am extremely pleased with our performance in the first full quarter of the XERMELO launch as we continue to make significant progress in growing our prescriber base and providing access to XERMELO. This momentum, along with the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) positive opinion on XERMELO, supports our confidence in the long-term outlook on the commercial business going forward," said Lonnel Coats, Lexicon's president and chief executive officer. "In parallel, we are making great strides towards advancing sotagliflozin to market in type 1 diabetes. We recently elected to exercise our co-promotion option with Sanofi and, if approved, we will have the right to play a significant role in the commercialization of sotagliflozin in type 1 diabetes in the U.S. Last but not least, we intend to create more value from our innovative pipeline as we continue to advance our other product candidates."

    Second Quarter 2017 Product and Pipeline Progress

    XERMELO (telotristat ethyl) 250 mg
    •In June, XERMELO was included as a recommended treatment option in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for neuroendocrine tumors (NET) patients with carcinoid syndrome diarrhea. The NCCN designated XERMELO together with somatostatin analog (SSA) therapy as a category 2A treatment for adults inadequately controlled by SSA therapy.
    •In June, XERMELO was included in the NCCN Drugs & Biologics Compendium (NCCN Compendium®).

    Sotagliflozin
    •In May, the Company reported additional positive efficacy and safety data from the U.S. Phase 3 inTandem1 study. Data included secondary endpoints such as body weight and systolic blood pressure in hypertensive type 1 diabetes mellitus (T1DM) patients and rates of adverse events like severe hypoglycemia and diabetic ketoacidosis (DKA).
    •At the 77th American Diabetes Association Scientific Session in June, Lexicon reported new positive efficacy and safety data for sotagliflozin from two-late breaking abstracts from the inTandem2 and JDRF studies and two oral presentations on pivotal data from the inTandem1 study.
    •In June, the Company reported positive top-line data from the global Phase 3 inTandem3 study evaluating approximately 1,400 T1DM patients treated with sotagliflozin 400 mg once daily or placebo on a background of any insulin therapy, but without insulin optimization prior to randomization. Sotagliflozin 400 mg demonstrated superiority compared to placebo in the proportion of patients with A1C ≤ 7.0% at Week 24 and no episode of severe hypoglycemia and no episode of DKA after randomization.

    LX2761
    •LX2761, an internally-generated oral SGLT1 inhibitor, is currently in Phase 1 clinical trials for the treatment of diabetes. These trials remain ongoing.

    Second Quarter 2017 Financial Highlights

    Revenues: Revenues for the three months ended June 30, 2017 decreased to $12.1 million from $20.1 million for the corresponding period in 2016, primarily due to lower revenues recognized from the collaboration and license agreement with Sanofi, partially offset by $3.9 million in net product revenues. Net product revenues for the three months ended June 30, 2017 included $3.6 million and $0.3 million, respectively, from the sale of XERMELO in the U.S. and sale of bulk tablets of telotristat ethyl to Ipsen.

    Cost of Sales: Lexicon had cost of sales related to sales of XERMELO of $0.5 million for the three months ended June 30, 2017, of which $0.4 million consisted of amortization of intangible assets.

    Research and Development Expenses: Research and development expenses for the three months ended June 30, 2017 decreased 44 percent to $26.9 million from $48.2 million for the corresponding period in 2016, primarily due to decreases in external clinical development costs relating to sotagliflozin.

    Selling, General and Administrative Expenses: Selling, general and administrative expenses for the three months ended June 30, 2017 increased 120 percent to $18.5 million from $8.4 million for the corresponding period in 2016, primarily due to increased costs associated with the commercial launch of XERMELO.

    Consolidated Net Loss: Net loss for the three months ended June 30, 2017 was $35.1 million, or $0.33 per share, compared to a net loss of $38.1 million, or $0.37 per share, in the corresponding period in 2016. For the three months ended June 30, 2017, net loss included non-cash, stock-based compensation expense of $2.4 million. For the three months ended June 30, 2016, net loss included non-cash, stock-based compensation expense of $2.0 million.

    Cash and Investments: As of June 30, 2017, Lexicon had $231.2 million in cash and investments, as compared to $259.7 million as of March 31, 2017 and $346.5 million as of December 31, 2016. Lexicon's use of cash remains consistent with prior guidance, and the Company continues to anticipate that its current liquidity and capital resources, together with expected revenues, will be sufficient to fund its operations at least through 2018.

    Anticipated Upcoming Milestones
    •September 11-15, 2017 – Two oral presentations (inTandem2 and JDRF studies) and two poster presentations (dose ranging and inTandem1 studies) at the 53rd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Lisbon
    •Q3 2017 - Secondary endpoint data from inTandem2
    •Q3 2017 - Pooled continuous glucose monitoring (CGM) data from inTandem1 and inTandem2
    •Q3 2017 – Potential EU approval of XERMELO in patients with carcinoid syndrome diarrhea in combination with SSA therapy in adults inadequately controlled by SSA therapy
    •2H 2017 – Initiation of several Phase 3 sotagliflozin studies in type 2 diabetes (T2DM) by Sanofi
    •2H 2017 – Initiation of a Phase 1 study for LX9211 in neuropathic pain
    •2H 2017 – Phase 1 data for LX2761 in healthy subjects and patients with T2DM

    https://seekingalpha.com/pr/16902087-lexicon-pharmaceuticals…

    Gruß Oberländler
    Avatar
    09.06.17 16:21:40
    Beitrag Nr. 8 ()
    Lexicon Pharmaceuticals Reports Positive Top-Line Results In Phase 3 inTandem3 Study For Sotagliflozin In Patients With Type 1 Diabetes

    PR NewswireJune 9, 2017

    THE WOODLANDS, Texas, June 9, 2017 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc.(LXRX) today announced positive top-line results from its Phase 3 in Tandem3 study of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, for the treatment of patients with type 1 diabetes on any background insulin therapy. The study met its primary endpoint, demonstrating the superiority of sotagliflozin 400 mg compared to placebo in the proportion of patients with A1C <7.0% at Week 24 and no episode of severe hypoglycemia and no episode of diabetic ketoacidosis (DKA) after randomization.

    Sotagliflozin demonstrated a generally well tolerated safety profile during a 24-week treatment period, with rates of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuations due to AEs that were consistent with rates seen in two prior pivotal Phase 3 studies, inTandem1 and inTandem2, including a similar rate of severe hypoglycemia for the sotagliflozin arm compared to placebo during the 24-week treatment period (2.4% for placebo compared to 3.0% for sotagliflozin 400 mg) and a slightly higher rate of DKA during the 24-week treatment period for sotagliflozin 400 mg (3.0%) than placebo (0.6%).

    A full analysis of the results from inTandem3, including safety data, will be submitted for publication in a peer-reviewed journal.

    "The results achieved with sotagliflozin in the inTandem3 study are scientifically and clinically important and significant," said Satish Garg, M.D., lead investigator of inTandem3 and Professor of Medicine and Pediatrics, and Director Adult Program at the Barbara Davis Center for Diabetes, University of Colorado Denver and Editor-in-Chief, Diabetes Technology and Therapeutics. "If approved, sotagliflozin may potentially be the first option as an adjunct to insulin to improve glycemic control for patients with type 1 diabetes."

    "These positive results represent an important milestone, further supporting sotagliflozin's differentiated profile as a novel, oral anti-diabetic agent with potential to benefit people with type 1 diabetes," said Lonnel Coats, Lexicon's president and chief executive officer. "Sotagliflozin is the first-ever oral anti-diabetic drug candidate to have achieved success in now three consecutive Phase 3 clinical trials in this population."

    "These compelling results speak to the potential long-term benefits that sotagliflozin may bring to people with type 1 diabetes," said Jorge Insuasty, senior vice president, head of global development, Sanofi. "There are more than 1 million adults with type 1 diabetes in the United States alone, and the majority of these are not at their A1C goal of 7 percent. The need for diabetes therapies that help adults with type 1 diabetes control their blood sugar with fewer complications is clear, and sotagliflozin added to insulin therapy can potentially help meet that need. We look forward to pursuing regulatory submissions for the treatment of type 1 worldwide and to continuing to study the use of sotagliflozin in adults with type 2 diabetes.
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    Lexicon Pharmaceuticals Aktie WKN: 936717 ISIN: US5288721047 Symbol: LXRX Typ: Aktie