Key Developments: Lexicon Pharmaceuticals Inc (LXRX.O)
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Latest Key Developments (Source: Significant Developments)
Lexicon Pharmaceuticals Inc Advances LX4211 In Type 1 Diabetes Phase 2 Trial
Lexicon Pharmaceuticals Inc announced that it is progressing into the placebo-controlled portion of its Phase 2 clinical trial of LX4211 in patients with type 1 diabetes, having completed the open-label, pioneer portion of the trial. LX4211 is an investigational, oral, dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2). The pioneer phase of the study was designed to gain important initial information regarding the safety of co-administration of LX4211 with insulin in this, the first test of dual inhibition of SGLT1 and SGLT2 in patients with insulin-dependent type 1 diabetes. The successful conclusion of the 28-day pioneer group enables the initiation of the placebo-controlled expansion phase of the study to commence in up to 30 patients with type 1 diabetes. Based on the results observed in the pioneer group, Lexicon has identified the 400 mg once daily dose of LX4211 as the appropriate treatment for the expansion phase of the trial. Full Article
Lexicon Pharmaceuticals Inc Announces Pricing Of Common Stock Offering
Lexicon Pharmaceuticals Inc announced that the pricing of a public offering of its common stock in which the aggregate net proceeds to Lexicon will be approximately $37.2 million. The public offering consists of 17,500,000 shares of its common stock at a public offering price of $2.25 per share. Lexicon has also granted the underwriters a 30-day option to purchase up to an aggregate of 2,625,000 additional shares of common stock to cover over-allotments, if any. J.P. Morgan Securities LLC and Jefferies & Company, Inc. are acting as joint book-runners for the offering, with Needham & Company, Stifel Nicolaus Weisel and Wedbush PacGrow Life Sciences acting as co-managers. Full Article
Lexicon Pharmaceuticals Inc Announces Second Phase 2 Trial Of Telotristat Etiprate Shows Positive Results In Carcinoid Syndrome
Lexicon Pharmaceuticals Inc announced positive, top-line data from a recently completed Phase 2 study in carcinoid syndrome with telotristat etiprate. Results from the trial will be presented at the North American Neuroendocrine Tumor Society on October 13, 2012 in San Diego, California. The primary efficacy endpoint of the trial was the reduction of bowel movements from baseline in patients with metastatic carcinoid syndrome who were refractory to or could not tolerate somatostatin analog therapy. Patients experienced a 46.4% median reduction from baseline at week 12, with the number of daily bowel movements steadily decreasing over time. All observed changes from baseline were statistically significant at p<0.001. This change corresponded with an increased proportion of patients reporting adequate relief of their carcinoid symptoms, a global assessment which also improved over time, with 75% of the patients with data at week 12 reporting improvement. Clinically relevant decreases from baseline were likewise seen for a number of key secondary endpoints, including statistically significant improvements in stool consistency (p < 0.001) and trends of reductions in abdominal pain (p=0.09) and the number of cutaneous flushing episodes (p=0.052). The median percentage reductions from baseline of urinary 5-HIAA at weeks 8 and 12 were 68.3% (p=0.019) and 72.7% (p=0.031), respectively. Urinary 5-HIAA is a biomarker of serotonin synthesis and is of key interest in these patients. Full Article
Lexicon Pharmaceuticals, Inc. Announces Positive Top-Line Results From Phase 2b Study Of LX4211
Lexicon Pharmaceuticals, Inc. announced positive top-line results from the Phase 2b study of LX4211 in advancement of Lexicon's clinical pipeline towards late-stage development. Lexicon announced positive top-line data from a Phase 2b study of LX4211, an oral, dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2), in patients with poorly-controlled type 2 diabetes who were concurrently treated with metformin, an established diabetes therapy. LX4211 treatment produced substantial, dose-dependent and statistically reductions in hemoglobin A1c (HbA1c), with patients in the LX4211 treatment arms (75 mg QD, 200 mg QD, 200 mg BID and 400 mg QD) having mean HbA1C reductions from baseline of 0.43, 0.52, 0.79 and 0.95%, respectively (p<0.001 for all treatment arms). In patients randomized to placebo, HbA1C decreased by 0.09%. LX4211 treatment also produced reductions in body weight and blood pressure. Lexicon completed an open-label Phase 2 clinical trial of telotristat etiprate (LX1032), an inhibitor of tryptophan hydroxylase that reduces peripheral serotonin production without affecting brain serotonin levels, in patients with carcinoid syndrome and anticipates announcing results in third quarter of 2012. Full Article
Lexicon Pharmaceuticals, Inc. Announces Publication Of Results Of Two Studies Of LX4211 In Patients With Type 2 Diabetes In The Journal Clinical Pharmacology & Therapeutics
Lexicon Pharmaceuticals, Inc. announced the publication of results from two initial trials of LX4211 in patients with type 2 diabetes in the online edition of the journal Clinical Pharmacology & Therapeutics. The paper, containing results from both trials, is entitled, "LX4211, a Dual SGLT1/SGLT2 Inhibitor, Improved Glycemic Control in Patients with Type 2 Diabetes in a Randomized, Placebo-controlled Trial," and will also appear in an upcoming print edition of the journal. In the 4-week Phase 2a study described in the paper, 36 patients received once-daily oral administration of placebo or 150 mg or 300 mg of LX4211 (randomized 1:1:1) in an in-patient setting. Patients receiving LX4211 exhibited rapid and significant improvements relative to placebo in multiple measures of glycemic control, including hemoglobin A1c (HbA1c), fasting plasma glucose, and oral glucose tolerance. In addition, serum triglycerides were significantly lower at the end of the four-week treatment period, and trends of meaningful reductions in body weight and blood pressure were observed. Importantly, LX4211 treatment demonstrated a favorable safety profile and was well tolerated in the study. Also described in the paper was a subsequent clinical study conducted in a similar population of poorly-controlled patients with type 2 diabetes that showed LX4211 treatment elevated GLP-1 and PYY, two gastrointestinal peptides known to be associated with enhanced metabolic control. Full Article
Lexicon Pharmaceuticals, Inc. Announces Positive Results Of LX4211 Phase 2b Trial For Type 2 Diabetes
Lexicon Pharmaceuticals, Inc. announced that LX4211, an investigational, oral, dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2), showed substantial, dose-dependent, statistically-significant reductions in hemoglobin A1c (HbA1c) in a Phase 2b trial in patients diagnosed with poorly-controlled type 2 diabetes who were concurrently treated with metformin, an established diabetes therapy. LX4211 treatment also produced significant reductions in body weight and blood pressure. Importantly, LX4211 treatment had a favorable safety profile and was well tolerated in the study. LX4211, a dual inhibitor, reduces the amount of glucose that enters the bloodstream from the gastrointestinal (GI) tract by inhibiting SGLT1, the major transporter responsible for glucose absorption, and enhances glucose excretion in the urine by inhibiting SGLT2, the major transporter responsible for glucose reabsorption by the kidney. Lexicon has previously demonstrated that SGLT1 inhibition by LX4211 increases GLP-1 and PYY, GI hormones associated with glycemic control and appetite. In this 12-week dose-ranging study conducted in over 50 centers in the United States, 299 patients with poorly controlled type 2 diabetes on metformin therapy were randomized to receive either LX4211 or placebo. The primary endpoint of the study was the change in HbA1C, a measure of glycemic control, from baseline to week 12. LX4211 was administered at doses of 75 mg QD, 200 mg QD, 200 mg BID and 400 mg QD. Full Article
Lexicon Pharmaceuticals, Inc. Announces Completion Of Rights Offering
Lexicon Pharmaceuticals, Inc. announced that it has completed its previously announced rights offering pursuant to an effective shelf registration statement. Under the rights offering, an aggregate of 142,492,883 shares of common stock will be issued at a subscription price of $1.13 per share, resulting in aggregate gross proceeds to Lexicon of approximately $161 million. Lexicon conducted the rights offering at the election of two of its stockholders, Invus, L.P. and Invus C.V., pursuant to their contractual rights to require Lexicon to initiate a pro rata rights offering to its stockholders. Invus, L.P. and its affiliates subscribed for an aggregate of 115,044,247 shares of common stock in the rights offering and will beneficially own approximately 58.3% of Lexicon's outstanding common stock following completion of the rights offering. Full Article
Lexicon Pharmaceuticals, Inc. Announces Commencement of Rights Offering to Stockholders
Lexicon Pharmaceuticals, Inc. announced that it has commenced its previously announced rights offering pursuant to an effective registration statement and began mailing a prospectus and other rights offering materials to its stockholders. In the rights offering, stockholders will receive one non-transferable subscription right for every share of common stock owned as of November 21, 2011 , which was the record date for the rights offering. Each subscription right will entitle stockholders to purchase 0.427175 shares of common stock at a subscription price of $1.13 per share. For example, a stockholder who owns 1,000 shares of common stock on the record date will be granted 1,000 subscription rights entitling the stockholder to purchase 427 shares of common stock (427.175 rounded down to the nearest whole share number) for an aggregate purchase price of $482.51 . Stockholders who exercise their basic subscription privilege in full may also exercise an over-subscription privilege to purchase additional shares that remain unsubscribed at the expiration of the rights offering, subject to availability and proration. Lexicon is offering an aggregate of 144,247,542 shares of common stock in the rights offering and, if fully subscribed, aggregate gross proceeds to Lexicon will be approximately $163 million. The subscription rights will be exercisable until December 22, 2011 . Full Article
Lexicon Pharmaceuticals, Inc. Announces LX4211 For Diabetes Shown To Reduce Fasting And Post-Prandial Blood Sugar In Healthy Subjects
Lexicon Pharmaceuticals, Inc. announced positive data from a recently completed clinical trial and mechanistic study of LX4211, a dual inhibitor of the sodium glucose transporters 1 and 2 (SGLT1 and SGLT2). The favorable safety profile and effects on multiple parameters of glycemic control and cardiovascular health in healthy normal subjects support the broad potential of LX4211 in the treatment of diabetes and associated metabolic conditions. Results from the study demonstrated that the 400 mg solid oral dose of LX4211 compared to placebo significantly reduced mean changes from baseline in fasting plasma glucose (p=0.005) and post-prandial glucose levels (p<0.001) in parallel with meaningful mean increases from baseline in total and active GLP-1 (p=0.055 and p=0.003, respectively) as well as PYY (p<0.001). GLP-1 is associated with improved glucose control and decreased food intake through reduction of appetite. PYY is a gastrointestinal-derived peptide hormone that has also been associated with reducing food intake and has been studied as an anti-obesity agent. These two gastrointestinal peptides (GLP-1 and PYY) are secreted into circulation by neuroendocrine cells (L cells) as part of a natural homeostatic mechanism that senses nutrient transit through the gastrointestinal tract. Such nutrient sensing and related mechanisms are thought to be enhanced as a result of certain types of bariatric surgery for weight loss and control of diabetes. Full Article
Lexicon Pharmaceuticals, Inc. Announces Positive Results In Phase 2 Trial Of LX1032
Lexicon Pharmaceuticals, Inc. announced positive, top-line proof-of-concept data from recently completed Phase 2 study in carcinoid syndrome with LX1032, telotristat etiprate. Carcinoid syndrome is a chronic condition caused by neuroendocrine tumors that usually originate from the gastrointestinal tract. It is characterized by severe diarrhea and flushing episodes with long-term consequences including malnutrition, heart disease, and death. Symptoms of carcinoid syndrome have been linked to excess production of serotonin by metastatic tumor cells. Telotristat etiprate is designed to reduce serotonin production. The randomized, double-blind, placebo-controlled study was conducted in the United States in 23 patients with carcinoid syndrome who were refractory to available therapy. Patients in the study had metastatic carcinoid disease and were experiencing an average of about six bowel movements per day at baseline. Patients received either placebo (n=5) or one of four doses of telotristat etiprate (n=18) daily for 28 days. The primary endpoint of the study was safety and tolerability. Efficacy measures included change in bowel movement frequency, relief of symptoms, and reduction in serotonin synthesis. Telotristat etiprate was well tolerated, and adverse events in the study were usually mild to moderate with similar frequencies overall between treatment groups and placebo. Full Article
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