LXRX Lexicon Pharmaceuticals Inc.

7.48
-0.27  -3%
Previous Close 7.75
Open 7.6
52 Week Low 1.03
52 Week High 9.65
Market Cap $1,058,394,127
Shares 141,496,541
Float 63,292,703
Enterprise Value $962,161,265
Volume 1,390,875
Av. Daily Volume 7,346,826
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Upcoming Catalysts

Drug Stage Catalyst Date
Sotagliflozin
Heart failure
NDA Filing
NDA Filing
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LX9211
Post-herpetic neuralgia
Phase 2
Phase 2
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LX9211 (RELIEF-DPN 1)
Diabetic Peripheral Neuropathy
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Sotagliflozin
Type 1 Diabetes
CRL
CRL
CRL issued March 22, 2019. Appeal rejected by FDA - December 2, 2019.

Latest News

  1. THE WOODLANDS, Texas, Jan. 14, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) announced today that it has received U.S. Food and Drug Administration (FDA) regulatory feedback that the results of its SOLOIST and SCORED Phase 3 clinical studies can support a new drug application (NDA) submission for an indication 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.

    The feedback was provided in response to a request made by Lexicon following the completion of the SOLOIST and SCORED studies relating to the potential submission of an NDA based…

    THE WOODLANDS, Texas, Jan. 14, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) announced today that it has received U.S. Food and Drug Administration (FDA) regulatory feedback that the results of its SOLOIST and SCORED Phase 3 clinical studies can support a new drug application (NDA) submission for an indication 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.

    The feedback was provided in response to a request made by Lexicon following the completion of the SOLOIST and SCORED studies relating to the potential submission of an NDA based on the results of such studies, taking into account their early close-out and other considerations. This regulatory feedback clears a key hurdle for partnership discussions around sotagliflozin in heart failure and enables a potential NDA filing in 2021.

    Lonnel Coats, Lexicon's president and chief executive officer, will present at the 39th Annual J.P. Morgan Healthcare Conference today at 2:50 p.m. ET. A webcast of the event will be available in the "Events" section of the Lexicon website at www.lexpharma.com.

    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. 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.

    About Lexicon Pharmaceuticals

    Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients' lives. Through its Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon advanced one of these medicines to market and has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, heart failure, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's clinical development of and regulatory filings for sotagliflozin, partnership discussions relating to sotagliflozin and the potential therapeutic and commercial potential of sotagliflozin, as well as Lexicon's financial position and long-term outlook on its business, including the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of its other drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon's growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon's ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of LX9211, sotagliflozin and its other potential drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Investor Relations

    Lexicon Pharmaceuticals

    (281) 863-3421



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  2. THE WOODLANDS, Texas, Jan. 06, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that Lonnel Coats, Lexicon's president and chief executive officer, will present at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14, 2021 at 2:50 p.m. ET. 

    A webcast of the event will be available in the "Events" section of the Lexicon website at www.lexpharma.com.  An archived version of the webcast will be available on the website for two weeks.

    About Lexicon Pharmaceuticals

    Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients' lives. Through its Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified…

    THE WOODLANDS, Texas, Jan. 06, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that Lonnel Coats, Lexicon's president and chief executive officer, will present at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14, 2021 at 2:50 p.m. ET. 

    A webcast of the event will be available in the "Events" section of the Lexicon website at www.lexpharma.com.  An archived version of the webcast will be available on the website for two weeks.

    About Lexicon Pharmaceuticals

    Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients' lives. Through its Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon advanced one of these medicines to market and has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, heart failure, diabetes and metabolism and other indications.  For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's financial position, long-term outlook on its business and the clinical development and therapeutic and commercial potential of its drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon's growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon's ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of LX9211, sotagliflozin and its other potential drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Investor Relations

    Lexicon Pharmaceuticals

    (281) 863-3421



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  3. THE WOODLANDS, Texas, Dec. 31, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today the commencement of patient dosing in RELIEF-PHN 1, a Phase 2 randomized, placebo-controlled, multi-center clinical study of LX9211 for the treatment of post-herpetic neuralgia. LX9211 is a potent oral small molecule inhibitor of adaptor associated kinase 1 (AAK1).

    "We are pleased to commence dosing in our second proof-of-concept study of LX9211," said Praveen Tyle, Ph.D., executive vice president of research and development. "People who develop shingles often suffer with persistent pain for months to years after the rash clears with limited treatment options. We believe LX9211 has the potential to offer a novel therapeutic…

    THE WOODLANDS, Texas, Dec. 31, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today the commencement of patient dosing in RELIEF-PHN 1, a Phase 2 randomized, placebo-controlled, multi-center clinical study of LX9211 for the treatment of post-herpetic neuralgia. LX9211 is a potent oral small molecule inhibitor of adaptor associated kinase 1 (AAK1).

    "We are pleased to commence dosing in our second proof-of-concept study of LX9211," said Praveen Tyle, Ph.D., executive vice president of research and development. "People who develop shingles often suffer with persistent pain for months to years after the rash clears with limited treatment options. We believe LX9211 has the potential to offer a novel therapeutic approach to treating post-herpetic neuralgia. We look forward to completing this study and our other proof-of-concept study of LX9211 in diabetic peripheral neuropathic pain toward the end of next year."

    About the RELIEF-PHN 1 Study

    RELIEF-PHN 1 is a Phase 2 randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy, safety and pharmacokinetics of LX9211 in the treatment of post-herpetic neuralgia. The study is designed to enroll approximately 74 patients at approximately 30 clinical sites. The primary efficacy endpoint under evaluation is the change from baseline (Day 1) to Week 6 in Average Daily Pain Score (ADPS), based on the 11-point numerical rating scale (NRS).

    About LX9211

    LX9211 is a potent, orally delivered, selective small molecule inhibitor of AAK1. Lexicon identified AAK1 in its target discovery efforts as a promising approach for the treatment of neuropathic pain, and identified LX9211 and another development candidate in a neuroscience drug discovery alliance with Bristol-Myers Squibb from which Lexicon holds exclusive development and commercialization rights. Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways. LX9211 has received Fast Track designation from the U.S. Food and Drug Administration for the development in diabetic peripheral neuropathic pain.

    About Lexicon Pharmaceuticals

    Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients' lives. Through its Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon advanced one of these medicines to market and has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, heart failure, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's financial position, long-term outlook on its business and the clinical development and therapeutic and commercial potential of its drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon's growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon's ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of LX9211, sotagliflozin and its other potential drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Investor Relations

    Lexicon Pharmaceuticals

    (281) 863-3421



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  4. THE WOODLANDS, Texas, Dec. 16, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today that it has entered a collaboration enabling the use by AC Bioscience LTD of preclinical and clinical data for LX2931 without granting any right or license under any of Lexicon's patent rights for the compound. LX2931 is a small molecule sphingosine-1-phosphate (S1P) lyase inhibitor that is currently not in active development at Lexicon.

    "In line with our realignment around the rapid development of the LX9211 program, we continue to evaluate our pipeline and determine the most effective way to advance our broad library of compounds and targets," said Praveen Tyle, Ph.D., executive vice president of research and development…

    THE WOODLANDS, Texas, Dec. 16, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today that it has entered a collaboration enabling the use by AC Bioscience LTD of preclinical and clinical data for LX2931 without granting any right or license under any of Lexicon's patent rights for the compound. LX2931 is a small molecule sphingosine-1-phosphate (S1P) lyase inhibitor that is currently not in active development at Lexicon.

    "In line with our realignment around the rapid development of the LX9211 program, we continue to evaluate our pipeline and determine the most effective way to advance our broad library of compounds and targets," said Praveen Tyle, Ph.D., executive vice president of research and development. "We are pleased to collaborate with AC Bioscience to accelerate their efforts around S1P and look forward to learning additional information about this potentially interesting pathway."

    Under the terms of the agreement, Lexicon will receive an upfront payment and is eligible to receive milestone payments totaling up to $5.3 million in the aggregate.

    About Lexicon Pharmaceuticals

    Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients' lives. Through its Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon advanced one of these medicines to market and has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, heart failure, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's financial position, long-term outlook on its business and the clinical development and therapeutic and commercial potential of its drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon's growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon's ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of LX9211, sotagliflozin and its other potential drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2019, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Investor Relations

    Lexicon Pharmaceuticals

    (281) 863-3421



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  5. THE WOODLANDS, Texas, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that it had entered into a securities purchase agreement with certain institutional investors providing for the purchase and sale, in a registered direct offering, of 20,312,500 shares of its common stock, par value $0.001 (the "Common Stock"), at a price of $3.20 per share, for aggregate gross proceeds to the Company of $65,000,000 before deducting fees to the placement agent and other estimated offering expenses payable by the Company. The transaction is expected to close on December 16, 2020, subject to satisfaction of customary closing conditions.

    The investors in the registered direct offering were Artal International S.C.A…

    THE WOODLANDS, Texas, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that it had entered into a securities purchase agreement with certain institutional investors providing for the purchase and sale, in a registered direct offering, of 20,312,500 shares of its common stock, par value $0.001 (the "Common Stock"), at a price of $3.20 per share, for aggregate gross proceeds to the Company of $65,000,000 before deducting fees to the placement agent and other estimated offering expenses payable by the Company. The transaction is expected to close on December 16, 2020, subject to satisfaction of customary closing conditions.

    The investors in the registered direct offering were Artal International S.C.A., an affiliate of Invus, L.P., and BVF Partners L.P. and certain affiliates of BVF Partners L.P.

    Citigroup Global Markets Inc. is acting as placement agent for the offering on a "reasonable best efforts" basis.

    The Common Stock described above is being offered by the Company pursuant to a "shelf" registration statement on Form S-3, which was originally filed with the Securities and Exchange Commission (the "SEC") on November 7, 2019, and was declared effective on November 18, 2019 (File No. 333-234568). A prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC's website at http://www.sec.gov or may be obtained from: Citigroup Global Markets Inc., c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About Lexicon Pharmaceuticals

    Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients' lives. Through its Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon advanced one of these medicines to market and has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, heart failure, diabetes and metabolism and other indications.

    Safe Harbor Statement

    This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements, including, without limitation, statements about the completion and timing of the offering, are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, including Lexicon's ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of LX9211, sotagliflozin and its other potential drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Risk Factors" in Lexicon's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2019 and under the heading "Risk Factors" in the final prospectus supplement related to the proposed public offering of common stock to be filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Investor Relations

    Lexicon Pharmaceuticals

    (281) 863-3421



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