BooDog
5 월 전
Implementing Strategic Restructuring to Eliminate Commercial Organization and Rationalize Operations Across All Functions
Prioritizing Strong R&D Pipeline Including Ongoing Studies in DPNP, HCM and Obesity
Efforts Expected to Reduce 2025 Operating Costs by $100 Million
Conference Call and Webcast at 9:00 am ET
THE WOODLANDS, Texas, Nov. 22, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the company has made the strategic decision to eliminate its commercial operations and rationalize resources across all functions in order to preserve cash and focus its resources on advancing its promising clinical development pipeline. This prioritization of investment is designed to advance the research and development programs that have the greatest potential for value creation and patient impact.
This decision follows the receipt of a “deficiencies preclude discussion” letter from the U.S. Food and Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). The letter noted deficiencies with the application that preclude discussion of labeling and/or post-marketing requirements and commitments at this time.
"While this decision was not made lightly, it reflects our commitment to make prudent business decisions that enhance value across our portfolio and deliver on our Lead to Succeed strategy," said Mike Exton, Ph.D., Lexicon’s chief executive officer and director. "We see significant potential in our strong pipeline of R&D opportunities, and we will focus our resources on programs with the potential for the greatest impact. We are confident that by carefully selecting therapeutic areas where we are the first and only therapy in class, and focusing our R&D efforts where there are significant needs, we can deliver innovations that will meaningfully benefit patients while simultaneously positioning Lexicon to fully realize future growth opportunities."
Details of the Strategic Restructuring
Complete elimination of the Company’s commercial field team and reduction in size of other functions across the organization, including the elimination of all promotional efforts for INPEFA® and all planned commercial activities for ZYNQUISTA.
A total reduction of approximately 60 percent of employees, effective for most affected employees by December 31st.
INPEFA to continue to be manufactured and made available to patients and existing prescribers.
An expected reduction of 2025 full year operating costs by $100 million. This amount is in addition to the $40 million in expected 2025 cost savings announced in August as part of a realignment of resources.
Reemerging as a Clinical Development-Focused Company
Lexicon will concentrate its resources on the continued research and development of its strong pipeline, including:
The Phase 2b PROGRESS study evaluating LX9211 in diabetic peripheral neuropathic pain (DPNP), with topline data anticipated in Q1 2025.
The pivotal Phase 3 SONATA HCM study evaluating sotagliflozin in hypertrophic cardiomyopathy (HCM), with enrollment underway.
IND-enabling studies of LX9851, a novel, non-incretin oral development candidate in obesity and associated cardiometabolic disorders.
Advancing earlier stage opportunities for LX9211 and LX9851 in additional indications.
Exploring strategic partnerships to advance and accelerate the value of our pipeline.
Conference Call and Webcast Information
Lexicon management will hold a live conference call and webcast today at 9:00 am ET / 8:00 am CT to review the details of this announcement. Participants can access the conference call live via webcast on the Events page of the Company’s website at https://www.lexpharma.com/media-center/events. Participants who wish to ask a question may register here to receive dial-in numbers and a unique pin to join the call. An archived version of the webcast will be available on the website for 14 days.
About Lexicon Pharmaceuticals
Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, 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 treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, metabolism and other therapeutic areas. 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 and long-term outlook on its business, 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, conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin, LX9211, LX9851 and its other 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, 2023 and other subsequent disclosure documents 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.
Investor Contact
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc.
lexinvest@lexpharma.com
Media Contact
Molly Devlin
Real Chemistry
corpcomm@lexpharma.com
https://www.globenewswire.com/news-release/2024/11/22/2985894/0/en/Lexicon-to-Reposition-as-Clinical-Development-Focused-Company-Following-Regulatory-Update-From-FDA.html
BooDog
6 월 전
Viatris Announces Exclusive Licensing Agreement with Lexicon Pharmaceuticals for Sotagliflozin in all Markets Outside of the U.S. and Europe
Viatris OUS Logo (PRNewsfoto/Viatris Inc.)
News provided by
Viatris Inc.
Oct 16, 2024, 16:34 ET
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Continues to Expand Viatris' Innovative Portfolio in Cardiovascular Diseases
Leverages Viatris' Unique Global Infrastructure and Expertise
Includes Opportunities to Leverage the Potential of Sotagliflozin to Additional Indications
PITTSBURGH, Oct. 16, 2024 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced it has entered into an exclusive licensing agreement with Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) for sotagliflozin in all markets outside of the United States and Europe.
https://www.prnewswire.com/news-releases/viatris-announces-exclusive-licensing-agreement-with-lexicon-pharmaceuticals-for-sotagliflozin-in-all-markets-outside-of-the-us-and-europe-302278473.html
BooDog
7 월 전
News: New Secondary Analysis of Phase 3 Data Demonstrates Sotagliflozin Improves Time-In-Range (TIR) and Several Parameters of Glucose Control and Variability in Basal Insulin-Treated Type 2 Diabetes
September 10, 2024 08:00 ET
| Source: Lexicon Pharmaceuticals, Inc.
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Study results aligned with positive clinical trial outcomes for type 1 diabetes treatment with sotagliflozin
TIR measures approach target set by American Diabetes Association
Data to be presented at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain and online
THE WOODLANDS, Texas, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that data from the SOTA-INS CGM Phase 3 randomized clinical trial demonstrated that once-daily dosing of sotagliflozin 400 mg improved time-in-range (TIR) and several continuous glucose monitoring (CGM) parameters, including glucose variability, in insulin-treated type 2 diabetes (T2D) patients. Researchers also observed positive trends with the once-daily dose of 200 mg. Study findings will be presented September 12th at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain and online.
The objective of the SOTA-INS CGM study was to evaluate the effect of sotagliflozin on TIR as assessed by CGM in people with T2D. The primary sub-study endpoint was mean change in percentage of time spent within TIR (glucose 70-180 mg/dL [3.9-10.0 mmol/L]) over 24 hours for sotagliflozin 400 mg versus placebo.
The American Diabetes Association recommends a TIR target of at least 70% (17 hours) in people with type 1 diabetes (T1D) or T2D. In this study, sotagliflozin 200 mg and 400 mg once daily TIR (15.3 and 15.9 hours, respectively) approached the ADA target, with modest reductions in time-above-range (TAR) and mild increases in time-below-range (TBR).
Sotagliflozin has previously demonstrated glycemic efficacy and improvements in TIR as an adjunct to insulin therapy in people with T1D who participated in the inTandem clinical trial program.
https://www.globenewswire.com/news-release/2024/09/10/2943581/0/en/New-Secondary-Analysis-of-Phase-3-Data-Demonstrates-Sotagliflozin-Improves-Time-In-Range-TIR-and-Several-Parameters-of-Glucose-Control-and-Variability-in-Basal-Insulin-Treated-Type.html
dcaf7
11 월 전
Interesting sales estimates for Sota.
Apr 30, 2024
Leerink initiated coverage of Lexicon with an Outperform rating and $5 price target. The firm believes Lexicon’s first-in-class dual SGLT1/2 inhibitor sotagliflozin could address unmet need across multiple indications with large market opportunities, including heart failure, hypertrophic cardiomyopathy and Type 1 diabetes with chronic kidney disease, which could collectively drive blockbuster sales. Inpefa’s U.S. launch in HF should benefit from several meaningful tailwinds, Leerink says. It forecasts peak U.S. sales of $1B for Inpefa in HF and peak U.S. sales of $325M for sotagliflozin in HCM in FY32. The firm also points out that Lexicon plans to resubmit Zynquista’s NDA filing by mid-2024, with an anticipated 6-month review. Leerink forecasts peak U.S. sales of $225M for Zynquista in T1D with CKD in FY32.
dcaf7
1 년 전
Lexicon will resubmit an NDA for sotagliflozin for patients with type 1 diabetes and chronic kidney disease. Good news. FDA rejected an NDA for type 1 diabetes in 2019. Now they changed their mind but only for patients with T1D+CKD. According to today's company presentation, slide 10, this population makes 21% of adults with T1D, or ~357,000 patients. Not a big addition to current indication. However, it will be the first gliflozin approved for T1D. No competition.
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