BooDog
3 weeks ago
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.)
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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
2 months ago
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
6 months ago
Interesting sales estimates for Sota.
Apr 30, 2024
Leerink initiated coverage of Lexicon with an Outperform rating and $5 price target. The firm believes Lexiconβs 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. Inpefaβs 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 Zynquistaβs 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
8 months ago
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.
BooDog
11 months ago
Ready to see this rock and roll. Get the Christmas rally going!
https://www.inpefahcp.com/
Lexicon Pharmaceuticals, Inc. is a biopharmaceutical company developing treatments for human disease. The company was founded in 1995 in The Woodlands, Texas under the name Lexicon Genetics, Incorporated by co-founders Professor Allan Bradley, FRS and Professor Bradley's postdoctoral fellow Arthur T Sands. Wikipedia
Stock price: LXRX (NASDAQ) $1.16 +0.01 (+1.32%)
Dec 6, 10:18?AM EST - Disclaimer
Headquarters: The Woodlands, TX
CEO: Lonnel Coats (Jul 7, 2014β)
Revenue: 324.1 million USD (2019)
Number of employees: 225 (2011)
Founded: 1995, The Woodlands, TX
Founder: Arthur T Sands
Subsidiaries: Lex-Gen Woodlands, L.P., Lexicon Pharmaceuticals (New Jersey), Inc
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https://www.lexpharma.com/
https://www.lexpharma.com/media-center/news