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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
Back under $2 again, printing 1.70's. Setting up for another swing.
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.
Almost added back in but want to see confirmation for bottom. Double bottoms can be tricky. But even so, long term I like this.
Zacks analysis.
https://www.zacks.com/stock/news/2256264/all-you-need-to-know-about-lexicon-lxrx-rating-upgrade-to-buy
Upgrading to buy while I'm watching for the gap to fill which may put this around 1.40's. We'll see. I think analysts are always late to the party but this report is actually pretty timely.
Quite the gap there if that's what you're looking at.
LXRX.......................................https://stockcharts.com/h-sc/ui?s=LXRX&p=W&b=5&g=0&id=p86431144783
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.
Lexicon Announces Oversubscribed $250 Million Private Placement of Equity Securities
Earnings expected next Thursday, a miss or a hit? Revenue a hit imo.
Form 4 filed
200 July 2.5 calls @.88 . Be back soon !!!
INBS**** AS ALWAYS SUPER FAST COMPUTERS***WHALES***HEDGES FUNDS*** TRADERS MIGHT SURGE THE VOLUME AT A VERY HIGH FREQUENCY****
WITHIN MINUTES*****UPTREND
SEEMS SETTING UP NICELY FOR THAT
Still looking pretty good here. Did trim a few 2.38's thouigh. Not sure if we'll see a reset soon or not.
LXRX..........................https://stockcharts.com/h-sc/ui?s=LXRX&p=W&b=5&g=0&id=p86431144783
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, 2014–)
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
Product
https://www.lexpharma.com/
https://www.lexpharma.com/media-center/news
Insider buying... Director Philippe Amouyal's Strategic 200,000 Share Purchase in Lexicon Pharmaceuticals Inc
https://finance.yahoo.com/news/director-philippe-amouyals-strategic-200-060356510.html?guccounter=1&guce_referrer=aHR0cHM6Ly9maW52aXouY29tLw&guce_referrer_sig=AQAAAIoi6pMjBlhAAWCTqsgFDgJ_L3Mq27MaOD9VoCvqo193rq8IznDFhr2okgZCfdpTcOoOQpbq-htdQ0dRd_C7SPjLqq1-XLfxoxxNvrWLXCfYfWwGJkWm40NnRnChJ7IS-3NNjcnArKcxghtaIU9gZcRtqotAVRnZUPj9phWfJymM
LXRX................................https://stockcharts.com/h-sc/ui?s=LXRX&p=W&b=5&g=0&id=p86431144783
Guess I wasn't watching the board here Monk. Have been watching the chart though and have been accumulating around 1.10' last week and added today.
Cheers
$LXRX https://finance.yahoo.com/news/lexicon-announces-planned-advancement-lx9211-004500120.html
Conference call this morning...
Conference Call and Webcast Information
Lexicon management will hold a live conference call and webcast Monday, June 26, 2023, at 8:00 am ET / 7:00 am CT. The dial-in number for the conference call is 888-317-6003 and the conference ID for all callers is 7186279. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/events. An archived version of the webcast will be available on the website for 14 days.
Quite the boost for institutionals.
https://www.sec.gov/Archives/edgar/data/1062822/000119312523160877/d449914dsc13da.htm
Agree. Too easy here. So predictable they'd be doing an offering though. Easy peasy this one is.
Taking nibbles in the 2.50's. Should have sold more on the highs yesterday.
LXRX MIGHT NOT BE LOOKING BACK AGAN, FDA APPROVED DRUG AND ALL BIG PHARMA EYEING. MY OPINION *******
ONE PAID $260M FOR BACKING OUT, NOW LOOK AT LXRX
Hey there Glenn. This puppy has been excellent. Certainly one to keep an eye on.
If I se what I think I see, there's a reason shorts are leaving this puppy alone.
Added back in this morning but when something starts really moving you always say in hindsight that you should have bought more.
LXRX.............................https://stockcharts.com/h-sc/ui?s=LXRX&p=W&b=5&g=0&id=p86431144783
High 2.96. Trip and rip potential. That's when the chart show either a tripple bottom or a tripple top and breaks through with some serious momentum.
See what this puppy does.
https://www.barchart.com/stocks/quotes/hils/technical-chart?plot=CANDLE&volume=total&data=DO&density=ML&pricesOn=1&asPctChange=0&logscale=0&indicators=ACCUM;SMA(20);SMA(50);SMA(100);SMA(200);CHKMF(20)&sym=LXRX&grid=1&height=210&studyheight=100
PUDUFA coming in a couple months. Looks like they're pretty confident.
GLTA
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Sotagliflozin Significantly Reduced Total Cardiovascular Deaths, Heart Failure Hospitalization and Urgent Visits, Achieving Primary Endpoint in Both Studies
THE WOODLANDS, Texas, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that both the SOLOIST and SCORED Phase 3 studies achieved their primary endpoints by demonstrating statistically significant reductions in total cardiovascular deaths, hospitalizations for heart failure and urgent heart failure visits in patients treated with sotagliflozin as compared with placebo.
In the SOLOIST study, the primary endpoint was achieved with a hazard ratio (HR) of 0.67 (p<0.001) in people with type 2 diabetes and a recent hospitalization for worsening heart failure. In the SCORED study, the primary endpoint was achieved with a hazard ratio of 0.74 (p<0.001) in people with type 2 diabetes and chronic kidney disease with an estimated glomerular filtration rate (eGFR) of 25 to 60 ml/minute per 1.73 m² of body-surface area.
The key results from SOLOIST and SCORED were presented today 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.” The articles may be accessed at www.nejm.org.
“Cardiovascular disease continues to be a leading cause of death in people with type 2 diabetes,” said Deepak L. Bhatt, M.D., M.P.H., executive director of Interventional Cardiovascular Programs at Brigham and Women's Hospital and a professor of medicine at Harvard Medical School and study chair and lead author for the NEJM publications of the SOLOIST and SCORED results. “SOLOIST demonstrates that early, in-hospital initiation of sotagliflozin in patients with worsening heart failure significantly reduces subsequent cardiovascular events, an effect that was consistent across groups with heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). SCORED demonstrates that sotagliflozin significantly reduces heart failure events in a patient population with stage 3 and 4 chronic kidney disease and cardiovascular risk. Both studies add to the evidence that SGLT2 inhibition should be standard of care in heart failure, and the SCORED data reflecting a reduction in myocardial infarction and stroke and better glucose control in CKD patients suggest potential benefits from the dual SGLT1 and SGLT2 mechanism of this particular agent.”
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