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Year: 2023

INPEFA® (sotagliflozin) Use Associated With Early Clinical Benefit in Heart Failure and Atherosclerotic Events in Analysis of Clinical Data

Oral presentation delivered at the American Heart Association (AHA) Scientific Sessions 2023 Analysis of clinical data shows statistically significant risk reductions in heart failure and separately in MACE related outcomes as early as approximately three months in patients at high risk for cardiovascular events INPEFA® (sotagliflozin) recently approved by FDA for treatment of heart failure THE WOODLANDS, Texas, Nov. 12, 2023 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that a post hoc analysis of clinical data from the SCORED trial demonstrated that clinical benefit from INPEFA® (sotagliflozin) use in heart failure (HF) and major adverse cardiovascular events (MACE) related outcomes was observed as early as approximately three months in patients at high risk for cardiovascular events. The data...

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Summary of Tallinna Sadam webinars

On 10 November 2023, Tallinna Sadam held a webinar for investors where the CEO Valdo Kalm and CFO Andrus Ait presented the unaudited results of the Group for 2023 Q3. Tallinna Sadam would like to thank all participants. The recording of the webinars can be followed up in Estonian and in English language. The presentation is available at the company’s web page: https://www.ts.ee/en/investor/presentations/ . Marju ZirelHead of Investor Relations Tel. +372 53 42 6591 E-mail: m.zirel@ts.ee

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89bio Announces Additional Data from the ENLIVEN Phase 2b Trial of Pegozafermin in Patients with Compensated Cirrhotic (F4) Nonalcoholic Steatohepatitis (NASH) at AASLD The Liver Meeting® 2023

—Reductions in key non-invasive tests (NITs) of liver inflammation and fibrosis support previously demonstrated fibrosis improvements across compensated cirrhotic (F4) patients at week 24— —A responder analysis suggests that responses in NITs were correlated with fibrosis improvement— —Pegozafermin continued to demonstrate a best-in-class tolerability profile— SAN FRANCISCO, Nov. 12, 2023 (GLOBE NEWSWIRE) — 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced additional data from a post-hoc analysis of the ENLIVEN Phase 2b trial evaluating treatment with pegozafermin in a subgroup of patients with F4 NASH. These data were featured in an oral presentation during the AASLD...

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BridgeBio Pharma Presents Additional Clinical Outcomes Data from the Phase 3 ATTRibute-CM Study of Acoramidis in Patients with Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

– As previously announced, the primary endpoint (a hierarchical analysis inclusive of all-cause mortality and frequency of cardiovascular-related hospitalization) was met (Win Ratio of 1.8) with a highly statistically significant p-value (p

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New REDUCE-IT® Analyses Show VASCEPA® (icosapent ethyl) Associated with 29 Percent Relative Risk Reduction Compared with Placebo in Prespecified Subgroup of Patients with Metabolic Syndrome, but Without Diabetes at Baseline

— Analysis Also Found IPE Was Associated with a 41% Reduction in Total Events Compared with Placebo — — Subgroup Almost Exclusively Comprised of Patients with Established Cardiovascular Disease — — Findings Continue to Reinforce the Scientific Data and Clinical Use of VASCEPA®/VAZKEPA® to Reduce Cardiovascular Risk — — Results Presented Today at the American Heart Association (AHA) Scientific Sessions 2023 and Simultaneously Published in the European Heart Journal Open — DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 12, 2023 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced results from new REDUCE-IT analyses showing that among statin-treated patients in a prespecified subgroup with history of Metabolic Syndrome, but without diabetes at baseline, the addition...

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Mineralys Therapeutics Further Defines Endotype-Specific, Targeted Approach to Treatment of Uncontrolled or Resistant Hypertension with Lorundrostat Data at AHA Scientific Sessions 2023

– New analysis on serum leptin levels among patients in the Target-HTN Phase 2 trial adds to emerging evidence of positive feedback loop linking obesity, leptin and aldosterone – – Excess aldosterone in patients with visceral obesity defines a unique hypertensive endotype with potential for an enhanced response to aldosterone-targeted therapy with lorundrostat – – Early identification and intervention with lorundrostat may result in improved clinical outcomes for obese patients with uncontrolled or resistant hypertension – RADNOR, Pa., Nov. 11, 2023 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today presented data from the...

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Partners Announce TRANSFORM Trial to Evaluate Personalized Heart Disease Care Strategies at American Heart Association 2023

– Data from Randomized Control Trial Will Advance Evidence for Evaluation and Treatment of Heart Disease by Studying Actual Disease: Atherosclerosis – ANN ARBOR, Mich., Nov. 11, 2023 (GLOBE NEWSWIRE) — Esperion (NASDAQ: ESPR) announced participation in the TRANSFORM trial at the American Heart Association’s (AHA) 2023 Scientific Sessions. TRANSFORM is a randomized control trial – sponsored by Cleerly – that aims to enroll 7,500 patients who have pre-diabetes, type 2 diabetes, or metabolic syndrome and have no symptoms of heart disease. TRANSFORM aims to prove that a personalized care strategy based on a Cleerly analysis of a patient’s actual disease state is better than traditional care based on typical risk factors for the primary prevention of cardiovascular events.  For TRANSFORM, Esperion is providing in-kind support of NEXLIZET®...

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Long-term Survival Data from Longeveron’s ELPIS 1 Trial Presented at the 2023 Scientific Sessions of the American Heart Association

Extended Follow Up Data Show Continued, Transplant Free Survival of All Patients Results Support Continued Investigation of Lomecel-BTM As Adjunct to Stage II Surgery in HLHS – Enrollment ongoing in Phase 2 ELPIS II trial – MIAMI, Nov. 11, 2023 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN NASDAQ: LGVNR) (“Longeveron” or “Company”), a clinical-stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer’s disease and Aging-related Frailty, announced today that extended long-term follow-up data from the Company’s ELPIS I trial of Lomecel-BTM for patients with hypoplastic left heart syndrome (HLHS) is being presented as a poster at the annual Scientific Sessions of the American Heart Association (AHA), being...

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Novo Nordisk A/S: Semaglutide 2.4 mg (Wegovy®) cardiovascular outcomes data presented at American Heart Association Scientific Sessions and simultaneously published in New England Journal of Medicine

Semaglutide 2.4 mg delivered a statistically significant 20% risk reduction in major adverse cardiovascular events (MACE) with risk reductions demonstrated consistently across age, gender, ethnicity and starting body mass index (BMI). Beneficial effects were seen consistently across measured cardiovascular endpoints with semaglutide 2.4 mg. Risk reductions in MACE were evident soon after initiation, suggesting an effect of semaglutide 2.4 mg beyond weight loss alone.Bagsværd, Denmark, 11 November 2023 – Novo Nordisk today announced the primary results of SELECT, its landmark phase 3 cardiovascular outcomes trial investigating the effects of once-weekly semaglutide 2.4 mg (Wegovy®) in adults with established cardiovascular disease (CVD) and overweight or obesity without diabetes at the American Heart Association (AHA) annual Scientific...

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Looking Glass Labs Announces Private Placement Financing and Debt Settlement

VANCOUVER, British Columbia, Nov. 10, 2023 (GLOBE NEWSWIRE) — Looking Glass Labs Ltd. (“LGL” or the “Company”) (NEO: NFTX) (AQSE: NFTX) (OTC: LGSLF) (FRA: H1N) is pleased to announce a non-brokered private placement offering (the “Offering”) of up to 11,000,000 units (the “Units”) at a price of $0.10 per Unit, for gross proceeds of up to $1,100,000. Each Unit will consist of one (1) common share in the capital of the Company (each a “Share”) and one common share purchase warrant (each a “Warrant”). Each Warrant will entitle the holder thereof to purchase one (1) additional Share of the Company at an exercise price of $0.10 for a period of two (2) years from the closing date of the Offering. The gross proceeds from the Offering will be used by the Company for general corporate and working capital purposes. The Company also advises...

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