WVE-007 is a novel approach for treating obesity and is designed to silence INHBE to achieve healthy, sustainable weight loss through fat burning, muscle maintenance and the potential for once or twice-annual administration WVE-007 is Wave’s first siRNA program to enter clinical development and uses best-in-class oligonucleotide chemistry and GalNAc delivery Wave expects to initiate the first-in-human study of WVE-007 in 1Q 2025 CAMBRIDGE, Mass., Dec. 23, 2024... Read more
Bagsværd, Denmark, 20 December 2024 – Novo Nordisk today announced headline results from REDEFINE 1, a phase 3 trial in the global REDEFINE programme. REDEFINE 1 is a 68-week efficacy and safety trial investigating subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to the individual components cagrilintide 2.4 mg, semaglutide 2.4 mg and placebo, all administered once-weekly. The trial included 3,417 randomised... Read more
Averaging up to 20% of weight loss, adults taking Zepbound had at least 25 fewer breathing interruptions each hour as they slept Up to 50% of adults taking Zepbound no longer had symptoms associated with OSA after one year INDIANAPOLIS, Dec. 20, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) approved Zepbound® (tirzepatide) as the first and only prescription medicine for adults with moder... Read more
Fully funded study to evaluate Wegovy and Ozempic patients at risk for increased inflammation associated with sarcopenic muscle deterioration Collaboration partner to use AI and machine learning to identify targeted patient pool Potential entry into high growth GLP-1 market valued at nearly $50 billion in 2024 and projected to surpass $100 billion by 2029 BALTIMORE / Dec 19, 2024 / Business Wire / TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNFA” or the “Company”),... Read more
NPM-115 clinical program utilizes a miniature, GLP-1 (exenatide) implant designed to provide comparable efficacy to semaglutide, with twice-yearly administration Study represents the first clinical application of NanoPortal™, the Company’s proprietary drug implant platform technology ALAMEDA, Calif. / Dec 19, 2024 / Business Wire / Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), an innovative biopharmaceutical company developing novel, ultra... Read more
HOUSTON, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today reported that results from preclinical studies of BP1001-A for obesity demonstrated enhanced insulin sensitivity, confirming BP1001-A as a potential treatment for obesity and related metabolic diseases in Type 2 diabetes... Read more
RAHWAY, N.J. / Dec 18, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Hansoh Pharma, a Chinese biopharmaceutical company, today announced that they have entered into an exclusive global license agreement for HS-10535, an investigational preclinical oral small molecule GLP-1 receptor agonist. “We continue to leverage science-driven business development to augment and complement our robust pipeline,” said Dr. Dean Y.... Read more
Preclinical studies with ACCG-2671 demonstrate potent target engagement, robust weight loss, favorable safety profile and PK properties supportive of once-daily dosing in humans ACCG-2671 is the most advanced oral small molecule amylin-based drug candidate, with Phase 1 study initiation expected by year end 2025 Company to host conference call today at 4:30 p.m. Eastern Time SAN FRANCISCO, Dec. 17, 2024 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR),... Read more
The ongoing obesity Phase 2 trial is a randomized, double-blind, placebo-controlled, dose finding, clinical trial to evaluate the safety and efficacy of KDS2010 in approximately 75 overweight or obese patients currently enrolling in South Korea with a cohort in U.S. to be added in 2025. KDS2010 has shown promising preclinical results with a novel mechanism of blocking MAO-B-dependent aberrant GABA (gamma-aminobutyric acid) production in reactive astrocytes and eliminates... Read more
Extensive Scientific Evidence Supporting Growth Factor Receptor Bound Protein-2 (Grb2) as Fundamental Link in Insulin Resistance Reallocates Resources to Metabolic Program and Discontinues Enrollment in Phase 1 Study of BP1002 to Treat Relapsed/Refractory Lymphoma and Relapsed/Refractory Chronic Lymphocytic Leukemia Due to Enrollment Challenges in Niche Patient Populations HOUSTON, Dec. 11, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology... Read more
Decision follows observations of liver transaminitis without clinically significant symptoms in some subjects on azelaprag Company will evaluate data from patients enrolled to date and share updated plans for azelaprag in Q1 2025 In parallel to evaluating azelaprag, Company will continue to advance earlier platform-derived programs, including IND submission for CNS penetrant NLRP3 inhibitor anticipated in the second half of 2025 RICHMOND, Calif., Dec. 06, 2024 (GLOBE... Read more
Participants using Zepbound lost 50.3 lbs (22.8 kg) and participants on Wegovy lost 33.1 lbs (15.0 kg) SURMOUNT-5 compared Zepbound, a dual GIP and GLP-1 receptor agonist, to Wegovy, a mono GLP-1 receptor agonist in adults living with obesity without diabetes INDIANAPOLIS, Dec. 4, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced topline results from the SURMOUNT-5 phase 3b open-label randomized clinical trial. Zepbound® (tirzepatide)... Read more
In preclinical studies, investigational ARO-ALK7 silenced Activin receptor-like kinase 7 (ALK7) expression in adipose tissue, which led to reduced body weight and fat mass with preservation of lean muscle PASADENA, Calif. / Dec 03, 2024 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has filed a request for regulatory clearance to initiate a Phase 1/2a clinical trial of ARO-ALK7, the company’s second investigational RNA interference... Read more
BOSTON, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that the United Kingdom’s Medicines & Healthcare products Regulatory Agency (MHRA) has expanded the marketing authorization for IMCIVREE® (setmelanotide) to include the treatment of obesity and control of hunger associated... Read more
MariTide Demonstrated up to ~20% Average Weight Loss at 52 Weeks Without a Weight Loss Plateau in People Living With Obesity or Overweight MariTide is the First Obesity Treatment With Monthly or Less Frequent Dosing to Demonstrate Safe and Effective Weight Loss in a Phase 2 Study In People With Type 2 Diabetes Living With Obesity or Overweight MariTide Demonstrated up to ~17% Average Weight Loss Without a Weight Loss Plateau and Lowered Average HbA1c by up to 2.2 Percentage... Read more
AllurionMeds is designed to address a critical demand from patients: The Weight Must Stay Off Features Coach Iris, a first-of-its-kind conversational AI behavioral agent for weight loss and maintenance, trained using real-world experience in over 150,000 patients Compounded GLP-1 program designed to provide long-term behavioral change while addressing weight re-gain and other negative side effects for patients Expands Allurion’s presence to all 50 states, helping to... Read more
In the RESILIENT SMA study, taldefgrobep alpha showed clinically meaningful improvements in motor function at all timepoints on the Motor Function Measurement-32 scale (MFM-32), but the treatment arm did not statistically separate on the primary outcome at Week 48 compared to the placebo+standard of care (SOC) group. Efficacy signals were observed in clinically relevant and biomarker-defined subgroups including those related to age, ambulatory status, background... Read more
In a first-of-its-kind study, tirzepatide also alleviated heart failure symptoms and physical limitations Patients on tirzepatide experienced improved exercise capacity, greater weight loss and reduced systemic inflammation Lilly has initiated submissions for tirzepatide for the treatment of HFpEF and obesity to global regulatory agencies INDIANAPOLIS, Nov. 16, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from the... Read more
World's First-Ever Study Tracking Biodistribution of DehydraTECH GLP-1 Molecules KELOWNA, BRITISH COLUMBIA / ACCESSWIRE / November 14, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces it has engaged a contract research organization to perform the world's first-ever fluorescently tagged DehydraTECH-semaglutide ("FTS") rodent biodistribution study (the "Study"). Distribution... Read more
SAN DIEGO, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biopharmaceutical company focused on unlocking new therapeutic pathways for metabolic health, today announced that it has achieved more than 50% of targeted patient enrollment for its CBeyond™ Phase 2 clinical trial assessing nimacimab, a differentiated CB1 inhibitor, in patients with overweight or obesity. Skye expects to report interim data for the... Read more
SURMOUNT-1 results show a 94% reduction in risk of progression to type 2 diabetes across all pooled doses of tirzepatide compared to placebo over three years Results suggest one new case of diabetes could be prevented for every nine patients treated with tirzepatide Participants treated with tirzepatide had an average weight reduction of 22.9% (15 mg dose) INDIANAPOLIS, Nov. 13, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today detailed results... Read more
Phase 2b ACCESS study designed to evaluate multiple doses up to 120 mg of GSBR-1290 over 36 weeks Comprehensive development program also includes Phase 2 ACCESS II study to evaluate even higher doses of GSBR-1290 over 36 weeks; first patient expected to be dosed by end of 2024 Topline data from both ACCESS and ACCESS II studies expected in the fourth quarter of 2025 Company to host conference call today at 4:30 p.m. Eastern Time SAN FRANCISCO, Nov.... Read more
DehydraTECH clinical test article manufacturing has been completed KELOWNA, BC / ACCESSWIRE / November 13, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX, LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces it has received lead clinical site human research ethics committee ("HREC") approval that was required before dosing can begin in the Company's Phase 1b, 12-week chronic study GLP-1-H24-4, (the "Study"). The Company is also... Read more
DehydraTECH™ for GLP-1 being optimized for global pharmaceutical use KELOWNA, BC / ACCESSWIRE / November 7, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms provides the following glucagon-like peptide-1 ("GLP-1") industry update. It is no surprise that Novo Nordisk's ("Novo") blockbuster drug, semaglutide, which is sold under the brand names Ozempic®, Wegovy®, and Rybelsus®,... Read more
Company and Agency aligned on key efficacy and safety measures to be studied in Phase 3 program Pivotal Phase 3 trials designed to leverage the differentiated attributes of pemvidutide and potential benefits of balanced GLP-1/glucagon dual agonism GAITHERSBURG, Md., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the successful completion of its End-of-Phase 2 Meeting with the U.S. Food and... Read more
13-week follow-up represents the longest data to-date demonstrating durable efficacy of RJVA-001 on weight and blood sugar in the diet-induced obesity (DIO) mouse model Company plans to use durable efficacy results as part of its FIH data package for RJVA-001 Fractyl also announces the nomination of RJVA-002, a GIP/GLP-1 dual agonist, as its first pancreatic gene therapy candidate for obesity BURLINGTON, Mass., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Fractyl Health,... Read more
Investigational New Drug (IND) application planned in 2025 for LX9851, a first-in-class, potent, selective, orally bioavailable molecule, as an anti-obesity agent Data from Lexicon’s Obesity Week presentations summarize the preclinical efficacy and mechanism of action of LX9851 THE WOODLANDS, Texas, Nov. 04, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced it will present data from two studies related to LX9851,... Read more
Up to 6.8% Placebo-Adjusted Mean Weight Loss (8.2% from Baseline) After 28 Days of Dosing with Oral Tablet of VK2735 Encouraging Tolerability Through 100 mg Daily Dosing with Oral VK2735; Mild GI-Related Adverse Event Profile Updated Results from VENTURE Phase 2 Study of Subcutaneous VK2735 Show Durable Effects and Support Potential Monthly Dosing Regimen SAN DIEGO, Nov. 4, 2024 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX),... Read more
NEW YORK, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced positive results demonstrating the anti-inflammatory potential of our anti-CD3 antibody (foralumab) in combination with semaglutide, a GLP-1 agonist marketed... Read more
DehydraTECH-liraglutide and select DehydraTECH-CBD formulations were the top performing weight loss groups Accelerated rates of weight loss were experienced during the final 4 weeks of the study in all DehydraTECH groups KELOWNA, BC / ACCESSWIRE / October 22, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX) & (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that it has received partial 12-week (final) body... Read more
Wisp debuts its first-ever exclusive over-the-counter weight-loss supplement, designed to promote women's metabolic health. Wisp introduces personalized, online consultations with access to four weight care solutions, including GLP-1 medications, to support women struggling with hormonal conditions such as perimenopause, menopause, Polycystic Ovary Syndrome (PCOS), and endometriosis. With over 1.2 million patients, Wisp Now Also Bolsters its Menopause Solutions, Empowering... Read more
SAN DIEGO, Oct. 10, 2024 (GLOBE NEWSWIRE) -- iBio, Inc. (NYSEA:IBIO), an AI-driven innovator of precision antibody immunotherapies, today provided an update on the myostatin program for cardiometabolic disease and obesity in collaboration with AstralBio. iBio’s technology stack enabled the Company to rapidly advance the joint myostatin program from inception to in vitro proof-of-concept in human muscle cells. Following early discovery, the companies have identified a... Read more
In a study of 167 patients, average weight reduction was 15.7% at four months, 17.1% at six months, and 14.7% at one year Body fat percentage decreased at six months with no change in muscle mass NATICK, Mass. / Oct 09, 2024 / Business Wire / Allurion Technologies, Inc. (NYSE: ALUR), a company dedicated to ending obesity, today announced the publication of a study in the journal Clinical Obesity on the impact of the Allurion Program on weight reduction and body com... Read more
KELOWNA, BC / ACCESSWIRE / October 8, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX) & (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery technology, provides an update on recent glucagon-like peptide-1 ("GLP-1") receptor agonist market sector advancements. In 2020 the total market size for GLP-1 drugs was less than $4 billion . That same year, Novo Nordisk® paid $1.8 billion to purchase Emisphere's® SNAC drug delivery technology which... Read more
HOUSTON, Oct. 08, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced the initiation of a therapeutic program to develop BP1001-A for the treatment of obesity and related metabolic diseases. This program marks the first application of DNAbilize technology for development of a... Read more
Dallas, Texas, Oct. 03, 2024 (GLOBE NEWSWIRE) -- Mangoceuticals, Inc. (NASDAQ: MGRX) (“MangoRx” or the “Company”), a company focused on developing, marketing, and selling men’s health and wellness products via a secure telemedicine platform, announces the release of its latest innovation, “TRIM,” a compounded, oral dissolvable Tirzepatide tablet. Available for purchase at $399 per month, this new product offers patients an advanced and convenient alternative... Read more
Systematic review of 11 studies involving 2,107 patients reports average weight reduction of 12.5% with significant improvements in metabolic health NATICK, Mass. / Oct 01, 2024 / Business Wire / Allurion Technologies, Inc. (NYSE: ALUR), a company dedicated to ending obesity, today announced the publication of a systematic review and meta-analysis evaluating the effectiveness and safety of the Allurion Program. The analysis reviewed studies conducted between 2016 and... Read more
MangoRx aims to capitalize on growing demand for GLP-1 treatments to drive revenue growth and expand market share in the weight loss category Dallas, Texas, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Mangoceuticals, Inc. (NASDAQ: MGRX) (“MangoRx” or the “Company”), a company focused on developing, marketing, and selling men’s health and wellness products via a secure telemedicine platform, proudly announces that its highly anticipated oral Semaglutide weight loss... Read more
Amneal to construct state-of-the-art manufacturing facilities and utilize existing manufacturing network to ensure supply of Metsera’s portfolio of novel injectable and oral development programs, including GLP-1 and amylin receptor agonists Agreement provides Amneal with a new high-growth vector to drive long-term value creation Metsera gains high-quality, efficient, large-scale manufacturing capabilities for its portfolio to enable rapid product development and anticipated... Read more
Data Revealed Favorable Safety, Tolerability and Dose-Linear Pharmacokinetics (PK) Top-Line Data Readout from the MAD Part 2 Expected in the First Quarter of 2025 Planned Phase 1 Part 3 Will Evaluate Early Proof of Concept CAMBRIDGE, Mass., Sept. 30, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced positive top-line safety, tolerability,... Read more
First-ever DehydraTECH-processed tirzepatide from Zepbound® to be tested in a swallowed oral format KELOWNA, BC / ACCESSWIRE / September 27, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that approval has been received from an independent review board, for human pilot study #3 (the "Study"), investigating a DehydraTECH-processed version of the dual action... Read more
JERUSALEM and MIAMI, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (Entera), a leader in the development of orally delivered peptides, and OPKO Health, Inc. (NASDAQ: OPK) (OPKO) announced today topline pharmacokinetic/pharmacodynamic (PK/PD) results from their ongoing collaborative research combining a proprietary long-acting oxyntomodulin (OXM) analog developed by OPKO and Entera’s proprietary N-Tab™ technology. The program is focused on developing... Read more
In preclinical studies ARO-INHBE reduced body weight and fat mass with a novel mechanism of action that may preserve lean muscle mass compared to currently approved obesity therapies PASADENA, Calif. / Sep 23, 2024 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has filed for regulatory clearance to initiate a Phase 1/2a clinical trial of ARO-INHBE, the company’s investigational RNA interference (RNAi) therapeutic being developed... Read more
Bagsværd, Denmark, 20 September 2024 – Novo Nordisk today announced headline results from a phase 2a clinical trial with monlunabant, a small molecule oral cannabinoid receptor 1 (CB1) inverse agonist. Monlunabant, formerly INV-202, was part of the acquisition of Inversago Pharmaceuticals Inc. announced in August 2023 [Link]. The trial investigated the efficacy and safety of a once-daily 10 mg, 20 mg and 50 mg dose of monlunabant compared to placebo on body weight... Read more
Topline results expected in 2Q 2025 CAMBRIDGE, Mass. / Sep 10, 2024 / Business Wire / Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today announced it has completed enrollment in the Phase 2 EMBRAZE trial designed to show proof-of-concept of apitegromab, an inve... Read more
Lean Loss Ratio of only 21.9%, representing class-leading preservation of lean mass Maintenance of lean mass preservation in individuals over the age of 60, a population at risk for frailty-related falls and fractures Visceral adipose tissue (VAT), a risk factor for cardiovascular disease, reduced by 25.6% at Week 48 GAITHERSBURG, Md., Sept. 10, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today presented data... Read more
Statistically significant mean weight loss up to 5.5% over 28 days (4.9% placebo adjusted) Well-tolerated with no treatment-related dose interruptions, reductions, or discontinuations even with rapid dose titration Distinct drug properties support potential to be a leading GLP-1R agonist Plans to initiate Phase 2 clinical trial in 2025 Company to host conference call today at 8:00 am ET FOSTER CITY, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals,... Read more
In a study of 91 adolescents, average weight loss was 13.1% at four months with no serious adverse events NATICK, Mass. / Sep 05, 2024 / Business Wire / Allurion Technologies, Inc. (NYSE: ALUR), a company dedicated to ending obesity, today announced the publication of a study on the safety and effectiveness of the Allurion Program in adolescents. In the study, 91 adolescents between 15 and 17 years-old with average body mass index (BMI) of 35.6 received the Allurion... Read more
SUNNYVALE, Calif., Aug. 28, 2024 (GLOBE NEWSWIRE) -- Lemonaid Health, Inc., a subsidiary of 23andMe Holding Co., (Nasdaq: ME), and a leading telemedicine provider, is now offering Ozempic®, Wegovy® and compounded semaglutide through a weight loss program on its telehealth platform, providing consumers with access to affordable weight management care through a convenient subscription-based model. If prescribed, Lemonaid Health patients will now have access to once-weekly... Read more
Trend toward higher overall absorption under fed conditions evidenced with DehydraTECH®-processed Rybelsus® KELOWNA, BC / ACCESSWIRE / August 27, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that the first results from human pilot study #2, GLP-1-H24-2 (the "Study"), have been received. Lexaria's DehydraTECH®-processed Rybelsus® evidenced a trend toward higher... Read more
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