New REVEAL-1 study results show early signs of weight maintenance after GLP-1 discontinuation REMAIN-1 pivotal study now more than 50% enrolled; midpoint data analysis anticipated in Q3 2025 BURLINGTON, Mass., April 01, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (“the Company”), a metabolic therapeutics company focused on pattern breaking approaches that treat root causes of obesity and type 2 diabetes (T2D), today announced positive early data... Read more
Primary endpoint met in the 8-week treatment study (highly statistically significant). Co-administered group had a 4.4% reduction in weight compared to 1.6% for the placebo group (p<0.0001). Primary analysis for the co-administered group in the 8-week treatment study showed: 40% of patients achieved 5% reduction in weight (p<0.05). 27% achieved 6% reduction in weight (p<0.05). 19% achieved 7% reduction in weight (p<0.1). Low dose&nb... Read more
Rybelsus® reduced major adverse cardiovascular events by 14% vs placebo in adults with type 2 diabetes and cardiovascular and/or chronic kidney disease in the SOUL cardiovascular outcomes trial1. Data were presented at the American College of Cardiology's (ACC) Annual Scientific Session and Expo in Chicago, US, while simultaneously published today in New England Journal of Medicine2. Rybelsus®, the only approved oral GLP-1 medicine, demonstrated this risk... Read more
CB1 inverse agonism is a clinically validated mechanism to induce weight loss CRB-913 is markedly more peripherally restricted compared to monlunabant and rimonabant SAD/MAD Phase 1 trial scheduled for completion Q3 2025 and Phase 1b dose-range finding scheduled for completion H2 2026 NORWOOD, Mass., March 28, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), an oncology and obesity company with a... Read more
NanoPortal™ technology successfully delivers semaglutide, the active ingredient in Ozempic®/Wegovy®, in a preclinical study with NPM-139 (semaglutide implant) NPM-139 treatment resulted in nearly 20% placebo-adjusted weight loss from a single administration with expected once or twice-yearly dosing NPM-139 is a miniature, subdermal implant in development for chronic weight management designed to guarantee medication adherence and potentially improve treatment... Read more
13-Week Study Evaluating the Safety and Efficacy of Oral VK2735 Dosed Once Daily Results Expected in 2H25 SAN DIEGO, March 26, 2025 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the completion of subject enrollment in its Phase 2 clinical trial of the oral tablet formulation of VK2735, the company's... Read more
Guangdong, China and Bagsværd, Denmark, 24 March 2025 –The United Laboratories International Holdings Limited (TUL) and Novo Nordisk A/S (Novo Nordisk) today announced that Novo Nordisk and TUL’s wholly-owned subsidiary The United Bio-Technology (Hengqin) Co., Ltd. (United Biotechnology), have entered into an exclusive license agreement for UBT251, a triple agonist of the receptors for GLP-1, GIP, and glucagon in early-stage clinical development for the treatment... Read more
Average Total Weight Loss of 20% With 15% Increase in Lean Body Mass After 8 Months of Combined Therapy NATICK, Mass. / Mar 20, 2025 / Business Wire / Allurion Technologies, Inc. (“Allurion” or the “Company”) (NYSE: ALUR), a company dedicated to ending obesity, today announced initial results on the combination of the Allurion Program with low-dose GLP-1 therapy to optimize muscle mass and GLP-1 adherence. 52 patients treated with the Allurion Balloon were started... Read more
BOSTON, March 19, 2025 (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 it has received orphan drug designation from Japan’s Ministry of Health, Labour and Welfare (MHLW) for setmelanotide as a treatment for acquired hypothalamic obesity. Setmelanotide is a melanocortin-4 receptor (MC4R) agonist designed... Read more
HOUSTON, March 18, 2025 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (OTCQB:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer and obesity drugs, today reported results from recent preclinical studies of BP1001-A that support its potential as a treatment for obesity. In these studies, BP1001-A attenuated fatty acid-induced insulin resistance and restored... Read more
MIAMI and JERUSALEM, March 17, 2025 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) and Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and proteins replacement therapies, entered into a collaboration and license agreement to advance into the clinic the first oral dual agonist GLP-1/glucagon peptide as a once-daily tablet treatment for patients with obesity, metabolic and fibrotic disorders. The program combines OPKO’s proprietary long-acting... Read more
Agreement allows for a range of potentially best-in-class therapy options as monotherapy and fixed dose combination with Roche`s lead incretin asset CT 388 Collaboration will complement Roche's portfolio in the field of cardiovascular, renal, and metabolic (CVRM) diseases Obesity is a heterogeneous disease with over 200 related comorbidities, including cardiovascular and metabolic diseases, and is expected to impact over 4 billion people globally by 2035 Basel, 12... Read more
Bagsværd, Denmark, 10 March 2025 – Today, Novo Nordisk announced headline results from REDEFINE 2, a phase 3 trial in the global REDEFINE programme. REDEFINE 2 is a 68-week efficacy and safety trial investigating once-weekly subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to placebo. The trial included 1,206 randomised people with obesity or overweight and type 2 diabetes and a mean baseline body weight... Read more
ARO-INHBE and ARO-ALK7 both target a known pathway that signals the body to store fat in adipose tissue with a novel mechanism of action that may better preserve lean muscle mass compared to currently approved obesity therapies Data highlight Arrowhead’s leadership in the use of RNA interference to potentially treat Obesity PASADENA, Calif. / Mar 06, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced presentation of preclinical data... Read more
PURCHASE, NY, March 06, 2025 (GLOBE NEWSWIRE) -- Teladoc Health (NYSE: TDOC) today announced a pharmacy integration agreement with Eli Lilly’s LillyDirect pharmacy partner, Gifthealth, which will help streamline access to FDA-approved Zepbound® (tirzepatide) for Teladoc Health members enrolled in its Comprehensive Weight Care Program. This option will help members without insurance coverage for GLP-1s for obesity have more seamless access to affordable, safe, and effective... Read more
NovoCare® Pharmacy provides direct-to-patient, convenient home shipments of all dose strengths of Wegovy® at a reduced cost of $499 per month for cash-paying patients While 90% of patients taking Wegovy ® have a co-pay of $0 to $25 per month, this offer was designed to support cash-paying patients without insurance coverage Amidst the dangers of fake or illegitimate compounded "semaglutide," NovoCare® Pharmacy offers reliable access to authentic, FDA-approved... Read more
Patent portfolio now exceeds 60 issued patents globally NATICK, Mass. / Mar 04, 2025 / Business Wire / Allurion Technologies, Inc. (“Allurion” or the “Company”) (NYSE: ALUR), a company dedicated to ending obesity, today announced that it has received two Issue Notifications from the U.S. Patent and Trademark Office (USPTO) dated February 19, 2025 for U.S. Patent No. 12,246,163 titled “Automatic-Sealing Balloon-Filling Catheter System” and U.S. Patent No.... Read more
Partnership marks AbbVie's entrance into the obesity field Agreement will enable the incorporation of GUB014295, an amylin peptide discovered and developed by Gubra, into AbbVie's global infrastructure for developing and commercializing therapies for patients in need NORTH CHICAGO, Ill. and HØRSHOLM, Denmark, March 3, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Gubra A/S (CPSE:GUBRA), a company specializing in preclinical contract research services and peptide-based... Read more
PASADENA, Calif. / Feb 25, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced preclinical results on ARO-ALK7, the company’s investigational RNA interference (RNAi) therapeutic targeting Activin receptor-like kinase 7 (ALK7) being developed as a potential treatment for obesity. The results were presented in a poster at the Keystone Symposia on Obesity and Adipose Tissue held February 23–26, 2025 in Banff, AB, Canada. ARO-ALK7 is the... Read more
New 7.5 mg and 10 mg Zepbound single-dose vials now available for $499 per month via Zepbound Self Pay Journey Program 2.5 mg and 5 mg vial prices reduced INDIANAPOLIS, Feb. 25, 2025 /PRNewswire/ -- Today Eli Lilly and Company (NYSE: LLY) announced the launch of 7.5 mg and 10 mg Zepbound (tirzepatide) single-dose vials, available for $499 with the new Zepbound Self Pay Journey Program.1 Lilly also reduced the price of the 2.5 mg and 5 mg vials. These new offerings... Read more
Dallas, Texas, Feb. 20, 2025 (GLOBE NEWSWIRE) -- Mangoceuticals, Inc. (NASDAQ: MGRX) ("Mangoceuticals" or the "Company"), a company focused on developing, marketing, and selling a variety of men’s wellness products via a secure telemedicine platform under the brand MangoRx, proudly announces the official launch of PeachesRx, an innovative women’s health and wellness brand focused on providing cutting-edge, convenient treatments tailored to women’s unique health needs.... Read more
NATICK, Mass. / Feb 18, 2025 / Business Wire / Allurion Technologies, Inc. (“Allurion” or the “Company”) (NYSE: ALUR), a company dedicated to ending obesity, today announced its intention to initiate a clinical study on the combination of the Allurion Balloon with GLP-1 agonists. The study will focus on combination use of the Allurion Balloon with lower dose GLP-1s with the goal of demonstrating improved long-term tolerability and adherence to GLP-1 therapy. Previous... Read more
WVE-007 is a novel, long-acting GalNAc-siRNA targeting INHBE mRNA – a genetically validated target that provides a new approach for healthy, sustainable weight loss (fat loss with muscle preservation) Proof-of-concept clinical data from INLIGHT are expected in 2025 CAMBRIDGE, Mass., Feb. 06, 2025 (GLOBE NEWSWIRE) -- Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform... Read more
Last Patient / Last Visit Completed Topline Data Readout Expected Later This Quarter CRANBURY, N.J., Feb. 6, 2025 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced the completion of its Phase 2 BMT-801 clinical study of the co-administration of MC4R bremelanotide + GLP-1/GIP tirzepatide for... Read more
Conference call scheduled for 4:30 p.m. ET today Initiation of Phase 3 Studies for Subcutaneous VK2735 for Obesity Planned for 2Q25 Phase 2 VENTURE-Oral Dosing Trial Evaluating VK2735 in Obesity Underway Strong Year-End Cash Position of $903 Million SAN DIEGO, Feb. 5, 2025 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders,... Read more
Prioritizing Revita’s clinical development on weight maintenance post-GLP-1 withdrawal in response to significant patient and physician demand in ongoing REMAIN-1 pivotal study; anticipate midpoint data analysis in Q2 2025 and full pivotal study enrollment in summer 2025 RJVA-001, first clinical candidate in Rejuva gene therapy program, has completed key preclinical in vivo studies; on-track to initiate first-in-human studies in H1 2025 Streamlined focus expected... Read more
Series of studies to observe signals of inflammation and TNF-alpha levels in patients taking GLP-1s including Wegovy® or Ozempic® Lean body mass accounts for up to 40% of weight loss from GLP-1 treatments Potential entry into high growth GLP-1 market of nearly $50 billion in 2024, projected value of $100 billion by 2029 BALTIMORE / Jan 29, 2025 / Business Wire / TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNF” or the “Company”), a clinical stage biopharmaceutical... Read more
Advancement of next-generation APJ agonists with discontinuation of azelaprag Nomination of NLRP3 inhibitor BGE-102 as a development candidate, with initial Ph1 clinical data anticipated by end of 2025 Expansion of discovery efforts based on insights from BioAge’s platform, including a target identification collaboration with Novartis and a newly announced antibody therapeutics development collaboration with Lilly ExploR&D RICHMOND, Calif., Jan. 28, 2025 (GLOBE... Read more
Study met primary endpoint: Enobosarm treatment resulted in statistically significant reduction in the loss of lean mass in subjects receiving WEGOVY (p=0.002) Patients on Enobosarm on average lost 71% less lean mass than patients receiving WEGOVY alone Patients on Enobosarm on average lost 27% more fat mass than patients receiving WEGOVY alone Enobosarm improved body composition as mean total body weight loss was similar compared to subjects receiving... Read more
Bagsværd, Denmark, 24 January 2025 – Novo Nordisk today announced topline results from a phase 1b/2a clinical trial with amycretin, a unimolecular GLP-1 and amylin receptor agonist intended for once weekly subcutaneous administration. The trial investigated the safety, tolerability, pharmacokinetics, and proof-of-concept after once-weekly subcutaneous administrations of amycretin in 125 people with overweight or obesity. The trial was a combined single ascending... Read more
NATICK, Mass. / Jan 23, 2025 / Business Wire / Allurion Technologies, Inc. (“Allurion” or the “Company”) (NYSE: ALUR), a company dedicated to ending obesity, today announced its intention to initiate a clinical study on the combination of the Allurion Program with GLP-1 agonists to improve muscle mass and overall body composition. Previous studies in patients undergoing GLP-1 therapy have demonstrated reductions in lean mass of approximately 40% as a proportion of... Read more
Bagsværd, Denmark, 17 January 2025 – Novo Nordisk today announced headline results from STEP UP, a phase 3b trial in the global STEP programme. STEP UP is a 72-week efficacy and safety trial investigating subcutaneous semaglutide 7.2 mg compared to semaglutide 2.4 mg and placebo, all administered once weekly. The trial included 1,407 randomised adults with obesity. All treatment arms were in conjunction with lifestyle intervention. The trial achieved its primary... Read more
BOSTON and SAN FRANCISCO, Jan. 15, 2025 (GLOBE NEWSWIRE) -- Amwell® (NYSE: AMWL), a leader in digital care, today announced that Vida Health, a leader in virtual cardiometabolic care, is now part of the clinical programs portfolio on the Amwell platform. The program, Amwell Cardiometabolic Care Powered by Vida, will be available to Amwell’s expansive client footprint of health plans and employers. Clients will be able to offer their members access to a suite of car... Read more
NEW YORK, Jan. 10, 2025 (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 findings on the prolonged benefits of its nasal anti-CD3 monoclonal antibody in sustaining tissue homeostasis and mitigating the side effects associated with... Read more
13-Week Study to Evaluate the Safety and Efficacy of Oral VK2735 Dosed Once Daily SAN DIEGO, Jan. 8, 2025 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the initiation of a Phase 2 clinical trial of the oral tablet formulation of VK2735, the company's dual agonist of the glucagon-like peptide 1 (GLP-1)... Read more
SAN DIEGO, Jan. 02, 2025 (GLOBE NEWSWIRE) -- iBio, Inc. (NYSEA: IBIO), an AI-driven innovator of precision antibody immunotherapies, today announced the expansion of its cardiometabolic and obesity treatment development program by in-licensing a potentially best-in-class long-acting anti-myostatin antibody from AstralBio, Inc. The antibody, now named IBIO-600, was identified by AstralBio using iBio’s proprietary technology stack and was designed for subcutaneous administration... Read more
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
