Category Archives: Topics

FDA Lifts BMF-219 Clinical Hold; Abvance ABV 101 Virtual KOL Event

Two cardiometabolic-related news items have been observed: FDA lifted the clinical hold on Biomea Fusion’s clinical trials of BMF-219 in T2DM and T1DM (view press release; view webcast); and Abvance Therapeutics hosted a virtual KOL event for its ABV 101 asset (view webcast). Below, FENIX provides highlights and insights for the respective news items. 

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Novo and Evotec Partner for Cell Therapy Development; J&J Divests CVRM Portfolio

Two cardiometabolic-related news items have been observed: Evotec and Novo Nordisk entered into another cell therapy development partnership (view press release); and Johnson & Johnson is divesting its CV and metabolic drug business unit (view article). Below, FENIX provides highlights and insights into the Evotec/Novo partnership and the J&J divestment.

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Galmed MASH Open-Label Publication; Entera/OPKO GLP-1/GCG Pre-Clinical Update

Two cardiometabolic-related news items have been observed: Galmed published one-year open-label results from its Ph3 MASH study (view press release; view publication); and Entera Bio and OPKO Health provided updates on its preclinical oxyntomodulin asset in obesity (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Metsera Reports Positive Ph1 Obesity Topline Results; Novo CEO Testifies at Senate HELP Committee Hearing

Two cardiometabolic-related news items have been observed: Metsera announced positive topline results from its Ph1 clinical trial of MET-097, its ultra-long-acting injectable GLP-1RA (view press release); and Novo Nordisk’s CEO, Lars Fruergaard Jørgensen, testified at the Senate Committee on Health, Education, Labor, and Pensions (HELP) hearing titled, “Why Is Novo Nordisk Charging Americans with Diabetes and Obesity Outrageously High Prices for Ozempic and Wegovy?” (view broadcast here). Below, FENIX provides insight into Metsera’s first obesity data readout as well as initial thoughts on the Senate HELP committee hearing.

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Skye Defends Nimacimab After Disappointing Novo Obesity Data; Sanofi Invests in Obesity Asset; Arrowhead Files to Initiate ARO-INHBE Obesity Study

Three cardiometabolic-related news items have been observed: Skye Bioscience released a statement highlighting differences between nimacimab and Novo Nordisk’s monlunabant following Ph2a monlunabant topline data (view press release); Ventyx Biosciences announced a $27M investment from Sanofi for first negotiation rights of its VTX3232 obesity asset (view press release); and Arrowhead announced it filed for regulatory clearance to initiate a Ph1/2a trial of ARO-INHBE in obesity (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Novo CB1 Ph2a Obesity Topline Results; Two Ph3 Tirzepatide Combo Psoriatic Studies Observed; Aligos Ph2a MASH Topline Results; AZ Initiates Ph2 LA Amylin Obesity Study; FTC Sues PBMs; Synjardy Receives Pediatric CHMP Positive Opinion

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Lilly, Aligos Therapeutics, AstraZeneca, FTC, and CHMP. Below, FENIX provides highlights and insights for the respective news items.

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Novo Enters Partnership with NanoVation for Cardiometabolic and Rare Diseases; Lilly and Axcelead Enter Development Partnership

Two cardiometabolic-related news items have been observed: NanoVation Therapeutics announced it entered into a multi-year partnership with Novo Nordisk for cardiometabolic and rare disease development (view press release); and Axcelead Drug Discovery Partners announced it entered into a development partnership with Lilly for multiple drug discovery programs (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Eversense 365 Day CGM Receives FDA Clearance

Senseonics Holdings and Ascensia Diabetes Care announced FDA cleared the implantable Eversense 365 CGM as an iCGM system for people with T1DM and T2DM aged 18 years and older. Senseonics stated it is continuing to progress partnership discussions with various pump manufacturers looking to leverage Eversense 365 with AID systems. Ascensia plans to initiate the US launch of Eversense 365 in early Q4 2024. Below, FENIX provides brief insights into the 510(k) clearance.

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