Category Archives: GLP-1RA

Ex-Novo Exec Joins BI; MetaVia Doses First Patient in Final Part of Ph1 Obesity Study; LifeMD to Offer Foundayo; Modular Medical Receives FDA Clearance for Pump Patch; MiniMed Pump Recall

A series of cardiometabolic-related news items has been observed from Novo Nordisk/Boehringer Ingelheim, MetaVia, LifeMD, Modular Medical, and FDA/MiniMed. Below, FENIX provides highlights and insights for the respective news items.

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Foundayo Available in the US; FDA Issues Warning Letters for Unapproved GLP-1RAs; EMA Wegovy Label Update; Novo’s Lotte Bjerre Knudsen Departs; 23andMe Study Identifies Genetic Connection for GLP-1RA-Induced Weight Loss; Noom Partnership

A series of cardiometabolic-related news items has been observed by Lilly, FDA, Novo Nordisk, 23andMe, and Noom. Below, FENIX provides highlights and insights for the respective news items.

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Foundayo Analysis: The Oral AOM Market is Heating Up

FDA recently approved Lilly’s orforglipron (branded Foundayo) as the first non-peptide oral GLP-1RA for the treatment of overweight or obesity (previous FENIX insight; view label). With Lilly set to begin shipments on April 6, 2026, Foundayo’s launch comes ~3 months after Novo Nordisk’s Wegovy Pill (the first oral peptide GLP‑1RA to market for obesity), setting the stage for one of the most highly anticipated commercial battles across the industry in recent years. Of note, immediately following the Foundayo approval, Novo issued a press release (view here) with two analyses suggesting Wegovy Pill outperforms Foundayo in terms of weight loss and tolerability. Below, FENIX has conducted a detailed analysis of Foundayo’s label, pricing, and website, as well as thoughts on a potentially new social media strategy from Novo.

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FDA Updates Compounding Policies; Skye Doses First Patient in Ph2 Expansion Study; Aspect Receives $79M in Funding

Three cardiometabolic-related news items have been observed: FDA updated its GLP-1RA compounding policies (view statement); Skye Bioscience dosed the first patient in Part C of the Ph2a CBeyond trial evaluating higher doses of nimacimab (view press release); and Aspect Biosystems received $79M in funding from the Canadian government (view press release). Below, FENIX provides highlights and insights on the respective news items.

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Orforglipron Approved by FDA as “Foundayo”

FDA has approved Lilly’s orforglipron (branded Foundayo) as the company’s first oral GLP-1RA therapy for the treatment of obesity (view press release; view label). Lilly stated orforglipron will be available immediately, with shipping beginning April 6, 2026. Recall, Lilly has stockpiled $1.5B worth of orforglipron in anticipation of the launch (previous FENIX insight). In the coming days, FENIX will conduct a detailed analysis of orforglipron’s label, pricing, and website, as well as an in-depth comparison to Novo Nordisk’s Wegovy Pill.

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Novo Pilots Subscription-Based Model for Wegovy; Novo Initiates Another Ph3 Zenagamtide Study; Inventiva Q4 ‘25 Earnings; Beta Bionics Launches New Data Analysis Feature; Vaxess Rebrands as Terrestrial Bio

A series of cardiometabolic-related news items has been observed from Novo Nordisk, Inventiva, Beta Bionics, and Vaxess Technologies. Below, FENIX provides highlights and insights for the respective news items.

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Kailera Files IPO; Diamyd Data Disappoints; Insilico and Lilly Partner for AI Drug Discovery; EMA Approves Bayer’s Kerendia for HFpEF; Gan & Lee QW Insulin; Roche Ph1 CAD Study; Lilly Ph3 TOGETHER-PsA Results

A series of cardiometabolic-related news items has been observed from Kailera Therapeutics, Diamyd Medical, Insilico, Bayer, Gan & Lee Pharmaceuticals, Roche, and Lilly. Below, FENIX provides highlights and insights for the respective news items.

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