Category Archives: Topics

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.

This content is for Read Less members only.
Already a member? Log in here

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.

This content is for Read Less members only.
Already a member? Log in here

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.

This content is for Read Less members only.
Already a member? Log in here

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.

This content is for Read Less members only.
Already a member? Log in here

Wave Crashes Following Disappointing Ph1 Obesity Data; Novo’s 2026 Annual General Meeting; Viking Completes VANQUISH-2 Enrollment

Three cardiometabolic-related news items have been observed: Wave Life Sciences announced updated data from its Ph1 INLIGHT study of WVE-007 in obesity (view press release); Novo Nordisk hosted its 2026 Annual General Meeting (view notice); and Viking Therapeutics completed enrollment for its Ph3 VANQUISH-2 study of VK2735 (view press release). Below, FENIX provides highlights and insights from the respective news items.

This content is for Read Less members only.
Already a member? Log in here

Novo Triple Agonist T2DM Data; BI 2026 Annual Press Conference; Pfizer Doses First Patient in VESPER-5; Merck Acquires Terns; Fractyl Q4 ’25 Earnings; Biomea FY 2025 Updates; BrightGene Ph1 Dual Agonist Data

A series of cardiometabolic-related news items has been observed by Novo Nordisk, Boehringer Ingelheim, Pfizer, Merck, Fractyl Health, Biomea Fusion, and BrightGene Bio-Medical Technology. Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Already a member? Log in here