Category Archives: Topics

Insulet Files Lawsuit Against EOFlow; Amazon Pharmacy Launches $35 Insulin Coupon; Welldoc Receives 510(k) Clearance for Connected Insulin Dosing Data; Dario Partners with PlanSource

Four cardiometabolic-related news items have been observed: Insulet filed a lawsuit against EOFlow, claiming the company copied patented components of its Omnipod devices (view article); Amazon Pharmacy announced it is rolling out “automatic coupons” to reduce customer costs for insulin to as low as $35/month (view article); Welldoc announced it received its tenth 510(k) clearance for BlueStar to use insulin dosing data from connected devices for its personalized bolus dosing recommendations (view press release); and DarioHealth announced a new agreement with PlanSource to offer digital health solutions to >5M consumers (view press release). Below FENIX provides highlights and insights for the respective news items.

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Lilly Completes Acquisition of Sigilon and Versanis; Galectin and Nemaura Q2 ‘23 Earnings; August CHMP Agenda

Five cardiometabolic-related news items have been observed: Lilly announced it completed the Sigilon Therapeutics (view press release) and Versanis Bio (view press release) acquisitions; Galectin Therapeutics (view press release) and Nemaura Medical (view press release) reported their respective Q2 ’23 earnings; and the CHMP agenda (view here) for this month’s meeting (August 14-17) has been released. Below, FENIX provides highlights and insights into the respective news items.

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Novo Q2 ’23 London Earnings; Akero Q2 ’23 Earnings Update

Two cardiometabolic-related news items have been observed: Novo Nordisk hosted its post-Q2 ’23 London earnings call (view webcast); and Akero reported its Q2 ’23 earnings (view press release). Below, FENIX provides highlights and insights from the respective news items.

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Senseonics and Dario Q2 ‘23 Earnings

Two cardiometabolic-related news items have been observed: Senseonics (view press release) and Dario (view press release) hosted their respective Q2 ‘23 earnings. Below, FENIX provides highlights and insights into the respective news items.

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Novo Nordisk Q2 ’23 Earnings Update

Novo Nordisk hosted its Q2 ’23 earnings call (view press release; slides) and provided updates across its CVRM portfolio, including the recently announced SELECT CVOT topline results, Wegovy supply, and the high-dose oral semaglutide regulatory submission. Importantly, senior management disclosed plans to present full SELECT CVOT results at AHA 2023 in Philadelphia (November 11-13). Below, FENIX provides highlights and insights from the earnings call.

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Terns Announces Positive Topline Ph2a NASH Data; Ionis Q2 ’23 Earnings

Two cardiometabolic-related news items have been observed: Terns Pharmaceuticals announced positive topline results from its Ph2a DUET trial evaluating TERN-501 as a monotherapy or in combination with TERN-101 for the treatment of NASH (view CT.gov record; press release); and Ionis hosted its Q2 ’23 earnings call (view press release; slides). Below, FENIX provides highlights and insights into the respective news items.

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Insulet, Xeris, Madrigal, and Bayer Q2 ‘23 Earnings

Four cardiometabolic-related news items have been observed: Insulet (view press release; slides), Xeris Biopharma (press release), Madrigal Pharmaceuticals (press release), and Bayer (press release; slides) reported their respective Q2 ‘23 earnings. Below, FENIX provides highlights and insights into the respective news items.

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Lilly Up Big Following Q2 ’23 Results and SELECT Data Readout

Lilly hosted its Q2 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. Of note, Mounjaro led Lilly’s new products category with WW Q2 ’23 sales reaching nearly $1B. Following the Q2 ’23 beat, increased FY 2023 guidance, and bolstered by Novo’s SELECT readout (previous FENIX insight), Lilly’s stock jumped +15% to an all-time high of ~$521/share. Unsurprisingly, Lilly also provided commentary surrounding the SELECT data readout. Below, FENIX provides highlights and insight from the call, including additional thoughts on the evolving obesity CVOT dynamic.

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Novo and Lilly Win with Positive SELECT CVOT Topline Results

Novo Nordisk announced positive topline results from the SELECT CVOT (view CT.gov record) demonstrating a 20% RRR in 3P-MACE for non-T2DM people with established CVD who were treated with QW 2.4mg semaglutide (Wegovy) compared to placebo. Following the news, Novo’s stock price increased +16%. Novo is anticipated to provide further commentary during its Q2 ’23 earnings call on Thursday, August 10, 2023, at 7:00 AM EST. Below, FENIX provides initial thoughts on the SELECT results, including potential readthrough to Lilly and other manufacturers looking to enter the obesity market.

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MannKind and Viatris Q2 ’23 Earnings Updates

Two cardiometabolic-related news items have been observed: MannKind (press release) and Viatris (press release; slides) hosted their respective Q2 ‘23 earnings calls. Below, FENIX provides highlights and insights into the respective news items.

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