Category Archives: Topics

Medtronic CY Q2 ’23 (FY Q1 ’24) Earnings; Lilly Initiates Retatrutide Test Device Study

Two cardiometabolic-related news items have been observed: Medtronic hosted its CY Q2 ’23 (FY Q1 ’24) earnings call (press release; slides); and Lilly initiated a Ph1 relative bioavailability study comparing SC retatrutide (LY3437943) administered by a test device vs. a reference device in healthy participants (view CT.gov record). Below, FENIX provides highlights and insights into the respective news items.

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Gan & Lee Submits Bs-glargine MAA

Gan & Lee Pharmaceuticals announced the MAA for its biosimilar insulin glargine U100 (Basalin) has been accepted for review by EMA. According to the press release, the MAA filing is supported by two randomized, multicenter Ph3 studies in the US and EU comparing its bs-glargine injection to Lantus in which bs-glargine demonstrated comparable immunogenicity, efficacy, and safety to Lantus in T1DM (n=576) and T2DM (n=567) patients (previous FENIX insight). G&L said it will continue to collaborate with Sandoz to commercialize its bs-glargine in the EU. Recall, in February 2023, G&L announced FDA accepted the BLA for its bs-glargine (previous FENIX insight). Below, FENIX provides brief thoughts on the G&L bs-glargine MAA in the context of the evolving basal insulin market.

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Zealand Q2 ’23 Earnings; TheracosBio Partners with SmithRx for Brenzavvy Access

Two cardiometabolic-related news items have been observed: Zealand Pharma hosted its Q2 ’23 earnings call (press release; slides); and TheracosBio announced a collaboration with SmithRx to offer access to Brenzavvy (bexagliflozin; view press release). Below, FENIX provides highlights and insights into the respective news items.

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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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