Category Archives: Uncategorized

89bio Q4 ‘23 Earnings Update

89bio reported its Q4 ‘23 earnings (view press release) and provided updates on its pegozafermin MASH development program. Of note, an associated webcast call was not held. Below, FENIX provides highlights and insights from the call.

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Lilly Initiates Retatrutide T2DM Pivotal Program; Medtronic CY Q4 ’23 (FY Q3 ’24) Earnings; February CHMP Agenda; Inventiva Pauses Ph3 MASH Trial; Better Therapeutics Receives BDD for MASH

A series of cardiometabolic-related news items have been observed from Lilly, Medtronic, EMA, Inventiva, and Better Therapeutics. Below, FENIX provides highlights and insights for the respective news items, including thoughts on Lilly’s Ph3 T2DM pivotal program for retatrutide.

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Tandem Mobi Launched in the US

Tandem announced the launch of its Tandem Mobi pump, which is consistent with the company’s guidance (see image below). Recall, Mobi received FDA clearance in July 2023 (previous FENIX insight). Below, FENIX provides brief insight into how the Mobi launch may impact Tandem’s business.

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AZ and Viking Q4 ‘23 Earnings; Madrigal Publishes MAESTRO-NASH Results

Three cardiometabolic-related news items have been observed: AstraZeneca (press release; slides) and Viking Therapeutics (press release) hosted their respective Q4 ’23 earning calls; and Madrigal published Ph3 MAESTRO-NASH results in the NEJM (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Lilly’s Mounjaro Receives Positive CHMP Opinion for Obesity; Lilly at UBS 2023; Novo Expands Existing Manufacturing Facilities; Madrigal Appoints Carole Huntsman as CCO; Madrigal, Akero, and Boston Present MASH Data at AASLD 2023; Diabetes Care Survey Results

A series of cardiometabolic-related news items have been observed from Lilly, Novo Nordisk, Madrigal, Akero, Boston Pharmaceuticals, and Smart Meter. Below, FENIX provides highlights and insights into the respective news items.

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Tirzepatide Obesity Indication Approved as “Zepbound” 

Lilly announced that FDA approved tirzepatide as “Zepbound” for adults with obesity or overweight that also have weight-related comorbidities such as hypertension, dyslipidemia, T2DM, OSA, or CVD (view label). Of note, FDA also made an announcement regarding the approval (view here). Tirzepatide remains under review in the EU, UK, China, and other markets. Lilly stated Zepbound is anticipated to be launched in the US by EOY 2023 in six doses (2.5mg, 5mg, 7.5mg, 10mg, 12.5mg, and 15mg). In the press release, Lilly specifically disclosed the Zepbound WAC price of $1,059.87, which Lilly noted is 20% less expensive than Wegovy. FENIX will conduct a full label analysis of Zepbound in the coming days.

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Lilly Q3 ’23 Earnings Update

Lilly hosted its Q3 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. Management noted the 2024 guidance call will be held in January which is new as the company traditionally hosted these calls in December of the preceding year. Below, FENIX provides highlights and insights from the call.

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