Category Archives: Insulin Delivery

Insulet Q3 ’23 Earnings Update

Insulet hosted its Q3 ’23 earnings call (press release; slides) and provided updates to its business, including the ongoing O5 launch and development programs, Omnipod GO commercial pilot, the EOFlow lawsuit, and more. Below, FENIX provides highlights and insights from the call.

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SELECT Receives Priority Review; High-dose Oral Sema Delayed; Novo Q3 ’23 Earnings

Novo Nordisk hosted its Q3 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. Novo provided important new disclosures including SELECT’s priority review, a high-dose oral sema regulatory filing delay, and a new subcutaneous amycretin asset in Ph1 development. Below, FENIX provides highlights and insights from the call, including thoughts on why SC amycretin makes sense from a strategic standpoint.

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Sibionics Receives GS1 CGM CE Mark; Silence Therapeutics Announces Positive Ph1 Lp(a) Results; Lilly Initiates Another Oral GLP-1RA Ph3 Trial; Tandem and Amarin Q3 ‘23 Earnings; Lexicon Expands Inpefa Access; Dario Launches BGM Compatible With iPhone 15; Abbott, Insulet, and BI/Lilly Announce National Diabetes Awareness Month Initiatives

A series of cardiometabolic-related news items have been observed from Sibionics, Silence Therapeutics, Lilly, Tandem, Amarin, Lexicon, Dario, Abbott, Insulet, and BI/Lilly. Below, FENIX provides highlights and insights into the respective news items.

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Dexcom Q3 ’23 Earnings

Dexcom hosted its Q3 ’23 earnings call (press release; slides) and provided updates across its business. Of note, Dexcom’s stock price increased approximately +15% in after-hours trading due to the positive quarterly performance. Below, FENIX provides highlights and insights from the call.

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Insulet Receives 510(k) Clearance for O5 iPhone App; Viking Completes Enrollment for Ph2 GLP-1/GIP RA Studyin Obesity

Two cardiometabolic-related news items have been observed: Insulet announced the Omnipod 5 iPhone app received FDA 510(k) clearance (view press release); and Viking Therapeutics announced enrollment completion for its Ph2 study of VK2735 (GLP-1/GIP RA) in patients with obesity (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Abbott Q3 ’23 Earnings; Tzield PROTECT Data at ISPAD 2023; Viking GLP-1/GIP RA Ph1 Data at ObesityWeek

Three cardiometabolic-related news items have been observed: Abbott hosted its Q3 ‘23 earnings call and disclosed there are now 5M Libre users globally (press release; infographic); Sanofi presented data from the PROTECT Ph3 trial evaluating teplizumab in newly diagnosed T1DM (view press release); and Viking Therapeutics announced new results from the Ph1 SAD/MAD clinical trial evaluating its GLP-1/GIP RA, VK2735 (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Novo’s FLOW Stops Early; Akero Misses in Ph2b NASH Study; Insulet Wins Preliminary Injunction Against EOFlow; Biocon Recieves Another CRL; Inpefa Receives Preferred Formulary Status with ESI; Carmot Oral GLP-1RA Ph1 Data

A series of cardiometabolic-related news items have been observed from Novo, Akero, Insulet, Biocon, Lexicon, and Carmot Therapeutics. Below, FENIX provides highlights and insights into the respective news items, including thoughts on the potential impact of Akero’s study results.

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EASD Key Press Releases (Oct 4)

On the third day of EASD 2023, four key news items were observed from Lilly, Vertex, Phillips-Medisize, and Welldoc. The following topics are covered below (hyperlinks to external items):

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