Category Archives: SGLT2i

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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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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Novartis Q3 ’23 Earnings; Counterfeit Ozempic Hospitalizes Patients in Austria; NexImmune Extends Partnership with Yale and JDRF

Three cardiometabolic-related news items have been observed: Novartis hosted its Q3 ‘23 earnings call (press release; slides); several people have been reportedly hospitalized in Austria after using suspected fake versions of Novo’s Ozempic (view article); and NexImmune announced its research partnership with Yale and JDRF has been extended (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Novo Partners with GE Healthcare for T2DM/Obesity; Cytokinetics’ Cardiac Myosin Inhibitor Programs Update; New Ph3 Dapa+Zibotentan Combination Trial in CKD and High Proteinuria

Three cardiometabolic-related news items have been observed: Novo Nordisk and GE HealthCare partner to further advance the clinical and product development of peripheral focused ultrasound (PFUS) for T2DM and obesity (view press release); Cytokinetics announced updates on its cardiac myosin inhibitor programs during its virtual Investor and Analyst Day (view webcast; slides); and AstraZeneca initiated a new Ph3 dapa+zibotentan combination trial in CKD and high proteinuria, called ZENITH High Proteinuria (view CT.gov record). Below, FENIX provides highlights and insights into the respective news items.

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Novo to Displace Metformin as 1L T2DM Treatment?; Zealand Presents Amylin Analog Data at ObesityWeek; JNJ Q3 ‘23 Earnings

Three cardiometabolic-related news items have been observed: Novo Nordisk initiated a Ph3 study evaluating high-dose oral sema vs. Jardiance and vs. metformin in T2DM (view CT.gov record); Zealand announced presentations of clinical and non-clinical results from its amylin analog (ZP8396) at ObesityWeek 2023 (previous FENIX insight); and Johnson & Johnson hosted its Q3 ‘23 earnings call (view press release; slides). Below, FENIX provides highlights and insights into the respective new items, including thoughts on how Novo may be trying to displace metformin as first-line treatment for T2DM. 

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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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Best Buy to Sell Dexcom G7; Gan & Lee Submits Bs-aspart and Bs-lispro MAAs; October CHMP Agenda; Tom Garner Joins Lexicon as SVP and CCO; Dario Partners with a Top Five Employee Benefits Consulting Firm; Senseonics and Ascensia Launch Eversense E3 Advertising Campaign

A series of cardiometabolic-related news items have been observed from BestBuy/Dexcom, Gan & Lee, EMA, Lexicon, Dario, and Senseonics/Ascensia. Below, FENIX provides highlights and insights into the respective news items.

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Ozempic Label Update; AZ, BMS, Merck, and BI to Participate in Medicare Price Negotiations; FDA and Health Canada Clear Expansion Portion of Biomea’s Ph2 Oral Menin Inhibitor Trial in T2DM

Three cardio-metabolic related news items have been observed: FDA updated the Ozempic label to include ileus (intestinal blockage) as an adverse reaction reported post-approval (view updated label); AZ, BMS, Merck, and BI have reportedly agreed to participate in the first round of Medicare price negotiations (view article); and Biomea Fusion announced FDA and Health Canada cleared the expansion portion of its Ph2 COVALENT-111 study evaluating BMF-219, an oral covalent menin inhibitor, in T2DM (view press release). Below, FENIX provides highlights and insights into the respective news items.

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FDA Approves Jardiance for Adults with CKD; Abbott Completes Bigfoot Acquisition; Insulet Publishes “Market Opportunity & Impact of GLP-1s” Presentation; Lilly initiates Ph3 H2H Orforglipron vs. Semaglutide and New Ph3b Tirzepatide Max Dose Study in Obesity

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

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