Category Archives: GLP-1RA + Basal

Novartis to Acquire Chinook; Novo Nordisk Expands Danish Facility

Two cardiometabolic-related news items have been observed: Novartis and Chinook Therapeutics announced they have entered into an agreement where Novartis will acquire Chinook for $3.2B; and Novo Nordisk announced plans to invest ~$2.3B (15.9B DKK) in expanding the company’s existing API production facility in Denmark (view press release). Below, FENIX provides highlights and insights into the respective news items, including brief thoughts on the Chinook acquisition.

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Lilly Completes SURMOUNT-2 Trial; FDA Clears Libre 3 Reader; Novo Initiates Ph3 Icodec + Semaglutide Treatment Intensification Trial

Three cardiometabolic-related news items have been observed: On April 13, 2023, the ClinicalTrials.gov record for SURMOUNT-2 was updated to reflect that the trial has been completed; Abbott announced FDA cleared a standalone reader for its FreeStyle Libre 3 iCGM system (view press release); and Novo Nordisk has initiated a Ph3 T2DM trial evaluating icodec as add-on therapy to semaglutide for treatment intensification (view CT.gov record). Below, FENIX provides highlights and insights into the respective news items. 

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Novo Nordisk Q4 ’22 Earnings Update

Novo Nordisk hosted its Q4 ’22 earnings call (press release; slides) and provided updates across its business, including Wegovy/Ozempic supply, GLP-1RA market dynamics, new QW insulin icodec data, and more. Below, FENIX provides highlights and insights from the call.

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Lilly Initiates Final Ph3 QWINT Trial; Madrigal Announces $300M+ in Financing Events to Advance Resmetirom; Akebia Receives Interim Response to Appeal for Vadadustat CRL

Three cardiometabolic-related news items have been observed: The final trial from Lilly’s Ph3 QW insulin QWINT program has been observed (QWINT-1; view CT.gov record); Madrigal announced plans to leverage $300M+ in financing events to support planned commercial and clinical activities for resmetirom in NASH (view press release); and Akebia announced it received an interim response from FDA to its Formal Dispute Resolution Request regarding the vadadustat CRL issued in March 2022 (view press release). Below, FENIX provides highlights and insight on the respective news items, including thoughts on Lilly’s strategy to pursue a QW insulin fixed-dose escalation regimen as well as readthrough from GSK’s impending daprodustat PDUFA to Akebia’s vadadustat.

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Medtronic CY Q3 ’22 Earnings Update; Novo Expands Manufacturing Facilities; FDA Approves Lilly’s Rezvoglar as an Interchangeable Biosimilar; Oramed Presents Additional Ph2 PRMD-0801 NASH Data

Four cardio-metabolic related news items have been observed: Medtronic hosted its CY Q3 ’22 earnings call (press release; slides); Novo announced plans to invest DKK 5.4B (~$750M USD) in the expansion of manufacturing facilities in Denmark (view press release); FDA approved Lilly’s Rezvoglar (bs-glargine) as an interchangeable to Sanofi’s Lantus (view label; view article); and Oramed hosted an event to discuss data from its Ph2 trial evaluating 8mg ORMD-0801 compared to placebo in 32 participants with T2DM and NASH (slides; webcast; press release). Below, FENIX provides context and insight on the respective news items.

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Abbott Expands Libre 3 Distribution to Pharmacy; Second Ph3 Cagrisema Trial Posted on CT.gov; Galectin NASH Trial to Continue After Second DSMB Meeting

Three cardiometabolic-related news items have been observed: Abbott’s Freestyle Libre US patient website has been updated to announce the expansion of Libre 3 distribution into retail pharmacies; the second trial in Novo Nordisk’s cagrisema pivotal program (REDEFINE) has been observed (REDEFINE 1; view CT.gov record); and Galectin Therapeutics announced positive feedback from its second DSMB meeting for the Ph2b/3 NAVIGATE study (view CT.gov record) evaluating belapectin in patients with liver cirrhosis caused by NASH. Below, FENIX provides highlights and insights for the respective new items.

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EASD 2022 Key Press Releases (Sept 22)

On the fourth day of EASD 2022, three key news items were observed from Novo Nordisk, Merck, and Better Therapeutics. Separately, it has been observed that the start date has been delayed for Novo’s first cagrisema Ph3 pivotal trial (Ph3 REDEFINE-2). Below FENIX provides insights and context for the respective announcements.

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“Mass” Layoff at Beta Bionics?; Novo Initiates Ph3 Ozempic + Lower-Dose Glargine Trial; Novartis to Spin Off Sandoz; Lannett and Adocia CY Q2 ’22 Earnings Updates; Hygieia Appoints New CEO

A series of cardiometabolic-related updates have been observed: Beta Bionics has reportedly laid off an unknown number of employees (view LinkedIn post); a Novo-sponsored Ph3 trial evaluating Ozempic and lower-dose insulin glargine has been observed (SUSTAIN OPTIMIZE; view CT.gov record); Novartis announced plans to spin off Sandoz (press release); Lannett (press release) and Adocia (press release) released their Q2 ’22 earnings; and Hygieia announced the appointment of a new CEO. Below, FENIX provides context and insight on the respective news items.

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Thoughts after ATTD and ADA 2022

Now that we’re on the other side of ADA 2022, FENIX provides provocative thoughts below on various items in the cardiometabolic space. Included are thoughts about Lilly, Novo, Sanofi, Dexcom, Abbott, Medtronic, Bigfoot, and Beta Bionics.

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