Category Archives: Uncategorized

Mounjaro Obesity Indication Filed in EU; March CHMP Agenda; Vertex Announces T1DM Licensing Agreement with CRISPR; Sanofi Helps Dario Secure Top-Ten PBM Contract

Three cardio-metabolic related news items have been observed: The CHMP agenda (view here) for this month’s meeting (March 27-30) has been released, which includes the new filing of the Mounjaro non-T2DM obesity indication; Vertex announced it has entered into a new non-exclusive licensing agreement with CRISPR Therapeutics for the use of CRISPR’s gene editing technology (view press release); and DarioHealth announced a new contract with an undisclosed top-ten PBM to provide Dario digital therapeutics beginning in Q2 2023 (view press release). Below, FENIX provides highlights and insights from the respective news items, including potential readthrough to the US Mounjaro obesity regulatory strategy.

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Teladoc, Alnylam, and Amarin Q3 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Teladoc (press release; slides), Alnylam (press release; slides), and Amarin (press release; slides) hosted their Q3 ’22 earnings calls. Below, FENIX provides highlights and insights for the respective new items.

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Biocorp and Novo Sign New Connected Care Agreement; Daprodustat Adcom: 13-3 in Favor of Dapro in DD; 5-11 Against Dapro in NDD

Two cardiometabolic-related news items have been observed: Biocorp announced it signed a new agreement with Novo Nordisk reinforcing their partnership to develop the Mallya smart add-on device compatible with the Novo FlexTouch platform; and FDA hosted an adcom for GSK’s daprodustat where the panel voted 13-3 in favor of the dapro benefit/risk profile in the DD patient population and 5-11 against the benefit/risk profile in the NDD patient population. Below, FENIX provides highlights and insights for the respective new items.

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Novartis and Adocia Q3 ’22 Earnings Updates

Two cardiometabolic-related news items have been observed; Novartis (press release; slides) hosted its Q3 ’22 earnings call; and Adocia issued a press release for its Q3 ’22 earnings, though it did not host an associated webcast. Below, FENIX provides highlights and insights from the respective new items.

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Roche Diabetes Partners with New Mark Cuban Company

Mark Cuban’s new company, Cost Plus Drugs, announced on Twitter (view tweet here) it has partnered with Roche Diabetes Care USA to provide patients with select Accu-Chek BGM products. Below, FENIX provides highlights and insights about the Cost Plus Drugs and Roche partnership.

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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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Tirzepatide Receives Fast Track Designation in Obesity; Provention Bio and Sanofi Join Forces for Potential Teplizumab US Launch

Two cardiometabolic-related news items have been observed: Lilly announced FDA granted Fast Track designation for the investigation of tirzepatide in adults that are obese or overweight with weight-related comorbidities; and Provention Bio and Sanofi US announced a co-promotion agreement for the commercialization of teplizumab in the US. Below, FENIX provides highlights and insights for the respective new items.

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Dexcom Expands ex-US G7 Launch; Novo to Initiate OASIS 4 Ph3 Oral Sema Obesity Trial; Lilly to Initiate two Lp(a) Ph2 Trials; Better Therapeutic Publishes BT-001 Pivotal Trial Results in Diabetes Care

Four cardiometabolic-related news items have been observed: Dexcom announced the launch of Dexcom G7 CGM in the UK, Ireland, Germany, Austria, and Hong Kong and hosted an associated pre-recorded streaming event (view here); a Novo-sponsored Ph3 study (OASIS 4) evaluating QD 25mg oral semaglutide in overweight and obese participants has been observed (view CT.gov record); Lilly initiated two Ph2 studies evaluating QD oral LY3453329 (KRAKEN; view CT.gov record) and injectable LY3819469 (view CT.gov record) in adults with elevated Lp(a); and Better Therapeutics announced the publication of 90-day results from its pivotal trial for BT-001, in Diabetes Care. Below, FENIX provides highlights and insights for the respective new items.

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Novo’s QW Insulin Icodec Meets Primary Endpoint in ONWARDS 5

Novo Nordisk announced positive topline results from the final QW insulin icodec Ph3 trial (ONWARDS 5). Recall, ONWARDS 5 is differentiated from the other five trials in the ONWARDS program as it uses the DoseGuide app for titration. Below, FENIX provides thoughts on Novo’s Ph3 ONWARDS icodec program, the utility of the DoseGuide app during icodec commercialization, and the potential regulatory timeline.

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