Category Archives: Basal Insulin

Novo Q4 ’20 Post-earnings Event; Sanofi Capital Markets Day 2021; Sanofi and Regeneron Q4 and FY ’20 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo Nordisk hosted its post-Q4 ’20 earnings event; Sanofi hosted its Capital Markets Day 2021 and Q4 and FY ’20 earnings call; and Regeneron hosted its Q4 and FY ’20 earnings call. Below, FENIX provides highlights and insights from the respective investor events.

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ViaCyte Initiates Ph2 Encapsulated Cell Therapy Trial in T1DM; Lannett, Merck, Roche, and BD Q4 and FY ’20 Earnings Updates; Merck CEO to Retire

A series of diabetes-related news items have been observed: ViaCyte announced the initiation of a Ph2 study of encapsulated cell therapy for the treatment of T1DM; and Lannett, Merck, Roche, and BD hosted their respective CY Q4 ’20 earnings calls. Importantly, Merck announced the retirement of CEO, Kenneth Frazier. Below, FENIX provides highlights and insights for the respective news items, including the observation that Januvia franchise US sales were -16% for FY 2020.

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Novo Broadens Icodec Ph3 program; CSO to Retire; Novo Q4 and FY ’20 Earnings Update

Novo Nordisk hosted its Q4 and FY ’20 earnings calls and provided updates across its pipeline and commercial activities, including plans to conduct a broader Ph3 QW insulin program and additional insight into the Ph3 high-dose oral semaglutide trial. Importantly, Novo disclosed Mads Krogsgaard Thomsen is retiring as EVP and CSO in February 2021 and Novo stock is trading at a near all-time high (view NVO). Below, FENIX provides highlights and insights from the call.

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Lilly Advances 5 New CV/Met Assets to Ph1; Lilly Q4 and FY ’20 Earnings Update

Lilly hosted its Q4 and FY ’20 earnings call and provided updates across its diabetes portfolio including the disclosure of five new early-stage pipeline assets that have advanced into Ph1 development. Of note, tirzepatide discussion was limited as much of the call focused on the development of donanemab in early symptomatic Alzheimer’s disease. Below, FENIX provides highlights and insights from the call.

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Lilly and Life for a Child Expand Partnership; ViaCyte Appoints Michael Yang as CEO

Two diabetes-related news items have been observed: Lilly and Life for a Child announced an expansion of their partnership to continue addressing inequity in accessing quality diabetes care for children and young adults around the world; and ViaCyte announced the appointment of Michael Yang as the company’s CEO and member of the Board of Directors. Below, FENIX provides highlights and insights for the respective news items.

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Adocia Reports Positive BC Lispro Data with Tonghua Dongbao Insulin; January 25-29 CHMP Agenda

A series of cardiometabolic-related news items have been observed: Adocia announced positive results from a BioChaperone Lispro trial using insulin sourced from Tonghua Dongbao; and the CHMP agenda for this month’s meeting (January 25-29, 2021) has been released, and it includes one notable item: EMPEROR-Reduced is on the CHMP agenda but not believed to be up for an opinion. Below, FENIX provides highlights and insights from the respective news items.

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Biocon CY Q4 ’20 (FY Q3 ’21) Earnings Update; Biocon Biologics CEO Resigns

Biocon hosted its CY Q4 ’20 (FY Q3 ’21) earnings call and provided updates on its biosimilar insulin portfolio. Importantly, Biocon disclosed that Christiane Hamacher, the CEO of Biocon Biologics, has resigned “due to professional differences with the chairperson on strategic priorities and vision for the company.” Below, FENIX provides highlights and insights from the call relating to the corporate restructuring and Biocon’s bs-insulin portfolio.

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Oramed Randomizes First Patients in Ph3 Oral Insulin Trial; Dario Hires New Employer Sales Lead

Two diabetes-related news items have been observed: Oramed has begun randomizing patients into its Ph3 ORMD-0801 T2DM study (view press release) and Dario announced the hiring of Chris Chan as the company’s new SVP of employer sales (view press release). Below, FENIX provides highlights and insights from the respective news items.

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Metacrine NASH Fast Track Designation; Senseonics Receives Positive Coverage Decision for EmblemHealth; Insulet Launches Omnipod DASH in Canada

A series of cardiometabolic-related news items have been observed: Metacrine announced FDA granted Fast Track designation to MET642 for the treatment of NASH; Senseonics announced a positive coverage decision for its implantable CGM from EmblemHealth; and yesterday, Insulet announced the Canadian launch of Omnipod DASH. Below, FENIX provides highlights and insights for the respective news items.

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JPM 2021 Day 4: Lexicon Poised for a Strong Comeback; Lexicon, Viatris, and Intercept @ JPM; Poxel/Metavant Partnership Terminated

On the final day of JPM 2021, FENIX has provided coverage of presentations by cardiometabolic companies including Lexicon, Viatris, and Intercept. Additionally, two separate cardiometabolic-related news items have been observed: Lexicon announced it received FDA feedback stating SOLOIST and SCORED results support a sotagliflozin NDA submission for a broad HF indication; and Poxel/Metavant announced the termination of their partnership. Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage, including Lexicon’s proposed broad HF label for sotagliflozin and Viatris’s biosimilar Toujeo.

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