Category Archives: GLP-1RA

Novo Invests in Danish Facility for Oral Sema Production; MNKD, PRVB, ICPT, BAYRY, and IONS Q4 ’20 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo Nordisk announced plans to invest 500M DKK (~82M USD) to expand its oral tablet production facilities in Måløv, Denmark; and Mannkind, Provention Bio, Intercept, Bayer, and Ionis hosted their Q4 and FY ’20 earnings call. Below, FENIX provides highlights and insights for the respective news items.

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DAPA-CKD filed with EMA; February 22-25 CHMP Agenda; G&L Partners with IDF

A series of cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (February 22-25, 2021) has been released, and it includes one notable item: DAPA-CKD appears for the first time; and Gan & Lee announced a new partnership with IDF. Below, FENIX provides highlights and insights from the respective news items.

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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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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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Dexcom Super Bowl DTC; Pfizer Q4 and FY ’20 Earnings Update

Two diabetes-related news items have been observed: Dexcom announced the debut of its first-ever Super Bowl commercial; and Pfizer hosted its Q4 ’20 earnings call, commenting on its oral GLP-1 pipeline developments. Below, FENIX provides highlights and insights for the respective news items, including thoughts on how the Dexcom Super Bowl commercial signals that Dexcom is ready to move on the CGM mass market opportunity.

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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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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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High-Dose Ozempic Filed with FDA; Andy Ajello Joins Vifor

Novo Nordisk announced it has filed the sNDA for high-dose Ozempic (2.0mg) based on results from the SUSTAIN FORTE trial, which read out in November 2020 (previous FENIX insight). Additionally, Andrew (Andy) Ajello, former Lexicon Commercial Lead and Novo SVP of US Diabetes/Obesity Sales, has joined Vifor Pharma as the VP of US sales (view LinkedIn profile). Below, FENIX provides thoughts and insights on the respective news items.

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JPM 2021 Day 3: Bayer, Esperion, Precision Bio, Hikma, Vifor; High-dose Oral Sema PIONEER PLUS Trial Posted on CT.gov; Dario Announces Two New Additions to Scientific Advisory Board

On day three of JPM 2021, FENIX has provided coverage of presentations from Bayer, Esperion, Precision Biosciences, Hikma, and Vifor. Additionally, two separate cardiometabolic-related news items have been observed: a CT.gov record has been observed for Novo Nordisk’s PIONEER PLUS trial investigating high-dose oral semaglutide in people with T2DM; and DarioHealth announced Marilyn Ritholz and David Horwitz will be joining the Scientific Advisory Board. Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage.

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JPM 2021 Day 2: LLY, NVO, ABT, PODD, AMRN, and IONS; Bayer’s Finerenone Receives Priority Review for DKD

On day two of JPM 2021, FENIX has provided coverage of presentations by Lilly, Novo Nordisk, Abbott, Insulet, Amarin, and Ionis. Additionally, one separate cardiometabolic-related news item has been observed: Bayer announced FDA granted priority review of finerenone for patients with DKD. Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage.

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