Tag Archives: NOVO

Novo to use PRV for Sema Obesity; Ph1 Glucose-responsive Insulin Trial Initiated; Novo Q3 ’20 Earnings Update

Novo Nordisk hosted its Q3 ’20 earnings call (press release; slides) and provided updates across its pipeline and commercial activities, including the ongoing Rybelus launch, positive ziltivekimab Ph2b topline results, and Ph1 initiation for a novel glucose-responsive insulin. Additionally, Novo disclosed plans to use its PRV for the semaglutide 2.4mg obesity FDA submission. Below, FENIX provides highlights and thoughts from the call, including insight into a hidden importance of using the PRV for the sema 2.4mg obesity filing.

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Abbott Q3 ’20 Earnings Update; Novo Licenses Antibody Engineering Tech From Chugai

Two diabetes-related news items have been observed: Abbott hosted its Q3 ’20 earnings call (press release) and Chugai licensed its antibody engineering technology to Novo Nordisk (press release). Below, FENIX provides highlights from the respective news items as well as insight into how Novo may leverage Chugai’s antibody technology.

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FDA Launches Digital Health Center of Excellence; Novo Initiates New Ozempic and Rybelsus Trials; vTv Presents TTP399 Data; EASD 2020 Key Press Releases (Sept 23)

On Day 3 of EASD 2020, two key press releases were observed from FDA and vTv Therapeutics. Additionally, two new semaglutide (Rybelsus and Ozempic) clinical trials were observed from Novo Nordisk. Below, FENIX provides insights and context from each respective announcement.

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Novo Signs New CKD Development Deal with Evotec

Evotec and Novo Nordisk announced a new strategic collaboration focusing on the discovery and development of treatments targeting CKD. Recall, in August 2018, Novo and Evotec entered into an initial partnership targeting diabetes, obesity, NASH, and DKD (previous FENIX insight). Below, FENIX provides brief thoughts on the new collaboration in the context of Novo’s ziltivekimab acquisition, also for the treatment of CKD (previous FENIX insight).

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Novo’s First Ph3 Icodec Trial (ONWARDS 1) Posted on CT.gov

A new CT.gov record has been observed for Novo Nordisk’s first Ph3 trial evaluating its QW insulin icodec insulin-naïve T2DM patients (ONWARDS 1). Novo appears to be branding the Ph3 program as “ONWARDS” in an effort to pay homage to the continued development story of insulin. In case you missed it, Lilly recently initiated two Ph2 trials for its QW insulin (LY3209590) in both T1DM and T2DM (previous FENIX insight). Below, FENIX provides an overview of the ONWARDS 1 trial as well as brief thoughts on Novo potentially providing additional clarity during its upcoming Q2 ’20 earnings call on August 6, 2020.

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New Lilly QW Insulin Ph2 Trials in T1DM and T2DM

Two new Ph2 trials have been observed on CT.gov evaluating Lilly’s QW basal insulin (LY3209590) in T1DM (view CT.gov record) and insulin-naïve T2DM patients (view CT.gov record). Below, FENIX provides trial details and thoughts on the new trials in the context of Novo Nordisk’s QW basal insulin (icodec), which recently had full Ph2 results presented at ADA 2020 (previous FENIX insight).

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Trulicity, Ozempic, Afrezza, Libre, Control IQ, and Onduo RWE at ADA 2020; Sota T2DM CKD Data; vTv Presents TTP399 Ph2 Results; ADA 2020 Key Press Releases (June 13)

Today, nine diabetes-related news items were observed: Trulicity, Ozempic, Afrezza, Libre, Control IQ, and Onduo RWE data were presented at ADA 2020 as well as new data from Lexicon (sota T2DM Ph3 CKD), vTv (Ph2 Simplici-T1), and Zealand (V-Go patch pump). Below, FENIX provides context and analysis for the announcements.

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Biocon/Mylan Bs-glargine Approved; Novo to Acquire Corvidia; Lifescan Launches Verio Reflect; Lannett FDA Bs-glargine Meeting; Medtronic 780G CE Mark; Dexcom Launches G6 Pro; ADA ’20 Key Data and Partnership Press Releases (June 11)

Ahead of the ADA 2020 conference start, a series of diabetes-related press releases have been observed: Biocon/Mylan received FDA approval for its bs-glargine, Novo Nordisk is set to acquire Corvidia, Lannett provided an update on its meeting with FDA for bs-glargine, LifeScan launched the Verio Reflect BGM, Medtronic received CE Mark for the 780G system, Dexcom launches G6 Pro, and DarioHealth entered into new partnership agreements. Below, FENIX provides context and analysis for the announcements.

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Semaglutide Positive Ph2 NASH Data; Novo Q1 ’20 Earnings Update

Novo Nordisk hosted its Q1 ’20 earnings call (press release; slides) and provided updates to its diabetes business including the ongoing launch of Rybelsus (oral semaglutide) and new Ph2 semaglutide NASH topline data. Unsurprisingly, much of the Q1 ’20 prepared remarks and Q&A were focused on NASH. Below, FENIX provides highlights from the call and additional thoughts on Novo’s PCSK9i/basal insulin hybrid approach.

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