Category Archives: Topics

Lilly Partners with Verve Therapeutics for Lp(a) Gene Editing Program; Zucara Receives Funding from JDRF

Two cardiometabolic-related news items have been observed: Verve Therapeutics announced a partnership with Lilly to advance Verve’s gene editing program targeting Lp(a) for the treatment of ASCVD, ischemic stroke, thrombosis, and aortic stenosis (view press release); and Zucara Therapeutics announced it received $2M in funding from JDRF for its ZONE study, a Ph2 trial evaluating ZT-01 to reduce nocturnal hypoglycemia events in T1DM patients (view press release). Below, FENIX provides context and insight on the respective news items, including brief thoughts on the Verve partnership.

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Wegovy Advertising Paused Due to High Demand; Inventiva Ph2 Lanifibranor T2DM and NAFLD Results; FDA Accepts Gan & Lee’s Bs-Aspart BLA

Three cardiometabolic-related news items have been observed: Ro has reportedly paused its Wegovy advertising due to the ongoing supply shortage (view article); Inventiva announced positive topline results from its Ph2 trial evaluating lanifibranor in patients with T2DM and NAFLD (view press release); and Gan & Lee announced FDA accepted the BLA for its biosimilar insulin aspart (view press release). Below, FENIX provides highlights and insights into the respective news items, including thoughts on the ongoing Wegovy supply issues.

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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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AstraZeneca Partners for T1DM Cell Therapy; New Lilly Care Trial

Two cardiometabolic-related news items have been observed: AstraZeneca and Quell Therapeutics announced a collaboration to develop, manufacture, and commercialize autologous, engineered Treg cell therapies for T1DM and IBD; and Lilly initiated a trial evaluating adherence and glucose control of its connected Tempo pen system in conjunction with Dexcom and Glooko (view CT.gov record). Below, FENIX provides highlights and insights for the respective news items, including thoughts on how AZ’s collaboration fits with another one of its recent partnerships.

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Know Labs Unveils Non-Invasive Glucose Monitor Prototype

Know Labs announced it has completed the prototype build for its first generation portable non-invasive glucose monitor. According to the press release, Gen 1 incorporates Know Labs’ Bio-RFID sensor in a portable device (view image below). Recall, on May 31, 2023, Know Labs announced the publication of a report showing the accuracy of its non-invasive Bio-RFID blood glucose reading in combination with algorithm optimization using a light gradient-boosting machine (lightGBM) machine learning model which demonstrated that BG levels measured by Bio-RFID sensors showed a 12.9% MARD when compared to the Dexcom G6 (previous FENIX insight). Below, FENIX provides brief thoughts on the regulatory path forward for the Gen 1 device.

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Lilly Initiates Ph3 Retatrutide Obesity Program; UnitedHealthcare Expands Coverage to Eversense E3 CGM

Two cardiometabolic-related news items have been observed: Lilly initiated the first trial in the Ph3 retatrutide obesity program (TRIUMPH-3; view CT.gov record); and Senseonics announced UnitedHealthcare will cover the Eversense E3 CGM starting July 1, 2023, for T1DM and insulin-requiring T2DM patients. Below, FENIX provides highlights of the respective news items, including insight into the potential retatrutide Ph3 TRIUMPH program and Lilly’s strategy for an obesity CVOT.  

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Inpefa Label and Pre-launch Analysis

Following the Inpefa (sotagliflozin) approval on May 26, 2023 (view label; previous FENIX insight), FENIX has conducted an analysis of the Inpefa label and HCP website. Additionally, Lexicon hosted a post-approval investor call on May 30, 2023, where the company provided insight into its go-to-market strategy (view webcast). Of note, Lexicon plans to launch Inpefa in the US by the end of June 2023. Below, FENIX provides insights and thoughts on the Inpefa label and pre-launch activities.

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Akebia Rejected Again by FDA; Know Labs Announces Positive Bio-RFID Results; Lilly and XtalPi Collaborate for AI Drug Discovery; Structure Doses First Patient in Ph2a Oral GLP-1RA Study

Four cardiometabolic-related new items have been observed: Akebia Therapeutics announced it received a written response from FDA denying the vadadustat CRL (view press release); Know Labs published a report showing the accuracy of its non-invasive Bio-RFID blood glucose reading used in combination with algorithm optimization using a light gradient-boosting machine (lightGBM) machine learning model (view press release; view report); XtalPi announced a collaboration with Lilly, using AI plus robotics to uncover first-in-class therapeutics for undisclosed targets (view press release); and Structure Therapeutics announced the first patient has been dosed in its Ph2a study evaluating GSBR-1290 in overweight/obese patients with and without T2DM (view press release). Below, FENIX provides highlights and insights into the respective news items.  

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