Category Archives: Glucagon

June CHMP Agenda; AstraZeneca Discontinues Oral GLP-1RA Development; Lilly Launches Insulin Affordability Awareness Campaign

Three cardiometabolic-related news have been observed: the CHMP agenda (view here) for this month’s meeting (June 19-22) has been released, including Jardiance’s EMPA-KIDNEY and Mounjaro obesity indication extensions; AstraZeneca announced it is discontinuing development of its oral, AZD0186 (view article); and Lilly announced a partnership with ADA and Adam Duvall to increase awareness of Lilly’s insulin affordability programs (view press release). Below, FENIX provides context and insight on the respective news items, including insight into how Novo’s OASIS 1 readout likely influenced AZ’s decision.

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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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AZ’s Farxiga Receives FDA Approval for DELIVER; Esperion, Xeris, Madrigal, and Sigilon Q1 ’23 Earnings; Ascensia Expands Eversense PASS Program; and Glooko Redesigns App

A series of cardiometabolic-related news items have been observed from AstraZeneca, Ascensia, and Glooko. Additionally, Esperion, Xeris, Madrigal, and Sigilon provided Q1 ’23 earnings updates. Below, FENIX provides highlights and insights into the respective news items.

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Lilly to Divest Baqsimi to Amphastar; Medtronic 780G+GS4 FDA Approval; April CHMP Agenda

Three cardiometabolic-related news items have been observed: Lilly announced it entered into a definitive agreement with Amphastar Pharmaceuticals to divest Baqsimi worldwide rights (view press release); Medtronic’s MiniMed 780G system with the Guardian Sensor 4 (GS4) has received FDA approval (view press release); and the CHMP agenda (view here) for this month’s meeting (April 24-26) has been released. Below, FENIX provides highlights and insights into the respective news items including insight into Lilly’s potential strategy behind the Baqsimi move.

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FDA Accepts Jardiance Pediatric sNDA; New Teplizumab Pediatric Trial; Sernova Completes Islet Transplantation in First Two Ph1/2 T1DM Patients; Xeris and vTv Therapeutics Q4 ’22 Earnings

A series of cardiometabolic-related news items have been observed: BI/Lilly announced FDA accepted the Jardiance (empagliflozin) pediatric T2DM sNDA (view press release); Provention Bio initiated a Ph4 open-label trial evaluating the safety and PK of teplizumab in participants with Stage 2 T1DM who are <8 years of age (PETITE-T1D; view CT.gov record); Sernova announced the first two patients in the second cohort of its US Ph1/2 clinical trial received their first islet transplant (view press release); and Xeris (press release) and vTv Therapeutics (press release) released their Q4 ’22 earnings. Below, FENIX provides highlights and insights from the respective news items.

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CMS Expands CGM Coverage; New Novo R&D Presence in Boston; Bigfoot Unity Android App Approval; Cytokinetic Receives Omecamtiv CRL; Galectin Finalizes Ph2b/3 NAVIGATE Randomization; Imcyse Completes Trial Enrollment; and Zealand, Intercept, and Amarin Q4 ’22 Earnings

A series of cardiometabolic-related news items has been observed from CMS, Novo Nordisk, Bigfoot, Zealand, Intercept, Cytokinetics, Amarin, Galectin, and Imcyse. Below, FENIX provides highlights and insights into the respective news items.

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AZ and Zealand Q3 ’22 Earnings Updates; Novo Smart Pen Integration with Libre

Three cardiometabolic-related news items have been observed: AstraZeneca (press release; slides) and Zealand (press release; slides) hosted their Q3 ‘22 earnings calls, where Zealand talked about its dual agonist’s weight loss data; and Novo Nordisk announced its smart pens can now connect to Abbott’s FreeStyle LibreLink app in the UK. Below, FENIX provides context and insight on the respective news items.

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Lexicon, Xeris, and Ionis Q3 ’22 Earnings Updates; Esperion Hosts 2022 R&D Day

A series of cardiometabolic-related news items have been observed: Lexicon (press release), Xeris (press release), and Ionis (press release; slides) hosted their respective Q3 ’22 earnings calls; and Esperion hosted its 2022 R&D webinar (press release; webcast) where it provided a review of the company’s pipeline, including its oral PCSK9i and ACL inhibitor programs. Below, FENIX provides highlights and insights for the respective news items.

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Novo Licenses Zealand’s Zegalogue; Adocia Announces Preclinical PoC Data for its Islet Transplant; First Patient Dosed in G&L’s QW Insulin Ph1 Trial

Three cardiometabolic-related news items have been observed: Zealand announced the licensing of Zegalogue (dasiglucagon) to Novo; Adocia announced the first preclinical PoC data for AdoShell Islets in T1DM; and Gan & Lee announced the first patient has been dosed in its QW insulin (GZR4) Ph1 trial. Below, FENIX provides context and insight on the respective news items.

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Xeris, Zealand, and MannKind Q2 ’22 Earnings Updates

Three cardiometabolic-related news items have been observed: Xeris Biopharma (press release), Zealand (press release; slides), and MannKind (press release; slides) hosted their Q2 ’22 earnings calls. Below, FENIX provides highlights and insights for the respective new items.

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