Category Archives: Other

Vertex Q1 ’23 Earnings; Lannett Restructures Debt and Files for Bankruptcy

Two cardiometabolic-related news items have been observed: Vertex hosted its Q1 ’23 earnings call (view press release; slides); and Lannett announced it has entered into a Restructuring Support Agreement (RSA) and plans to file voluntary petitions for reorganization pursuant to Chapter 11 of the US Bankruptcy Code in the US Bankruptcy Court for the District of Delaware (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Dexcom, Amgen, and Merck Q1 ’23 Earnings; JDRF and Humacyte Collaborate on Insulin-Producing Biovascular Pancreas for T1DM

Four cardiometabolic-related news items have been observed: Dexcom (press release; slides), Amgen (press release; slides), and Merck (press release; slides) hosted their respective Q1 ’23 earnings calls; and JDRF and Humacyte announced a collaboration to advance the development of Humacyte’s Biovascular Pancreas (BVP) product candidate for the treatment of T1DM (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Intercept, AZ, and Sanofi Q1 ’23 Earnings; Sanofi Completes Provention Acquisition; DRI Sells Tzield Royalties to Sanofi

Five cardiometabolic-related news items have been observed: Intercept (press release; slides), AstraZeneca (press release; slides), and Sanofi (press release; slides) hosted their respective Q1 ’23 earnings calls; Sanofi announced it has completed its acquisition of Provention Bio (view press release); and DRI Healthcare Trust announced that it has sold its Tzield royalty interests and milestone payment obligations to Sanofi for $210M (view press release). Below, FENIX provides highlights and insights from the call.

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Lilly to Use PRV for Tirzepatide Obesity Submission Following Positive SURMOUNT-2 Topline Results; Lilly, Viking, and Teladoc Q1 ’23 Earnings

Four cardiometabolic-related news items have been observed: Lilly announced tirzepatide’s SURMOUNT-2 trial showed -15.7% weight loss in obese adults and said it will use a PRV for an obesity PDUFA date by YE 2023 (view press release); and Lilly (press release; slides), Viking Therapeutics (press release) and Teladoc Health (view press release; slides) hosted their respective Q1 ’23 earnings calls. Below, FENIX provides highlights and insights into the respective news items.

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Medtronic Resolves FDA Warning Letter; HSR Waiting Period for Sanofi’s Provention Bio Acquisition Expires; Roche Q1 ’23 Earnings

Three cardiometabolic-related news items have been observed: Medtronic announced FDA lifted the warning letter issued at its diabetes headquarters in Northridge, CA, in December 2021 (view press release); Sanofi announced the waiting period under the Hart-Scott-Rodino Act of 1976 (HSR Act) for its proposed acquisition of Provention Bio has expired (view press release); and Roche hosted its Q1 ‘23 earnings call (press release; slides). Below, FENIX provides highlights and insights into the respective news items.

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Novartis Q1 ’23 Earnings; Insulet Basal-Only T2DM Pod Receives FDA Clearance; Vadadustat Approved by EC; Sernova Announces Positive T1DM Preclinical Data with Evotec’s iPSC-Derived ILCs

Four cardiometabolic-related news items have been observed: Novartis hosted its Q1 ’23 earnings call (press release; slides); Insulet announced its basal-only T2DM pod, Omnipod GO, received FDA clearance for use in T2DM patients 18 years of age or older (view press release); Akebia Therapeutics announced the European Commission granted marketing authorization for Vafseo (vadadustat) for the treatment of symptomatic anemia associated with CKD in adults on chronic maintenance dialysis (view press release); and Sernova announced positive T1DM preclinical data for its implantable Cell Pouch device in combination with Evotec’s iPSC-derived islet-like clusters (view press release). Below, FENIX provides highlights and insight 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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Abbott Q1 ’23 Earnings; Eversense 365-Day Sensor Inserted Into First Pediatric Patient; Esperion Partners With Currax for Nexletol/Nexlizet Promotion; Zucara ZT-01 Ph2 T1DM IND Cleared

Four cardiometabolic-related news items have been observed: Abbott hosted its Q1 ’23 earnings call (view press release; infographic); Senseonics announced the Eversense 365-day sensor has been inserted into the first pediatric patient as part of the ENHANCE clinical trial (view press release); Esperion announced a co-promotion agreement with Currax for Nexletol and Nexlizet (view press release); and Zucara Therapeutics announced FDA has cleared the ZT-01 IND application for the prevention of nocturnal hypoglycemia in patients with T1DM (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Resmetirom Receives Breakthrough Therapy Designation; Tiziana Initiates Foralumab T1DM Program; Teladoc Expands Provider-Based Care; J&J Q1 ’23 Earnings

Four cardiometabolic-related news items have been observed: Madrigal announced resmetirom received Breakthrough Therapy Designation (BTD) from FDA for the treatment of NASH with liver fibrosis (view press release); Tiziana Life Sciences announced it is initiating a program to develop intranasal foralumab for the treatment or prevention of T1DM (view press release); Teladoc Health announced the expansion of its Provider-Based Care for weight management and prediabetes programs (view press release); and Johnson & Johnson hosted its Q1 ’23 earnings call (press release; slides). Below, FENIX provides highlights and insights into the respective news items.

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Lilly Invests $1.6B in Indiana Manufacturing; Dexcom and Abbott Highlight Medicare CGM Coverage Expansion; Tandem Announces Positive Control-IQ Meta-Analysis

Three cardiometabolic-related news items have been observed: Lilly announced that it will invest an additional $1.6B and add another 200 jobs to its new manufacturing sites within LEAP Innovation Park in Boone County, Indiana (view press release); Dexcom (view press release) and Abbott (view press release) separately issued statements regarding CMS’s decision to expand Medicare coverage for T2DM, including certain non-insulin-using individuals; and Tandem Diabetes announced that Diabetes Technology & Therapeutics published a meta-analysis of three Control-IQ AID trials (view press release; publication). Below, FENIX provides highlights and insights into the respective news items.

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