Category Archives: Topics

Lilly Partners with Abbisko Therapeutics and Evotec; Novo Partners with EraCal Therapeutic; Fractyl Announces Initial Interim Feasibility Data

A series of cardiometabolic-related news items have been observed: Abbisko Therapeutics announced it has entered into a worldwide collaboration and exclusive licensing agreement with Lilly for the development of novel cardiometabolic therapies; Evotec announced a three-year drug discovery collaboration with Lilly for metabolic diseases focusing on kidney diseases and diabetes; EraCal Therapeutics announced a research collaboration with Novo Nordisk for development of anti-obesity pharmacotherapy; and Fractyl Health announced initial interim feasibility data from its open-label REVITA-T2Di trial. Below, FENIX provides highlights and insights for the respective new items.

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Can Michael Davidson Strike Gold Again with NewAmsterdam’s CETPi?

In early January 2022, Michael Davidson’s NewAmsterdam Pharma announced it has dosed the first patient in its Ph3 BROADWAY trial evaluating obicetrapib, a novel cholesteryl ester transfer protein (CETP) inhibitor in patients with HeFH or established ASCVD (view CT.gov record). Below FENIX provides brief thoughts on the NewAmsterdam obicetrapib program in the context of Michael Davidson’s other successful company exits.

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JPM 2022 Day 4: Lexicon and Esperion; Imcyse Reports Positive Data from Interim Analysis of Ph2 IMPACT Trial; vTv Therapeutics Provides Update on TTP399 Development; Nemaura Launches Miboko to Employers and Insurers

On the final day of JPM 2022, FENIX has provided coverage of presentations by major CVRM companies including Lexicon and Esperion. Additionally, three separate cardiometabolic-related news items have been observed: Imcyse reported positive biomarker data from an interim analysis of the Ph2 IMPACT trial (view press release); vTv Therapeutics has published a new corporate presentation in which the company disclosed plans to initiate the TTP399 Ph3 program in 2022 (view press release); and Nemaura has launched its Miboko wellness program for employer and payer reimbursement (view press release). Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage.

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JPM 2022 Day 3: Akebia, Ionis, and Hikma; Oramed Provides Updates on Ph3 Oral Insulin Program

On the third day of JPM 2022, FENIX has provided coverage of presentations by major CVRM companies including Akebia, Ionis, and Hikma. Additionally, a separate cardiometabolic-related news item has been observed: Oramed issued an annual message to shareholders and provided an update on the ORMD-0801 Ph3 oral insulin program for T2DM (view press release). Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage.

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JPM 2022 Day 2: LLY, ABT, AMRN, SNY, AMGN, RHHBY, and TEVA

On the second day of JPM 2022, FENIX has provided coverage of presentations by major CVRM companies including Lilly, Abbott, Amarin, Sanofi, Amgen, Roche, and Teva. Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage

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JPM 2022 Day 1: DXCM, NVS, BAYRY, MDT, TDOC, VRTX; Sanofi Partners with BrightInsight; Viking Initiates GLP-1/GIP Dual Agonist Ph1 Trial

On the first day of JPM 2022, FENIX has provided coverage of presentations by major CVRM companies including Dexcom, Novartis, Bayer, Medtronic, Teladoc, Vertex, Pfizer, Merck, and JNJ. Additionally, two separate cardiometabolic-related news items have been observed: Sanofi announced a partnership with BrightInsight for a digital companion app (potentially for diabetes); and Viking Therapeutics announced the initiation of a Ph1 trial evaluating its novel GLP-1+GIP dual agonist (VK2735). Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage.

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Senseonics Announces FDA Review for 180-day CGM Nearing Completion; Alnylam and Novartis Announce Collaboration for Liver Failure

Two cardiometabolic-related news items have recently been observed: Senseonics announced updates to its business, including an anticipated PMA supplement approval for its Eversense 180-day CGM “in the coming weeks”; and Alnylam and Novartis announced an exclusive three-year research collaboration to develop an siRNA-based targeted therapy for end-stage liver diseases. Below, FENIX provides highlights and insights for the respective new items.

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Abbott Announces New Category of Biowearables at CES 2022

During Abbott’s Keynote at CES 2022, Abbott announced plans to develop a new category of consumer Biowearables called “Lingo” designed to help people “understand their body’s unique language” (view Keynote Speech here starting at 1:22:22). These new sensors will separately monitor glucose, ketones, lactate, and alcohol biomarkers to allow patients to make better decisions about general health, nutrition, and athletic performance (view image below). Abbott did not disclose details on the launch timing; however, the company may provide additional context during its upcoming JPM Healthcare Conference presentation on Tuesday, January 11, 2022 at 9:00 AM ET. Below, FENIX provides insights on Abbott’s Lingo platform, including thoughts on how Dexcom’s G7 may be a catalyst for it to also expand into the wellness category.

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Holiday Hangover: Novo Completes Dicerna Acquisition; FDA Approves Novartis’s Leqvio; Lexicon Submits NDA for Sotagliflozin; CMS Medicare Coverage Expansion Includes Non-adjunctive CGMs; Viatris Beats Sanofi’s Insulin-Pen Patent Invalidation Appeal; Beta Bionics iLet Bionic Pancreas Pivotal Trials Update

During the holiday break, a series of cardiometabolic-related news items were observed from Novo Nordisk, Novartis, Lexicon, Medtronic, Viatris, and Beta Bionics. Below, FENIX provides highlights and insights for the respective news items.

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Novo Hosts Wegovy Shortage Call with Investors; Lannett Files Bs-glargine IND; Provention Adds New Management; Intercept NASH Data Delayed

A series of CVRM-related news items have been observed: Novo Nordisk hosted a call with investors to provide additional information and context on the recent announcement regarding its Wegovy supply constraints (view slides); Lannett announced it has filed an IND for its bs-glargine with the pivotal trial to begin in March 2022; Provention Bio announced it has expanded its executive team; and Intercept announced its Ph3 REVERSE trial topline data readout will be delayed to Q1 ’22. Below, FENIX provides highlights and insights from the respective news items.

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