Category Archives: Uncategorized

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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Sigilon Announces Strategic Reprioritization; Jaguar Gene Therapy Includes T1DM in Initial Pipeline Program

Two cardiometabolic-related news items have been observed: Sigilon Therapeutics announced plans for a strategic reprioritization to focus on its MPS-1 and beta cell therapy for T1DM, including a 38% workforce reduction; and Jaguar Gene Therapy announced target genes for its initial pipeline programs in T1DM, autism, and T1 Galactosemia. Below, FENIX provides highlights and insights for the respective new items.

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December 13-16 CHMP Agenda; Novo Invests Further in Kalundborg Manufacturing Facilities; CytoDyn Reports Additional Data from Ph2 Leronlimab NASH Trial; Adocia Files Patent for Oral Delivery Technology of Peptides

A series of cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (December 13-16) has been released, and Bayer’s finerenone is up for an opinion; Novo Nordisk announced an investment of DKK 17B (~$2.6B USD) into expanding its manufacturing facilities in Kalundborg, Denmark; CytoDyn announced additional preliminary results to date from the 20 patients who have completed the Ph2 open-label trial evaluating the impact of leronlimab on liver fibrosis associated with NASH; and Adocia announced it has filed a patent for an oral delivery technology. Below, FENIX provides highlights and insights for the respective new items. 

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vTv Therapeutics to Reduce Workforce by 65%; Innovent Announces Positive Results for Ph1 GLP-1/GCG from Lilly; Nemaura Completes Initial Shipment of CGM Devices to MySugarWatch DuoPack Limited

Three cardiometabolic-related news items have been observed: vTv Therapeutics announced restructuring plans in order to prioritize its Ph3 TTP399 program, including a workforce reduction of 65%; Innovent Biologics announced that results from its Ph1b clinical trial of IBI362 (LY3305677), a dual GLP-1/GCG receptor agonist, for T2DM were presented at the 2021 IDF conference; and Nemaura announced it has completed its initial shipment of sugarBEAT CGM to its UK licensing partner MySugarWatch Limited. Below, FENIX provides highlights and insights for the respective new items.

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Novartis Hosts 2021 R&D Webinar

Novartis hosted its 2021 R&D webinar (view here; slides) and provided a company-wide outlook through 2030 with regard to its cardio-renal pipeline, management focused on Leqvio (PCSK9i for ASCVD), pelacarsen (Lp(a) for ASCVD), and iptacopan (Factor B Complement for nephrology and hematology). There was only brief commentary regarding Entresto’s continued growth. Below, FENIX provides highlights and insights from the Novartis R&D event.

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Libre 2 Android App Cleared in US; CytoDyn Reports Positive Leronlimab NASH Data; Kadimastem Raises $3.2 to Support T1DM Cell Therapy Development; Integrity Applications Changes Name to GlucoTrack, Inc.

A series of cardiometabolic-related news items have been observed: It has been observed that the Libre 2 Android app recently received FDA clearance (view FDA 510(k) database); CytoDyn announced positive data from the leronlimab open-label NASH trial; Kadimastem announced it has raised $3.2M from ILEX Medical in a private financing round to support Kadimastem’s T1DM and ALS cell therapy development programs; and Integrity Applications announced it has changed its name to GlucoTrack, Inc. Below, FENIX provides highlights and insights for the respective new items.

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Intarcia Files Notice of Opportunity for a Hearing; Provention Bio Advances popPK Model for Teplizumab; Zealand Announces Dapiglutide Topline Results

Three cardiometabolic-related news items have been observed: It has been reported that Intarcia Therapeutics has filed for a Notice of Opportunity for a Hearing with FDA for ITCA-650 (link to WSJ article); Provention Bio announced topline results from preliminary analysis of popPK model; and Zealand announced topline results for Ph1b trial with GLP1-GLP2 dual receptor agonist (dapiglutide). Below, FENIX provides highlights and insights for the respective new items.

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Alnylam Hosts 2021 R&D Webinar

Alnylam hosted its 2021 R&D webinar (view here; slides) and discussed its 2022 product and pipeline goals, including CVRM assets. Below, FENIX provides highlights and insights from the Alnylam R&D event.

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Teladoc Hosts 2021 Investor Day; Better Therapeutics Pivotal BT-001 Trial for T2DM Completes Enrollment; Dario Announces New Employer Contracts

Three cardiometabolic-related news items have been observed: Teladoc Health hosted its 2021 Investor Day (view here; slides); Better Therapeutics announced the pivotal study evaluating the safety and efficacy of BT-001 for the treatment of T2DM has completed enrollment; and Dario announced it has entered into contracts with a national transportation employer for diabetes, and a regional employer for behavioral health. Below, FENIX provides highlights and insights for the respective new items.

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