Category Archives: Other

CORRECTING AND REPLACING: JPM 2021 Day 1: DXCM, MDT, TDOC, NVS; FDA Accepts EMPEROR-Reduced sNDA Without Priority Review; Adocia to Develop Beta Cell Therapy for T1DM Treatment

On the first day of JPM 2021, FENIX has provided coverage of presentations by major cardiometabolic companies including Dexcom, Medtronic, Teladoc, and Novartis. Additionally, three separate cardiometabolic-related news items have been observed: BI/Lilly announced FDA has accepted the Jardiance sNDA for the reduction of HFrEF in patients with and without T2DM; Dexcom and Teladoc announced the pilot launch of the new “CGM-powered insights” feature for Livongo for Diabetes users; and Adocia filed a patent for cell therapy in patients with T1DM. Below, FENIX provides a topline summary of key takeaways by company followed by more in-depth coverage.

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Novo Selects First Liver Therapy From Dicerna Collab; Metacrine Initiates Ph2a Jardiance Combo Trial in T2DM/NASH; Terns Pharma Raises $87M in Series C Funding; Dario Announces First Self-insured Employer Client

A series of cardiometabolic-related news items have been observed: Dicerna announced Novo Nordisk selected its first GalXC RNAi candidate for IND-enabling studies in liver-related cardiometabolic diseases; Metacrine announced the initiation of a Phase 2a combination trial of MET409 50g with empagliflozin in patients with T2DM and NASH; Terns Pharmaceuticals announced the closing of its Series C funding round with $87M raised for NASH-related trials; Dario announced an agreement with the first self-insured employer group to come from its partnership with Vitality Group. Below, FENIX provides highlights and insights for the respective news items.

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Happy Holidays from FENIX!

This holiday season, we genuinely thank you for your readership to our FENIX cardiometabolic syndicated service. Despite the COVID-19-related challenges in 2020, we successfully shared 300+ updates on the most current CV-Met news with impactful market insights using our deep thought leadership. The FENIX team will be back to delivering the latest in cardiometabolic news on January 4, and we look forward to another successful year in 2021.

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Servier Terminates Omecamtiv Agreement; Oramed Oral Leptin PoC Results

Two CV-met news items have been observed: Cytokinetics announced Servier has decided to terminate its sublicense agreement with Amgen for the development and commercialization of omecamtiv in EU and CIS; and Oramed announced topline results from a PoC study of its oral leptin drug candidate. Below, FENIX provides highlights and insights for the respective news items.

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Xeris Enters Gvoke Distribution Agreement in Israel and Palestine; Dario Partners with Presbyterian Medical Services

Two diabetes-related news items have been observed: Xeris announced an exclusive distribution agreement with Megapharm Ltd. for the commercialization of Gvoke in Israel and Palestine; and DarioHealth announced a partnership with Presbyterian Medical Services to provide patients with chronic conditions access to Dario’s digital therapeutics. Below, FENIX provides highlights and insights from the respective news items.

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CRL for Novartis’s Inclisiran (PCSK9i)

Novartis announced it has received a CRL from FDA for the inclisiran NDA. According to the press release, the CRL is not related to efficacy or safety concerns, but rather, it was “due to unresolved facility inspection-related conditions.” Recall, the EC granted marketing authorization for inclisiran on December 11, 2020 (view press release). Below, FENIX provides brief thoughts on the inclisiran CRL.

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Novo to Initiate Oral Sema Alzheimer’s Ph3 Program; Novo Ph3 High-dose Rybelsus Trial in 2021; Lilly to Initiate Tirzepatide HFpEF Trial; Highmark and BI Announce Jardiance OBC Results; Medtronic’s Sean Salmon Takes on CV Responsibilities; + Five Other News Items

A series of diabetes-related news items have recently been observed from Novo Nordisk, Lilly, BI/Highmark, Medtronic, Diamyd, Provention Bio, Zealand, and Sensyne Health. Below, FENIX provides highlights and insights for the respective news items.

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Lifescan Launches Online Store with Subscription-based Coaching Services; Welldoc Submits 510(k) with FDA to Expand Insulin Dosing Support; Biocon/Viatris (Mylan) Bs-aspart Receives Positive CHMP Opinion; Poxel Announces Ph2a data from PXL770 in NASH

A series of diabetes-related news items have been observed: Lifescan announced the launch of its OneTouch Store which includes subscription offerings for live diabetes coaching services accessible through the OneTouch Reveal app; Welldoc announced the submission of its 510(k) filing with FDA to expand its insulin dosing support to include bolus and premixed insulin titration for users with T2DM; Biocon/Viatris (Mylan) announced the companies received a positive CHMP opinion for their bs-insulin aspart; and Poxel announced additional results from its Ph2a study of PXL770 in NASH. Below, FENIX provides highlights and insights for the respective news items.

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Entresto HFpEF Adcom Pre-read Materials Posted

FDA posted the pre-read materials for the upcoming Entresto HFpEF FDA advisory committee meeting on December 15, 2020 (view materials here). As previously stated by FENIX, the outcome of the Entresto adcom is believed to have broad ripple effects throughout the CV/Met market. Below, FENIX provides a brief overview of the key points FDA will consider as well as preliminary thoughts on the adcom.

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