Category Archives: Uncategorized

Novartis Q1 ’22 Earnings Update

Novartis hosted its Q1 ’22 earnings call (press release; slides) and provided brief updates to its CVRM business, including Entresto’s market performance and Leqvio’s commercialization. Additionally, management stated that the Sandoz strategic review remains in progress and reiterated expectations to provide an update by EOY. Below are highlights from the call.

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Daprodustat NDA Accepted by FDA; Sean Saint Looks to Do It Again; April 19-22 CHMP Agenda; J&J Q1 ’22 Earnings Update

Several cardiometabolic-related news items have recently been observed: GSK announced FDA accepted the daprodustat NDA for the treatment of patients with anemia due to CKD; Sean Saint has started a new company called Luna Diabetes (view website); the CHMP agenda for this month’s meeting (April 19-22) has been released; and J&J hosted their Q1’ 22 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective new items.

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AZ/Ionis Ph2b Data @ ACC 2022; Novartis Restructures Pharma Business; Eversense E3 Launched in the US; Dexcom ONE to Launch in UK; New Sota and Kerendia Subanalyses @ ACC 2022; Fractyl Receives IDE for Second Pivotal Trial

A series of cardiometabolic-related news items have been observed from AZ/Ionis, Novartis, Ascensia/Senseonics, Dexcom, Lexicon, Bayer, DiaMedica, and Fractyl. Below, FENIX provides highlights and insights for the respective new items.

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Lannett Initiates Bs-glargine Pivotal Trial; Tirzepatide Meta-analysis Shows No Increased MACE Risk in T2DM; Provention Bio’s PRV-101 Vaccine Positive Final Results

A series of cardiometabolic-related news items have been observed: Lannett announced the initiation of its biosimilar insulin glargine pivotal trial; A CV safety meta-analysis for the tirzepatide Ph3 SURPASS program was published in Nature Medicine and showed no increased MACE risk in T2DM (view publication); and Provention Bio announced PRV-101 vaccine positive final results (press release). Below, FENIX provides highlights and insights for the respective new items.

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Dexcom to Implement 4:1 Stock Split; Libre Reimbursed in Japan for Basal-Only Patients; Ypsomed/CamDiab Ltd Collaboration; Movano Q4 ’21 and FY ‘21 Earnings Update

A series of cardiometabolic-related news items have been observed: Dexcom announced that the company’s Board of Directors has approved a four-for-one forward split of Dexcom’s common stock; Abbott announced the Japanese Ministry of Health, Labor and Welfare has approved reimbursement coverage for Libre in basal-only patients; Ypsomed announced a partnership with CamDiab Ltd for AID system development; and Movano hosted its Q4 ’21 earnings call (press release). Below, FENIX provides highlights and insights for the respective new items.

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Supersapiens Energy Band Review Published in Rouleur; Arecor Granted US Patent for Insulin Products; 9am.health and Ascensia Collaboration

A series of cardiometabolic-related news items have been observed: A review of the Supersapiens Energy Band Version Zero has been published in a well-known British cycling magazine (view review here); Arecor announced it has been granted patent US11278624 by the US Patent and Trademark Office protecting novel formulations of insulin products AT247 and AT278; and 9am.health announced Ascensia’s CONTOUR NEXT ONE blood glucose meter and CONTOUR NEXT test strips are now available to its prediabetes and T2DM patients. Below, FENIX provides highlights and insights for the respective new items.

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Medtronic Appoints New Diabetes EVP and Operating Unit President; Lexicon Loan Suggests No Priority Review for Sota; Diamyd Opens First EU Clinic for Ph3 DIAGNODE-3 Trial; Xeris Launches Gvoke Kit in US; DiaMedica Q4 and FY ’21 Earnings Update

A series of cardiometabolic-related news items have been observed: Medtronic announced leadership transitions for three of its operating units including diabetes, surgical robotics, and cardiac rhythm management; Lexicon announced it has entered into a loan facility agreement with Oxford Finance, providing up to $150M in borrowing capacity; Diamyd announced it has opened the first clinic in EU for initiation of its Ph3 DIAGNODE-3 trial in T1DM; Xeris announced it has launched its Gvoke Kit RTU glucagon (1mg/0.2 mL single-dose vial and syringe kit) in the US; and DiaMedica hosted its Q4 and FY ’21 earnings (press release). Below, FENIX provides highlights and insights for the respective new items.

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Jardiance EMPULSE Trial Published; Senseonics Q4 ’21 Earnings Update; Novo Initiates Icosema COMBINE 2 Ph3 Trial; Merck’s Oral PCSK9i Enters Ph2; BI Partners with Lifebit; Intercept and Amarin Q4 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed from BI/Lilly, Senseonics, Novo, Merck, BI/Lifebit, Intercept, and Amarin. Below, FENIX provides highlights and insights for the respective new items.

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