Category Archives: SGLT2i

Bayer Hosts Kerendia Investor Webinar

Bayer hosted its Kerendia (finerenone) investor webinar (view here), highlighting Kerendia’s clinical profile, how it fits into the treatment landscape, US market strategy, and LCM initiatives. Unsurprisingly, much of the event, including the Q&A, focused on the differentiation with the SGLT2i class. Separately, Bayer announced the initiation of a new Ph3 trial (FIONA) evaluating finerenone in pediatrics with CKD and severely increased proteinuria. Below, FENIX provides highlights from the presentation as well as additional thoughts on the Kerendia launch.

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BI/Lilly’s Jardiance Receives FDA Priority Review; Novo’s Wegovy Receives Positive CHMP Opinion; Merck/Bayer Initiate New Ph3 Verquvo Study; Dario Enters Three New Commercial Agreements; Gmax Administers First in Human Dose of GMA106 in Ph1 Obesity Study; Metacrine and Zealand Q3 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed from BI/Lilly, Novo Nordisk, Zealand, Merck/Bayer, Dario, Gmax Biopharma, and Metacrine. Below, FENIX provides highlights and insights for the respective news items, including an updated projection of the EMPEROR-Preserved PDUFA date.

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Bayer and Senseonics Q3 ’21 Earnings Updates; Abbott and ADA Launch Community Initiative; Provention Bio Launches #Type1TestedPledge Campaign; Beyond Type 1 Receives $750,000 Grant

A series of cardiometabolic-related news items have been observed: Bayer (press release; slides) and Senseonics (press release) hosted their respective Q3 ’21 earnings calls; Abbott and the American Diabetes Association (ADA) announced the launch of their first joint community initiative in Columbus, Ohio; Provention Bio announced the launch of its #Type1TestedPledge Campaign for Diabetes Awareness Month; and Beyond Type 1 announced it has received a $750,000 Grant from the Helmsley Charitable Trust. Below, FENIX highlights and insights for the respective new items.

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GSK’s Daprodustat Ph3 Data Positive But Not Entirely Clean; BI/Lilly’s Jardiance Demonstrates Consistent Cardio-Renal Benefits in HF; Novo Announces Positive Ph3b STEP 5 Trial Results; CytoDyn Reports Positive Preliminary Data from Ph2 Leronlimab Trial; Roche and Sanofi Mallya Collaboration; Intuity Medical’s Automatic BGM Available in US; Zealand and DEKA Collaboration for Continuous Infusion Pump

A series of cardiometabolic-related news items have been observed from GSK, BI/Lilly, Novo Nordisk, CytoDyn, Roche, Intuity Medical, and Zealand. Below, FENIX provides highlights and insights for the respective news items.

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Lexicon, Tandem, Amarin, Intercept, and Amgen Q3 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Lexicon (press release), Tandem (press release), Amarin (press release; slides), Intercept, (press release; slides), and Amgen (press release; slides), hosted their respective Q3 ’21 earnings calls. Importantly, Lexicon discussed its US sotagliflozin commercial strategy suggesting it is moving forward on its own. Below, FENIX provides highlights and insights from the respective news items.

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Ionis Initiates New Ph3 Study in Hypertriglyceridemia; Real-World Evidence Study of PDT BT-001 for T2DM; Metacrine Announces MET409 Topline Results; Esperion and Pfizer Q3 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Ionis announced the initiation of a second Ph3 clinical study (CORE) evaluating olezarsen in patients with severe hypertriglyceridemia; Better Therapeutics and Mass General Brigham announced a partnership for real-world evidence study evaluating the long-term effectiveness of Better Therapeutics’s BT-001; Metacrine announced topline results from the MET409 + empagliflozin Ph2a trial in patients with T2DM and NASH; and Esperion (press release; slides) and Pfizer (press release; slides) hosted their respective Q3 ’21 earnings calls. Below, FENIX provides highlights and insights from the respective news items.

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Novartis’s Entresto Marketing Under DOJ Investigation?; Inventiva’s Ph2a Lanifibranor + Empa Trial (LEGEND); Merck and Sanofi Q3 ’21 Earnings Updates; Roche and Zur Rose Group Collaboration

A series of cardiometabolic-related news items have been observed: It has been reported that Novartis received a request from DOJ regarding details about the marketing and pricing of Entresto since 2016 (view article); Inventiva announced the design of its Ph2a combination (lanifibranor+empa) trial (LEGEND) in patients with NASH and T2DM; Merck (press release; slides) and Sanofi (press release; slides) hosted their respective Q3 ’21 earnings calls; and Roche and the Zur Rose Group announced their collaboration of healthcare products and solutions. Below, FENIX provides highlights and insights for the respective news items.

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Lilly and Novartis Q3 ’21 Earnings Updates

Today, Lilly (press release; slides) and Novartis (press release; slides) hosted their Q3 ’21 earnings calls. Below, FENIX provides highlights and insights from the respective news items.

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