Category Archives: Uncategorized

Insulet Partners with Nintendo’s Animal Crossing Game; Beta Bionics Raises $57M in Series C Financing

Two cardiometabolic-related news items have been observed: Insulet announced it will be partnering with Nintendo for integration into the Animal Crossing: New Horizons game; and Beta Bionics announced the closing of its $57M Series C. Below, FENIX provides highlights and insights for the respective new items, including thoughts on how Insulet is likely using Animal Crossing to source new Omnipod 5 patients.

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Novo Q4 ’21 London Earnings; Sanofi and Regeneron Q4 ‘21 and FY ‘21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo Nordisk hosted its post-Q4 ’21 earnings event (see previous FENIX insight on Q4 ’21 Novo earnings from February 2); and Sanofi (press release; slides; view infographic) and Regeneron (press release; slides), hosted their respective Q4 and FY ’21 earnings calls. Below, FENIX provides highlights and insights for the respective new items.

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Lannett, Merck, Roche, and BD Q4 ‘21 and FY ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Lannett (press release), Merck (press release; slides), Roche (press release; slides), and BD (press release; slides) hosted their respective Q4 ’21 earnings calls. Below, FENIX provides highlights and insights for the respective new items.

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Novo Q4 and FY ’21 Earnings Update

Novo Nordisk hosted its Q4 and FY ’21 earnings call (press release; slides) and provided updates across its commercial and pipeline activities, including the ongoing Wegovy supply shortage and a Rybelsus launch update. Of note, Novo disclosed it has been notified of four Paragraph IV ANDA filings for generic Ozempic. Additionally, Novo reminded about its upcoming 2022 Capital Markets Day on March 3, 2022. Below, FENIX provides highlights and insights from the call.

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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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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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