Category Archives: Topics

Novo Nordisk’s QW Insulin Icodec Receives CRL

Novo Nordisk announced FDA issued a CRL regarding the QW insulin icodec BLA for the treatment of diabetes. According to the press release, the CRL outlines requests related to the manufacturing process and the T1DM indication. Novo stated it is evaluating the content of the CRL and will work closely with FDA to fulfill the requests. Of note, Novo does not expect to be able to fulfill the requests during 2024. Below, FENIX provides brief thoughts on the CRL in the context of the recent negative FDA adcom vote.

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BI Announces Triple Agonist for Obesity Treatment; Merck Initiates Ph2a Trial of Efinopegdutide in MASLD

Two cardiometabolic-related news items have been observed: Boehringer Ingelheim and Gubra announced the launch of a Ph1 trial evaluating its triple agonist, BI 3034701, in obesity (view press release); and Merck initiated a Ph2a trial evaluating Q2W vs. QW administration of efinopegdutide (MK-6024) in MASLD (view CT.gov record). Below, FENIX provides highlights and insights for the respective news items, including thoughts on potential MOAs for BI’s triple agonist.

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Novo’s Ocedurenone CLARION-CKD Trial Fails; NeuroBo Doses First Patient in MAD Ph1 Obesity Trial; Another Generic Liraglutide FDA Approval

Three cardiometabolic-related news items have been observed: Novo Nordisk announced its CLARION-CKD Ph3 trial evaluating ocedurenone (nsMRA) failed to meet its primary endpoint (view CT.gov record; view press release); NeuroBo Pharmaceuticals announced it dosed first patients in the Part 2 MAD portion of its Ph1 trial of DA-1726 for obesity (view CT.gov record; view press release); and Hanyu Pharmaceuticals (and Hikma) announced its liraglutide ANDA has been granted tentative approval (view press release). Below, FENIX provides highlights and insights for the respective news items.

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EXCLUSIVE: FENIX Interview with CGM Newcomer Allez Health (Part 2)

As promised, FENIX delivers on Part 2 of the exclusive interview with Leif Bowman, the co-founder of Allez Health, an emerging biosensor venture founded by veterans in the CGM space. In case you missed it, Part 1 of the exclusive interview covered insights into Allez’s business philosophy and an early look into the features of its CGM (view here). Below, FENIX provides further details on Allez’s launch timelines, data-sharing strategy, and perspective on the market heavyweights, Dexcom and Abbott.

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Ionis’s Olezarsen FCS Filing Accepted with Priority Review; Scholar Rock Obesity Development Updates; Zealand Raises $900M Towards Obesity Development; Sernova Ph1/2 Cell Pouch T1DM Updates; Fractyl Pipeline Updates; New Dario Digital Health GLP-1RA Data

A series of cardiometabolic-related news items have been observed from Ionis, Scholar Rock, Zealand, Sernova, Fractyl Health, and Dario Health. Below, FENIX provides highlights and insights for the respective news items.

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ADA 2024 Key Press Releases (June 24)

On the final day of the ADA 2024 conference, nine cardiometabolic-related news items have been observed from Novo Nordisk, Adipo Therapeutics, Trinity Biotech, Alnylam, Viking, Teva, Teladoc Health, and CHMP. Below, FENIX provides context and analysis for the announcements, including thoughts on the potential FLOW label.

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ADA 2024 Key Press Releases (June 23)

On the third day of ADA 2024, four cardiometabolic-related news items have been observed from Senseonics, Altimmune, Fractyl Health, and Gan & Lee. Below, FENIX provides context and analysis for the announcements.

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