Category Archives: Basal Insulin

Tirzepatide SUMMIT HFpEF Topline Results; Regeneron, Alnylam, Ionis, Teladoc, Amarin, and Biomea Q2 ’24 Earnings; Antag Increases Series A Funding for GIP Antagonism; Sanofi Expands Insulin Manufacturing in Germany; Boston Pharmaceuticals MASH Updates

A series of cardiometabolic-related news items have been observed from Lilly, Regeneron, Alnylam, Antag Therapeutics, Sanofi, Boston Pharmaceuticals, Ionis, Teladoc, Amarin, and Biomea Fusion. Below, FENIX provides highlights and insights for the respective news items, including initial thoughts on Lilly’s tirzepatide HFpEF results in the context of Novo’s STEP HFpEF and apparent regulatory delay.

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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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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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ADA 2024 Key Press Releases (June 22)

On the second day of ADA 2024, six cardiometabolic-related news items have been observed from Insulet, Medtronic, Terns Pharmaceuticals, MannKind, Tandem, and Altimmune. Below, FENIX provides context and analysis for the announcements.

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May CHMP Agenda; Noom and Ro GLP-1RA Ads Observed; NewAmsterdam Lp(a) Results

Three cardiometabolic-related news items have been observed: The CHMP agenda for this month’s meeting (May 27-31) has been released (view here); New Ro and Noom GLP-1RA ads have been observed; and NewAmsterdam announced obicetrapib (CETP inhibitor) results (view article). Below, FENIX provides highlights and insights for the respective news items.

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FDA Adcom Votes 4-7 Against Insulin Icodec T1DM Approval

Today, FDA held an Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to discuss the use of Novo Nordisk’s QW insulin icodec in T1DM patients, and panelists voted 4-7 against the icodec benefit/risk profile in T1DM patients. The split vote is largely unsurprising in the context of FDA’s concerns raised in the adcom briefing documents (previous FENIX insight). Below, FENIX provides highlights and insights from the icodec adcom, including additional thoughts on how a T2DM-only icodec indication would be a significant win for Novo (and Lilly).

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Novo to Face Uphill Battle; Insulin Icodec Adcom Briefing Documents Available

Briefing documents have been posted for FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to discuss the use of Novo Nordisk’s QW insulin icodec in T1DM patients (view here) which is being held on May 24, 2024. Below, FENIX provides an overview of FDA’s thoughts/concerns about the icodec benefit/risk profile and a prediction on how the adcom will turn out.

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Hengrui Licenses GLP-1RA-Based Assets to US Biotech; Inventiva Announces Positive DMC Recommendation for Ph3 MASH Trial; US Senate Releases Report on Anti-Obesity Medication Pricing; Biocon Q1 ’24 Earnings

A series of cardiometabolic-related news items have been observed from Hengrui Pharmaceuticals, Inventiva, US Senate HELP Committee, and Biocon. Below, FENIX provides highlights and insights for the respective news items.

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Lilly Ph3 QW Insulin Results; Roche Ph1 GLP-1/GIP RA Obesity Results; Zealand Q1 ’24 Earnings

Three cardiometabolic-related news items have been observed: Lilly announced QWINT-2 and QWINT-4 topline results, the first from its Ph3 QW insulin program (press release); Roche announced positive Ph1 CT-388 (GLP-1/GIP RA) obesity results (press release); and Zealand hosted its Q1 ’24 earnings call (press release). Below, FENIX provides highlights and insights for the respective news items, including thoughts on Lilly’s QW insulin program in the context of the impending Novo Nordisk QW icodec adcom on May 24, 2024.

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