Category Archives: Other

Novo Launches New Wegovy Campaign; Structure Reports Positive GSBR-1290 Topline Obesity Data

Two cardiometabolic-related news items have been observed: Novo Nordisk launched a campaign for Wegovy called “Power of Wegovy” highlighting Wegovy 2.4mg clinical data which includes CV risk reduction based on SELECT (view press release); and Structure Therapeutics reported positive topline data from its Ph2a GSBR-1290 obesity trial and its capsule to tablet PK study (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Zegalogue Receives Positive CHMP Opinion

Zealand Pharma announced CHMP adopted a positive opinion recommending granting marketing authorization for Zegalogue (dasiglucagon) for the treatment of severe hypoglycemia in adults, adolescents, and children with diabetes aged 6 years and over. A final decision from the European Commission is expected within ~3 months. Below, FENIX provides brief insight into Zegalogue’s market potential. 

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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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Zealand Ph2a Dapiglutide Results; SixPeaks Launches as Obesity Startup with AZ Investment; Medtronic CY Q1 ’24 Earnings; Scholar Rock and Sagimet Investor Days; CLEAR Outcomes EU Approval

A series of cardiometabolic-related news items have been observed from Zealand Pharma, SixPeaks Bio, Medtronic, Scholar Rock, Sagimet Biosciences, and Esperion Therapeutics. Below, FENIX provides highlights and insights for the respective news items.

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New CGM Player to Enter the Market

Allez Health announced it secured $60M in a Series A+ financing round led by Osang Healthcare Co. Ltd. and with participation from existing investors. For context, Allez (formerly called Zense-Life; view website) is an emerging biosensor venture founded by veterans in the CGM space. The company is said to be developing a CGM biosensor platform with novel sensor technology that aims to “disrupt today’s cost barrier while enhancing performance and user experience.” Stay tuned for an exclusive, in-depth FENIX interview with the Allez founders, Leif Bowman and Bob Boock. Below, FENIX provides initial insight into Allez and poses key questions about the novel sensor platform.

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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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Fractyl Preclinical Rejuva Obesity Data; Hims and Hers to Sell Compounded Semaglutide; Sanofi T1DM Screening Campaign

Three cardiometabolic-related news items have been observed: Fractyl Health presented preclinical Rejuva obesity data at DDW 2024 (view press release); Hims & Hers Health added compounded semaglutide to its virtual weight management program (view article); and Sanofi has launched a T1DM screening campaign titled, “Take the 1 Pledge,” featuring celebrity spokespeople (view website). Below, FENIX provides highlights and insights for the respective news items.

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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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