Category Archives: Topics

BI Presents MASH Data at EASL 2024; Scholar Rock Initiates Ph2 Apitegromab Trial in Obesity; Biomea’s BMF-219 Placed on Clinical Hold

Three cardiometabolic-related news items have been observed: Boehringer Ingelheim announced full results from its Ph2 survodutide MASH trial were presented at the EASL 2024 conference (view press release); Scholar Rock’s Ph2 apitegromab obesity trial has been posted to CT.gov (view CT.gov record); and Biomea Fusion’s BMF-219 trials have been placed on clinical hold due to an increase in liver enzymes observed in the Ph1/2 trial (view press release). Below, FENIX provides highlights and insights into the respective news items.

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Madrigal and Sagimet Present MASH Data at EASL 2024

Two cardiometabolic-related news items have been observed: Madrigal Pharmaceuticals announced new Rezdiffra MASH data at the EASL 2024 conference (view press release); and Sagimet Biosciences presented Ph2b FASCINATE-2 denifanstat data at the EASL 2024 conference (view press release). Below, FENIX provides highlights and insights into the respective news items.

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NICE to Recommend Tirzepatide for Obesity; Lilly and Altimmune MASH Data at EASL 2024; Lilly Initiates Ph1 Orforglipron Capsule vs. Tablet Bridging Study; Dexcom G7 Direct to Apple Watch Now Available

A series of cardiometabolic-related news items have been observed from UK’s NICE, Lilly, Altimmune, and Dexcom. Below, FENIX provides highlights and insights for the respective news items.

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CinRx Raises $73M to Fund its Startups, Including Obesity; Dexcom ONE Reimbursement for T2DM Patients in France; Viking Positive Ph2b Histology MASH Data; Lilly Initiates Ph3 SURMOUNT-ADOLESCENTS-2 Trial

A series of cardiometabolic-related news items have been observed from CinRx Pharma, Dexcom, Viking Therapeutics, and Lilly. Below, FENIX provides highlights and insights for the respective news items.

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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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Tandem Mobi Integrated with Dexcom G7; Ro Launches GLP-1 Supply Tracker; Novartis Initiates Ph4 Inclisiran vs. BA H2H Study; AZ Ph1 Oral PCSK9i Results; Catalent Stockholders Approve Acquisition by Novo

A series of cardiometabolic-related news items have been observed from Tandem, Ro, Novartis, AstraZeneca, and Catalent/Novo. Below, FENIX provides highlights and insights for the respective news items.

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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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Full FLOW Results at ERA; Lilly Increases Manufacturing Investment to $9B

Two cardiometabolic-related news items have been observed: the full FLOW results were presented at ERA 2024 and simultaneously published in the NEJM (press release); and Lilly announced it increased its manufacturing investment for tirzepatide API production (press release). Below, FENIX provides highlights and insights for the respective news items.

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