Category Archives: Topics

Pfizer and Merck Q2 ’24 Earnings Updates; Fractyl Receives FDA Breakthrough Designation for Revita; NewAmsterdam Announces Ph3 HeFH Data; Liraglutide Associated with Decreased Risk of Cognitive Decline

A series of cardiometabolic-related news items have been observed from Pfizer, Merck, Fractyl Health, NewAmsterdam Pharma, and Imperial College London. Below, FENIX provides highlights and insights for the respective news items.

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Roche Ph2 Obesity Trial Observed; Altimmune Ph1 MASLD Data Published

Two cardiometabolic-related news items have been observed: Roche initiated a Ph2 CT-388 obesity trial (view CT.gov record); and Altimmune announced the publication of pemvidutide MASLD data in the Journal of Hepatology (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Dexcom Q2 ’24 Earnings

Dexcom hosted its Q2 ’24 earnings call (press release; slides) and provided updates across its business, including the impending launch of its first OTC CGM (Stelo). Dexcom lowered its full-year guidance which has led to a ~38% drop in the company’s stock price. Below, FENIX provides highlights and insights from the call.

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UK MHRA Approves SELECT; Skye Obesity Development Plans; New Lilly Obesity Ads Observed

Three cardiometabolic-related news items have been observed: The UK’s MHRA approved SELECT (view press release); Skye Biosciences hosted a virtual KOL event discussing the nimacimab obesity development program and timeline (view press release); and new Lilly obesity awareness ads have been observed. Below, FENIX provides highlights and insights for the respective news items.

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BioAge Initiates Ph2 POC Oral Azelaprag+Tirzepatide Combination Trial in Obesity; TIXiMED Receives IND Approval from FDA for Oral Non-Immunosuppresive T1DM Drug; Novo Buys Land in Denmark for Potential Production Plant

Three cardiometabolic-related news items have been observed: BioAge Labs initiated a Ph2 POC study evaluating co-administered oral azelaprag QD or BID with QW SC injection of tirzepatide in obesity (STRIDES; view CT.gov record); TIXiMED announced it obtained IND approval from FDA for its oral T1DM drug, TIX100 (view press release); and Novo Nordisk reportedly will begin construction for a potential new production plant in Denmark (view article). Below, FENIX provides highlights and insights for the respective news items.

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Abbott and Novartis Q2 ’24 Earnings

Two cardiometabolic-related news items have been observed: Abbott (press release; infographic) and Novartis (press release; slides) hosted their respective Q2 ’24 earnings calls. Below, FENIX provides highlights and insights about the respective items.

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Roche Positive Ph1 Oral GLP-1RA Obesity Results

Roche announced positive topline results for CT-996 (QD oral GLP-1RA) from its ongoing Ph1 trial in participants with and without T2DM (view CT.gov record). According to the press release, treatment with CT-996 resulted in a clinically meaningful placebo-adjusted mean weight loss of -6.1% within four weeks (p <0.001). Following the news, Roche’s stock increased ~7.5%. Below, FENIX provides highlights and brief thoughts on the potential CT-996 differentiation.

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