Tag Archives: roche

BI Receives BTD for Survodutide and Initiates 2 Ph3 MASH Trials; Roche Ph2 CT-388 Trial in Obesity+T2DM; Drug Compounder Group Sues FDA; WeightWatchers to Offer Compounded Semaglutide; Novo Invests $158M in Insulin Plant

A series of cardiometabolic-related news items have been observed from Boehringer Ingelheim, Roche, the Outsourcing Facilities Association, WeightWatchers, and Novo Nordisk. Below, FENIX provides highlights and insights for the respective news items.

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Roche in Damage Control Mode After EASD Obesity Data Readout

Roche hosted a post-EASD investor event (view slides) where management reviewed its obesity data presentations and provided additional insight into the company’s obesity development strategy and pipeline. Of note, Roche spent a significant portion of the call discussing the emerging AE profile for its obesity assets and the company’s future plans to remain a player in the obesity market. Below, FENIX provides highlights and insights into the Roche event, including thoughts on whether Roche overpaid for Carmot.

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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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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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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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