Tag Archives: Diabetes

Sanofi Discontinues Efpeg Development

Ahead of Sanofi’s Capital Markets Day on December 10, 2019, the company issued a press release outlining its new commercial strategy and direction. As part of the new strategy, Sanofi disclosed that it is no longer pursuing commercialization of its QW GLP-1RA, efpeglenatide (in partnership with Hanmi). Tomorrow, FENIX will be providing full coverage of Sanofi’s Capital Markets Day. 

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Arecor uRAI (AT247) Positive Topline Results

Arecor announced positive topline results for a Ph1 study of its ultra-rapid-acting insulin (AT247). Arecor did not provide any specifics of the Ph1 data, but the company plans to publish and present results from the study in 2020. Below, FENIX provides brief thoughts on AT247 and its market potential.

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Tirzepatide Ph3 Obesity Program Initiated (SURMOUNT-1)

The first tirzepatide Ph3 obesity study (SURMOUNT-1) has been observed on CT.gov. Below, FENIX provides an overview of the trial, thoughts on the tirzepatide obesity program in the context of Novo Nordisk’s ongoing Ph3 semaglutide obesity program (STEP), and a projection of how far behind Lilly could be.

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Positive Lannett Bs-Glargine Ph1 Results; Zealand Initiates 2nd Ph3 CHI Study

Lannett has announced positive results from the Ph1 PK/PD study evaluating their biosimilar insulin glargine vs. Lantus, which initiated in June 2019. In light of meeting all primary endpoints, Lannett indicated they are planning to meet with FDA to discuss the next steps for bs-glargine development. Below, FENIX provides context and insights, particularly related to the FDA’s recent biosimilar insulin draft guidance.

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Dario BGM System Distributed on Walmart.com; Shares Climb ~50%

DarioHealth has announced the launch and distribution of the Dario-powered digital diabetes program on Walmart.com. The day of the news, Dario’s stock jumped nearly 50%. Below, FENIX provides context and insights on the Dario system, including points of differentiation and the importance of its Walmart.com availability.

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Toujeo Pediatric Indication Approved in US

The FDA has approved an expanded indication for Sanofi’s Toujeo in pediatric patients aged 6 years and older based on the positive results from EDITION JUNIOR, which were announced earlier this month. Previously, Toujeo was only approved for adults aged 18 and over. A Sanofi press release has not yet been observed. Below, FENIX provides context and insights on the expanded indication.

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Lexicon Loses Sota T1DM Formal Appeal

Lexicon Pharmaceuticals announced the FDA’s Office of New Drugs has denied Lexicon’s appeal of the CRL issued for sotagliflozin in T1DM. Lexicon’s stock fell ~15% in response to this news. In a conference call hosted shortly after the announcement, Lexicon outlined next-steps for sotagliflozin in T1DM and provided comments on additional indications and partnership opportunities. Below, FENIX provides highlights and insights from the call.

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Thoughts on FDA Bs-Insulin Draft Guidance; Did Development Just Get Easier?

Yesterday, FDA issued a new draft guidance titled, “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.” In the draft guidance, FDA outlines its updated thinking on the need for immunogenicity studies for biosimilar insulin products. Recall, on March 23, 2020, insulin products are being reclassified as biologics, and biosimilars will be governed by the 351(k) pathway. Below, FENIX provides an overview of the FDA’s new draft guidance and implications to the insulin market since it appears that the barriers to developing biosimilar insulins have been significantly reduced.

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Poxel Reports Positive Imeglimin Ph3 Japan Topline Results

Poxel announced positive topline results from the Imeglimin Ph3 (TIMES 3) 36-week open-label extension which evaluated the drug in Japanese patients with T2DM. Following the announcement, Poxel hosted a conference call to discuss the results. The company continues to state that it plans to file a Japanese NDA in 2020. Below, FENIX provides an overview of the Imeglimin Ph3 topline results as well as analysis of the market potential for Imeglimin in Japan.

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