Tag Archives: crl

Novo Q3 ’25 Earnings; Lowers FY 2025 Guidance…Again

Novo Nordisk hosted its Q3 ’25 earnings call (press release; slides) and provided updates across its CVRM portfolio and obesity pipeline. Of note, the company has lowered its FY 2025 sales growth guidance again from 8-14% to 8-11% due to continued underperformance of its semaglutide franchise. Recall, at the beginning of the year, Novo originally guided that FY 2025 sales growth would be in the range of 16-24% (view slide). Below, FENIX provides highlights and insights from the Q3 ’25 earnings call, including thoughts on the Metsera acquisition saga.

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Novo Nordisk’s QW Insulin Icodec Receives CRL

Novo Nordisk announced FDA issued a CRL regarding the QW insulin icodec BLA for the treatment of diabetes. According to the press release, the CRL outlines requests related to the manufacturing process and the T1DM indication. Novo stated it is evaluating the content of the CRL and will work closely with FDA to fulfill the requests. Of note, Novo does not expect to be able to fulfill the requests during 2024. Below, FENIX provides brief thoughts on the CRL in the context of the recent negative FDA adcom vote.

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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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