Tag Archives: sotagliflozin

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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Lexicon @ Stifel; First Presentation Since Empa T1DM Adcom

Lexicon participated in the 2019 Stifel Healthcare conference and provided brief updates on the sotagliflozin regulatory situation including commentary regarding the recent BI/Lilly empa T1DM adcom. Recall, the empa T1DM adcom ended in a 2-14 vote not favoring approval. Below, FENIX provides highlights and insights from the Stifel event including potential readthrough to the ongoing sotagliflozin appeal with the Office of New Drugs.

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Lexicon Disputes Sota CRL with FDA; Lexicon and Xeris Q3 ’19 Earnings Updates; Dexcom +30% Today

Lexicon hosted its Q3 ’19 earnings call and provided an update on the sotagliflozin T1DM regulatory situation as well as the T2DM Ph3 development program. Of note, Lexicon disclosed it has disputed the sota T1DM CRL with the Office of New Drugs, and it is awaiting a decision shortly. Additionally, Xeris released its Q3 ’19 earnings, and Dexcom stock has jumped +30% following its earnings beat. Below, FENIX provides insights on the sotagliflozin dispute including analysis of Peter Stein’s involvement in the Office of New Drugs review.

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Lexicon +188% Post DAPA-HF and Sanofi Partnership Dissolution

Over the last few months, the fate of Lexicon and sotagliflozin have remained in question; however, in recent days it appears that both have the potential to make a strong comeback. Below, FENIX analyzes Lexicon’s stock price in the context of the recent DAPA-HF results and settlement with Sanofi.

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Lexicon-Sanofi Dispute Settled for $208M Up Front

Today, Lexicon announced that Sanofi and Lexicon have amicably settled their differences in the termination of their collaboration for sotagliflozin. The settlement includes Sanofi to pay Lexicon $208M up front with the balance of $52M to be paid within 12 months ($260M total). Below, FENIX provides thoughts and perspective from the press release and the associated investor call.

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Lexicon @ Wells Fargo; First Presentation Since DAPA-HF Results

Lexicon participated in the 2019 Wells Fargo Healthcare conference and provided brief updates on the sotagliflozin development situation following Sanofi’s announcement that it was withdrawing from the partnership. Additionally, Lexicon briefly commented on sota’s potential in CV and CKD T2DM patients, but senior management made no statements regarding the recent Farxiga DAPA-HF results (previous FENIX insight). Below, FENIX provides highlights and insights from the event.

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Sanofi Q2 ’19 Earnings Update

Sanofi hosted its Q2 ’19 earnings call and provided updates to its diabetes business unit including the recent Ph1 initiation for its GLP/GIP/GCG triple agonist (SAR441255). Unsurprisingly, Sanofi did not discuss its recent decision to terminate the Lexicon partnership for sotagliflozin. Below, FENIX provides diabetes-related highlights and insights from the call.

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