Following the T1DM sotagliflozin FDA adcom, Lexicon held an investor call (Sanofi and Lexicon press release) to discuss the panel’s 8-8 split vote (previous FENIX insight). Lexicon senior management briefly summarized the panel’s commentary before answering questions from financial analysts. Following the vote, Lexicon’s stock opened ~24% down. Below, FENIX provides an overview of post-adcom Lexicon webcast as well as additional thoughts on how the companies will overcome the split vote.  The -24% market reaction to Lexicon’s stock price (shown in the chart above) is anticipated to rebound, particularly as Lexicon senior management seek to do damage control with institutional investors…….

Today, the FDA advisory committee panel split the vote (8-8) on whether the sotagliflozin benefit in T1DM outweighs the risks. Of note, the clinicians who treat glycemic control and T1DM tended to vote “yes” while the cardiologists and biostatisticians tended to vote “no.” Below, FENIX provides key highlights of the FDA adcom as well as market implications and read-through to the other SGLT inhibitors being developed for T1DM.

Lexicon stock trading has been halted ahead of today’s sotagliflozin T1DM FDA adcom. The previous close was $7.70. FENIX will be providing a full analysis of the adcom.

Briefing documents for the Sanofi/Lexicon sotagliflozin in T1DM FDA adcom were posted today in advance of the January 17, 2019 meeting. As anticipated, FDA’s primary concern appears to be the increased risk of DKA with sotagliflozin; however, Sanofi/Lexicon’s mitigation strategy is projected to quell the concerns of the FDA adcom voting panel. Below, FENIX provides further analysis of the briefing documents, and in light of this evidence, FENIX predicts the results of the adcom will be positive for Sanofi/Lexicon. Executive Summary The 16-member panel will be asked to respond to 4 discussion questions (sota benefits for T1DM, concern for risk of DKA, differences between……

Today, Lexicon announced that FDA will hold an advisory committee meeting for Zynquista (sotagliflozin in T1DM) on January 17, 2019. This news is in-line with previous guidance from Lexicon’s Q3 ‘18 earnings call. Recall, the PDUFA date for Zynquista is March 22, 2019 (previous FENIX insight). FENIX will provide coverage and analysis of the FDA briefing documents as well as the adcom meeting. The following updates are occurring in the map: Adcom announcement is being added under respective map entries… If you receive our email blasts, you already have an account. Log in nowContext counts when making decisions.Purchase Blast$599.00You can read the article’s full…