FDA Panel Rejects Lexicon's Zynquista For Type 1 Diabetes
Portfolio Pulse from Vandana Singh
The FDA's advisory committee voted against Lexicon Pharmaceuticals' Zynquista for type 1 diabetes, citing that the benefits do not outweigh the risks. Despite this, Lexicon plans to resubmit the NDA and anticipates a potential launch in early 2025. The stock price of Lexicon Pharmaceuticals dropped significantly following the news.
November 01, 2024 | 1:05 pm
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Lexicon Pharmaceuticals faced a setback as the FDA advisory committee voted against the approval of Zynquista for type 1 diabetes, leading to a significant drop in stock price.
The FDA panel's rejection of Zynquista is a major regulatory setback for Lexicon Pharmaceuticals, directly impacting its stock price negatively. The company's plan to resubmit the NDA indicates ongoing challenges and uncertainty in achieving approval.
CONFIDENCE 100
IMPORTANCE 90
RELEVANCE 100
NEUTRAL IMPACT
Sanofi previously terminated its agreement with Lexicon regarding sotagliflozin, which is now facing regulatory challenges in the US.
Sanofi's decision to terminate its agreement with Lexicon in 2019 may be seen as a strategic move given the current regulatory challenges faced by Lexicon. However, the direct impact on Sanofi is limited as they are no longer involved.
CONFIDENCE 90
IMPORTANCE 50
RELEVANCE 30
NEUTRAL IMPACT
Viatris recently obtained an exclusive license to commercialize sotagliflozin outside the US and Europe, while Lexicon retains rights in these regions.
Viatris' licensing deal with Lexicon for sotagliflozin outside the US and Europe is not directly impacted by the FDA's decision, but it highlights the regulatory hurdles the drug faces in the US market.
CONFIDENCE 80
IMPORTANCE 40
RELEVANCE 20