The FDA’s Advisory Committee’s vote deliberated on Lexicon’s Zynquista (Sotagliflozin) drug, an adjunct to insulin therapy.
Shares of Lexicon Pharmaceuticals tanked nearly 33.6% as of 11:30 am ET after the drug company’s sotagliflozin drug candidate received a negative vote by a US Food and Drug Administration (FDA) panel, pushing retail sentiment down.
The FDA’s Advisory Committee’s vote deliberated on Lexicon’s Zynquista (Sotagliflozin) drug, an adjunct to insulin therapy aimed at glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease. The FDA Advisory Committee (AdCom) gave three ‘Yes’ and 11 ‘No’ votes.
“We are disappointed in the outcome of today’s Advisory Committee vote. However, we were encouraged by the rich discussion and outpouring of support across the diabetes community in favor of sotagliflozin being made available to appropriate people with T1D and CKD,” said Dr. Mike Exton, chief executive officer and director of Lexicon Pharmaceuticals.
He added that an FDA-approved treatment and education on managing risks for insulin therapy is “urgently needed.”
Retail sentiment on the company slid to ‘bullish’ (69/100) compared to ‘extremely bullish’ (82/100) a day ago.
Following the vote, Wainwright revised its outlook on Lexicon, cutting its price target to $6.00 from $10.00, but maintained a ‘Buy’ rating on the stock, Investing.com reported. The decision was based on the exclusion of Zynquista from “revenue projections, pending further clarity from the FDA on the drug’s approval path.”
Advisory Committee votes, while not binding, are considered by the FDA when making its decision regarding the potential approval of a regulatory application, according to Lexicon.
The FDA had previously hinted at the possibility of considering a new patient population for the trial to further study sotagliflozin’s risk and benefits. The voting panel examined if additional trial data proved benefits without raising risks.
To be sure, many Stocktwits users were optimistic about the company’s prospects.
Lexicon stock is down 21% year-to-date.
