- The stock price of Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) increased by 78.21% this past week as it went from $3.86 on January 11 morning to $6.87 on Friday January 15. This is why it happened.
The stock price of Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) increased by 78.21% this past week as it went from $3.86 on January 11 morning to $6.87 on Friday January 15. One of the biggest triggers for the stock price increase has to do with Lexicon Pharmaceuticals announcing it received feedback from the U.S. Food and Drug Administration (FDA) about its two long-term phase III outcome studies SOLOIST and SCORED being eligible to support a new drug application (NDA) submission for an indication to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure.
This feedback was provided in response to a request made by Lexicon after the completion of the SOLOIST and SCORED studies relating to the potential submission of an NDA based on the results of such studies, taking into account their early close-out and other considerations. And this regulatory feedback clears a key hurdle for partnership discussions around sotagliflozin in heart failure and enables a potential NDA filing in 2021.
SOLOIST is a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 1,222 patients with type 2 diabetes who had recently been hospitalized for worsening heart failure. And the primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo.
SCORED was a multi-center randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 10,584 patients with type 2 diabetes, chronic kidney disease with eGFR of 25 to 60 ml per minute per 1.73 m2 of body-surface area, and risks for cardiovascular disease. And the primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo.
Both SOLOIST and SCORED had achieved their respective primary endpoints. And results from both studies were presented at the Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions 2020 and simultaneously published in The New England Journal of Medicine (NEJM) in two separate articles titled: “Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure” and “Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease.”
Price Target Increased
Another reason why the stock price of LXRX increased this week is due to Citi increasing the price target of Lexicon Pharmaceuticals. Citi director Yigai Nochomovitz increased the price target from $7 to $13. And Nochomovitz is maintaining a buy rating on the shares.
“We expect Lexicon’s ongoing partnership discussions will accelerate on the heels of this news, as it was our understanding that some interested parties were waiting for regulatory clarity,” said Nochomovitz in a research note to clients via Seeking Alpha. “With that clarity now in hand, we believe a partnership for sota is imminent.”
Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.
