Back to top

Image: Bigstock

Lexicon (LXRX) Soars on FDA Permission for Sotagliflozin NDA

Read MoreHide Full Article

Lexicon Pharmaceuticals, Inc. (LXRX - Free Report) announced that it has received feedback from the FDA, which stated that data from its two long-term phase III outcomes studies — SOLOIST and SCORED — are eligible to support a new drug application filing for its dual SGLT inhibitor candidate, sotagliflozin. A potential NDA will be seeking approval for the candidate as treatment to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in type II diabetes patients with either worsening heart failure or additional risk factors for heart failure.

Top-line data from both studies demonstrated that sotagliflozin in combination with standard of care improved risk of death from cardiovascular causes, and reduced hospitalizations for heart failure and urgent visits for heart failure.

Lexicon’s shares soared 105.4% on Jan 14, following the announcement as it has now moved a step closer to approval of the drug targeting an attracting diabetes market. In fact, shares of the company have gained 89.9% in the past year, compared with the industry’s growth of 8.2%.

 

Please note that sotagliflozin is approved as Zynquista for treating type I diabetes in addition to insulin in Europe. However, in the United States, the FDA denied approval to Zynquista as type I diabetes treatment in 2019. During the same year, the company’s partner in sotagliflozin development, Sanofi (SNY - Free Report) also left the partnership, citing lower-than-expected results in patients with chronic kidney disease and paid Lexicon $260 million for the termination of contract.

Apart from the SOLOIST and SCORED studies, Lexicon successfully completed four other late-stage studies last year evaluating sotagliflozin as monotherapy or in combination with sulfonylurea as potential treatment to lower blood glucose (A1C) level in type II diabetes patients. Data showed that treatment with sotagliflozin significantly reduced blood glucose levels.

The company is also developing another pipeline candidate, LX9211, in a mid-stage study as potential treatment for post-herpetic neuralgia, the most common complication of shingles. Lexicon intends to complete this study and its other proof-of-concept study of LX9211 for diabetic peripheral neuropathic pain by the end of 2021.

We note that Lexicon identified LX9211 and another development candidate in a neuroscience drug discovery alliance with Bristol-Myers Squibb (BMY - Free Report) and holds exclusive development and commercialization rights to them.

Zacks Rank

Lexicon currently carries a Zacks Rank #3 (Hold). Halozyme Therapeutics, Inc. (HALO - Free Report) is a better-ranked stock from the same sector, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Halozyme’s earnings estimates have grown from $1.68 per share to $1.72 per share for 2021 in the past 60 days.

Zacks Names “Single Best Pick to Double”

From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.

You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.

Free: See Our Top Stock and 4 Runners Up >>