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Lexicon (LXRX) Submits NDA to the FDA for Cardiovascular Drug

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Lexicon Pharmaceuticals, Inc. (LXRX - Free Report) announced the submission of a new drug application (NDA) to the FDA for sotagliflozin.

The NDA is seeking approval for the marketing and sale of sotagliflozin to reduce the risk of cardiovascular death and hospitalization and urgent visits for heart failure in adult patients with type 2 diabetes with either worsening condition or additional risk factors irrespective of left ventricular ejection fraction.

The regulatory body has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.

The NDA was supported by the phase III SOLOIST study results in patients with type 2 diabetes who had recently been hospitalized for worsening heart failure and phase III SCORED clinical study in patients with type 2 diabetes, chronic kidney disease and risks for cardiovascular disease.

Sotagliflozin is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract. SGLT2 is responsible for glucose reabsorption by the kidney.

The successful development and commercialization of the candidate will be a significant boost for the company.

It is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy. However, it has not yet been commercially launched.

Shares of the company have gained 11.9% in the past year against the industry’s decline of 21.9%.

Zacks Investment ResearchImage Source: Zacks Investment Research

Lexicon is also developing LX9211, an orally-delivered small molecule drug candidate, as a treatment for neuropathic pain. It has reported results from two phase I studies of LX9211. LXRX is now conducting a phase II study of LX9211 in diabetic peripheral neuropathic pain and a second phase II study of LX9211 in post-herpetic neuralgia. The candidate has received Fast Track designation from the FDA for development in diabetic peripheral neuropathic pain.

Please note that LX9211 originated from its collaborative neuroscience drug discovery efforts with Bristol-Myers Squibb (BMY - Free Report) .

Lexicon and Bristol-Myers Squibb established a drug discovery alliance in December 2003 to discover, develop and commercialize small molecule drugs in the neuroscience field.  The company acquired the rights to LX9211 under an amendment to the neuroscience alliance. It has agreed to pay BMY development and regulatory milestones starting with the commencement of the first phase II study in the first indication.

Zacks Rank and Stocks to Consider

Lexicon currently carries a Zacks Rank #3 (Hold).  Some better-ranked stocks in the healthcare sector include GlaxoSmithKline (GSK - Free Report) and Sarepta Therapeutics, Inc. (SRPT - Free Report) , each carrying a Zacks Rank of 2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

GlaxoSmithKline’s estimates for 2022 earnings per share have moved north from $2.94 to $3.05 in the past 60 days. Shares of Glaxo have risen 16.9% in the year.

Earnings of Glaxo beat estimates in three of the last four quarters and missed the mark once. It has a trailing four-quarter earnings surprise of 15.3%, on average.

Estimates for Sarepta have narrowed from a loss per share of $6.95 to $4.83 for 2022 in the past 60 days.

SRPT delivered an earnings surprise of 11.06%, on average, in the last four quarters.