On December 30, the company announced the submission of the NDA for Sotagliflozin for the treatment of heart failure in Type2 Diabetes patients. Following the news, Lexicon Pharmaceutical Inc. (LXRX) surged in the after hours. Consequently, the stock was trading at $4.44 apiece in the after hours.
During the regular session, the stock saw a mild gain of 1.71% at its closing price of $4.17. The emergence of the news caused the stock to gain 6.47% at an after-hours volume of 72.08K shares.
Currently, Lexicon Pharmaceutical Inc. has a market capitalization of $610 million with its 148.9 million outstanding shares.
LXRX’s NDA Submission
The company had been conducting Phase 3 SOLOIST and Phase 3 SCORD clinical studies. The SOLOIST study was designed for the evaluation of the efficacy of sotagliflozin in patients with type 2 diabetes recently hospitalized for worsening heart failure. Moreover, the SCORD study had been evaluating the cardiovascular efficacy of sotagliflozin in patients with type2 diabetes, chronic kidney disease.
Based on the positive results of the studies, LXRX submitted New Drug Application to the U.S. FDA. The NDA was submitted for sotagliflozin for the reduction of cardiovascular death risk, hospitalization for heart failure, and urgent visits for heart failure in type2 diabetes patients. Moreover, the FDA will review the NDA’s acceptability and completion for filing in a 60-day review period.
According to the CEO of LXRX, Lonnel Coats, this submission has brought the company closer to providing this innovative treatment to patients. In addition, the company plans to work closely with the FDA for the reviewing process of the NDA.
Recent Developments
As per the recent announcement, LXRX participated in two conferences. Firstly, the company’s CEO participated in the Jefferies London Healthcare Conference. The conference took place from November 16 to 19, 2021.
Secondly, the company’s executive management participated in the Piper Sandler 33rd Annual Healthcare Conference. Furthermore, this conference took place from November 30 to December 2, 2021.
LXRX’s Q3 Earnings Highlights
On November 03, the company announced the financial results for its third quarter of 2021.
In the third quarter of 2021, LXRX generated almost negligible revenue as compared to Q3 2020s $6.6 million. The reason for this was the sale of its XERMELO® product and assets to TerSera Therapeutics LLC in Q3 2020.
Moreover, Q3 2021 witnessed a net loss of $23.1 million ($0.16/share) against a net income of $82.6 million ($0.71/share) in Q3 of 2020.
