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Lexicon Pharma Initiates Dosing in Biliary Tract Cancer Study

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Lexicon Pharmaceuticals, Inc. (LXRX - Free Report) announced that it has dosed the first patient in a phase IIa study — TELE-ABC — evaluating its sole marketed drug, Xermelo (telotristat ethyl), in patients with biliary tract cancer.

Lexicon’s shares were up 1.1% on Mar 15, following the news. The shares of the company have gained 11.6% so far this year compared with the industry’s growth of 15.7%.

Xermelo, which was launched in March 2017, is already approved in combination with somatostatin analog (“SSA”) therapy for treating carcinoid syndrome diarrhea in patients having inadequate response to SSA therapy alone.

The two-stage phase IIa study is evaluating Xermelo in combination with standard-of-care, first-line chemotherapy (cisplatin plus gemcitabine), in patients with locally advanced, recurrent or metastatic biliary tract cancer. First stage will evaluate 250mg of Xermelo for seven days, followed by 500mg of the drug for 21 days with intermediate administration of chemotherapy. Primary endpoint of the study is progression-free-survival at six months, with overall survival at six and 12 months, and PFS at 12 months as secondary endpoints. Top-line data from the study is expected in 2020.

Xermelo sales in the United States were $25 million in 2018 compared with $15.1 million in 2017. Sales of the drug have increased sequentially in every quarter of 2018. Lexicon has a collaboration with Ipsen to commercialize the drug in Europe and earns milestone payments on European sales.

Apart from Xermelo, the company is developing several other pipeline candidates in multiple indications. The lead pipeline candidate, Zynquista (sotagliflozin) is under review in the United States and Europe as a treatment for type I diabetes. A decision from the FDA is expected on Mar 22 and European approval is expected in the second quarter of 2019, following the recommendation from the Committee for Medicinal Products for Human Use last month.

Lexicon is developing Zynquista in collaboration with Sanofi (SNY - Free Report) . A phase III study is evaluating the candidate in type II diabetes.

Two early-stage candidates — LX2761 and LX9211 — are being developed for treating type I diabetes and neuropathic pain, respectively.

Zacks Rank & Stocks to Consider

Lexicon currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include Celgene Corporation (CELG - Free Report) and Kamada Ltd. (KMDA - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Celgene’s earnings estimates have been revised 3.8% upward for 2019 over the past 60 days. The stock has rallied 38% so far this year.

Kamada’s earnings estimates have been revised 34.3% upward for 2019 over the past 60 days. The stock has rallied 52.6% so far this year.

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