Key Developments For Lexicon Pharmaceuticals, Inc.
Lexicon Pharmaceuticals, Inc. (LXRX.O) (Consolidated Issue listed on NASDAQ Global Market)
Lexicon Pharmaceuticals, Inc. Announces Positive Phase 2 Results of LX1031 in Non-Constipating Irritable Bowel Syndrome
Lexicon Pharmaceuticals, Inc. announced that the Company's investigational new drug, LX1031, a tryptophan hydroxylase (TPH) inhibitor, demonstrated positive results in clinically important parameters for the treatment of non-constipating irritable bowel syndrome (IBS). Top-line results showed that treatment with one gram of LX1031 four times daily produced a statistically significant improvement in global assessment of relief of IBS pain and discomfort over the four-week dosing period as compared to placebo (p=0.0465). Improvements in global assessment parameters also corresponded with statistically significant improvements in stool consistency. Notably, increased clinical response correlated with a greater reduction in serotonin synthesis as reflected by measures of urinary 5-HIAA, a breakdown product of serotonin. The study included 155 patients with either diarrhea-predominant IBS or mixed IBS. Two dose levels were evaluated: a 250 mg dose and a 1,000 mg dose, each administered four times daily (QID). LX1031 was well tolerated, with no statistically significant differences in adverse events observed between placebo and either treatment group. Efficacy endpoints evaluated included a global assessment of adequate relief, as well as measures of specific symptoms associated with IBS. Based on the positive data obtained, Lexicon intends to pursue the development of LX1031 as a treatment for patients with IBS.
Lexicon Pharmaceuticals, Inc. Raises Low End Of Prior FY 2009 Revenue Guidance-Conference Calls
Lexicon Pharmaceuticals, Inc. announced that for fiscal 2009, it expects revenues to be in the range of $10-$11 million, up slightly from previous guidance of $9-$11 million.
Lexicon Pharmaceuticals, Inc. Provides Clinical Pipeline Update
Lexicon Pharmaceuticals, Inc. announced that it has updated its drug development progress and the key developments are that it has completed patient enrollment ahead of schedule in a Phase 2a clinical trial of its drug candidate for non-constipating irritable bowel syndrome , LX1031, an inhibitor of tryptophan hydroxylase that acts locally in the gastrointestinal tract. Top-line data from the trial is expected to be available in November 2009, with detailed results available in the first quarter of 2010, completed Phase 1 studies of its drug candidate for type 2 diabetes, LX4211, an inhibitor of sodium-glucose cotransporter 2 . The Company also initiated a Phase 2a clinical trial of the drug candidate in patients with diabetes. In the Phase 1 clinical trial, LX4211 was well tolerated at all dose levels and produced a dose-dependent increase in urinary glucose excretion. LX4211 also demonstrated a favorable pharmacokinetic profile supporting the potential for once daily dosing. The Phase 2 clinical trial is designed as a four-week, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LX4211 and its effect on biomarkers associated with type 2 diabetes. The trial will be conducted in the United States and is expected to enroll 36 patients with non-insulin dependent type 2 diabetes. Lexicon advanced LX2931, an inhibitor of sphingosine-1-phosphate (S1P) lyase, into a Phase 2a study in patients with rheumatoid arthritis.
Lexicon Pharmaceuticals, Inc. Announces Completion Of Public Offering Of Common Stock
Lexicon Pharmaceuticals, Inc. announced the completion of its previously-announced public offering of shares of its common stock. The offering included an aggregate of 38,333,332 shares of Lexicon's common stock after the exercise in full by the underwriters of their over-allotment option and by Invus, L.P., Lexicon's largest stockholder, of its associated right to purchase additional shares. Of this total, 22,878,187 shares were offered through the underwriters and 15,455,145 shares are being purchased by Invus, including 2,015,888 shares being purchased by Invus pursuant to its right to purchase additional shares. Lexicon expects to receive proceeds from Invus' exercise of its right to purchase additional shares on October 15, 2009. The net proceeds to Lexicon from the offering are approximately $55.2 million, after deducting the underwriting discount and estimated offering expenses and giving effect to the anticipated receipt of proceeds from Invus' exercise of its right to purchase additional shares.
Lexicon Pharmaceuticals, Inc. Pricing Of Common Stock In Public Offering
Lexicon Pharmaceuticals, Inc. announced the pricing of a public offering of 33,333,333 shares of its common stock at $1.50 per share, of which 19,894,076 shares are being offered through the underwriters and 13,439,257 shares are being offered to Invus, L.P., Lexicon Pharmaceuticals, Inc.'s stockholder. All of the shares are being offered by Lexicon pursuant to an effective shelf registration statement previously filed with the Securities and Exchange Commission. Lexicon Pharmaceuticals, Inc. has also granted the underwriters a 30-day option to purchase up to an aggregate of 2,984,111 additional shares of common stock to cover over-allotments, if any. Morgan Stanley is acting as the sole book-runner for the offering, with Thomas Weisel Partners LLC acting as co-manager.
