Lexicon drug receives fast track status from FDA
Lexicon Pharmaceuticals jumped in premarket trading Monday after saying its irritable bowel syndrome treatment will be reviewed under the Food and Drug Administration's fast-track program.
The FDA's fast-track program is designed to speed up the approval of drugs that treat serious or life-threatening diseases for which there are few other therapies. Those that receive fast track status receive extra meetings and correspondence with regulators throughout the review process.
Lexicon's oral treatment, labeled LX1033, is in mid-stage testing for diarrhea-predominant irritable bowel syndrome. The drug's safety and effectiveness is being compared to a placebo in a study involving about 360 patients. Results are expected in the first half of next year.
Lexicon Pharmaceuticals Inc. is also performing mid-stage testing on potential treatments for diabetes, rheumatoid arthritis and carcinoid syndrome, an illness that causes severe diarrhea and can lead to malnutrition, heart disease, and death. Lexicon doesn't have any approved drugs.
Shares climbed nearly 11 percent, or 17 cents, to $2.07 before markets opened.