NEW YORK (AP) — A Food and Drug Administration advisory panel on Tuesday recommended that the FDA approve NPS Pharmaceuticals Inc.'s experimental bowel drug Gattex.
In two unanimous votes, the 12 panelists said clinical trials of Gattex showed the drug delivered meaningful benefits as a treatment for short bowel syndrome, and that the benefits of the drug outweigh its potential risks. Short bowel syndrome is a potentially life-threatening chronic condition that prevents patients from absorbing nutrients. People with short bowel syndrome are prone to malnutrition, diarrhea and dehydration.
The positive recommendation from the Gastrointestinal Drugs Advisory Committee makes it more likely the FDA will approve Gattex, although does not guarantee approval. The FDA is scheduled to make a decision on Gattex by Dec. 30.
NPS Pharmaceuticals shares were halted on Tuesday. The stock jumped 19 percent Friday after the panel's briefing documents were posted online, as Wall Street felt the questions and assessment of Gattex were favorable. During Friday's session the shares peaked at $11.22, their highest price in more than six years. The stock slipped 6.2 percent Monday to close at $10.19.
In aftermarket trading Tuesday, NPS shares lost 29 cents, or 2.9 percent, to $9.90.
- Pharmaceuticals & Drug Trials
- Food and Drug Administration
- short bowel syndrome