Shares of Adolor Corp. (ADLR) fell to an all-time low Monday after the U.S. Food and Drug Administration requested additional safety data for the company's lead candidate drug, Entereg.
First Albany Capital lowered its rating for the therapeutic-based biopharmaceutical company to neutral from strong buy, saying the FDA request implies substantial delay to market "or worse."
In the second so-called approvable letter from the FDA, the agency requested 12-month safety data, including an analysis of any serious cardiovascular events, from an ongoing study of Entereg, or alvimopan, as a treatment for opioid-induced bowel dysfunction in patients with chronic noncancer pain. Such a letter typically means a drug might ultimately get approved, but only after the FDA reviews more data.
"Our reaction is that the FDA, clearly not considering Entereg a medical breakthrough, is concerned about extended off-label use in chronic-pain patients," First Albany analyst David Webber said in a note. First Albany makes a market in Adolor shares. Webber doesn't own any shares in the company.
Adolor shares recently changed hands at $7.91, down $6.03, or 43.3%, on about 14 times the average daily volume. Earlier Monday, the stock dipped to $7.63, an all-time low for Adolor, which went public in November 2000. The previous bottom was set February 2005 at $7.97 a share.
Some analysts had expected FDA approval for Entereg, despite mixed clinical-trial results across five Phase III studies.
Adolor and its partner, GlaxoSmithKline PLC (GSK), said Sept. 5 that the drug did not achieve statistical significance in the studies, though both companies also said they would continue to investigate the data.
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