Talon Therapeutics Inc. fell the most since November 2010 after the U.S. Food and Drug Administration said it wants more time to review information about Talon’s Marqibo blood-cancer treatment.
Talon dropped 31 cents, or 29 percent, to 77 cents at the close in New York, after earlier declining as much as 39 percent. Shares of the San Mateo, California-based company had more than doubled this year before today.
Talon, a biotechnology company with no marketed products, was informed by the FDA that its application seeking accelerated approval of Marqibo was given a three-month prescription drug user fee act, known as Pdufa, date extension until Aug. 12
“It’s a fairly standard move when there is a submission of a new drug,” Gregory Wade, a biotechnology analyst at Wedbush Securities Inc. in San Francisco, said in a telephone interview. “The FDA wants more information and they extended the review period.”
Wade, who doesn’t cover Talon, follows biotechnology companies including Pharmacyclics Inc., which also makes blood cancer treatments.
On March 21, Talon won the backing of a U.S. advisory panel for accelerated approval of its product. The advisers voted 7-4 that the benefits of the anti-leukemia therapy outweigh its risks.
The FDA is considering Marqibo, Talon’s lead product candidate, based on the second of three phases of clinical trials typically required for approval. The latest request from the FDA is unrelated to clinical trials for the product.
“The FDA is regularly pushing folk out about three months so we are part of a crowd,” Craig Carlson, Talon’s chief financial officer, said in a telephone interview. “The FDA regulations allow that if new information is provided they have the opportunity to extend the review period.”
“We have answered everything the FDA asked us for,” Carlson said. “We are in label negotiations with them. We submitted our first response to their label suggestions. We feel like we are on track and are at the point that we are waiting for responses to the information we provided the FDA.”
The therapy would treat adults with a form of acute lymphoblastic leukemia, a fast-growing cancer of the white blood cells. Talon has no annual revenue.
“This appears to be an approvable product, and labeling negotiations are generally a positive thing,” Wade said. “It’s a delay but reasonably so. It looks like they are on track.”
Talon, formerly Hana Biosciences Inc., licensed Marqibo in 2006 from Inex Pharmaceuticals Corp.