Investors have kicked Talon Therapeutics' shares into penny-stock territory. It happened yesterday after the company revealed that U.S. regulators want more time to review its application for approval of the experimental blood-cancer drug Marqibo.
Talon's ($TLON) stock price fell 29% to 77 cents per share on Monday.
The FDA told the drug developer that the agency is extending the review of Marqibo by three months, providing the company with a PDUFA date of Aug. 12. Talon, which has no products on the market and no revenue, aims to market its lead drug to treat adults with certain cases of adult lymphoblastic leukemia. Marqibo is a new formulation of an old cancer drug called vincristine, and the company is in talks with the FDA about the label for the treatment.
Talon executives stressed that the prolonged review shouldn't reflect on the company as much as the status quo at the agency. "The FDA is regularly pushing folks out about three months, so we are part of a crowd," Craig Carlson, Talon's financial chief, told Bloomberg. "The FDA regulations allow that if new information is provided, they have the opportunity to extend the review period."
The San Mateo, CA-based company has asked for approval of Marqibo based on a modest package of data that features upbeat results from a single-arm, mid-stage trial involving adults with a rare form of ALL. Despite the limited data, FDA advisers backed approval of the drug in March in a 7-4 vote. The agency doesn't have to follow such recommendations but (as many readers know) it often does. Bloomberg noted that the delayed review has nothing to do with the clinical data on the drug.
- check out Bloomberg's article
- and RTT News' brief