Introgen shares plunge on BLA rejection

Shares of Austin-based Introgen Therapeutics plunged 26 percent this morning after investors learned that the FDA has rejected its BLA for the cancer therapy Advexin [1]. According to Introgen, regulators had rejected the BLA as incomplete. Introgen was seeking approval to use the drug--a p53 [2] tumor suppressor therapy--to treat head and neck cancer. Introgen says it plans to appeal the decision and will work with the FDA to gain acceptance of its BLA.

"We believe in the potential of Advexin as a treatment option for head and neck cancer, an area of significant unmet need for today's cancer patient," said David G. Nance, Introgen's CEO. "We are encouraged by our clinical data and believe that the 40,000 Americans who are diagnosed with head and neck cancer each year would benefit from Advexin as a treatment option in the future. We will work with FDA to determine our next steps in the U.S. as we continue to pursue potential approval in Europe."

- here's Introgen's release [3]
- read the report [4] from the Austin American-Statesman

Related Articles:
Introgen files first gene therapy for FDA approval [5]
Introgen gets positive Phase III Advexin data [1]
Introgen reports biomarker link to new therapy [6]
Introgen touts cancer data [7]