On the Radar…

Allos Therapeutics announced that last night the FDA had granted accelerated approval for Folotyn (pralatrexate injection) for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), following the 10 to 4 recommendation of its oncology committee made at the beginning of the month. This decision makes Folotyn the first drug approved for the treatment of relapsed or refractory PTCL and marks the first approval for the drug which is also being evaluated for use in other types of cancer. The approval was based on patients’ response rate to Folotyn; overall response rate was 27% in the pivotal Phase II PROPEL trial. Although the FDA usually follows the recommendation of its committee, there had been speculation in the investment community that the agency might not do so in this case leading to a high put volume in recent days with the most activity at a strike price of $7.50 according to Schaeffer’s Investment Research. At the opening of the market today, share prices for Allos had jumped to $8.57 from a closing price of $8.15 yesterday, about a 5% increase. Allos, based in Westminster, Colorado, expects Folotyn to be available to patients in October.