Shares of Telik (TELK +11.8%) settle in to trade solidly higher after a volatile open on heavy volume after the company announced late yesterday that it had reached an agreement with the FDA on its Phase 3 Telintra design. The stock had initially soared over 22% in the pre-trade session.
Telik (TELK) says it's completed its End of Phase 2 meeting with the FDA for its MDS treatment Telintra, with a preliminary agreement reached regarding the design of a Phase 3 trials. In order to focus its resources on the registration program, Telik has decided to stop further enrollment in its ongoing Phase 2 exploratory trials.
Telik (TELK -21%) reverses course and gives back a big chunk of its +55% gain posted on Friday, after the company said its myelodysplastic syndrome treatment Telintra had been given an Orphan Drug designation by the FDA, which will give it U.S. market exclusivity for seven years. The stock is no stranger to volatility however, and Fridays move is just a drop in the bucket compared to the bigger picture for a stock that just less than a year ago had been trading at $8.