Roth Capital Partners has raised its price target for Celator Pharmaceuticals (NASDAQ:CPXX) to $26 from $22, after the company’s Vyxeos drug candidate received breakthrough therapy designation from the FDA. The stock closed at $15.07 on Wednesday
“This is an important next step for Vyxeos on the path to what we believe is likely approval,” writes analyst Joseph Pantginis.
“Our confidence is boosted that the company’s projected launch timeline of mid-2017 will be met or beat,” he added. “We also project an ex-U.S. partner by the end of the year.”
Breakthrough therapy designation was based on a positive Phase 3 study with Vyxeos. The designation includes patient populations enrolled in the study, including therapy-related AML or AML with myelodysplasia-related changes.
Celator expects to file a NDA by the end of the third quarter this year. An MAA filing in Europe may come earlier this year based on the timing of a partnership.