Until yesterday, shares of CTI BioPharma (CTIC) had been firmly planted in the red in 2020. But sentiment can turn fast in the biotech world and the cancer drug maker provided investors with a dreamy week. The stock surged 135% over the past two trading sessions, after the FDA cleared the way for one of its treatment’s quick approval.
Specifically, the company announced that after a pre-NDA meeting with the FDA, the agency has granted the biotech a rolling NDA submission for possible accelerated approval of pacritinib in thrombocytopenic myelofibrosis patients. The NDA submission should be completed by 1Q21.
CTI managed to persuade the regulators that based on the existing data, the risk mitigation measures have shifted the risk/benefit profile enough to allow for a review. Results from the Phase III PERSIST-1 and 2 and the dose-finding PAC203 study have been deemed strong enough for NDA submission.
Needham analyst Chad Messer believes “the surprising development highlights the lack of therapeutic options in this group of patients.” The analyst expects pacritinib to make its market entrance a lot earlier than initially expected.
“If pacritinib is accepted for priority review, which we believe likely, it will be subject to a ~6 month review period,” the analyst said. “As a reminder, in July 2018 following the 1st interim analysis of PAC203, CTI had a Type B meeting with the FDA, in which the FDA indicated an additional Phase III trial would be necessary for filing. This recent development accelerates timelines for pacritinib which may now be on the market late 2021.”
CTI saw out the second quarter with approximately $70 million in cash, which should be enough to fund operations into 4Q21 and pass the potential approval, according to Messer.
As a result, the Needham analyst reiterates a Buy rating on CTIC shares, while boosting the price target from $3.5 to $6. Investors could be pocketing gains of nearly 140%, should the target be met over the next 12 months. (To watch Messer’s track record, click here)
Overall, there is little action on the Street heading CTIC's way right now, with only one other analyst chiming in with a bullish view on the company's prospects. An additional Buy rating means the stock qualifies as a Moderate Buy. The average price target, though, is $5, and implies nearly 100% upside potential. (See CTIC stock analysis on TipRanks)
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