A biopharma stock to have recorded remarkable gains in recent gains in recent days is that of CTI BioPharma Corp (NASDAQ:CTIC). In the space of the past week, the CTI stock has rallied as much as threefold and it came about after a major announcement from the company last week. Here is a closer look at the events that led to the strong rally in the CTI stock.
Back on September 30, CTI sent the markets into a frenzy after it announced that it was planning to submit a New Drug Application (NDA). As per the press release from CTI, the company was in the process of finalizing its NDA its product pacritinib.
The product in question is meant for treating patients suffering from myelofibrosis coupled with severe thrombocytopenia. Another reason why the markets were excited by the news was possibly due to the fact that the company also revealed that prior to preparing the NDA, CTI also had fruitful meetings with the United States Food and Drug Administration.
For any company which is looking to file an NDA, positive interactions with the FDA are a must. In that regard, CTI is well placed. The company revealed that the FDA has agreed to allow a rolling submission from CTI. CTI believes it is going to be able to make a submission at some point in Q4 2020. It is expected to be completed in its entirety by Q1 2021.
Status of the Product
CTI BioPharma also provided details with regards to the status of the product in its release. The company stated that it has decided to go ahead with its NDA in light of the Persist 1 and Persist 2 Phase 3 trials.
It should be noted though that CTI also cited the results from the PAC203 dose-ranging Phase 2 trial as another reason for going ahead with the NDA. CTI aims to conduct the Phase 3 Pacifica trial for pacritinib after the treatment eventually hits the market.
The CTI stock may not have performed well up until last week but recent events have boosted the stock considerably. In the midst of the rally last week, the stock received a boost analyst Chad Messer of Needham.
He revealed that the product is prepared by CTI shows that there is a lack of options among patients for treating myelofibrosis. He went on to state that the product could hit the market earlier than expected. Messer set a target price of $6 on the CTI stock.
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