CTI BioPharma (CTIC) Stock Is Rocketing On NDA Submission News

CTI BioPharma CTIC Stock News

CTI BioPharma Corp (NASDAQ: CTIC) is running for the top in the market this morning, trading on gains in multiples. The gains come after the company announced that it will soon submit an NDA. Here’s what’s going on:

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CTIC Stock Rockets On NDA News

In the press release, CTI BioPharma said that it has reached an agreement with the FDA to submit an NDA for the potential accelerated approval of pacritinib. Pacritinib is being developed as a potential treatment option for patients with myelofibrosis with severe thrombocytopenia.

CTIC said that the data will be based on the available data from its completed Phase 3 PERSIST-1 and PERSIST-2 trials as well as the Phase 2 PAC203 dose-ranging trial.

Importantly, the FDA has agreed to a rolling NDA submission. This means that CTIC will not have to complete the NDA in its entirety prior to submission. Instead, the company can submit the NDA in sections as it completes them. Nonetheless, completion of the NDA submission is expected to take place in the first quarter of 2021.

As a result of the news, the company said that its ongoing Phase 3 PACIFICA trial is expected to be completed as a post-marketing commitment. In a statement, Adam R. Craig, M.D., Ph.D., President and CEO at CTIC, had the following to offer:

Since the completion of the PAC203 Phase 2 dose-ranging trial, we have been working collaboratively with the FDA to identify an expeditious approval pathway for pacritinib in myelofibrosis patients with severe thrombocytopenia, a patient population with an important unmet medical need due to reduced survival and limited therapeutic options. During a recent Pre-NDA meeting, we identified a data package from the PERSIST-1, PERSIST-2 and PAC203 Phase 2 trials that will serve as the basis for an accelerated approval application. In particular, we discussed risk mitigation measures to address the FDA’s prior concerns regarding safety.

In myelofibrosis patients, severe thrombocytopenia occurs as a result of disease or drug-related toxicity from current therapies. There is no approved drug that specifically addresses the unmet need of the myelofibrosis patients who have severe thrombocytopenia. Pacritinib has demonstrated clinical benefit in treating these patients in multiple trials and now has the potential to become a new treatment option for treatment-naïve and second-line myelofibrosis patients in 2021.

This News Is Huge

The news released by CTI BioPharma proved to be overwhelmingly postiive. After all, the company may have an NDA in with the FDA by early next year. As a result, and considering the accelerated approval pathway, the company’s treatment could hit the market as soon as next year.

That’s a big deal. Especially when you consider the fact that we’re talking about a company with a sub $100 million market cap that may break into a nearly $1 billion market with a leading therapeutic option. This could be the pivotal point for CTIC and those that own CTIC stock should be excited.

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