CTI BioPharma Corp. (CTIC) shares plunged 18.67% in after-hours on Tuesday, November 30, 2021, and closed at $1.83. Even in the regular trading session of Tuesday, CTIC’s stock lost 15.41%. CTIC shares have fallen 37.50% over the last 12 months, and they have moved down 6.64% in the past week. Over the past three months, the stock has lost 25.50%, while over the past six months, it has declined 5.46%.
Let’s see why did it sink on Tuesday?
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FDA extended the CTIC pacritinib review period
On November 30, 2021, the U.S. Food and Drug Administration (FDA) extended the review period to February 28, 2022, for the CTI BioPharma Corp. (CTIC) New Drug Application (NDA) for pacritinib for the treatment of adult patients with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) with a baseline platelet count of <50 × 109/L.
FDA granted priority review for CTI’s NDA for patients with myelofibrosis with a The Prescription Drug User Fee Act IPDUFA) date of November 30, 2021. FDA requested additional clinical data, which was submitted to the agency on November 24, 2021, therefore the PDUFA date has been extended by three months to provide additional time for a full review of the submission.
Earlier on October 1, 2021, CTI BioPharma announced topline results from the PRE-VENT trial (NCT04404361) of pacritinib in hospitalized patients with severe COVID-19.
Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, IRAK1 and CSF1R, but not JAK1.
CTIC participation in the upcoming event
CTI BioPharma Corp. (CTIC) will do poster presentations about the pacritinib program at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition, being held virtually on December 11-14, 2021, in Atlanta, Georgia.
CTIC inducement grants
On November 26, 2021, the compansion committee of CTI BioPharma Corp. granted equity awards to nine new employees as equity inducement awards outside of the Company’s Amended and Restated 2017 Equity Incentive Plan. The employees received options to purchase an aggregate of 162,000 shares of CTI BioPharma common stock.
Earlier on November 9, 2021, the CTIC compensation committee approved equity awards to two new employees as equity inducement awards.
Well, the recent FDA extension was the reason behind its poor performance on Tuesday. The investors and analysts were expecting that FDA will announce that it has completed its review but now the review timeline has been extended to February 2022.
Let’s see whether it can return towards positivity or not on Wednesday?