CTI BioPharma Corp (CTIC) Shares Tumble After FDA Issues Clinical Hold on Pacritinib Drug

Share

Shares of CTI BioPharma Corp (NASDAQ:CTIC) are down huge this morning after the company got some rather disappointing news from the U.S. Food and Drug Administration. The company said that they have been informed by the FDA that their New Drug Application for pacritinib has received a partial clinical hold on further clinical studies. This is a setback, and investors are showing their disappointment by selling the stock.

The partial clinical hold will prevent the company from enrolling new patients and any patients who have not derived benefits after 30 weeks of treatment must stop taking the drug.

“In addition, the FDA has recommended that the Company make certain modifications of protocols, including modifying all protocols for randomized trials to disallow crossover to pacritinib, provide certain notifications, revise relevant statements in the related investigator’s brochure and informed consent documents, and take certain other actions,” CTII BioPharma Corporation announced. “The Company intends to implement the FDA’s recommendations. All clinical investigators worldwide have been delivered a notice of the partial clinical hold.”

The stock is down 64.93% or $0.727 following the news, hitting $0.393 per share. Approximately 456,034 shares traded hands. CTIC shares have declined 43.43% since July 2, 2015 and are currently downtrending. It has underperformed the S&P500 by 36.14%.

The institutional sentiment decreased to 0.6 in Q2 2015. It’s down 0.74, from 1.34 in 2015Q2. The ratio is negative, as 17 funds sold all their CTI BioPharma Corp shares they owned while 30 reduced their positions. 9 funds bought stakes while 19 increased their total positions. Institutions now own 59.35 million shares which is 22.89% more than the previous share count of 48.30 million in 2015Q2.

Bvf Inc Il holds 2.95% of its total portfolio in CTI BioPharma Corp, equating to 10.00 million shares. Lombard Odier Asset Management (Usa) Corp owns 1.30 million shares representing 0.17% of their total US portfolio. Moreover, Consonance Capital Management Lp has 0.09% of their total portfolio invested in the company, equating to 460,000 shares. The Missouri-based First Heartland Consultants Inc. has a total of 0.05% of their portfolio invested in the stock. Washington Trust Co, a Rhode Island-based fund reported 410,616 shares owned.

Since March 6, 2015, the stock had 0 insider purchases, and 14 selling transactions for a total of $1.84 million in net activity. Bianco Louis A sold 10,000 shares worth $15,800. Singer Jack W sold 15,000 shares worth $24,335. Plunkett Matthew sold 10,000 shares worth $15,204. Nudelman Phillip M Phd sold 150,000 shares worth $217,502. The insider Love Richard L sold 13,660 shares worth $19,853.

CTI BioPharma Corp. , formerly Cell Therapeutics, Inc., is a biopharmaceutical firm focused on the acquisition, development and commercialization of targeted therapies covering a spectrum of blood-related cancers that offer a benefit to patients and healthcare providers. The company has a market cap of $108.23 million. The Firm is focused on commercializing PIXUVRI (pixantrone), or PIXUVRI, in the European Union, for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL), and conducting a Phase III clinical trial program of pacritinib for the treatment of adult patients with myelofibrosis to support regulatory submission for approval in the United States and Europe. It currently has negative earnings. It is also engaged in evaluating pacritinib in earlier clinical trials as treatment for other blood-related cancers.

COMMENTS: