Cell Therapeutics, Inc. (NASDAQ: CTIC) is getting a major boost this morning, but the move is from news out of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) rather than out of the Food & Drug Administration (FDA).
This troubled company has received conditional approval for Pixuvri from the EMA and it has recommended that Pixuvri be granted conditional approval to treat non-Hodgkin’s B-cell lymphoma. The new medicine contains the active substance pixantrone and is indicated for use in patients who have aggressive cancer which has relapsed after multiple rounds of previous chemotherapy or where the cancer is not responding to other treatments.
The data supplied shows that the benefits outweigh its risks, although it is not yet considered comprehensive and more information is needed covering the benefits. News is also out that the committee found that Pixuvri satisfies an unmet medical need with no approved treatments or standards of care.
Shares are up 34% at $1.49 in heavy trading right after the open, and the 52-week trading range is $0.95 to $3.30.
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