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What: Shares of TESARO (NASDAQ:TSRO) are trading about 22% higher today after the biotech company reported good results out of its final Phase 3 trial of Rolapitant.
So what: Rolapitant, an investigational neurokinin-1 (NK-1) receptor antagonist developed to prevent chemotherapy-related nausea and vomiting (CINV), completed its phase 3 trials for oral dosing with successful achievement of all primary and secondary endpoints. The drug managed to prevent significant nausea symptoms in all trial patients -- who had been undergoing cisplatin-based highly emetogenic chemotherapy -- in both its acute (first 24 hours) and overall (first five days) windows of dosing. The company now plans to submit a new drug application to the FDA by midyear, and rolapitant is also undergoing phase 2 trials for intravenous dosing, which will likely expand its availability in the future.
Now what: Fool health-care specialist Leo Sun has already noted that rolapitant will compete with Merck's Emend, which also treats CINV, but TESARO believes it offers advantages over the much larger company's $500-million drug. BMO Capital also sees some major upside in TESARO's shares after this news release, as it's raised its price target to $66 -- a 125% upside even after today's pop. TESARO has several cancer treatments also in development, and rolapitant's sales could provide more than enough cash flow to allow the company to move these drugs through the trial process while simultaneously developing new ones. There's a lot to like about today's news, but TESARO is still a development-stage biotech. If you plan to invest on this news, do so optimistically, but cautiously.
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