Shares of Novocure (NVCR) rose nearly 2% to $21.80 in early trading Monday, Sept. 25, after the St. Helier, Jersey-based firm on Sunday unveiled results form a Phase 3 study of Optune in tandem with temozolomide for the treatment of newly diagnosed glioblastoma, a form of brain tumor.
Shares were up as much as 7% pre market.
The study results, which were presented at the American Society for Radiation Oncology's 2017 Annual Meeting in San Diego, "demonstrated unprecedented five-year survival results in newly diagnosed GBM," Novocure said.
"Patients treated with Optune in combination with temozolomide experienced a significant extension of overall survival without added toxicity compared to patients treated with temozolomide alone," the company said.
Meanwhile, shares of Intercept Pharmaceuticals Inc. (ICPT) were up almost 8% to $65.11 after the New York firm issued a statement regarding its liver disease treatment Ocaliva (obeticholic acid). The statement came on the heels of a Sept. 8 letter issued by the company to healthcare providers highlighting prescriber information for Ocaliva, and a Sept. 21 safety announcement from the Food and Drug Administration warning that Ocaliva is being dosed incorrectly in some patients.
"In the course of Intercept's post-marketing pharmacovigilance activities, deaths have been reported in PBC patients with moderate or severe hepatic impairment (Child Pugh B or C cirrhosis)," Intercept said. "In an analysis performed by Intercept and in consultation with the FDA, Intercept concluded that these patients were prescribed once daily doses of Ocaliva, which is seven times higher than the recommended weekly dose in such patients."
"As a result, Intercept issued the DHCP [Dear Healthcare Provider] letter and the FDA subsequently issued their own safety communication to reinforce recommended label dosing," the company added. "Both communications remind healthcare providers of the importance of the recommended reduced dosing of Ocaliva in PBC patients with moderate or severe hepatic impairment (Child Pugh B or C cirrhosis), while reiterating the importance of close monitoring of PBC patients for progression of their disease and the occurrence of liver-related adverse reactions."
Intercept said it is working with the FDA on updates to the label in order to better ensure the appropriate and safe use of Ocaliva.
Among the other biotech stock movers was Regenxbio Inc. (RGNX) , up 10.6% to $31.25.
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