DBV Technologies SA's (DBVT) American depository receipts advanced 6.3% to $24.90 in premarket trading on Monday, Nov. 20, after the Montrouge, France-based firm unveiled positive topline results from its Phase 3 Realise study of peanut allergy treatment Viaskin Peanut. The study compared Viaskin Peanut 250 μg versus placebo for six months.
"Today's top-line data was in-line with previously reported outcomes, with the majority of AEs limited to skin reactions (mild to moderate) at the site of administration that led to extremely low discontinuation (2.5%) and dropout rates (1%), respectively," wrote Leerink's Dae Gon Hain a note Monday morning. "Convenience also contributed favorably to pt. experience as compliance remained high (>95%, mean) with 97.5% of the total enrolled subjects entering the extension phase of the trial after the first 6 mos."
Meanwhile, shares of Intra-Cellular Therapies Inc. (ITCI) were up 5.4% to $16.14 after the U.S. Food and Drug Administration gave fast track designation for the New York firm's lumateperone for the treatment of schizophrenia.
Also among the biotech stock movers was Tesaro Inc. (TSRO) , up 3.6% to $88.98. The European Commission has given marketing authorization for the Waltham, Mass.-based company's Zejula (niraparib) for women with recurrent ovarian cancer, regardless of BRCA mutation or biomarker status.
"While this is largely in-line with expectations, the approval allows the company to begin EU marketing of the drug, starting with planned launches in Germany and the UK in December 2017," wrote Seamus Fernandez of Leerink in a morning note. "TSRO plans to expand to additional countries beginning in 2018, noting that it has a direct presence in a total of 17 European countries."
Fernandez holds a $121 price target on Tesaro, "based on an average of our base-case DCF valuation ($88/shr) and takeout price analysis ($153/shr)."
In other Tesaro news, the company said Monday that its co-founders Lonnie Moulder, who serves as CEO, and Mary Lynne Hedley, who serves as president and chief operating officer, named EY Entrepreneurs of the Year 2017 overall national award winners. In addition, the two were recognized as the national award winners in the life sciences category.