European advisory backs new labeling for two AbbVie meds; shares up 1% PM
The European Medicines Agency’s advisory group CHMP has adopted positive opinions recommending expanded uses of AbbVie’s (NYSE:ABBV) HCV med Maviret (glecaprevir/pibrentasvir) and blood cancer med Venclyxto (venetoclax).
Maviret: Shorten treatment duration to eight weeks from 12 weeks in treatment-naïve, compensated cirrhotic patients with genotype 3.
Venclyxto: for adults with previously untreated chronic lymphocytic leukemia, in combination with obinutuzumab (Roche’s Gazyva).
Shares up 1% premarket.
Merck withdraws Keytruda application in Europe for esophageal cancer
Merck (NYSE:MRK) has withdrawn its marketing application in Europe seeking approval to use Keytruda (pembrolizumab) to treat cancer of the esophagus. The EMA determined that the data supporting the application were not sufficient to prove that treatment prolonged survival.
J&J ordered to pay $344M in pelvic mesh case
“Johnson & Johnson (NYSE:JNJ) knew the danger of its mesh products but put profits ahead of the health of millions of women,” California Attorney General Xavier Becerra said in a statement.
The products, also called transvaginal mesh, are a synthetic surgically implanted through the vagina of women whose pelvic organs have sagged or who suffer from stress urinary incontinence when they cough, sneeze or lift heavy objects.
The ruling comes as J&J deals with thousands of other lawsuits over drug side effects, its role in the U.S. opioid epidemic and allegations its baby powder caused cancer in some consumers.
Intec Pharma prices $6.5M public offering
Intec Pharma (NASDAQ:NTEC) has priced its public offering of 16.25M ordinary shares and warrants to purchase up to same number of ordinary shares at $0.40/share, for gross proceeds of $6.5M.
The five-year warrants have an exercise price of $0.40 per share.
Underwriters’ over-allotment is an additional 2,437,500 ordinary shares and/or warrants to purchase same number of shares.
Closing date is February 4.
Arcutis Biotherapeutics prices initial public offering
Arcutis Biotherapeutics (ARQT) has priced its initial public offering of 9.375M common shares at $17.00 per share, for gross proceeds of ~$159.4M.
The shares are expected to begin trading today on the Nasdaq Global Select Market.
Closing date is February 4.
Underwriters’ over-allotment is an additional 1,406,250 shares.
