AbbVie's (ABBV) phase III trial of its investigational, all-oral, ribavirin-free, two direct-acting antiviral treatment with ombitasvir/paritaprevir/ritonavir in patients with genotype 1b chronic hepatitis C virus infection in Japan has achieved the primary endpoint.
The trial, dubbed GIFT-I study, has demonstrated a 95 per cent sustained virologic response rate at 12 weeks post treatment in the sub-group of previously untreated, non-cirrhotic adult GT1b Japanese patients who were eligible for therapy with interferon and had a high viral load.
The company expects to make a regulatory submission for the all-oral treatment for hepatitis C in Japan in the first quarter of 2015.
ABBV closed Friday's trading at $60.35, down 4.39%.
Chimerix Inc. (CMRX) has decided to cease further participation in all current and future clinical studies of its drug candidate Brincidofovir for Ebola Virus Disease.
Accordingly, the company has pulled the plug on a study of Brincidofovir in Liberia sponsored by investigators at the University of Oxford and a supportive phase II trial, dubbed Study 205.
The company noted that over the last several weeks the number of new cases of confirmed Ebola Virus Disease in Liberia has decreased significantly, with only a handful of patients enrolled to date in the single-arm study of Brincidofovir led by the University of Oxford and ISARIC (International Severe Acute Respiratory and Emerging Infection Consortium) with operational support from Médecins Sans Frontières (MSF).
CMRX closed Friday's trading at $40.11, down 0.79%. In after-hours, the stock was down 4.01% at $38.50.
Shire plc.'s (SHPG) attention deficit/hyperactivity disorder drug Vyvanse has received FDA approval for yet another indication - for adults with binge eating disorder.
Binge eating disorder is the most common adult eating disorder in the United States, and Vyvanse becomes the first and only medication to be approved for the treatment of moderate to severe binge eating disorder in adults.
Vyvanse is not indicated or recommended for weight loss or for the treatment of obesity.
Approved in 2007 for attention deficit/hyperactivity disorder, Vyvanse generated sales of $1.1 billion in the first nine months of 2014.
SHPG closed Friday's trading at $219.26, down 1.31%.
Stemline Therapeutics Inc.'s (STML) investigational drug candidate SL-701 has received Orphan Drug designation from the FDA for the treatment of glioma.
SL-701 is currently under a phase 1/2 trial in adult patients with recurrent glioblastoma multiforme.
STML closed Friday's trading at $15.48, up 3.27%.
Vital Therapies Inc. (VTL) has completed enrolment in its phase III clinical trial of VTI-208 in alcohol induced liver decompensation, achieving the enrolment target of 200 subjects.
The company expects to announce topline data from the trial in the second quarter of 2015.
VTL closed Friday's trading at $19.74, down 5.78%.
Zogenix Inc.'s (ZGNX) pain drug Zohydro ER has received FDA approval for a new formulation - as Zohydro ER with BeadTek - and is expected to be available in the second quarter of 2015.
BeadTek is a formulation technology designed to provide abuse-deterrent properties without changing the release properties of hydrocodone when Zohydro ER is used as intended.
Zohydro ER was approved by the FDA in October 2013 for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
The new formulation contains additional inactive ingredients that are intended to make the product more difficult to abuse by injection and nasal insufflation.
The company began commercializing Zohydro ER in March 2014, and the drug's gross factory sales to wholesalers was $18.1 million year-to-date.
ZGNX closed Friday's trading at $1.35, down 1.46%. In after-hours, the stock gained 7.41% to $1.45.
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