Amgen's (AMGN) Marketing Authorization Application of Kyprolis has been accepted for accelerated assessment by the European Medicines Agency. The company is seeking approval of Kyprolis for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy.
Kyprolis was granted accelerated approval by the FDA in July 2012. The drug is also approved for use in Argentina, Israel and Mexico.
Kyprolis came under Amgen's fold following the acquisition of Onyx Pharmaceuticals in 2013. The sales of Kyprolis in 2014 totaled $331 million in the first full year of commercialization since the acquisition of Onyx.
AMGN closed Thursday's trading at $158.97, up 0.56%.
Columbia Laboratories Inc. (CBRX) is planning to initiate a phase II clinical trial for COL-1077, a lidocaine bioadhesive 10% gel, in women undergoing transvaginal pipelle-directed endometrial biopsy, in the second quarter of 2015.
CBRX touched a new high of $7.99 on Thursday before closing the day's trading at $7.39.
Chimerix Inc. (CMRX) now expects enrolment in its ongoing phase 3 SUPPRESS trial to be completed in the summer of 2015 with data anticipated in early 2016. The enrolment was previously expected to be completed in early 2015.
The SUPPRESS trial is evaluating Chimerix's drug candidate Brincidofovir for the prevention of clinically significant cytomegalovirus (CMV) infection in hematopoietic cell transplant (HCT) recipients.
CMRX closed Thursday's trading at $41.08, up 3.97%.
Cytori Therapeutics Inc. (CYTX) surged nearly 57% on Thursday after the company announced that it has received approval from FDA to expand its STAR trial from 12 to 20 centers in the United States.
The STAR study is an 80 patient randomized double blind, placebo-controlled, phase III clinical trial to study the effects of Cytori's lead drug candidate ECCS-50 for treatment of patients with hand manifestations of Scleroderma.
CYTX closed Thursday's trading 56.94% higher at $1.13. In after-hours, the stock gained another 3.54% to $1.17.
Gilead Sciences Inc.'s (GILD) two phase III studies of its investigational once-daily single tablet regimen containing Tenofovir Alafenamide for the treatment of HIV-1 infection in treatment-naïve adults have demonstrated that the investigational therapy is statistically non-inferior to its approved HIV drug Stribild.
The company added that patients receiving the TAF regimen also had significantly better renal and bone laboratory parameters than those treated with Stribild.
GILD closed Thursday's trading at $104.19, down 0.23%.
Novavax Inc. (NVAX) has several milestones coming its way this year. The company expects to announce top-line data from a phase 1 clinical trial of its investigational Ebola virus vaccine - EBOV GP - in mid-2015.
In the second quarter, the company is scheduled to announce top-line data from its phase 2 clinical trial of seasonal influenza virus-like particle (VLP) vaccine candidate (Seasonal Influenza VLP).
The other events to watch out for are the announcement of top-line data from a phase 2 clinical trial of the company's RSV F Vaccine in healthy women in their third trimester of pregnancy, and release of top-line data from a phase 2 clinical trial of the RSV F Vaccine in elderly adults in the third quarter of 2015.
The company is also slated to announce top-line data from a phase 1 clinical trial of its RSV F Vaccine in healthy pediatrics in late 2015 or in the first half of 2016.
NVAX closed Thursday's trading at $9.31, down 0.21%.
Portola Pharmaceuticals' (PTLA) Andexanet alfa, an investigational drug under phase III testing, for reversing the anticoagulant effect of direct or indirect Factor Xa inhibitors in patients experiencing a serious uncontrolled bleeding event has been designated orphan drug by the FDA.
Andexanet alfa was designated as a breakthrough therapy by the FDA in 2013.
PTLA closed Thursday's trading at $38.64, up 0.23%.
Shares of Vitae Pharmaceuticals Inc. (VTAE) plunged more than 22% in extended trading on Thursday after the company announced that its partner Boehringer Ingelheim has voluntarily placed BI 1181181 on a temporary clinical hold, and has notified regulatory agencies of its decision.
BI 1181181 is an orally-active beta secretase (BACE) inhibitor being evaluated in phase 1 clinical trials for the treatment and prevention of Alzheimer's disease. This action was taken to further investigate skin reactions observed in some study participants during the multiple rising dose trial.
VTAE closed Thursday's trading at $13.28, down 4.46%. In after-hours, the stock was down 22.59% at $10.28.
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