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News Breaks
May 27, 2014
08:36 EDTADXSAdvaxis' HER2 immunotherapy candidate receives Orphan Drug Designation
Advaxis announced that it has been granted Orphan Drug Designation, or ODD, from the FDA Office of Orphan Products Development for ADXS-cHER2 for the treatment of osteosarcoma. ADXS-cHER2 is an immunotherapy under investigation for targeting the HER2 receptor, which is overexpressed in certain solid-tumor cancers, including bone cancer and breast cancer. Based on strong pre-clinical and canine osteosarcoma clinical data, Advaxis is planning to initiate a clinical development program with ADXS-cHER2 in pediatric patients with osteosarcoma. Pediatric osteosarcoma affects about 400 children and teens in the U.S. every year, representing a small but significant unmet medical need that has seen little therapeutic advancement in decades. Both veterinary and human osteosarcoma specialists consider canine osteosarcoma to be the most analogous disease to human osteosarcoma.
News For ADXS From The Last 14 Days
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October 6, 2015
18:58 EDTADXSOn The Fly: After Hours Movers
DOWN AFTER EARNINGS: Yum! Brands (YUM), down 16.7%. ALSO LOWER: Advaxis (ADXS), down 25.3% following its report of a clinical hold of axalimogene filolisbac... ContraVir (CTRV), down 11.8% after filing to sell common stock and warrants... Adobe (ADBE), down 3.7% after providing growth target guidance for fiscal 2015 through fiscal 2018 and fiscal 2016 guidance... McDonald's (MCD), down 2%, Starbucks (SBUX), down 1.3% following Yum! Brands results.
16:56 EDTADXSAdvaxis down 27% after report of clinical hold of axalimogene filolisbac
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16:25 EDTADXSAdvaxis to resume trading at 4:30 pm ET
Quotes resume at 4:25 pm ET.
16:03 EDTADXSAdvaxis reports clinical hold of investigational agent axalimogene filolisbac
Advaxis announced that last Thursday the company received verbal notice from the U.S. FDA that its Investigational New Drug application for axalimogene filolisbac has been placed on clinical hold, affecting four clinical trials. The clinical hold, which pertains only to axalimogene filolisbac, was issued in response to Advaxis's recent submission of a safety report to the FDA. The report involved a single event of one patient with end-stage cervical cancer who last received axalimogene filolisbac in early 2013 in an investigator-initiated trial. In late July 2015, the patient was hospitalized for end-stage cervical cancer symptoms. During hospitalization, routine blood cultures were positive for Listeria monocytogenes. Subsequent analysis determined that it was the highly attenuated strain of Lm used in axalimogene filolisbac which was incapable of causing infection and was highly sensitive to antibiotics. The patient received a course of intravenous antibiotics and was discharged. The patient returned to the hospital in mid-August, approximately two weeks later, with respiratory distress caused by her metastatic disease. The patient passed away later that day. The investigator ruled that the cause of death was due to progression of her cervical cancer. The company has evaluated this case and agrees with the investigator's conclusion that the cause of death was due to cervical cancer progression. The company believes that axalimogene filolisbac played no role in the patient's death. In investigating this event, Advaxis learned that the patient underwent multiple surgical procedures during the time she was receiving axalimogene filolisbac, including extensive orthopedic reconstruction and receipt of a bone graft and other medical implants. Due to these circumstances, the company believes these implants could have provided a location for axalimogene filolisbac to exist within the body without causing any infection. Advaxis is working closely with the FDA to facilitate the review and evaluation of this isolated event. The Agency has requested additional information to support a determination that axalimogene filolisbac did not contribute to the patient's death. This additional information has now been provided to the FDA. Advaxis expects that this clinical hold will be resolved expeditiously and without significant interruption to our HPV clinical development program. Ongoing clinical trials with Advaxis's other product candidates, ADXS-PSA and ADXS-HER2, are not affected by this hold and continue to actively enroll and dose patients.
16:01 EDTADXSAdvaxis trading halted, news pending
October 2, 2015
10:10 EDTADXSOptions with increasing implied volatility
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September 30, 2015
10:36 EDTADXSOptions with increasing implied volatility
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September 29, 2015
10:48 EDTADXSOptions with increasing implied volatility
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September 28, 2015
09:06 EDTADXSFirst patient treated in Advaxis' Phase 1b study of ADXS-HER2
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