The outcome of clinical trials and FDA decisions can send a stock soaring or into tailspin. The following are some of the stocks awaiting FDA/panel decisions in the month of December.
Zogenix Inc (ZGNX)
On December 12, Zogenix's New Drug Application for Zohydro ER, previously known as ZX002, is slated to be reviewed by an FDA panel for the proposed treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy. The FDA's final decision date is set for March 1, 2013.
ZGNX has thus far hit a 52-week low of $1.31 and a 52-week high of $3.30. The stock closed Wednesday's trading at $2.60, down 2.99% on above average volume.
GlaxoSmithKline PLC (GSK)
On December 15, the FDA will decide whether or not to approve Raxibacumab for the treatment of inhalational anthrax. Earlier this month, an FDA Advisory Committee backed the approval of Raxibacumab for the proposed indication. Raxibacumab was developed by Human Genome Sciences, which was acquired by GlaxoSmithKline in July of this year.
GSK has lost more than 5% of its value in the last 1 month. The stock closed Wednesday's trading at $42.98, up 0.59%.
Hemispherx Biopharma Inc (HEB)
On December 20, Hemispherx's Ampligen NDA seeking approval in the indication of chronic fatigue syndrome, or CFS, is scheduled to be reviewed by an FDA panel of outside experts. The FDA's decision date is set for February 2, 2013.
HEB has gained more than 22% in the last 1 month. The stock closed Wednesday's trading at $0.79, up 2.84%.
Alexza Pharmaceuticals Inc (ALXA)
On December 21, the FDA is slated to announce its decision on Alexza Pharma's New Drug Application for Adasuve, seeking approval for the rapid control of agitation in adult patients with schizophrenia or bipolar disorder. This is Adasuve's third go-around with the FDA. The drug was issued a complete response letter twice - in October 2010 and May 2012. The CHMP, or Committee for Medicinal Products for Human Use, is also slated to announce its scientific opinion on Adasuve this month.
ALXA has thus far hit a 52-week low of $2.55 and a 52-week high of $11.50. The stock closed Wednesday's trading at $5.17, up 2.99%.
Johnson & Johnson (JNJ)
On December 29, the FDA is slated to announce its decision on Johnson & Johnson's (JNJ) subsidiary, Janssen Research & Development LLC's tuberculosis drug Bedaquiline. The company has sought accelerated approval for Bedaquiline as an oral treatment to be used as part of combination therapy for pulmonary, multi-drug resistant tuberculosis in adults. Bedaquiline won the backing of an FDA panel yesterday.
JNJ closed Wednesday's trading at $69.29, up 0.70% on a volume of 9.98 million shares.
NPS Pharmaceuticals Inc (NPSP)
On December 30, NPS Pharma will get to know whether or not its investigational drug for short bowel syndrome - Gattex, clears the final regulatory hurdle of FDA decision. The FDA panel, which reviewed the Gattex NDA in October of this year, recommended approval of the compound for the proposed indication. Gattex, known as Revestive in Europe, was approved as a treatment for short bowel syndrome in adults by the European Medicines Agency in September of this year.
NPSP has gained over 7% in the last 1 month. The stock closed Wednesday's trading at $10, up 1.11%.
Anika Therapeutics Inc (ANIK)
In the next one month, Anika Therapeutics expects FDA's decision on its premarket approval filing for Monovisc, a single injection viscosupplement for the treatment of symptoms of osteoarthritis and for the relief of joint pain in all synovial joints. Anika submitted its premarket approval filing for Monovisc to the FDA in December 2009. Monovisc is approved for use in the European Economic Area and Turkey.
ANIK has thus far hit a 52-week low of $7.66 and a 52-week high of $17.70. The stock closed Wednesday's trading at $11.51, up 5.60%.
by RTT Staff Writer
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