25.09.2014 07:27:26
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ACOR Opens Wallet, CYNO Gets FDA Nod, INO To Advance Ebola Vaccine Study
(RTTNews) - Acorda Therapeutics Inc. (ACOR) is all set to acquire Civitas Therapeutics, a privately-held biopharmaceutical company, for $525 million in cash. The acquisition brings in CVT-301, a phase III treatment candidate for OFF episodes of Parkinson's disease, to Acorda's stable.
The pivotal phase III study of CVT-301 is expected to begin enrolling in early 2015 and if successful, a filing for regulatory approval in the United States is expected by the end of 2016.
ACOR rose 28.18% to close Wednesday's trading at $37.62.
Cynosure Inc.'s (CYNO) flagship PicoSure Picosecond Laser Workstation with its new disposable energy delivery system, the FOCUS lens array, has received FDA clearance for the treatment of wrinkles.
The PicoSure system gained FDA clearance to treat acne scars last month. The device also has FDA clearance for the removal of tattoos and benign pigmented lesions.
CYNO closed Wednesday's trading at $22.03, down 0.50%.
Inovio Pharmaceuticals Inc. (INO) is advancing its DNA vaccine for Ebola into a phase I clinical trial in collaboration with GeneOne Life Science Inc., an international DNA vaccine manufacturer in which Inovio holds a minority interest.
There is no vaccine or standard of care treatment for people infected with the Ebola virus, and according to the World Health Organization, more than 2,622 people have died in the current outbreak of Ebola virus, which is the worst in history.
INO rose 5.32% on Wednesday to close the day's trading at $10.29.
Lipocine Inc.'s (LPCN) pivotal phase III study evaluating LPCN 1021 in hypogonadal men with low testosterone, dubbed SOAR, has met its primary efficacy endpoint with no serious adverse events. LPCN 1021 is a twice-a-day, oral product candidate.
The company continues to expect to file a New Drug Application for LPCN 1021 with the FDA in the second half of 2015.
LPCN closed Wednesday's trading 38.51% higher at $7.23.
Shares of Rexahn Pharmaceuticals Inc. (RNN) were up more than 14 percent to $0.87 in extending trading Wednesday after the company announced that its drug candidate RX-3117 has been granted Orphan Drug Designation by FDA for the treatment of patients with pancreatic cancer.
The company is currently enrolling patients in a phase Ib clinical trial in cancer patients and expects to complete this trial in the first quarter of 2015.
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