Shares of Omeros Corp. (OMER) fell more than 7 percent to $5.40 in after-hours trading on Thursday after the company announced that its first pivotal phase III trial of OMS103HP in patients undergoing arthroscopic partial meniscectomy surgery failed to reach statistical significance in the primary endpoint of Symptoms Subscale of the Knee Injury and Osteoarthritis Outcome Score.
The Symptoms Subscale of the Knee Injury and Osteoarthritis Outcome Score is a patient-reported measure that is comprised of questions about knee swelling, clicking, catching and stiffness.
However, OMS103HP did demonstrate statistically significant reduction of postoperative pain, says the company.
The second OMS103HP phase III trial is scheduled to begin in the first half of 2013.
Cepheid (CPHD) on Thursday received FDA clearance to market Xpert CT/NG, an in vitro molecular diagnostic test for the rapid detection and differentiation of Chlamydia trachomatis and Neisseria gonorrhoeae.
The test provides for same-day patient consultation and treatment for the two most common sexually transmitted bacterial infections in the United States for the first time.
The device will be shipped beginning January, 2013.
Catalyst Pharmaceutical Partners Inc. (CPRX) has been issued a Nasdaq Staff Deficiency Letter for not being in compliance with the Minimum Bid Price requirement for continued listing on the Nasdaq Capital Market.
The company has a grace period of 180 calendar days in which to regain compliance failing which it may be eligible for an additional 180-day grace period.
CPRX closed Thursday's trading at $0.44, down 2.65%.
Oculus Innovative Sciences Inc. (OCLS) was up more than 7 percent in after-hours trading on Thursday after the company announced it has been issued a new U.S. patent for the use of Microcyn Technology in the treatment of skin ulcers.
The Microcyn Technology, which is a super-oxidized, pH-neutral solution that is ready for use with no dilution or mixing, with no need for special handling or disposal, has FDA clearance for the management of chronic wounds including arterial, diabetic, pressure and venous ulcers.
According to Oculus, the latest patent provides it with the intellectual property protection necessary for an optimum return on its commercialization efforts, as well as those of its industry partners.
NPS Pharmaceuticals Inc. (NPSP) has signed agreements with leading specialty home infusion providers to support distribution and home-based clinical care services for its newly approved drug for short bowel syndrome, Gattex.
The specialty home infusion providers in the patient-centric distribution and clinical service network established by NPS Pharma include, Accredo Health Group, Inc.; BioScrip Inc.; Coram LLC; ThriveRx and Walgreens Infusion Services.
Gattex, which won approval on Dec.21, 2012, is the first-and-only FDA-approved therapy for the long-term treatment of short bowel syndrome and the first major treatment advance for short bowel syndrome in nearly 40 years.
Coronado Biosciences Inc. (CNDO) has acquired the manufacturing rights to its lead product TSO (Trichuris suis ova or CNDO-201) from Ovamed GmbH, for North America, South America, and Japan.
TSO, the microscopic eggs of the porcine whipworm, is a novel, orally administered, natural immunomodulator that regulates T-Cells and pro-inflammatory cytokines.
As part of the transaction, Coronado entered into a lease agreement to establish a manufacturing facility in Woburn, Massachusetts to produce TSO.
CNDO closed Thursday's trading 2.16% higher at $4.72.
by RTT Staff Writer
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