By RTT News, September 26, 2013, 11:30:00 PM EDT
(RTTNews.com) - CANTEL MEDICAL CORP. ( CMN ) touched a new 52-week high of $30.62 on Thursday following record sales and earnings in its fiscal Q4. The company is optimistic about its prospects to expand sales and increase profits in fiscal year 2014.
Durata Therapeutics Inc. ( DRTX ) has submitted a New Drug Application to the FDA seeking approval for the marketing and sale of Dalbavancin for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive microorganisms, including MRSA (methicillin resistant Staphylococcus aureus).
If approved, Dalbavancin would be the first drug for ABSSSI requiring once-weekly 30-minute intravenous doses.
DRTX closed Thursday's trading at $8.89, down 1.98%.
Integra LifeSciences Holdings Corp. ( IART ) gained nearly 3 percent to $39.78 on Thursday following the FDA's closeout of quality systems and compliance issues related to the company's Plainsboro, New Jersey manufacturing facility.
The Plainsboro facility had been operating subject to an FDA Warning Letter dated December 21, 2011. After concluding its recent inspection of that facility in August, the FDA determined that the company's remediation activities were effective and its quality management system was adequate.
Shares of Nektar Therapeutics ( NKTR ) plunged over 24 percent to $10.44 in extended trading on Thursday after the company announced that a phase II study of its investigational drug NKTR-181 in chronic pain patients with osteoarthritis of the knee did not meet the trial goal.
NeoGenomics Inc. ( NEO ) rose over 9 percent to $3 on Thursday after it boosted its outlook for Q3, 2013. The company now expects revenue in the range of $16.6 million to $16.9 million and earnings per share of $0.01 - $0.02 for the third quarter.
Previously, the company was expecting to report revenue of $15.8 million to $16.4 million and earnings per share of $0.00 - $0.01 in Q3, 2013.
The company is scheduled to release its full third quarter financial results on October 23, 2013.
Nu Skin Enterprises Inc. ( NUS ) touched another high of $99.60 for the year on Thursday following the receipt of FDA clearance to market a facial spa device for over-the-counter cosmetic use. The company estimates that the facial spa will become available for sale some time during the first half of 2014.
The stock was trading around $73 in July when we alerted readers to the stock after it upped its revenue outlook for Q2-2013.
Nymox Pharmaceutical Corp.'s ( NYMX ) phase II clinical trial of NX-1207 for localized prostate cancer has enrolled over 80% patients. Based on current screening and enrollment rates, the company anticipates that enrollment will be completed in the near future. Initial top line study results are expected to be available approximately 2 months after completion of enrollment.
NYMX closed Thursday's trading 7.34% higher at $6.58.
Sarepta Therapeutics Inc. ( SRPT ) announced that its investigational drug, Eteplirsen, demonstrated continued stability on walking test through 96 weeks in phase IIb study in Duchenne muscular dystrophy. The company intends to submit NDA for Eteplirsen in the first half of 2014.
SRPT closed Thursday's trading at $46.52, up 0.17%.
Venaxis Inc.'s ( APPY ) pivotal clinical trial for its CE Marked APPY1 Test, a rapid, multiple biomarker-based assay for identifying patients that are at low risk for appendicitis, has been recommended for continuation by the external Data and Safety Monitoring Board (DSMB) based upon completion of the second and final futility analysis included in the clinical trial design.
The pivotal study will enroll a total of 2,000 evaluable patients, of which approximately 1,300 have been enrolled to date. Venaxis said it is on track to complete enrollment as guided by the end of 2013.
APPY closed Thursday's trading at $1.93, down 10.65%.
Verastem Inc. ( VSTM ) has initiated a phase II trial of Defactinib, a potent inhibitor of focal adhesion kinase (FAK), in KRAS-mutated non-small cell lung cancer. Defactinib is also under a phase I trial in mesothelioma in Japan, and in combination with Paclitaxel in a phase Ib study in ovarian cancer.
VSTM closed Thursday's trading 0.16% higher at $12.88.
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