06.12.2013 04:15:24
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BSDM Gets Business, BOTA's IGLOO Building Up, PBYI Leaps To New High
(RTTNews) - Biota Pharmaceuticals Inc. (BOTA) has commenced dosing patients in the Northern Hemisphere portion of its ongoing phase II clinical trial of experimental drug laninamivir octanoate (LANI) in adults with presumed influenza A or B infection, dubbed IGLOO. The Southern Hemisphere portion of the trial was initiated in June.
The company expects to have top-line data from the IGLOO trial in mid-2014.
BOTA closed Thursday's trading 0.49% higher at $4.13.
BSD Medical Corp. (BSDM) has received a purchase order for multiple MicroThermX Microwave Ablation systems and antennas from its exclusive distributor in Turkey, ADA Medikal. This is the second order for multiple MicroThermX Microwave Ablation (MicroThermX) systems and antennas from ADA, according to the company. MicroThermX is used in diseased soft tissue (tumor) ablation treatment.
The company's revenues for the fiscal year ended August 31, 2013 increased 77% to $3.7 million compared to last year.
BSDM closed Thursday's trading at $1.29, down 0.77%.
Dyax Corp.'s (DYAX) drug candidate DX-2930 for use in the treatment of hereditary angioedema has been granted orphan drug designation by FDA. DX-2930 is currently being studied in a placebo-controlled, dose-escalation phase 1 trial in normal individuals. Results from this study are expected in the first quarter of 2014.
DYAX closed Thursday's trading at $8.26, down 1.67%.
Puma Biotechnology Inc. (PBYI) touched an all-time high of $80.77 on Thursday before closing at $77.70, following positive results from a phase II clinical trial of its investigational drug PB272 for the neoadjuvant treatment of breast cancer.
In the phase II trial, dubbed I-SPY 2, treatment with PB272 plus paclitaxel followed by doxorubicin and cyclophosphamide resulted in a higher pathological complete response rate in the breast and lymph nodes at the time of surgery compared to standard neoadjuvant chemotherapy (paclitaxel in combination with Herceptin followed by doxorubicin and cyclophosphamide).
We alerted our readers of a trading opportunity in PBYI in our report titled "It's Spy Time..." on June 14, 2013 when the stock was trading around $36. Had you bought the stock then, your gain is now over 110 percent based on today's closing price.
Shire plc's (SHPG) phase III trial of its investigational drug Lifitegrast ophthalmic solution in adults with dry eye disease, dubbed OPUS-2, has shown mixed results. While Lifitegrast met the prespecified co-primary endpoint for the patient-reported symptom of eye dryness, it did not meet the prespecified co-primary endpoint for the sign of inferior corneal staining score using fluorescein staining compared with placebo.
The phase III clinical development program for Lifitegrast for dry eye disease consists of one more study, known as SONATA. This trial is scheduled for completion in mid 2014.
Biotech stocks can be risky as their fortunes depend on two key events namely clinical trial results and FDA decisions. Nevertheless, the returns can be impressive when the stocks are bought and sold at the right time. So far, 33 of our 2013 stock picks have delivered triple-digit returns.
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