06.05.2014 06:34:22
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MusclePharm Flexes Muscles, PRTA Surges After-hours, TXMD Hopes To Deliver
(RTTNews) - Cellectar Biosciences Inc.'s (CLRB.OB) investigational product I-124-CLR1404 as a diagnostic for the management of glioma, the most common and aggressive form of brain cancer, has been granted orphan drug designation by FDA.
Cellectar expects to complete a phase II trial evaluating I-124-CLR1404 in glioblastoma in 2014. Additionally, multiple investigator-sponsored phase I/II clinical trials are ongoing across 11 solid tumor indications, according to the company.
CLRB.OB closed Monday's trading at $0.40, up 5.26%.
MEI Pharma Inc. (MEIP) has initiated a phase Ib clinical study of its investigational mitochondrial inhibitor drug candidate ME-344 in combination with Hycamtin in patients with solid tumors, including small cell lung and ovarian cancers. The open-label study is expected to enroll up to 64 patients with preliminary data anticipated by the first quarter of 2015.
MEIP closed Monday's trading at $7.34, down 0.14%.
MusclePharm Corp. (MSLP.OB) reported record results for the first quarter of 2014, fueled by strong international sales.
Net income was roughly $2.7 million or $0.23 per share on net sales of $50.2 million in Q1, 2014. This compared with a net loss of approximately $7.4 million or $1.78 per share and net sales of $22.6 million in the year-ago quarter.
Looking ahead to full-year 2014, the company now expects net sales of approximately $165 million to $175 million and earnings per share range of $0.41 to $0.51. Previously, the company had forecast revenue of approximately $150 million and earnings per share range of $0.20 to $0.22 for full-year 2014.
MSLP.OB closed Monday's trading at $9.48, up 20%.
Prothena Corp. plc (PRTA) surged over 14 percent to $24.78 in extended trading on Monday following the release of its financial results for the first quarter ended March 31, 2014.
In Q1, 2014, the company's net income was $17.9 million or $0.78 per share on total revenue of $32.2 million. This compares with a net loss of $9.0 million or $0.51 per share and total revenue of $0.2 million for the first quarter of 2013. The increase in total revenue was primarily due to the collaboration revenue recognized in relation to the PRX002 collaboration with Roche in the current quarter.
PRX002 is Prothena's investigational monoclonal antibody for the treatment of Parkinson's disease.
QIAGEN N.V.'s (QGEN) artus C. difficile QS-RGQ MDx Kit has been cleared by FDA to qualitatively detect Clostridium difficile, a widespread healthcare-associated infection. The regulatory agency has also granted 510(k) clearance for QIAsymphony RGQ MDx system, QIAGEN's flagship automation platform that is transforming laboratory workflows and driving dissemination of molecular diagnostics.
QGEN closed Monday's trading at $22.09, up 1.61%.
TherapeuticsMD Inc. (TXMD), a women's health care company, rose more than 8 percent to $4.29 in after-hours on Monday following its Q1, 2014 results.
The net loss for the first quarter of 2014 was $9.2 million or $0.06 per share on net revenue of $2.8 million. This compared with a net loss of $6.4 million or $0.06 per share and net revenue of $1.5 million for the first quarter of 2013.
The company said it remains on track to complete enrollment this fall in the investigational combination estradiol and progesterone (E+P) therapy phase III trial for treatment of vasomotor symptoms in menopausal women.
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