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OPXA Skyrockets, CPTS Pursues CE Mark, MSLP Closes Offering, NBY Progresses


Celsion Corp. (CLSN), whose investigational product ThermoDox failed in a phase III liver cancer study recently, said that its partner Zheijang HISUN Pharmaceutical Co. does not plan to pursue the exclusive option to license ThermoDox for the Greater China market.

However, the Technology Development Contract entered into on January 18, 2013 remains in force and the two companies continue to collaborate and evaluate the next steps in relation to ThermoDox.

CLSN closed Tuesday's trading 5.13% higher at $1.23. In the after-hours, the stock gained 2.44% to $1.26.

Conceptus Inc. (CPTS) on Tuesday initiated enrollment in its European clinical study designed to support the company's CE Mark application for its next generation Essure device, a type of permanent birth control for women.

According to the company, the European clinical trial will enroll up to 60 patients in multiple sites in Europe, and will assess effectiveness for pregnancy prevention at both the 3-months and 1-year endpoints.

The Essure procedure is the first FDA approved method of permanent birth control for women and has been available since 2002.

MusclePharm Corp. (MSLP.OB) on Tuesday successfully completed the final closing of a $12.0 million registered direct offering of its Series D Convertible Preferred Stock. According to the company, Frost Group, LLC, headed by Miami entrepreneur Phillip Frost, has increased its investment as the lead investor to $2.9 million.

NovaBay Pharmaceuticals Inc. (NBY) Tuesday said that its partner Galderma S.A has initiated the South African arm of its Phase 2b clinical study of a proprietary topical formulation of NVC-422 for the treatment of impetigo. The study is expected to enroll over 300 patients at 24 clinical sites in four countries worldwide. The first patients were enrolled in the U.S. arm of the study last September. Galderma expects to report results from the phase 2b clinical study of NVC-422 in impetigo in mid 2013.

Opexa Therapeutics Inc. (OPXA) rose more than 320% in intraday trading Tuesday after the company announced that it has granted an option to Merck Serono, a division of Merck, Darmstadt, Germany, for the exclusive license of Tcelna, an investigational T-cell therapy for patients suffering from multiple sclerosis.

Tcelna is currently in a phase IIb clinical trial in patients with Secondary Progressive multiple sclerosis.

Opexa is entitled to total potential payments of $225 million based upon the successful development and commercialization of Tcelna for multiple sclerosis.

Perrigo Co.'s (PRGO) testosterone gel 1% has been approved by the FDA. The approval was based on a bioequivalence study that compared Perrigo's product to AbbVie's AndroGel 1%.

AndroGel 1%, which is indicated to treat adult males who have low or no testosterone, has annual sales of approximately $705 million, according to Symphony Health.

Protalix BioTherapeutics Inc. (PLX) rose more than 14% to $6.15 on Tuesday after the company confirmed it has engaged Citigroup to assist it in reviewing a broad array of product partnering, technology sharing and other strategic alternatives.

Regen BioPharma, a wholly-owned subsidiary of Bio-Matrix Scientific Group Inc. (BMSN.OB), has filed an Investigational New Drug application with the FDA to initiate clinical trials of its HemaXellerate I stem cell drug in patients with drug-refractory aplastic anemia.

Somaxon Pharmaceuticals Inc. (SOMX), which has agreed to be acquired by Pernix Therapeutics, has entered into a settlement agreement with Actavis Elizabeth LLC and Actavis Inc. to resolve pending patent litigation involving insomnia drug Silenor 3 mg and 6 mg tablets.

The settlement agreement paves way for Actavis to begin selling a generic version of Silenor on January 1, 2020, or earlier under certain circumstances. With this recent settlement agreement, Somaxon has resolved the last of its four patent litigation lawsuits relating to Silenor.

by RTTNews Staff Writer

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