Rosetta Blooms, FLXN Knocked Down, RNA In Demand, Concert Strikes Sweet Note

(RTTNews) - BioBlast Pharma Ltd. (ORPN), on Wednesday, announced positive preclinical and clinical pharmacokinetic data on Cabaletta, its drug candidate for patients suffering from oculopharyngeal muscular dystrophy.

The company also announced that according to initial interim safety and tolerability analysis, there were no drug related adverse events in patients in an ongoing phase 2/3 study evaluating Cabaletta in treatment of Oculopharyngeal Muscular Dystrophy, dubbed HOPEMD.

ORPN closed Wednesday's trading at $8.60, up 1.18%.

Concert Pharmaceuticals Inc. (CNCE) has initiated a phase 1 clinical trial of CTP-730 in healthy subjects. CTP-730 is a novel product candidate that is being developed for the treatment of inflammatory diseases under the company's strategic collaboration with Celgene Corp. (CELG).

The phase I study is designed to enroll up to 40 healthy subjects and is expected to be completed in 2015.

CNCE closed Wednesday's trading at $13.79, up 5.27%.

Eagle Pharmaceuticals Inc. (EGRX) announced that Cephalon Inc., a subsidiary of Teva Pharmaceutical Industries Ltd. (TEVA), has moved to dismiss with prejudice its first lawsuit, filed last October, alleging that Eagle's tentatively approved bendamustine hydrochloride injection infusion product infringes one of its patents.

However, a second lawsuit which alleges that Eagle's bendamustine product infringes Cephalon's newly-issued U.S. Patent remains pending.

Eagle's New Drug Application for its bendamustine product received tentative approval for the treatment of Indolent B-cell non-Hodgkin lymphoma from the FDA on July 22, 2014. Due to orphan drug exclusivity held by Cephalon, the tentative approval will not convert to final approval until September 2015.

EGRX closed Wednesday's trading at $12.67, up 4.54%.

Flexion Therapeutics Inc. (FLXN) fell more than 22 percent in extended trading Wednesday following announcement that the FDA has placed a clinical hold on patient enrollment and dosing in the company's ongoing phase 2b clinical trial evaluating FX006 in patients with osteoarthritis of the knee.

The company has been informed by the FDA that the clinical hold is due to a single occurrence of an infection in the injected knee joint of a patient in the phase 2b clinical trial.

FLXN closed Wednesday's trading at $19.38, down 1.17%. In after-hours, the stock plunged 22.60% to $15.

Isis Pharmaceuticals Inc. (ISIS) has earned a $4 million milestone payment from Achaogen Inc. (AKAO) associated with the initiation of a phase 3 study of Plazomicin, an investigational aminoglycoside, in patients with serious multi-drug resistant, gram-negative bacterial infections.

ISIS, which licensed its proprietary aminoglycosides program to Achaogen in 2006, is eligible to receive up to $19.5 million as Plazomicin advances in development. The company has thus far received $7 million from Achaogen, including the $4 million milestone payment of today.

Isis is also entitled to receive up to $20 million in milestone payments as well as royalties based on sales of Plazomicin.

ISIS closed Wednesday's trading at $41.20, up 4.30%.

OXiGENE Inc. (OXGN) has initiated a phase II study of Fosbretabulin monotherapy in patients with locally advanced, recurrent or metastatic gastrointestinal neuroendocrine tumors, or GI-NETs, with elevated biomarkers. The study will enroll approximately 20 GI-NET patients with increased biomarkers and/or clinical symptoms.

OXGN closed Wednesday's trading at $2.25, up 2.74%. In after-hours, the stock was up another 3.11% to $2.32.

Shares of PDL BioPharma Inc. (PDLI) dropped 12.12 percent on Wednesday after the company disclosed in a regulatory report that its independent registered accounting firm, Ernst & Young LLP, last week, had orally informed it was resigning effective September 11, 2014. The resignation was confirmed in a letter delivered to the company on September 15, 2014.

Commenting on the resignation of the corporate auditors, Peter Garcia, vice president and chief financial officer of the company said, "We are surprised by the resignation as we did not have any disagreements with EY on accounting practices, scope or procedures nor did we have any reportable events that would have caused EY to resign their position as our auditors".

PDLI closed Wednesday's trading down 12.12% at $8.48.

Prosensa Holding N.V. (RNA) has commenced re-dosing of Drisapersen, its lead product candidate for Duchenne Muscular Dystrophy, in a phase II study, named DEMAND V, and phase III study, dubbed DEMAND III.

All dosing in the Drisapersen clinical program had been placed on hold by GSK, Prosensa's then partner, on September 20, 2013, upon announcement of the DEMAND III study results. Prosensa regained the rights to Drisapersen from GSK in January 2014. In the DEMAND III study, Drisapersen failed to show a statistically significant improvement in the six-minute walk test compared to placebo.

RNA closed Wednesday's trading at $8.66, up 6%.

Rosetta Genomics Ltd. (ROSG), a molecular diagnostics company, announced that its revenue for the first half of 2014 was $554,000, up 187% from $193,000 reported in the year-ago period.

The company noted that it is on track to publish proof-of-concept data for its thyroid neoplasia assay by the end of the year. Rosetta is expected to begin final validation testing in early 2015 and to launch its microRNA-based thyroid neoplasia assay in the third quarter of 2015.

ROSG closed Wednesday's trading 9.52% higher at $3.91. In after-hours, the stock gained another 8.70% to $4.25.