BMRN To Seek Review Of PTAB Ruling, CERC Awaits Phase 2 Data In Nov, OCRX Abuzz

(RTTNews) - BioMarin Pharmaceutical Inc. (BMRN) intends to seek a review of the Patent Trial and Appeal Board's ruling in the composition of matter patent interference pertaining to exon 51 skipping antisense oligonucleotides, which has gone in favor of Sarepta Therapeutics Inc. (SRPT).

Sarepta's Duchenne muscular dystrophy drug EXONDYS 51, which is designed to skip exon 51, was granted accelerated approval by the FDA on September 19, 2016.

Last September, the Patent Trial and Appeal Board ruled in BioMarin's favor on the method of use (MOU) patent interference of exon 51 skipping antisense oligonucleotides to treat Duchenne muscular dystrophy. A final ruling from the Federal Circuit Court of Appeals on this decision is expected in late 2017 or early 2018. If the verdict goes in favor of BioMarin, Sarepta's EXONDYS 51 would infringe the MOU patents of BioMarin.

BMRN closed Wednesday's trading at $97.57, down 0.39%.

Cerecor Inc. (CERC) has completed patient enrollment in its phase 2 clinical trial evaluating CERC-301 as an adjunctive treatment of major depressive disorder.

The trial has enrolled 115 subjects with major depressive disorder, and its primary objective is to evaluate the antidepressant effect of CERC-301 in 12 mg and 20 mg dosages compared to placebo.

The company now expects to report top-line data from this trial in November 2016.

CERC closed Wednesday's trading 4.94% higher at $4.46.

Neuralstem Inc. (CUR) has reached over 50% enrollment in its phase 2 clinical trial of NSI-189 in the treatment of major depressive disorder. The study is designed to enroll a total of 220 moderately depressed patients.

The primary efficacy endpoint is a reduction in depression symptoms while the secondary endpoints include additional clinical outcomes and cognition improvement measures. Results from this study are expected in the second half of 2017.

CUR closed Wednesday's trading at $0.31, unchanged from the previous day's close.

Ocera Therapeutics Inc. (OCRX) has completed enrollment in its phase 2a clinical trial of OCR-002 in patients with acute liver failure.

In the study, dubbed STOP-ALF, 36 of 47 patients enrolled are considered evaluable having completed at least 72 hours of treatment. The study, which was started in June 2012, is expected to be completed in September 2017. (Data sourced from ClinicalTrials.gov).

OCRX closed Wednesday's trading at $2.40, up 1.27%. In after hours, the stock was up 18.75% at $2.85.