BMRN Awaits EMA Nod, KIN Hits A High, Nuvilex Gets Rich, OHRP A Sight Better

(RTTNews) - BioMarin Pharmaceutical Inc.'s (BMRN) Marketing Authorization Application for VIMIZIM for the treatment of Morquio A syndrome, also called Mucopolysaccharidosis Type IVA, has received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency. The European regulatory agency is expected to render its final decision for VIMIZIM in the second quarter of 2014.

VIMIZIM received FDA approval for the treatment of patients with Mucopolysaccharidosis type IVA on February 14, 2014.

BMRN closed Thursday's trading at $80.13, up 4.95%.

Kindred Biosciences Inc. (KIN) has initiated a pivotal clinical trial for AtoKin in dogs with atopic dermatitis. AtoKin is a beef-flavored, chewable, high-dose, second generation histamine H1-receptor antagonist.

If all goes well as planned, the company expects AtoKin to be approved by 2015.

KIN touched a new high of $20.61 in intraday trading on Thursday before closing at $20.29.

Nuvilex Inc. (NVLX.OB) has entered into a stock purchase agreement with Lincoln Park Capital Fund LLC, under which the Chicago-based institutional investor initially purchased 8 million shares of Nuvilex's common stock at $0.25 per share for $2 million.

Lincoln Park has also committed to invest, at the sole option of Nuvilex, up to an additional $25 million of equity capital over the term of the purchase agreement.

Nuvilex intends to use the proceeds from the investment for its late-stage clinical trials in advanced inoperable pancreatic cancer, for research into the use of constituents of marijuana in the emerging medical marijuana arena and for general operating purposes.

NVLX.OB closed Thursday's trading 16.96% higher at $0.23.

Ohr Pharmaceutical's (OHRP) investigator sponsored trial of topical Squalamine Lactate Ophthalmic Solution, 0.2% in the treatment of retinal neovascularization resulting from proliferative diabetic retinopathy, conducted by Elman Retina Group, has demonstrated promising results in the first patient treated in the ongoing 5-patient trial.

According to the data, topical application of squalamine eye drops was associated with regression of retinal neovascularization within two months.

Commenting on the results, Michael Elman, Principal Investigator for the clinical trial said, "These are promising results which provide the first evidence in a human eye that topical application of Squalamine can produce a biological effect in retinal disease."

OHRP rose 4% to close Thursday's trading at $15.61.

Pluristem Therapeutics Inc. (PSTI), which is seeking FDA's Orphan Drug Designation for its PLacental eXpanded (PLX-PAD) cells in the treatment of severe preeclampsia, has submitted an application in this regard.

The PLX cells are in clinical trials for a variety of indications.

The company has successfully received Orphan Drug Designation from the FDA for its PLX cells in two other indications namely, the treatment of aplastic anemia and the treatment of Buerger's disease.

PSTI closed Thursday's trading at $4.02, up 0.50%.

Raptor Pharmaceutical Corp. (RPTP) rose 14.88 percent to close Thursday's trading at $17.14, following positive 18-month data from an ongoing 3 year phase 2/3 clinical trial of RP103 (delayed-release cysteamine) for the potential treatment of Huntington's disease.

According to the trial results, there was a positive trend towards slower progression of Total Motor Score in patients treated with RP103 vs. those patients on placebo, the primary endpoint of the study.