MSLP Muscling Up, SRPT Gets FDA Date, SKBI Put On Notice

(RTTNews) - The Patent Trials and Appeal Board has ruled in favor of Acorda Therapeutics Inc. (ACOR) by denying inter parties review of the '685 patent and '826 patent of AMPYRA, the company's lead drug and a standard of care for improving walking in multiple sclerosis.

The inter parties review petitions were filed by the Coalition for Affordable Drugs, an entity affiliated with a Kyle Bass hedge fund, challenging the AMPYRA patents.

ACOR closed Tuesday's trading 8.32% higher at $31.37.

Amgen Inc. (AMGN) has submitted a New Drug Application for Etelcalcetide (formerly AMG 416) for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis.

If approved, Etelcalcetide will be the first calcimimetic agent (a drug that mimics the action of calcium on tissues) that can be administered intravenously at the end of the dialysis session.

AMGN closed Tuesday's trading at $145.19, down 1.66%.

Corium International Inc. (CORI) has commenced dosing in a phase I clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of Corplex Donepezil Transdermal System for the sustained and controlled delivery of a treatment for Alzheimer's disease.

The product, which is based on Corium's proprietary transdermal formulation and adhesive technology, is designed to deliver donepezil (the active ingredient in Aricept) for up to seven days in a single-patch application. Donepezil, an anticholinesterase inhibitor, is a leading Alzheimer's drug approved for the treatment of mild, moderate, and severe disease as a daily tablet.

The trial is expected to be completed in late 2015.

CORI closed Tuesday's trading at $10.14, up 4.43%.

Lannett Co. Inc. (LCI), which reported better-than-expected earnings and revenue for its fiscal 2015 fourth quarter and full year ended June 30, 2015, has guided fiscal 2016 revenue in-line with estimates.

For fiscal 2016, the company expects net sales to range between $425 million and $435 million while the range of analysts' estimate is $408.44 million at the low-end to $465 million at the high-end.

LCI closed Tuesday's trading at $46.65, up 1.11%.

MusclePharm Corp. (MSLP) is planning to better focus and align its resources toward profitable growth. The initiative could yield cost savings in excess of $20 million on an annual basis going forward, and profitability in 2016 and beyond, according to the company.

MusclePharm said it will be working to increase operating profit margins to 10% and earnings before interest, taxes, depreciation and amortization (EBITDA) margins to 15% by 2020.

MSLP.OB closed Tuesday's trading at $5.05, up 3.06%.

Sequenom Inc. (SQNM) has entered into a clinical research collaboration with the University of California, San Diego Moores Cancer Center - the first of a series of collaborations with leading cancer centers worldwide that will utilize the company's new liquid biopsy assay as part of their clinical research programs.

Under this collaboration, Moores Cancer Center will explore the utility of Sequenom's liquid biopsy assay to comprehensively profile circulating cell-free tumor DNA in blood to enable serial monitoring and assist with therapy selection in cancer patients.

Sequenom, through its wholly owned subsidiary Sequenom Laboratories, intends to carry out further studies in order to bring to market a liquid biopsy assay for use in patient care in 2016.

SQNM closed Tuesday's trading at $2.01, down 1.95%. In after hours, the stock was up 5.47% at $2.12.

Sarepta Therapeutics Inc.'s (SRPT) New Drug Application for Eteplirsen has been accepted for priority review by the FDA. The FDA's decision date is set for February 26, 2016.

The company is seeking approval of Eteplirsen for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping.

SRPT closed Tuesday's trading at $32.58, down 0.91%. In after hours, the stock was up 2.52% at $33.40.

Skystar Bio-Pharmaceutical Co. (SKBI) has received the Nasdaq Non-Compliance Letter due to delay in filing Quarterly Report on Form 10-Q for the quarter ended June 30, 2015.

The company previously submitted a plan of compliance to Nasdaq, responded to an initial request for additional information from Nasdaq, and is preparing responses to a second request for additional information from Nasdaq. If its plan is approved by the Nasdaq staff, the company may be eligible for a listing exception of up to 180 calendar days, or until October 12, 2015, to regain compliance.

SKBI closed Tuesday's trading at $1.16, down 4.92%.