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Diffusion Pharmaceuticals ($DFFN) stock saw a spike in its price as the company announced the data from a Phase 1/2 clinical trial assessing its trans sodium crocetinate (TSC) in newly diagnosed glioblastoma multiforme (GBM) showing a treatment benefit. The data collected from 59 patients showed that 36.3% of those who received the full dose (n=18/50) of TSC were alive at two years, compared to the historical rate of 27 - 30%. Survival in the biopsy-only subset of patients was 40% and 42.9% for those undergoing a complete resection before treatment.
Diffusion stock has shown strong performance in the past 12 months as it grew over 188 percent during this time period.

Regeneron Pharmaceuticals Inc. ($REGN) received a reprieve as a federal judge granted the company’s request to stay a ban of a LDL-buster Praluen. The stay means that the drug may remain available in the market, while the appeal process continues. Praluent and Amgen's drug Repatha are part of an expensive class of drugs that cost upward of $14,000 a year. The company stock jumped over 2.6 percent during after hour trading session.
Regeneron Pharmaceuticals stock has lost more than 10 percent of its value in the past 12 months. The company also recently announced that its pipeline candidate, sarilumab, has been approved in Canada for the treatment of adult patients with moderate-to-severely active rheumatoid arthritis. The company is developing the treatment in conjunction with Sanofi.

 

• Shire ($SHPG) suffered a setback as its subsidiary Shire ViroPharma has been sued by the US Federal Trade Commission with regard to its antibiotic Vancocin (vancomycin). The civil action is related to the company's role in the filing of a citizen's petition in 2006 (and multiple supplements thereafter) challenging the FDA's change of policy allowing in vitro testing to establish bioequivalence of a generic formulation instead of in vivo testing, the previous standard. Shire says the FTC's challenge to ViroPharma is without merit and it intends to vigorously defend its actions.
• Biogen ($BIIB) reported that Humana has initiated the coverage of Spinraza (nusinersen) for the treatment of spinal muscular atrophy (SMA). However, the coverage is confined to the most severe form of SMA called type 1, which accounts for about half of SMA cases. Types 2 - 4 not covered at this time.

• Amgen Inc. ($AMGN) reported that the FDA has approved its drug candidate, etelcalcetide, for treating secondary hyperparathyroidism in adult patients with chronic kidney disease undergoing dialysis. The drug will be sold under the brand name Parsabiv. Amgen said that it is the first new therapy approved for the condition in 12 years. The treatment is designed to be administered intravenously three times a week at the end of a dialysis session.
• XBiotech ($XBIT) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has granted it a 30-day extension to submit its responses to its Day 180 List of Outstanding Issues related to the company's marketing application for Xilonix. The company was notified by the advisory committee that additional data were needed to support the application. The extension will allow it to complete a pharmacokinetic study in healthy subjects.

 
• Jaguar Animal Health ($JAGX) has announced its merger with Napo Pharmaceuticals. The merger is expected to provide Jaguar Animal Health with an important prescription revenue stream from sales of Mytesi, an FDA-approved human drug for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. The terms of the agreement provide for a 3-to-1 Napo-to-Jaguar value ratio to calculate relative ownership of the combined entity.
• Jazz Pharmaceuticals ($JAZZ) announced that It has enrolled its first subject for a Phase 2 clinical trial assessing JZP-110, a selective dopamine and norepinephrine reuptake inhibitor, for the treatment of excessive sleepiness in adult Parkinson's disease (PD) patients. The estimated study completion date is April 2018. Phase 3 trial results for excessive sleepiness associated with sleep apnea are expected this quarter. The results from a narcolepsy study is due in the second quarter.

 
• The Ensign Group Inc. ($ENSG) reporting its fourth quarter GAAP diluted earnings per share of $0.35 and $0.96 for the year. Its adjusted earnings per share for the quarter stood at $0.30 and $1.29 for the year. Consolidated GAAP revenues for the year was reported up $313.0 million or 23.3% over the prior year to $1.65 billion. The company adjusted its 2017 guidance to $1.76 billion to $1.80 billion in revenues and $1.46 to $1.53 adjusted annual earnings per diluted share for 2017.
• LifeVantage ($LFVN) reported its second quarter results. Its Revenue decreased 5.9% to $48.9 million, compared to $52.0 million in the second quarter of fiscal 2016. The company’s Adjusted EBITDA decreased 13.7% to $3.9 million, compared to $4.5 million in the comparable period of fiscal 2016. Its adjusted earnings per diluted share were $0.11, compared to $0.14 in the second quarter of fiscal 2016.

• Loxo Oncology ($LOXO) receives Buy rating from Jefferies. The price target for the stock has been set at $50.
• Gilead Sciences ($GILD) receives Neutral rating from Citigroup. The price target for the stock has been set at $76.

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