Apr 19, 2016

Posted by in Biotech Stocks | 0 Comments

Stock’s Buzzers: Regulus Therapeutics Inc (NASDAQ:RGLS), Biogen Inc (NASDAQ:BIIB), BioDelivery Sciences International Inc (NASDAQ:BDSI)

Stock’s Buzzers: Regulus Therapeutics Inc (NASDAQ:RGLS), Biogen Inc (NASDAQ:BIIB), BioDelivery Sciences International Inc (NASDAQ:BDSI)

Regulus Therapeutics Inc (NASDAQ:RGLS) stock is at $6.87, down -4.98 percent from its previous close of $7.23. The stock opened the session at $7.08 and touched its highest price point at $7.13. The company’s stock’s lowest price point for the session stood at $6.75. Its yesterday’s volume was 1.48 million shares in comparison to its usual trading volume of 881,080.00 shares.

Regulus Therapeutics Inc (NASDAQ:RGLS) on April 15, 2016 announced additional interim results from one of the company’s ongoing Phase II studies of RG-101 for the treatment of Hepatitis C Virus infection (HCV) during an oral presentation at the International Liver Congress 2016 (ILC 2016) taking place April 13-17 in Barcelona, Spain. The study was designed to evaluate a shortened, four-week treatment regimen containing a subcutaneous administration of 2 mg/kg of RG-101 at Day 1 and Day 29, in combination with 4 weeks of once/daily approved anti-viral agents Harvoni®, Olysio®, or Daklinza™.  The study enrolled 79 treatment naïve genotype 1 and 4 HCV patients (Harvoni® arm, n=27, Olysio® arm, n=27, Daklinza™ arm, n=25).

To date, RG-101 has been generally well tolerated with the majority of adverse events considered mild or moderate, and with no study discontinuations.  Changes in pharmacodynamic markers are indicative of effective target engagement and consistent with the company’s prior experience with miR-122 inhibition.  The primary endpoint analysis (12 week follow up) for all 79 patients in the study is anticipated to be reported in late Q2 2016.

Biogen Inc (NASDAQ:BIIB) stock is at $272.92, up +1.65 percent from its previous close of $268.50. Its yesterday’s volume was 1.51 million shares in comparison to its usual trading volume of 1.91 million shares. Previous 5 days graph demonstrated a positive move of 2.91%. Its quarterly performance remained red with the percentage of -0.15, while its year to date performance showed that the stock plunged overall -10.91%.

April 18, 2016 — Biogen Inc (NASDAQ:BIIB) unveiled new TECFIDERA® (dimethyl fumarate) research that reinforces its strong and sustained efficacy in newly diagnosed relapsing-remitting multiple sclerosis (RRMS) patients and further supports its long-term, well-characterized safety profile. These data were presented at the 68th annual meeting of the American Academy of Neurology (AAN) in Vancouver, Canada.

Data from a post-hoc analysis show that more than half of newly diagnosed patients treated with TECFIDERA were free from relapses and disability progression for six years, reinforcing that early, effective treatment with TECFIDERA improves long-term clinical outcomes. Additional real-world data from a claims database indicate that TECFIDERA is associated with significantly lower annualized relapse rates (ARR) relative to multiple disease modifying therapies (DMTs), including glatiramer acetate, interferon β and teriflunomide. These rates were similar between TECFIDERA and fingolimod.

BioDelivery Sciences International Inc (NASDAQ:BDSI) traded in the range of $3.43 and $3.61 in its previous trading session. The stock recorded the volume of 1.54 million shares so far, in comparison its average daily trading volume of 1.20 million shares. Company’s year to date performance remained declining as it lost almost -25.89%. The stock opened at $3.45 and its closing price for the day was $3.55, up +1.72 percent from its previous close.

BioDelivery Sciences International Inc (NASDAQ:BDSI) on March 10, 2016 reported financial results for the fourth quarter and full-year ended December 31, 2015.

Fourth Quarter 2015 Financial Results Overview

  • Net revenue for the fourth quarter ended December 31, 2015, was $32.2 million, nearly all attributable to the $50 million BELBUCA-related FDA approval payment of which $30 million was recognized as revenue immediately. The remaining $20 million will be recognized as revenue over the patent extension period. Revenue for the corresponding period for 2014 was $2.5 million, primarily related to BREAKYL. BUNAVAIL revenue for the fourth quarter was $1.5 million, an increase of 29% over third quarter.
  • Total operating expenses for the fourth quarter ended December 31, 2015, were $18.6 million, compared to $17.6 million in the corresponding period of 2014.
  • Net income for the fourth quarter ended December 31, 2015, was $10.2 million, or $0.19 per diluted share, compared to a net loss of $17.6 million, or ($0.36) per diluted share, in the corresponding period of 2014.

12-Months Ended December 31, 2015 Financial Results Overview

  • Net revenue for the twelve months ended December 31, 2015, was $48.2 million, compared to $38.9 million in the corresponding period of 2014.
  • Total operating expenses for the twelve-month period ended December 31, 2015, were $75.3 million, compared to $72.7 million the same period of 2014.
  • Net loss for the 12-months ended December 31, 2015, was $37.7 million, or ($0.72) per diluted share, compared to $54.2 million, or ($1.12) per diluted share, in the corresponding period of 2014.
  • As of December 31, 2015, BDSI had $83.6 million in cash and cash equivalents, as compared to $70.5 million as of December 31, 2014.

 

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