Apr 18, 2016

Posted by in Biotech Stocks | 0 Comments

Mix Stocks in Focus: Medivation Inc (NASDAQ:MDVN), Bio Blast Pharma Ltd (NASDAQ:ORPN), Regulus Therapeutics Inc (NASDAQ:RGLS)

Mix Stocks in Focus: Medivation Inc (NASDAQ:MDVN), Bio Blast Pharma Ltd (NASDAQ:ORPN), Regulus Therapeutics Inc (NASDAQ:RGLS)

Medivation Inc (NASDAQ:MDVN) stock is at $51.17, up +3.96 percent from its previous close of $49.22. The stock opened the session at $49.54 and touched its highest price point at $52.25. The company’s stock’s lowest price point for the session stood at $49.41. Its yesterday’s volume was 6.17 million shares in comparison to its usual trading volume of 4.17 million shares.

Medivation Inc (NASDAQ:MDVN) on April 17, 2016 announced that Phase I data from its investigational agent talazoparib, a highly-potent PARP inhibitor, was presented at the American Association for Cancer Research (AACR) Annual Meeting 2016 in New Orleans by the study’s lead investigator Zev A. Wainberg, M.D., Associate Professor of Medicine at the University of California Los Angeles (UCLA) and Co-Director of the UCLA GI Oncology Program, during a Clinical Trials Mini-Symposium. The primary objective of the study was to determine the maximum tolerated dose (MTD) of talazoparib in combination with either low-dose temozolomide or low-dose irinotecan in heavily pretreated patients with advanced malignancies.

The data from the 40 patient trial demonstrated that combination treatment with talazoparib and low-dose chemotherapy resulted in stable disease or an objective response in 23 of 40 heavily pretreated patients with a variety of advanced cancers (clinical benefit rate of 58%). Most notably, objective responses were seen in four of seven (57%) heavily pre-treated non-BRCA-mutated ovarian cancer patients when talazoparib was used in combination with either low-dose temozolomide or low-dose irinotecan. Six of seven individuals (86%) with non-BRCA ovarian cancer had clinical benefit (four partial responses and two stable disease) and had a reduction in CA 125 levels by 50% or greater.

Importantly, the overall study demonstrated responses to combination talazoparib/low-dose chemotherapy in patients with multiple tumor types in which specific deleterious mutations in certain DNA repair genes extended beyond BRCA deficiency, including one patient who did not meet the criteria of having homologous recombination deficiency (HRD). These effects may be mediated through PARP inhibition, as well as enhanced PARP trapping, which interferes with the tumor cell’s ability to replicate DNA by locking PARP molecules onto the DNA strand.

Bio Blast Pharma Ltd (NASDAQ:ORPN) stock is at $2.71, up +12.92 percent from its previous close of $2.40. Its yesterday’s volume was 5.68 million shares in comparison to its usual trading volume of 680,924.00 shares. Previous 5 days graph demonstrated a positive move of 19.91%. Its quarterly performance remained red with the percentage of -7.51, while its year to date performance showed that the stock plunged overall -35.17%.

Bio Blast Pharma Ltd (NASDAQ:ORPN) on February 23, 2016 announced financial results for the fourth quarter and fiscal year ended December 31, 2015.

Fourth Quarter and Full Year 2015 Financial Results:

  • Research and development (R&D) expenses for the fourth quarter of 2015 amounted to $1.9 million, a 12% increase over the $1.7 million recorded in the third quarter of 2015 but approximately 5% less than the $2.0 million incurred in the fourth quarter of 2014. The increase compared with the third quarter was primarily due to $0.2 million in expenses associated with salaries and related share-based compensation.
  • Full year 2015 R&D expenses amounted to $7.7 million compared with $4.4 million in 2014. The increase was primarily due to an increase of $1.1 million in clinical study and manufacturing related-expenses associated with the trehalose 90mg/mL IV solution platform, a $0.1 million increase in clinical study and manufacturing-related expenses associated with the mitochondrial protein replacement (mPRT) platform, a $1.0 million increase in professional services, and $0.9 million increase in salaries, including related share-based compensation.
  • Pre-commercialization expenses for the fourth quarter of 2015 were $0.6 million and consisted primarily of $0.3 million in professional services and $0.3 million in salaries and related share-based compensation. This compares with pre-commercialization expenses of $0.2 million incurred in the third quarter of 2015.  There were no pre-commercialization expenses recorded in the fourth quarter of 2014.
  • Full year 2015 pre-commercialization expenses amounted to $0.8 million. There were no pre-commercialization expenses incurred in full year 2014.
  • General and administrative (G&A) expenses for the fourth quarter of 2015 increased to $2.4 million, compared with $1.6 million in the third quarter of 2015 and $1.2 million in the fourth quarter of 2014. The increase compared with the third quarter is primarily a result of an increase of $0.5 million in expenses related to professional services, $0.1 million increase in salaries and related share-based compensation expense, and $0.2 million in other general and administrative expenses.
  • Full year 2015 G&A expenses amounted to $7.0 million compared with $2.6 million in 2014. The increase was primarily due to $2.1 million increase in salaries and related share-based compensation, $0.9 million increase in professional services, and $1.4 million in other general and administrative expenses.
  • Net loss for the fourth quarter of 2015 was $4.8 million, or $0.34 per share, compared with a net loss of $3.6 million, or $0.25 per share, in the third quarter of 2015, and a net loss of $3.2 million, or $0.22 per share, in the fourth quarter of 2014.
  • Net loss for the full year 2015 was $15.4 million compared with a net loss of $7.0 million in 2014.

Regulus Therapeutics Inc (NASDAQ:RGLS) traded in the range of $6.70 and $8.90 in its previous trading session. The stock recorded the volume of 5.32 million shares so far, in comparison its average daily trading volume of 718,628.00 shares. Company’s year to date performance remained declining as it lost almost -21.41%. The stock opened at $8.77 and its closing price for the day was $7.23, down -11.07 percent from its previous close.

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.

 

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