Biotech Stocks to bet on: Northwest Biotherapeutics, Inc (NASDAQ …

Biotech Stocks to bet on: Northwest Biotherapeutics, Inc (NASDAQ …

Investors have been flocking to biotech stocks this year, with the IBB, the ETF that tracks biotech stocks, making noteworthy gains. So far in 2015, several industries have either underperformed or provided mixed results, leading to a rather ho-hum showpiece for U.S. blue-chip indices.

Biotech stocks, on the other hand, have consistently returned positive results in the markets over the past seven years. On paper, there’s very little evidence to suggest that the magical rally in biotech stocks will abate any time soon.

Since 2010, the annualized average of the month-over-month performance rate for the exchange-traded fund iShares NASDAQ Biotechnology Index (IBB) has outpaced the benchmark S&P 500, often with a wide margin averaging a 1.64% difference. In addition, both indicators peaked in performance in 2011, but the subsequent decline in blue-chip stocks was heavily pronounced. However, biotech stocks bucked the trend, continuing to make strong inroads.

On the trading floor, shares of Northwest Biotherapeutics, Inc (NASDAQ:NWBO) gained 7.90% to close at $7.51. The $544.06M company on August 21, 2015 confirmed that its Phase III trial of DCVax®-L for newly diagnosed glioblastoma multiforme (GBM) is ongoing and the patients enrolled in the trial are continuing to be treated per the protocol. Over 300 patients have been recruited for the trial.  The total anticipated enrollment is 348 patients.

The only change in status of the trial is that new screening of patient candidates for the trial has been temporarily suspended while the Company submits certain information from the trial for regulatory review.

Such screening involves the initial evaluation of patient candidates to determine whether they meet eligibility criteria for the trial (e.g., whether they are within the eligible age range, do not have certain viral diseases, etc.)

Some blogs and social media comments have noted that the EudraCT trials database in Europe states that there is a “Temporary Halt” of the trial in Germany.  In actuality, the trial status in Germany is that the trial is ongoing as noted above, and the Company has only undertaken a temporary suspension of new screening.

The Company has sought to have the EudraCT listing corrected, but the database includes only certain pre-specified categories and there is no category that corresponds to a temporary suspension of new screening only, while a trial is ongoing.

The Company is in the process of preparing the trial information for regulatory review and anticipates submission within the next couple of weeks.

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) closed at $119.68 with a decrease of 5.14%. On August 24, 2015 Medivation, Inc. (MDVN) and BioMarin Pharmaceutical Inc. (BMRN) announced that they have entered into an asset purchase agreement under which Medivation will acquire all worldwide rights to talazoparib (formerly referred to as BMN 673), a highly-potent, orally-available poly ADP ribose polymerase (PARP) inhibitor currently in a Phase 3 study for the treatment of patients with deleterious germline BRCA 1 or BRCA 2 mutations and locally advanced and/or metastatic breast cancer. Under the agreement, Medivation will be responsible for all research, development, regulatory and commercialization activities for all indications on a global basis.

Inovio Pharmaceuticals Inc (NASDAQ:INO) ended at $6.54 by losing 7.04%. The $507.34M company on August 19, 2015 announced its DNA vaccine targeting the virulent Middle East Respiratory Syndrome (MERS) induced 100% protection from a live virus challenge in a preclinical study. This medical advancement is notable because there is no vaccine or effective treatment for the MERS virus, which is clearly able to transmit from human to human. Since 2012, MERS has infected 1,400 people and killed over 500. Recently, the largest outbreak outside of Saudi Arabia of this emergent global health concern infected 186 people with 36 fatalities in South Korea.

In preclinical studies, Inovio and its collaborators evaluated its synthetic DNA-based MERS vaccine in mice, camels and monkeys, or non-human primates. In all three species, the vaccine induced robust immune responses capable of preventing the virus from infecting cells. The data from camels is an important finding because camels represent not only a host reservoir of the disease but act as a mode of transmission to humans. In monkeys, all vaccinated animals in the study were protected from symptoms of MERS disease when challenged with a live MERS virus. Inovio has reported on the preventive power of its synthetic DNA-based vaccines in a variety of infectious diseases including HIV, influenza, hepatitis B, Ebola and dengue.

 

 

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Biotech Stocks to bet on: Northwest Biotherapeutics, Inc (NASDAQ …

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