Galena Biopharma Inc (NASDAQ: GALE)
Galena Biopharma is having an incredibly hard day in the market today, and for good reason. The company announced early this morning that it will be ending a key ongoing clinical study. Today, we’ll talk about the news, how the news affected the market, and what we can expect to see from GALE moving forward. So, let’s get right to it…
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GALE Sinks On Discontinuation Of Ongoing Study
As mentioned above, Galena Biopharma is having a tough trading session today. Early this morning, the company announced that it would be putting an end to a Phase 3 trial. The clinical trial is known as the PRESENT trial. PRESENT means Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment.
In their statement today, GALE announced that the independent data monitoring committee on the interim analysis for the NeuVax trial made a key recommendation. The IDMC said that the company should cease the trial immediately due to futility. In a statement, Mark W. Schwartz, Ph.D., President and CEO at GALE, had the following to offer:
“We are extremely disappointed with the outcome of the PRESENT futility analysis… On behalf of our entire company, I would like to thank all of the courageous patients and their families, investigators, study staff and independent committees who participated in the PRESENT study. To date, the trial has not been un-blinded other than by the IDMC, and we need to evaluate the data. We expect to host a conference call next week to provide a preliminary review of the PRESENT trial and an update on all of our immunotherapy and hematology clinical development programs.”
How The Market Reacted To The News
As investors, one of the first things that we learn is that the news moves the market. When positive news is released with regard to a publicly-traded company, we can expect to see gains in the value of the stock associated with the company as a result. Unfortunately, the news released with regard to Galena Biopharma was overwhelmingly negative. After all, the company spent massive amounts of time and money focusing on a treatment that seems to be falling apart. As a result, we’re seeing tremendous declines surrounding GALE today. Currently (12:42), the stock is trading at $0.31 per share after a massive decline of $1.72 per share, or 84.73%, thus far today.
What We Can Expect To See Moving Forward
Moving forward, I have a relatively bearish opinion of what we can expect to see from GALE. Unfortunately, the company’s lead candidate is proving to be something that won’t likely come to fruition. After the large amount of money and time spent on the project, this is a big hit to Galena Biopharma. While the company has paused the study due to the IDMC recommendation, they will still be going over the data on their own. Nonetheless, when an Independent Data Monitoring Committee makes this type of recommendation, there are strong chances that the companies will abandon studies entirely. At the moment, we don’t have much data with regard to what GALE plans on doing next and uncertainty is in the air. There are few things investors like less than uncertainty. So, this will likely lead to further declines on the stock.
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What Do You Think?
Where do you think GALE is headed moving forward and why? Join the discussion at TalkTRENDZ from CNA Finance!
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