Clovis Oncology Inc (NASDAQ: CLVS)
Clovis Oncology is having an incredible day in the market today, and for good reason. The stock is continuing gains that started yesterday as the result of an NDA acceptance. Today, we’ll talk about the news, what we’re seeing from the stock as a result, and what we can expect to see from CLVS ahead.
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CLVS Is Gaining On FDA News
As mentioned above, Clovis Oncology is having an incredibly strong day after announcing great news from the United States Food and Drug Administration. Yesterday, it was announced that the Administration accepted a New Drug Application surrounding rucaparib. The application has been accepted for accelerated approval and granted priority review status. It is expected that the FDA’s response will come by no later than February 23rd, 2017.
Rucaparib is a treatment that is designed for advanced ovarian cancer in patients with deleterious BRCA-mutated tumors that include both germline and somatic BRCA mutations. If approved, patients will be ineligible for the treatment unless they have been treated with two or more chemotherapies. The FDA granted Breakthrough Therapy Designation for the treatment designed by CLVS for the proposed indication in April of 2015. In a statement, Patrick J. Mahaffy, President and CEO at CLVS, had the following to offer:
“The acceptance of the rucaparib NDA submission represents an important milestone for rucaparib, and Clovis… There is tremendous need for additional therapeutic options for patients with advanced mutant BRCA ovarian cancer and we look forward to cooperating with FDA on the rucaparib NDA review.”
The above statement was followed up by Robert L. Coleman, MD, Professor & Deputy Chairman, Vice Chair, Clinical Research, Ann Rife Cox Chair in Gynecology, Department of Gynecologic Oncology and Reproductive Medicine at University of Texas MD Anderson Cancer Center in Houston and one of the principal investigators on the ARIEL clinical trial by Clovis Oncology. Here’s what he had to say:
“Recurrent ovarian cancer remains a very difficult disease to treat, even among women who carry, or whose tumors have a mutation in the BRCA genes. Despite the available treatment options, few effective therapies are at our disposal. Thus, the opportunity to treat women with germline or somatic BRCA mutations with rucaparib after two prior lines of platinum-based therapy, represents a meaningful step forward for our patients…”
How The Market Reacted To The News
As you could imagine, following such incredibly positive news, we saw massive gains in the stock yesterday. Today, we’re seeing more upward movement. While it is much slower, we’re still seeing the stock value climb. Currently (12:28), CLVS is trading at $23.92 per share after a gain of $0.89 per share (3.86%).
What We Can Expect To See Moving Forward
Moving forward, I have an overwhelmingly bullish opinion of what we can expect to see from CLVS. Throughout the company’s history, they have proven their ability to come up with solid treatments that generate revenue. With the news that the NDA for rucaparib has been accepted for priority review, I’m only expecting to see more positivity. At the end of the day, the trials surrounding the treatment yielded overwhelmingly positive results. As a result, I’m expecting to see FDA acceptance. With a strong track record with regard to selling its therapies, this is likely to become a new revenue stream for the company, pushing the stock further and further upward!
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What Do You Think?
Where do you think CLVS is headed moving forward? Join the discussion at TalkTRENDZ!