BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) is having an overwhelmingly strong start to the trading session this morning, and for good reason. The company announced the approval of one of its treatment candidates. Of course, this led to excitement among investors, sending the stock screaming for the top. Today, we’ll talk about:
- The drug approval;
- what we’re seeing from BMRN as a result;
- and what we’ll be watching for ahead.
BMRN Announces FDA Approval
As mentioned above, BioMarin Pharmaceutical Inc. is having an incredibly strong start to the trading session in the pre-market hours this morning after the company announced that it has received FDA approval for one of its candidates. In a press release, the company announced that the United States Food and Drug Administration has approved the company’s treatment for a rare metabolic disorder. The drug, known as Palynziq was designed by BMRN and has been approved for the treatment of phenylketonuria. Phenylketonuria is a hereditary disease that causes the body to have problems breaking down the amino acid known as phenylalanine. Unfortunately, the condition can lead to brain damage, seizures and other mental disorders. In a statement, Jean-Jacques Bienaime, Chairman and CEO at BMRN, had the following to offer:
BioMarin is thrilled to be able to offer this important new therapy to adults with PKU who are unable to control their Phe levels with existing options. The approval of Palynziq is the culmination of more than a decade of perseverance by BioMarin employees dedicated to bringing treatments to PKU adult patients… We are proud of this medical achievement and appreciate the FDA’s thoughtful review of our application. We also are grateful to the PKU patients and medical communities for their continued partnership and participation in the clinical program that led to the approval of this effective therapy.
The above statement was followed up by Cary Harding, M.D., professor at Oregon Health & Science University and investigator for the Phase 3 studies surrounding Palynziq. Here’s what she had to offer:
The goal in treating PKU is to keep blood Phe levels within the range set in the medical guidelines, as elevation of Phe can be toxic and damaging to the brain. Palynziq provides another much needed tool for us to help adult patients control their Phe levels, which previously had not been achievable for many adults living with the condition.
What We’re Seeing From The Stock
As investors, one of the first lessons that we learn is that the news moves the market. In this particular case, the news proved to be overwhelmingly positive. With the new drug approval from the FDA, Biomarin can now market the treatment, likely leading to a boost in revenue and earnings. So, it’s no surprise that excited investors are sending the stock on a run for the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:24), BMRN is trading at $91.00 per share after a gain of $2.72 per share or 3.08% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on BMRN. In particular, we’re interested in following the story surrounding the company’s newly approved treatment and the commercialization of the product. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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