Mylan (MYL) Stock: Headed Up On FDA Approval


Mylan Inc NASDAQ MYL Stock NewsMylan NV (NASDAQ: MYL) is having an overwhelmingly strong start to the trading session this morning, and for good reason. The company announced that the United States Food and Drug Administration has approved one of its treatments. Of course, the news led to excitement among investors, sending the stock screaming for the top. Today, we’ll talk about:

  • The approval;
  • what we’re seeing from MYL as a result; and
  • what we’ll be watching for with regard to the stock ahead.

MYL Announces FDA Approval

As mentioned above, Mylan is having an incredibly strong start to the trading session this morning after announcing FDA approval. In a press release issued early this morning, the company, along with its partner, Biocon, announced that the United States Food and Drug Administration (FDA) has approved Fulphila™ (pegfilgrastim-jmbd), a biosimilar to Neulasta® (pegfilgrastim). MYL said that the treatment has been appoved as a therapy to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cell) in patients that are treated with chemotherapy in certain types of cancer.

Fulphila is the first FDA-approved biosimilar to Neulasta and second biosimilar from Mylan and Biocon’s joint portfolio. It is anticipated that MYL will launch the product in the coming weeks, making the first alternative and more affordable treatment option when compared to Neulasta available to oncology patients. In a statement, Heather Bresch, CEO at MYL, had the following to offer:

I couldn’t be prouder of this approval for Fulphila, the first alternative option for pegfilgrastim approved in the U.S., as it represents an important milestone for patients and further demonstrates Mylan’s continued fight to expand access to medicine. FDA’s approval of this product, as well as the agency’s continued focus on biosimilars, mark crucial steps towards lowering treatment costs and providing alternative options for patients. As a leading supplier of cancer medicines in the U.S, Mylan is committed to offering affordable and accessible solutions for patients with cancer at every step of their journey. Enhancing access to treatment has always been our top priority and what we’ll continue to deliver to the healthcare system in the U.S. and beyond.

The above statement was followed up by Rajiv Malik, President at MYL. Here’s what he had to offer:

Today’s approval of Fulphila represents a meaningful step forward in the affordability and accessibility of cancer care in the U.S. It also is yet another confirmation of Mylan’s deep scientific, clinical, regulatory and intellectual property capabilities, which are widely recognized in the industry and bolster Mylan’s reputation as a partner of choice in the global effort to bring complex medicines to market. The approval of Fulphila, the first biosimilar to Neulasta, joins other recent examples such as the approval of Ogivri™, the first biosimilar to Herceptin®, in the growing portfolio of complex medicines that Mylan is making available for patients who need them. We’re pleased to reach this important milestone in partnership with Biocon and proud of the progress of our biosimilars program. We look forward to launching Fulphila and continuing to increase access to more affordable treatments.

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 the case of Mylan, the news proved to be overwhelmingly positive. With Fulphila being the lower cost option on the market, chances are that it will drive tremendous revenue for the company. So, it’s no surprise that excited investors are sending the stock screaming for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (10:36), MYL is trading at $41.16 per share after a gain of $2.66 per share or 6.91% 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 MYL. In particular, we’re interested in following Fulphila and excited to see the revenue the product generates. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!


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