BioMarin Pharmaceutical Inc. (BMRN) Likely to Get EU Approval of Voxzogo in Next 10 Days, Opening a $4.4B Opportunity - Cowen

Cowen analyst Phil Nadeau reiterated an Outperform rating and $135.00 price target on BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) after hosting a virtual investor event with Chairman and CEO, Jean-Jacques Bienaimé. The highlight of the event was bullishness around Voxzogo (vosoritide) for achondroplasia. The therapy is poised for regulatory approvals in both the EU and U.S with the EMA's CHMP issuing a positive opinion on June 25. The EMA's decision typically follows the CHMP opinion by approx. 67 days, placing Voxzogo on pace for an EMA approval by the end of next week. In the U.S., formal packaging and labeling discussions have started and management has been through its mid cycle review meeting with FDA and is preparing for its late cycle meeting. Since the FDA typically informs companies of the need for an Ad. Com. during the mid-cycle meeting, management thinks one is unlikely. Management believes the FDA does not have major issues with Voxzogo's clinical data, and that an approval on or around the November 2021 U.S. PDUFA is likely.

The analyst stated "BioMarin estimates that there are 11K children with achondroplasia in the EU, Middle East and Africa, with an additional 3.5K in the U.S, 5.5K in South America, and 2K in APAC. 80% of kids with achondroplasia are born to parents who do not have the condition and BioMarin anticipates the vast majority of these parents will be motivated to put their children on therapy. At a price of $200K/patient/year, Voxzogo's worldwide total addressable market is approx. $4.4B."

For an analyst ratings summary and ratings history on BioMarin Pharmaceutical Inc. click here. For more ratings news on BioMarin Pharmaceutical Inc. click here.

Shares of BioMarin Pharmaceutical Inc. closed at $75.47 yesterday.

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