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BioMarin Pharma's FDA advisory committee meeting news an 'extreme positive'

By Sam Boughedda Biomarin Pharmaceutical Inc (NASDAQ:BMRN) announced Wednesday that the U.S. Food and Drug Administration (FDA) informed them that they no longer plan to hold an...
BioMarin Pharma's FDA advisory committee meeting news an 'extreme positive' © Reuters BioMarin Pharma's (BMRN) FDA advisory committee meeting news an 'extreme positive'
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By Sam Boughedda

Biomarin Pharmaceutical Inc (NASDAQ:BMRN) announced Wednesday that the U.S. Food and Drug Administration (FDA) informed them that they no longer plan to hold an advisory committee meeting to discuss the BLA for ROCTAVIAN.

The news resulted in Biomarin shares jumping 8% and saw analysts at Stifel and Truist react positively.

"The review of a BLA is a dynamic process, and we appreciate FDA's ongoing engagement as we work toward delivering a potentially transformative treatment choice to those patients with severe hemophilia A," said Hank Fuchs, President of Worldwide Research and Development at BioMarin. "We look forward to further dialogue with the Agency as it reviews our application."

Stifel said the news is "probably a positive" and reiterated a Buy rating on BioMarin.

"We believe yesterday's QURE/CSL hemeB HEMGENIX approval holds favorable read-throughs onto the gene therapy space and, specifically for BMRN/Roctavain, on FDA's comfort with approving GTx for a disease has other good therapeutic options. That said, there are two distinctions with BMRN's submission - durability and questions around steroid use - that, given the FDA's original communicated plans for an AdComm, indicated that Roctavian presents different and more nuanced review issues. Conversely, news today that FDA now no longer plans to hold a panel for Roctavian (note: there also wasn't a panel for HEMGENIX) appears to be a positive," the analysts wrote.

Truist analysts also reiterated a Buy rating on the stock following the news, telling investors in a note that it is an "extreme positive."

"We view this as very positive for BMRN and for the pending approval of Roctavian," wrote the analysts. "We remain bullish on the approval of Roctavian and remind investors that BMRN is on track to host the FDA's inspection of their gene therapy manufacturing facility, which we believe would not be happening if the FDA did not intend to approve the drug."

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    EUR/USD 1.0357 Neutral  
    GBP/USD 1.2050 Neutral  
    USD/JPY 138.65 ↑ Buy  
    AUD/USD 0.6691 Sell  
    USD/CAD 1.3446 Buy  
    EUR/JPY 143.60 ↑ Buy  
    EUR/CHF 0.9808 ↑ Buy  
    Gold 1,750.60 Neutral  
    Silver 21.262 Sell  
    Copper 3.5657 ↑ Sell  
    Crude Oil WTI 74.11 ↑ Sell  
    Brent Oil 81.35 ↑ Sell  
    Natural Gas 7.274 Buy  
    US Coffee C 164.40 ↑ Sell  
    Euro Stoxx 50 3,962.41 ↑ Buy  
    S&P 500 4,026.12 Neutral  
    DAX 14,541.38 ↑ Buy  
    FTSE 100 7,486.67 ↑ Buy  
    Hang Seng 17,241.00 Neutral  
    Small Cap 2000 1,869.19 ↑ Buy  
    IBEX 35 8,416.60 Sell  
    BASF 49.605 Neutral  
    Bayer 55.45 Sell  
    Allianz 205.35 ↑ Buy  
    Adidas 123.98 Neutral  
    Lufthansa 7.567 ↑ Sell  
    Siemens AG 132.06 ↑ Buy  
    Deutsche Bank AG 10.390 ↑ Buy  
Mua/Bán 1 chỉ SJC
# So hôm qua # Chênh TG
SJC Eximbank6,640/ 6,710
(6,640/ 6,710) # 1,469
SJC HCM6,655/ 6,735
(-5/ -25) # 1,494
SJC Hanoi6,655/ 6,737
(-5/ -25) # 1,496
SJC Danang6,655/ 6,737
(-5/ -25) # 1,496
SJC Nhatrang6,655/ 6,737
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(-5/ -25) # 1,496
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