One Rejected BioMarin's Hemophilia Gene Therapy Goes Under FDA Review


27% profit every 20 days?

This is what Nic Chahine averages with his option buys. Not selling covered calls or spreads… BUYING options. Most traders don’t even have a winning percentage of 27% buying options. He has an 83% win rate. Here’s how he does it.


  • The FDA accepted BioMarin Pharmaceutical Inc's (NASDAQ: BMRN) resubmission of the marketing application for its investigational AAV gene therapy, valoctocogene roxaparvovec, for severe hemophilia A. 
  • The Prescription Drug User Fee Act (PDUFA) target action date is March 31, 2023. At this time, the FDA has not communicated any plans to hold an advisory committee meeting. 
  • If approved, valoctocogene roxaparvovec would be the first gene therapy in the U.S. to treat severe hemophilia A.
  • The European Commission granted conditional marketing authorization to valoctocogene roxaparvovec gene therapy under the brand name Roctavian.
  • The BLA resubmission incorporates the company's responses to all deficiencies identified in the FDA Complete Response Letter in August 2020, including two-year outcomes from all study participants in the global GENEr8-1 Phase 3 study. 
  • The GENEr8-1 Phase 3 study demonstrated stable and durable bleed control, including a reduction in the mean annualized bleeding rate and the mean annualized Factor VIII infusion rate. 
  • Price Action: BMRN shares are down 1.25% at $87.84 on the last check Thursday.

27% profit every 20 days?

This is what Nic Chahine averages with his option buys. Not selling covered calls or spreads… BUYING options. Most traders don’t even have a winning percentage of 27% buying options. He has an 83% win rate. Here’s how he does it.


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Posted In: BiotechNewsHealth CareFDAGeneralBriefs