On September 25, 2020, Pomerantz LLP filed a class action against BioMarin for making materially false and misleading statements regarding its gene therapy product for Hemophilia A patients. In a press release, Pomerantz LLP states that "defendants made false and/or misleading statements and/or failed to disclose that: (i) differences between the Phase 1/2 and Phase 3 study of valoctocogene roxaparvovec limited the reliability of the Phase 1/2 study to support valoctocogene roxaparvovec’s durability of effect; (ii) as a result, it was foreseeable that the FDA would not approve the BLA for valoctocogene roxaparvovec without additional data; and (iii) as a result, the Company’s public statements were materially false and misleading at all relevant times."
Investors feel like they have been mislead. As you may know from our previous posts, Biomarin's gene therapy product for Hemophilia A patients was supposed to be FDA approved back in August. However, the FDA want to see more of the Phase 3 data on the product's durability.
When the FDA told BioMarin that they want to see more data on the durability, BioMarin's stock took a sharp dive.
HemoAware Founder, Jesse John Francis Clark, thinks BioMarin will settle this quietly with the investors.
We have included a copy of the complaint if you would like to read it.
We will keep you posted regardless of the outcome.