Investors suffering losses on their BioMarin investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in this class action at 888-638-4847 or by email to email@example.com.
On August 19, 2020, BioMarin announced receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the Company’s Biologics License Application (“BLA”) for valoctocogene roxaparvovec. Therein, the FDA concluded that the “differences between Study 270-201 (Phase 1/2) and the Phase 3 study limited its ability to rely on the Phase 1/2 study to support durability of effect.” As a result, the FDA recommended that BioMarin “complete the Phase 3 Study and submit two-year follow-up safety and efficacy data on all study participants.”
On this news, the Company’s stock price fell $41.82 per share, or 35%, to close at $76.72 per share on August 19, 2020, thereby injuring investors.
The complaint filed alleges that throughout the Class Period, Defendants made materially false and/or misleading statements and/or failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) the 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; (2) as a result, it was foreseeable that the FDA would not approve the BLA for valoctocogene roxaparvovec without further data; and (3) that, as a result of the foregoing, Defendants’ positive statements about the Company’s busines, operations, and prospects were materially misleading and/or lacked a reasonable basis.
If you purchased BioMarin securities, you may move the Court no later than November 24, 2020 to ask the Court to appoint you as lead plaintiff if you meet certain legal requirements. To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action. If you wish to learn more about this class action, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020, by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to firstname.lastname@example.org, or visit our website at www.howardsmithlaw.com.
Law Offices of Howard G. Smith
Howard G. Smith, Esquire