BENSALEM, Pa.–()–Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased BioMarin Pharmaceuticals Inc. (“BioMarin” or the “Company”) (NASDAQ: BMRN) securities between February 28, 2020 and August 18, 2020 (the “Class Period”). BioMarin investors have until November 24, 2020 to file a lead plaintiff motion.

On August 19, 2020, the Company announced receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding BioMarin’s Biologics License Application (“BLA”) for valoctocogene roxaparvovec. Therein, the FDA determined 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, BioMarin’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, have information or would like to learn more about these claims, or 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 howardsmith@howardsmithlaw.com, or visit our website at www.howardsmithlaw.com.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

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