GlobeNewswire Inc | Dec 7, 2021 05:14PM EST

December 07, 2021

NEW YORK, Dec. 07, 2021 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against BioMarin Pharmaceutical Inc. (BioMarin or the Company) (NASDAQ: BMRN) and certain of its officers. The class action, filed in the United States District Court for the Northern District of California, and docketed under 21-cv-08254, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired BioMarin securities between January 13, 2020 and September 3, 2021, both dates inclusive (the Class Period), seeking to recover damages caused by Defendants violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the Exchange Act) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.

If you are a shareholder who purchased or otherwise acquired BioMarin securities during the Class Period, you have until December 22, 2021 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at newaction@pomlaw.com or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.

[Click here for information about joining the class action]

BioMarin develops and commercializes therapies for people with serious and life-threatening rare diseases and medical conditions. The Company is developing, among other product candidates, BMN 307, an AAV5 mediated gene therapy, which is in a phase 1/2 clinical trial to normalize blood phenylalanine concentration levels in patients with phenylketonuria (PKU). The Companys Phearless Phase 1/2 study is evaluating BMN 307 in adults with PKU.

On November 7, 2018, BioMarin shared pre-clinical data of BMN 307, which demonstrated lifetime Phe corrections in mouse models, and announced that the Company was planning to file an investigational new drug application (IND) for BMN 307 with the United States Food and Drug Administration (FDA) in the second half of 2019. On January 13, 2020, the Company announced that the FDA granted IND status for BMN 307 for the treatment of PKU. On September 24, 2020, the Company announced that it had dosed the first human participant in the global Phearless Phase 1/2 study of BMN 307.

The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Companys business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) BMN 307 was less safe than BioMarin had led investors to believe; (ii) BMN 307s safety profile made it likely that the FDA would place a clinical hold on the Phearless Phase 1/2 study; (iii) accordingly, the Company had overstated BMN 307s clinical and commercial prospects; and (iv) as a result, the Companys public statements were materially false and misleading at all relevant times.

On September 5, 2021, BioMarin issued a press release announcing, that the [FDA] placed a clinical hold on the BMN 307 Phearless Phase 1/2 study, which is evaluating BMN 307, an investigational AAV5-phenylalanine hydroxylase (PAH) gene therapy, in adults with [PKU]. BioMarin advised investors that [t]he FDAs clinical hold was based on interim safety findings from a pre-clinical, non-GLP pharmacology study.

On this news, BioMarins stock price fell $7.14 per share, or 8.4%, to close at $77.81 per share on September 7, 2021, the next trading day.

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com.

CONTACT:Robert S. WilloughbyPomerantz LLPrswilloughby@pomlaw.com888-476-6529 ext. 7980