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SAN DIEGO, Nov. 30, 2021 (GLOBE NEWSWIRE) -- The law firm of Robbins Geller Rudman & Dowd LLP announces that purchasers of BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) securities between January 13, 2020 and September 3, 2021, inclusive (the “Class Period”) have until December 21, 2021 to seek appointment as lead plaintiff in Berlinger v. BioMarin Pharmaceutical Inc., No. 21-cv-08254 (N.D. Cal.). Commenced on October 22, 2021, the BioMarin class action lawsuit charges BioMarin as well as certain of its top executives with violations of the Securities Exchange Act of 1934.
If you wish to serve as lead plaintiff of the BioMarin class action lawsuit, please provide your information by clicking here. You can also contact attorney J.C. Sanchez of Robbins Geller by calling 800/449-4900 or via e-mail at jsanchez@rgrdlaw.com. Lead plaintiff motions for the BioMarin class action lawsuit must be filed with the court no later than December 21, 2021.
CASE ALLEGATIONS: BioMarin 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 (“Phe”) concentration levels in patients with phenylketonuria (“PKU”). BioMarin’s 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 BioMarin was planning to file an investigational new drug application (“IND”) for BMN 307 with the U.S. Food and Drug Administration (“FDA”) in the second half of 2019.
The BioMarin class action lawsuit alleges that, throughout the Class Period, defendants made false and misleading statements and failed to disclose that: (i) BMN 307 was less safe than BioMarin had led investors to believe; (ii) BMN 307’s safety profile made it likely that the FDA would place a clinical hold on the Phearless Phase 1/2 study; (iii) accordingly, BioMarin had overstated BMN 307’s clinical and commercial prospects; and (iv) as a result, BioMarin’s 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 FDA’s clinical hold was based on interim safety findings from a pre-clinical, non-GLP pharmacology study.” On this news, BioMarin’s stock price fell by more than 8%, damaging investors.