A lawsuit was filed on behalf of investors in BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) shares over alleged securities laws violations.
San Diego, CA -- (SBWIRE) -- 11/18/2021 -- An investor, who purchased NASDAQ: BMRN shares, filed a lawsuit against BioMarin Pharmaceutical Inc. over alleged violations of Federal Securities Laws.
Investors who purchased shares of BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) have certain options and for certain investors are short and strict deadlines running. Deadline: December 22, 2021. NASDAQ: BMRN investors should contact the Shareholders Foundation at email@example.com or call +1(858) 779 - 1554.
San Rafael, CA BioMarin Pharmaceutical Inc., a biotechnology company, 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 Company's Phearless Phase 1/2 study is evaluating BMN 307 in adults with PKU.
On November 7, 2018, BioMarin Pharmaceutical Inc. 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.
BioMarin Pharmaceutical Inc. reported that its annual Total Revenue rose from over $1.7 billion in 2019 to over $1.86 billion in 2020, and that its Net Loss of $23.84 million in 2019 turned into a Net Income of $859.1 million in 2020.
On September 24, 2020, BioMarin Pharmaceutical Inc announced that it had dosed the first human participant in the global Phearless Phase 1/2 study of BMN 307.
On September 5, 2021, BioMarin Pharmaceutical Inc announced "that the U.S Food and Drug Administration (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 phenylketonuria (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."
Shares of BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) declined from $85.28 per share on September 1, 2021, to $76.00 per share on September 15, 2021.
The plaintiff claims that between January 13, 2020 and September 3, 2021, the defendants made false and/or misleading statements and/or failed to disclose that BMN 307 was less safe than BioMarin had led investors to believe, that BMN 307's safety profile made it likely that the FDA would place a clinical hold on the Phearless Phase 1/2 study, that accordingly, the Company had overstated BMN 307's clinical and commercial prospects, and that as a result, the Company's public statements were materially false and misleading at all relevant times.
Those who purchased shares of BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) have certain options and should contact the Shareholders Foundation.
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