SAN FRANCISCO, Sept. 28, 2020 /PRNewswire/ -- Hagens Berman urges BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) investors to contact the firm now. A securities fraud class action has been filed and certain investors may have valuable claims.
BioMarin Pharmaceutical (BMRN) Securities Class Action:
The complaint alleges that Defendants' statements misrepresented and concealed material information about BioMarin's valoctocogene roxaparvovec product candidate, potentially the first gene therapy approved by the U.S. FDA for hemophilia in the U.S.
Specifically, throughout the Class Period, Defendants misstated or omitted to disclose that (1) 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, and (2) as a result, it was foreseeable that the FDA would not approve BioMarin's Biologics License Application ("BLA") for valoctocogene roxaparvovec without additional data.
Investors allegedly began to learn the truth on Aug. 19, 2020, when BioMarin announced it received the FDA's complete response letter ("CRL") to the BLA indicating the FDA recommended the company submit additional data upon completion of the phase 3 study since the difference between the phase 1/2 and phase 3 studies limited the FDA's ability to rely on the phase 1/2 study to support the durability of effect.
Analysts at Guggenheim were shocked by the Company's disclosure, noting "[t]his news came as a negative surprise to us in light of mgt commentary and other launch-related prep (by BMRN and other payers) and pushes out a potential Roctavian approval until ~2022."
This news drove the price of BioMarin shares down over 35% that day.
"We're focused on investors' losses and proving Defendants misled investors about the phase 1/2 reliability for the BLA," said Reed Kathrein, the Hagens Berman partner leading the investigation.
Whistleblowers: Persons with non-public information regarding BioMarin should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email [email protected].
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