SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in BioMarin Pharmaceuticals, Inc. of

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on
their Investment in BioMarin Pharmaceuticals, Inc. of Class Action Lawsuit and
Upcoming Deadline – BMRN

NEW YORK, Oct.  08, 2020 (GLOBE  NEWSWIRE) -- Pomerantz  LLP announces that  a
class action lawsuit  has been  filed against  BioMarin Pharmaceuticals,  Inc.
 (“BioMarin” or the “Company”)  (NASDAQ: BMRN) and  certain of its  officers. 
The class  action, filed  in United  States District  Court for  the  Northern
District of California,  and docketed  under 20-cv-06719,  is on  behalf of  a
class consisting  of  all  persons  other than  Defendants  who  purchased  or
otherwise, acquired BioMarin securities between  February 28, 2020 and  August
18, 2020,  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 BioMarin  securities during the  class
period, you have until November 24, 2020,  to ask the Court to appoint you  as
Lead Plaintiff for  the class.  A  copy of  the Complaint can  be obtained  at  To discuss this action, contact Robert S. Willoughby at
[email protected] 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 is a biotechnology company that develops and commercializes therapies
for people  with  serious  and  life-threatening  rare  diseases  and  medical
conditions.  The   Company’s  product   candidates  include,   among   others,
valoctocogene roxaparvovec, an investigational adeno-associated virus  (“AAV”)
gene therapy, which is  in Phase 3 clinical  development for the treatment  of
patients with severe hemophilia A.

Based on  BioMarin’s  Phase  1/2  study results,  the  investing  and  medical
community viewed valoctocogene roxaparvovec as a likely candidate for becoming
the first  gene therapy  approved by  the U.S.  Food and  Drug  Administration
(“FDA”) for hemophilia in the U.S.

In May 2019, BioMarin announced the interim results from its Phase 3 study  of
valoctocogene roxaparvovec for adults suffering from severe hemophilia A.  The
results, although  showing  the treatment’s  effectiveness,  disappointed  the
market because they indicated a reduction in durability of effectiveness  from
the results  shown in  the  Phase 1/2  results. That  is,  under the  Phase  3
results, it was not  clear whether valoctocogene roxaparvovec’s  effectiveness
would last as  long as indicated  in the  Phase 1/2 study,  and thus,  whether
valoctocogene roxaparvovec would be a single treatment, or one requiring  more
than one treatment  over the life  of a patient.  These concerns echoed  those
that first arose in 2018, after the Company reported a disappointing  two-year
update from the Phase 1/2 study,  which showed factor VIII levels waning  over

Apparently dismissing these concerns, in  December 2019, BioMarin submitted  a
Biologics  License   Application  (“BLA”)   to  the   FDA  for   valoctocogene
roxaparvovec for adults with hemophilia A based on the interim analysis of the
ongoing Phase 3  study of  valoctocogene roxaparvovec, as  well as  three-year
data from  the  Company’s  Phase  1/2  study  of  valoctocogene  roxaparvovec.
BioMarin also announced that the  European Medicines Agency (“EMA”)  validated
the Company’s Marketing  Authorization Application  (“MAA”) for  valoctocogene
roxaparvovec for  adults with  severe hemophilia  A, with  the MAA  review  to
commence in January 2020 under accelerated assessment.

The complaint  alleges  that  throughout the  Class  Period,  Defendants  made
materially false and misleading  statements regarding the Company’s  business,
operational, and  compliance policies.   Specifically, Defendants  made  false
and/or misleading statements and/or failed  to disclose that: (i)  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; (ii) as a result, it was foreseeable that the FDA  would
not approve the  BLA for valoctocogene  roxaparvovec without additional  data;
and (iii) as a result, the  Company’s public statements were materially  false
and misleading at all relevant times.

On August 19, 2020, BioMarin announced  receipt of a Complete Response  Letter
(“CRL”) from the  FDA to  the Company’s BLA  for valoctocogene  roxaparvovec. 
BioMarin advised  investors  that  in  the CRL,  “the  FDA  introduced  a  new
recommendation for two years of data from the Company’s ongoing 270-301  study
(Phase 3) to provide substantial evidence of a durable effect using Annualized
Bleeding Rate (ABR) as the primary endpoint” and “recommended that the Company
complete the Phase 3 Study and  submit two-year follow-up safety and  efficacy
data on all study  participants.”  In explaining  the new recommendation,  the
“FDA concluded 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
the durability of effect.”

On this news,  BioMarin’s stock  price fell $41.82  per share,  or 35.28%,  to
close at $76.72 per share on August 19, 2020.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and  Paris
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,  the Pomerantz  Firm
pioneered the field  of securities class  actions. Today, more  than 80  years
later, the Pomerantz Firm 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

Robert S. Willoughby
Pomerantz LLP
[email protected]
888-476-6529 ext. 7980

Source Article