Life Science News

Jakubowitz Law announces that securities fraud class action lawsuits have commenced on behalf of shareholders of the following publicly-traded companies who purchased shares within the class periods listed below. Shareholders interested in representing the class of wronged shareholders have until the lead plaintiff deadline to petition the court. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. For more details and to speak with our firm without cost or obligation, follow the links below

Meta Platforms, Inc. (NASDAQ:FB)

CONTACT JAKUBOWITZ ABOUT FB:
https://claimyourloss.com/securities/meta-platforms-inc-loss-submission-form/?id=26486&from=1

Class Period: March 2, 2021 - February 2, 2022

Lead Plaintiff Deadline: May 9, 2022

The filed complaint alleges that defendants made materially false and/or misleading statements and/or failed to disclose that: (1) Apple's iOS privacy changes were having a material impact on Meta's ability to provide the kind of targeted advertising that its customers wanted and, as a result, customer ad spending was dropping precipitously; (2) Meta's mitigation efforts were either not properly implemented or ineffective; (3) measurement of ads was not accurate as mitigation efforts were failing; and (4) Meta did not have a plan in place to properly address the impact of the iOS privacy changes.

ABBVie Inc. (NYSE:ABBV)

CONTACT JAKUBOWITZ ABOUT ABBV:
https://claimyourloss.com/securities/abbvie-inc-loss-submission-form/?id=26486&from=1

Class Period: April 30, 2021 - August 31, 2021

Lead Plaintiff Deadline: June 6, 2022

The filed complaint alleges that defendants made materially false and/or misleading statements and/or failed to disclose that: (1) safety concerns about Pfizer Inc.'s drug Xeljanz extended to Abbvie's drug Rinvoq and to other Janus kinase enzyme inhibitor drugs; (2) as a result, it was likely that the U.S. Food and Drug Administration would require additional safety warnings for Rinvoq and would delay the approval of additional treatment indications for Rinvoq; and (3) therefore, defendants' statements about the Company's business, operations, and prospects lacked a reasonable basis.

Playstudios, Inc. (NASDAQ:MYPS)

CONTACT JAKUBOWITZ ABOUT MYPS:
https://claimyourloss.com/securities/playstudios-inc-loss-submission-form/?id=26486&from=1

This lawsuit is on behalf of a class consisting of all persons and entities other than defendants who: (a) purchased, or otherwise acquired securities of Playstudios between June 22, 2021 and March 1, 2022, both dates inclusive, including, but not limited to, those who purchased or acquired Playstudios securities pursuant to the offering of the private investment in public equity; (b) held common stock of Acies as of May 25, 2021, and were eligible to vote at Acies' June 16, 2021 special meeting who exchanged their shares of Acies stock for shares of Playstudios stock pursuant to the merger of Acies and Old Playstudios; and/or (c) purchased or otherwise acquired Playstudios common stock pursuant to or traceable to Acies' documents issued in connection with the June 2021 merger.

Lead Plaintiff Deadline: June 6, 2022

The filed complaint alleges that defendants made materially false and/or misleading statements and/or failed to disclose that: (i) Playstudios was having significant problems with its flagship game, Kingdom Boss; (ii) Playstudios would not be releasing Kingdom Boss as expected; and (iii) Playstudios had not revised its financial projections to account for the problems it had encountered with Kingdom Boss. As a result of defendants' wrongful conduct, Class members paid artificially inflated prices for their Playstudios securities and suffered substantial losses and damages.

Jakubowitz Law, Thursday, April 28, 2022, Press release picture

Jakubowitz Law is vigorous in pursuit of justice for shareholders who have been the victim of securities fraud. Attorney advertising. Prior results do not guarantee similar outcomes.

CONTACT:

JAKUBOWITZ LAW
1140 Avenue of the Americas
9th Floor
New York, New York 10036
T: (212) 867-4490
F: (212) 537-5887

SOURCE: Jakubowitz Law



View source version on accesswire.com:
https://www.accesswire.com/699275/LAWSUITS-FILED-AGAINST-FB-ABBV-and-MYPS--Jakubowitz-Law-Pursues-Shareholders-Claims

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ABBV

Biogen and AbbVie Receive Positive Opinion from the CHMP on ZINBRYTA™ (Daclizumab) for Treatment of Multiple Sclerosis

CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.–(BUSINESS WIRE)–The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion
recommending the granting of a marketing authorization for ZINBRYTA™
(daclizumab) intended for the treatment of relapsing forms of multiple
sclerosis (RMS), Biogen
(NASDAQ: BIIB) and AbbVie (NYSE:
ABBV) announced today. ZINBRYTA is a once-monthly, self-administered,
subcutaneous investigational treatment for RMS. ZINBRYTA is also
currently under regulatory review in the United States, Switzerland,
Canada and Australia.
For people with relapsing forms of MS (RMS) and active disease,
ZINBRYTA has the potential to offer robust efficacy, a manageable safety
profile through patient monitoring, and once-monthly subcutaneous
dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and
chief medical officer at Biogen. “ZINBRYTA may offer another option for
people with multiple sclerosis (MS) with its targeted mechanism of
action (MOA) which did not cause broad and prolonged immune cell
depletion.”
The CHMP positive opinion is now referred to the European Commission
(EC), which grants marketing authorizations for centrally authorized
medicines in the European Union. A decision from the EC is expected
within the coming months.
Together with Biogen, AbbVie is committed to meeting the needs of
patients with MS, and the positive opinion issued by the CHMP is a
critical step that moves us closer to bringing ZINBRYTA to patients in
Europe,” said Michael Severino, M.D., executive vice president, research
and development and chief scientific officer, AbbVie.
According to the CHMP opinion, the benefits of ZINBRYTA are its ability
to reduce the annualized relapse rate (ARR), as well as the risk of
24-week confirmed disability progression. The opinion is based on
results from two clinical trials, DECIDE and SELECT, in which ZINBRYTA
150 mg, administered subcutaneously every four weeks improved results on
key measures of MS disease activity in patients with RMS compared to
AVONEX 30 mcg intramuscular injection administered weekly and placebo,
respectively.
In the DECIDE study, the overall incidence of adverse events was similar
in the ZINBRYTA and AVONEX groups. In patients treated with ZINBRYTA
compared to AVONEX, there was an increased incidence of serious
infections (4% versus 2%), serious cutaneous reactions (2% versus <1%),
elevations of liver transaminases greater than five times the upper
limit of normal (6% versus 3%), gastrointestinal disorders (31% versus
24%), and depression (8% versus 6%).
About ZINBRYTA™ (daclizumab)
ZINBRYTA (daclizumab) is an investigational compound being developed for
the treatment of relapsing forms of MS. ZINBRYTA is a new form of a
humanized monoclonal antibody that selectively binds to the
high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is
expressed at high levels on T-cells that become activated in people with
MS. ZINBRYTA modulates IL-2 signaling without general immune cell
depletion.
Biogen and AbbVie are jointly developing ZINBRYTA.
About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops
and delivers worldwide innovative therapies for people living with
serious neurological, autoimmune and rare diseases. Founded in 1978,
Biogen is one of the world’s oldest independent biotechnology companies
and patients worldwide benefit from its leading multiple sclerosis and
innovative hemophilia therapies. For more information, please visit www.biogen.com.
Follow us on Twitter.
Biogen Safe Harbor
This press release contains forward-looking statements, including
statements about the anticipated timing of the EC’s decision on the
marketing authorization for ZINBRYTA, and potential impact of ZINBRYTA,
if approved. These statements may be identified by words such as
“believe,” “expect,” “may,” “potential,” “will” and similar expressions,
and are based on our current beliefs and expectations. You should not
place undue reliance on these statements. Drug development and
commercialization involve a high degree of risk. Factors which could
cause actual results to differ materially from our current expectations
include the risk that the EC may fail to approve or may delay approval
of ZINBRYTA or may not follow the recommendation of the CHMP,
uncertainty of success in commercialization of ZINBRYTA For more
detailed information on the risks and uncertainties associated with our
drug development and commercialization activities and risks relating to
our collaborations with third parties, please review the Risk Factors
section of our most recent annual or quarterly report filed with the
Securities and Exchange Commission. Any forward-looking statements speak
only as of the date of this press release and we assume no obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in
2013 following separation from Abbott Laboratories. The company’s
mission is to use its expertise, dedicated people and unique approach to
innovation to develop and market advanced therapies that address some of
the world’s most complex and serious diseases. Together with its
wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000
people worldwide and markets medicines in more than 170 countries. For
further information on the company and its people, portfolio and
commitments, please visit www.abbvie.com.
Follow @abbvie on
Twitter or view careers on our Facebook or LinkedIn
page.
Forward-Looking Statements
Some statements in this news release may be forward-looking statements
for purposes of the Private Securities Litigation Reform Act of 1995.
The words “believe,” “expect,” “anticipate,” “project” and similar
expressions, among others, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements are
subject to risks and uncertainties that may cause actual results to
differ materially from those indicated in the forward-looking
statements. Such risks and uncertainties include, but are not limited
to, challenges to intellectual property, competition from other
products, difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry.
Additional information about the economic, competitive, governmental,
technological and other factors that may affect AbbVie’s operations is
set forth in Item 1A, “Risk Factors,” in AbbVie’s 2014 Annual Report on
Form 10-K, which has been filed with the Securities and Exchange
Commission. AbbVie undertakes no obligation to release publicly any
revisions to forward-looking statements as a result of subsequent events
or developments, except as required by law.

Enbrel Biosimilar Marks Victory for Merck and Samsung

The biosimilar alliance between Merck (NYSE:MRK) and Samsung Bioepis appears to have paid off, as the companies have won South Korean approval for their copy of Amgen’s (NASDAQ:AMGN) blockbuster drug Enbrel.
According to Fierce Biotech:

Korea’s Ministry of Food and Drug Safety signed off on the injection, to be marketed as Brenzys, to treat rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and psoriasis in adults. The biosimilar, developed as SB4, proved itself equivalent to Amgen’s cash cow in a 596-patient study disclosed this year, reducing symptoms of rheumatoid arthritis on pace with its reference product, according to Merck and Samsung.
Brenzys’ approval marks the first marketing victory for the two companies, a milestone Merck hopes will be a harbinger of future success in biosimilars.
The approval could also have major implications for Samsung Bioepis, long rumored to be considering a U.S. IPO. Details of the company’s Wall Street plans have been tricking out for months, and The Wall Street Journal reported in August that Samsung is planning a $1 billion debut offering for its biologics division, valuing the company at about $7 billion.
Samsung Bioepis, a joint venture with Biogen ($BIIB) that is 85% owned by the South Korean company, joined forces with Merck in 2013 in a wide-ranging deal designed to crack the growing market for off-patent biological treatments. Beyond Enbrel, the pair are working on copies of the similar Humira from AbbVie ($ABBV) and Remicade from Johnson & Johnson ($JNJ). The companies are also developing biosimilars of Sanofi’s ($SNY) blockbuster insulin Lantus and Roche’s ($RHHBY) cancer treatment Herceptin.

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Lawsuits Filed Against ABBV, RSKD and ARQQ - Jakubowitz Law Pursues Shareholders Claims

Jakubowitz Law announces that securities fraud class action lawsuits have commenced on behalf of shareholders of the following publicly-traded companies who purchased shares within the class periods listed below. Shareholders interested in representing the class of wronged shareholders have until the lead plaintiff deadline to petition the court. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. For more details and to speak with our firm without cost or obligation, follow the links below

ABBVie Inc. (NYSE:ABBV)

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The Klein Law Firm Reminds Investors of Class Actions on Behalf of Shareholders of AUPH, LILM and LICY

The Klein Law Firm announces that class action complaints have been filed on behalf of shareholders of the following companies. There is no cost to participate in the suit. If you suffered a loss, you have until the lead plaintiff deadline to request that the court appoint you as lead plaintiff

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH)
Class Period: May 7, 2021 - February 25, 2022
Lead Plaintiff Deadline: June 14, 2022

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The Klein Law Firm Reminds Investors of Class Actions on Behalf of Shareholders of VRT, VLTA and ABBV

The Klein Law Firm announces that class action complaints have been filed on behalf of shareholders of the following companies. There is no cost to participate in the suit. If you suffered a loss, you have until the lead plaintiff deadline to request that the court appoint you as lead plaintiff

Vertiv Holdings Co (NYSE:VRT)
This lawsuit is on behalf of persons and entities that: (a) purchased or otherwise acquired Vertiv securities between February 24, 2021, and February 23, 2022, inclusive; and/or (b) purchased Vertiv shares in or traceable to the Company's secondary public offering of Class A common stock conducted on or around November 4, 2021.
Lead Plaintiff Deadline: May 23, 2022

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AbbVie Submits New Drug Application to U.S. FDA for Investigational ABBV-951 for the Treatment of Advanced Parkinson's Disease

  • If approved, ABBV-951 will offer patients the first continuous subcutaneous delivery of carbidopa/levodopa prodrugs
  • Submission is supported by Phase 3 study that demonstrated patients had significant increases in hours of "On" time without troublesome dyskinesia, compared to oral immediate-release carbidopa/levodopa

ABBVie (NYSE: ABBV) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ABBV-951 (foscarbidopafoslevodopa) for the treatment of motor fluctuations in patients with advanced Parkinson's disease (PD).

The submission is based on results from a Phase 3, head-to-head, randomized and controlled clinical trial demonstrating statistically significant improvement in "On" time without troublesome dyskinesia compared to oral immediate-release carbidopa/levodopa (CD/LD).

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Lawsuits Filed Against Vrt, Abbv And Ibm - Jakubowitz Law Pursues Shareholders Claims

Jakubowitz Law announces that securities fraud class action lawsuits have commenced on behalf of shareholders of the following publicly-traded companies who purchased shares within the class periods listed below. Shareholders interested in representing the class of wronged shareholders have until the lead plaintiff deadline to petition the court. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. For more details and to speak with our firm without cost or obligation, follow the links below

Vertiv Holdings Co (NYSE:VRT)

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The Gross Law Firm Announces Class Actions on Behalf of Shareholders of VLTA, AUPH and BKKT

The securities litigation law firm of The Gross Law Firm issues the following notice on behalf of shareholders in the following publicly traded companies. Shareholders who purchased shares in the following companies during the dates listed are encouraged to contact the firm regarding possible Lead Plaintiff appointment. Appointment as Lead Plaintiff is not required to partake in any recovery

Volta Inc. (NYSE:VLTA)

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