The Gross Law Firm Announces Class Actions on Behalf of Shareholders of ABBV, UPST and AXSM

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

ABBVie Inc. (NYSE:ABBV)

Investors Affected: April 30, 2021 - August 31, 2021

A class action has commenced on behalf of certain shareholders in AbbVie Inc. 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.

Shareholders may find more information at https://securitiesclasslaw.com/securities/abbvie-inc-loss-submission-form/?id=27381&from=1

Upstart, Inc. (NASDAQ:UPST)

Investors Affected: November 9, 2021 - May 9, 2022

A class action has commenced on behalf of certain shareholders in Upstart, Inc. The filed complaint alleges that defendants made materially false and/or misleading statements and/or failed to disclose that: (1) Upstart's AI model could not adequately account for macroeconomic factors such as interest rates that impact the market-clearing price for loans; (2) as a result, Upstart was experiencing a negative impact on its conversion rate; (3) as a result, the Company was reasonably likely to use its balance sheet to fund loans; and (4) as a result of the foregoing, defendants' positive statements about the Company's business, operations, and prospects were materially false and/or misleading and/or lacked a reasonable basis.

Shareholders may find more information at https://securitiesclasslaw.com/securities/upstart-inc-loss-submission-form/?id=27381&from=1

Axsome Therapeutics, Inc. (NASDAQ:AXSM)

Investors Affected: December 30, 2019 - April 22, 2022

A class action has commenced on behalf of certain shareholders in Axsome Therapeutics, Inc. The filed complaint alleges that defendants made materially false and/or misleading statements and/or failed to disclose that: (i) Axsome's chemistry, manufacturing, and control ("CMC") practices were deficient with respect to AXS-07, the Company's medicine for the acute treatment of migraine, and its manufacturing process; (ii) as a result, Axsome was unlikely to submit the AXS-07 New Drug Application ("NDA") on its initially represented timeline; (iii) the foregoing CMC issues remained unresolved at the time that the U.S. Food and Drug Administration ("FDA") reviewed the AXS-07 NDA; (iv) accordingly, the FDA was unlikely to approve the AXS-07 NDA; (v) as a result of all the foregoing, Axsome had overstated AXS-07's regulatory and commercial prospects; and (vi) as a result, the Company's public statements were materially false and misleading at all relevant times.

Shareholders may find more information at https://securitiesclasslaw.com/securities/axsome-therapeutics-inc-loss-submission-form/?id=27381&from=1

The Gross Law Firm, Tuesday, May 17, 2022, Press release picture

The Gross Law Firm is committed to ensuring that companies adhere to responsible business practices and engage in good corporate citizenship. The firm seeks recovery on behalf of investors who incurred losses when false and/or misleading statements or the omission of material information by a Company lead to artificial inflation of the Company's stock. Attorney advertising. Prior results do not guarantee similar outcomes.

CONTACT:
The Gross Law Firm
15 West 38th Street, 12th floor
New York, NY, 10018
Email: dg@securitiesclasslaw.com
Phone: (212) 537-9430
Fax: (833) 862-7770

SOURCE: The Gross Law Firm



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Health Canada Approves AbbVie's RINVOQ®  for the Treatment of Adults with Active Non-Radiographic Axial Spondyloarthritis

Health Canada Approves AbbVie's RINVOQ® for the Treatment of Adults with Active Non-Radiographic Axial Spondyloarthritis

- Approval is based on results from the Phase 3 SELECT-AXIS 2 pivotal clinical trial in which RINVOQ delivered rapid and meaningful disease control, meeting the primary endpoint of ASAS40 response at week 14 versus placebo 1
- RINVOQ is the first and only Janus Kinase (JAK) inhibitor approved to treat patients across the spectrum of axial spondyloarthritis (nr-axSpA and ankylosing spondylitis) in Canada 1, 2, 3

AbbVie (NYSE: ABBV), today announced that Health Canada has approved RINVOQ ® (upadacitinib, 15 mg), the first oral, once-daily selective and reversible JAK inhibitor for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response to a biologic disease modifying anti-rheumatic drug (DMARD) or when use of those therapies is inadvisable.

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AbbVie Releases New Data Demonstrating Breadth of Its Gastroenterology Portfolio at 2023 Digestive Disease Week®

AbbVie Releases New Data Demonstrating Breadth of Its Gastroenterology Portfolio at 2023 Digestive Disease Week®

- Oral presentations highlight efficacy and safety outcomes from the upadacitinib (RINVOQ ® ) clinical trial program in adults with moderately to severely active Crohn's disease, and investigational use of linaclotide (LINZESS ® ) in treating functional constipation in pediatric patients aged 6 to 17 years

- Twenty-nine abstracts showcase AbbVie's vast portfolio and continued commitment to changing the way patients living with gastrointestinal disorders manage their condition

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Sirona Biochem Announces Exclusive Global Licensing Agreement with Allergan Aesthetics

Sirona Biochem Announces Exclusive Global Licensing Agreement with Allergan Aesthetics

Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") is pleased to announce it has entered into a global exclusive licensing agreement with Allergan Aesthetics, an AbbVie company (NYSE: ABBV), pursuant to which Allergan Aesthetics will develop and commercialize topical skin care treatments based on active ingredients derived from certain of Sirona's patents for TFC-1067 and related family of compounds.

"We are very pleased to have finalized terms with a global leader in medical aesthetics and the innovator behind SkinMedica™, a leader in the science of skin rejuvenation," said Dr. Howard Verrico, CEO of Sirona Biochem. "Our most recent clinical trial of TFC-1067 was a collaborative effort with Allergan Aesthetics to demonstrate the clinical potential in topical skin care treatments. This further validates our platform technology as viable for additional commercial products which we are actively pursuing. We would like to thank Dr. Linda Pullan of Pullan Consulting who assisted with our current success."

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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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AMGEN TO HOST CONFERENCE CALL ON RARE DISEASE

Amgen (NASDAQ:AMGN) will host a webcasted call at 1:00 p.m. PT on Thursday, February 22, 2024 to discuss Rare Disease, its newly added fourth pillar of growth, and provide insights on its rare disease strategy and opportunities, including marketed products and pipeline. Murdo Gordon executive vice president of Global Commercial Operations at Amgen, Jay Bradner executive vice president of Research and Development and chief scientific officer at Amgen, Vikram Karnani executive vice president of Global Commercial Operations and Medical Affairs (Rare Disease) at Amgen, and Paul Burton senior vice president and chief medical officer at Amgen, will participate in the conference call. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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Sirona Biochem Provides Update on Loan

Sirona Biochem Provides Update on Loan

Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona " or the " Company ") announce that, further to its news release on January 29, 2024, it has entered into an amendment to the demand grid promissory note dated September 22, 2023 (the " Amended Note ") with 0906462 B.C. Ltd. (the " Lender "). The Amended Note evidences a loan in the aggregate principal amount of up to $1,000,000 (the " Loan "). Pursuant to the terms and conditions of the Amended Note:

(a)   the Loan is repayable on demand by the Lender at any time following the one-year anniversary of the date of the applicable advance;

(b)   the Loan bears interest at a rate of 12% per annum, calculated yearly not in advance; and

(c)   the Company has agreed to, subject to TSX Venture Exchange approval (" TSXV Approval "), issue the Lender 450,000 common shares in the capital of the Company (" Bonus Shares ") at a price of $0.12 per Bonus Share, as consideration for the risks taken by the Lender in providing the Company the Loan.

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Sirona Biochem Engages Global Beauty Consulting

Sirona Biochem Engages Global Beauty Consulting

Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona " or the " Company ") has announced its partnership with Global Beauty Consulting Cosmetics Laboratory (GBC), under the leadership of CEO Gaël Boutry, a distinguished French formulator. GBC is currently developing an exclusive premium formulation for GlycoProteMim TM in anticipation of its launch in the first quarter of 2025.

GBC has a history of working with Sirona Biochem on the formulation of TFC-1067 for clinical development. This new venture is pivotal in building a brand and competitive product line that showcases GlycoProteMim's potent anti-aging benefits through its exclusive distribution brand Sirona Laboratories TM .

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Sirona Biochem Eyes 2025 Launch of New Anti-aging Product

Sirona Biochem Eyes 2025 Launch of New Anti-aging Product

Following successful clinical trials for its groundbreaking anti-aging and anti-wrinkle molecule, TFC-1326, Sirona Biochem (TSXV:SBM) is pursuing a path to commercialization for a final cosmetic product, according to the company’s chief scientific officer, Géraldine Deliencourt-Godefroy.

“We are still pursuing a final compound to launch on the market, which is pretty good because it will allow us to have a better control on the final product. We can launch fast on the market, we can generate revenue earlier and also the level of revenue will be higher,” Deliencourt-Godefroy said.

Sirona has already trademarked its anti-aging skincare ingredient, GlycoProteMim, as one of the first steps for commercialization. In January of this year, the company also launched a new cosmetics subsidiary, Sirona Laboratories, which is dedicated to maximizing the commercial potential of GlycoProteMim.

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AMGEN TO PRESENT AT THE 34TH ANNUAL OPPENHEIMER HEALTHCARE LIFE SCIENCES CONFERENCE

- Amgen (NASDAQ:AMGN) will present at the 34 th Annual Oppenheimer Healthcare Life Sciences Conference at 12:00 p.m. ET on Wednesday Feb. 14, 2024. Jay Bradner executive vice president of Research and Development and chief scientific officer at Amgen, Murdo Gordon executive vice president of Global Commerical Operations at Amgen, and Susan Sweeney senior vice president of Global Marketing, Access and Capabilities at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com , under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

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male doctor holding cell phone

How Big Tech is Helping Leverage Big Data in Healthcare

The use of artificial intelligence (AI) and machine learning in healthcare was a prominent theme discussed at this year's Biotech Showcase, a three day event held in San Francisco in January.

While experts agree that Big Tech has the potential to improve patient outcomes by revolutionizing the way illnesses are diagnosed and treated, there are also challenges and ethical considerations when implementing AI in healthcare.

The Investing News Network sat in on several Biotech Showcase discussions on the role of AI and machine learning in healthcare, as well as the impact of digital medicine. These talks shed light on the opportunities and challenges of bringing these industries together, and explored strategies for overcoming obstacles and maximizing the benefits of these technologies. Read on to learn about key takeaways from the event.

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