Gamida Cell to Present Corporate Highlights at the Oppenheimer 33rd Annual Healthcare Conference
March 07 2023 - 08:00AM
Business Wire
Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working
to turn cells into powerful therapeutics, today announced that
Abbey Jenkins, President and Chief Executive Officer, will present
its corporate highlights at the upcoming Oppenheimer 33rd Annual
Healthcare Conference on March 14th, 2023 at 9:20 a.m. ET.
Ms. Jenkins will discuss company updates, including preparations
for the potential approval of the lead product candidate,
omidubicel, which has a target PDUFA action date with the U.S. Food
and Drug Administration (FDA) of May 1, 2023.
The webcast will be available on the “Investors & Media”
section of Gamida Cell’s website at www.gamida-cell.com, and will
be available for at least 14 days following the event.
About Omidubicel
Omidubicel is an advanced cell therapy candidate for allogeneic
hematopoietic stem cell (bone marrow) transplant that, if approved,
has the potential to expand access and improve outcomes for
patients with blood cancers. Omidubicel demonstrated a
statistically significant reduction in time to neutrophil
engraftment in comparison to standard umbilical cord blood in an
international, multi-center, randomized Phase 3 study (NCT02730299)
in patients with hematologic malignancies undergoing allogeneic
bone marrow transplant. The Phase 3 study also showed reduced time
to platelet engraftment, reduced infections and fewer days of
hospitalization. One year post-transplant data showed sustained
clinical benefits with omidubicel as demonstrated by significant
reduction in infectious complications as well as reduced
non-relapse mortality and no significant increase in relapse rates
nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel
is the first stem cell transplant donor source to receive
Breakthrough Therapy Designation from the FDA and has also received
Orphan Drug Designation in the US and EU. Omidubicel has a PDUFA
target action date of May 1, 2023.
Omidubicel is an investigational stem cell therapy candidate,
and its safety and efficacy have not been established by the FDA or
any other health authority. For more information about omidubicel,
please visit https://www.gamida-cell.com.
About Gamida Cell
Gamida Cell is a cell therapy pioneer working to turn cells into
powerful therapeutics. The company has a diverse pipeline of
potentially curative cell therapy candidates for patients with
blood cancers and solid tumors. We apply a proprietary expansion
platform leveraging the properties of NAM to allogeneic cell
sources including umbilical cord blood-derived cells and NK cells
to create therapy candidates with the potential to redefine
standards of care. These include omidubicel, an advanced cell
therapy candidate for allogeneic hematopoietic stem cell transplant
that, if approved, has the potential to expand access and improve
outcomes for patients with blood cancers, and a line of enhanced
and engineered NK cells targeted at solid tumors and hematological
malignancies. For additional information, please visit
www.gamida-cell.com or follow Gamida Cell on LinkedIn, Twitter,
Facebook or Instagram at @GamidaCellTx.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as that
term is defined in the Private Securities Litigation Reform Act of
1995, including with respect to timing of the FDA’s review of the
BLA for omidubicel, and the potentially life-saving or curative
therapeutic and commercial potential of Gamida Cell’s product
candidates (including omidubicel). Any statement describing Gamida
Cell’s goals, expectations, financial or other projections,
intentions or beliefs is a forward-looking statement and should be
considered an at-risk statement. Such statements are subject to a
number of risks, uncertainties and assumptions, including those
related to the impact that the COVID-19 pandemic could have on our
business; clinical, scientific, regulatory and technical
developments; and those inherent in the process of developing and
commercializing product candidates that are safe and effective for
use as human therapeutics. In light of these risks and
uncertainties, and other risks and uncertainties that are described
in the Risk Factors section and other sections of Gamida Cell’s
Quarterly Report on Form 10-Q, filed with the Securities and
Exchange Commission (SEC) on November 14, 2022, and other filings
that Gamida Cell makes with the SEC from time to time (which are
available at http://www.sec.gov), the events and circumstances
discussed in such forward-looking statements may not occur, and
Gamida Cell’s actual results could differ materially and adversely
from those anticipated or implied thereby. Although Gamida Cell’s
forward-looking statements reflect the good faith judgment of its
management, these statements are based only on facts and factors
currently known by Gamida Cell. As a result, you are cautioned not
to rely on these forward-looking statements.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230306005599/en/
Investor Contact: Courtney Turiano Stern Investor
Relations, Inc. Courtney.Turiano@sternir.com 1-212-362-1200
Media Contact: Dan Boyle Orangefiery dan@orangefiery.com
1-818-209-1692
Gamida Cell (NASDAQ:GMDA)
Historical Stock Chart
From May 2023 to Jun 2023
Gamida Cell (NASDAQ:GMDA)
Historical Stock Chart
From Jun 2022 to Jun 2023