- Results from the BEYOND Phase 2 trial in
non-transfusion dependent beta-thalassemia to be presented during
Presidential Symposium –
- Additional presentations to feature data from
longer-term use of REBLOZYL in populations of patients with
beta-thalassemia, myelodysplastic syndromes -
Acceleron Pharma Inc. (Nasdaq: XLRN), a biopharmaceutical
company dedicated to the discovery, development, and
commercialization of TGF-beta superfamily therapeutics to treat
serious and rare diseases, today announced that multiple abstracts
on REBLOZYL® (luspatercept-aamt) will be presented at the upcoming
2021 European Hematology Association (EHA2021) Virtual Congress, to
be held from June 9-17.
Of particular note, results from the BEYOND Phase 2 trial of
luspatercept in adults with non-transfusion dependent
beta-thalassemia will be presented on Friday, June 11th, during the
Presidential Symposium, which honors the top six research papers
submitted for presentation at the meeting.
“It’s a privilege to have such a prominent platform from which
to share exciting new data on the effects of luspatercept in a
patient population long in need of new therapeutic options,” said
Habib Dable, President and Chief Executive Officer of Acceleron.
“Moreover, it’s quite gratifying to present additional research
that helps further establish luspatercept’s efficacy and safety
profile.”
Presentations at EHA2021
Title:
The BEYOND Study: Results of a Phase 2,
double-blind, randomized, placebo-controlled multi-center study of
luspatercept in adult patients with non-transfusion dependent
beta-thalassemia – Abstract: S101
Session:
Presidential Symposium
Date:
June 11, 2021
Time:
4:00 p.m. to 5:30 p.m. CEST
Title:
Fewer red blood cell transfusion units
and visits across baseline transfusion burden levels in patients
with beta-thalassemia treated with luspatercept in the Phase 3
BELIEVE trial – Abstract: e-Poster 1304
Session:
Thalassemias
Title:
Long-term efficacy and safety outcomes
in the Phase 2 study of luspatercept in beta-thalassemia –
Abstract: e-Poster 1305
Session:
Thalassemias
Title:
Benefit of continuing therapy with
luspatercept in patients with beta-thalassemia who do not achieve
≥33% reduction in red blood cell (RBC) transfusion burden (TB) in
weeks 13-24 in the BELIEVE trial – Abstract: e-Poster 1306
Session:
Thalassemias
Title:
Benefit of continuing luspatercept
therapy in patients with lower-risk myelodysplastic syndromes who
did not achieve red blood cell transfusion independence by week 25
in the MEDALIST study – Abstract: e-Poster 915
Session:
Myelodysplastic syndromes
Title:
Luspatercept reduces red blood cell
transfusions in patients with lower-risk myelodysplastic syndromes
regardless of baseline transfusion burden in the MEDALIST study –
Abstract: e-Poster 920
Session:
Myelodysplastic syndromes
All e-Poster presentations will be available on the on-demand
EHA2021 Virtual Congress Platform on June 11, 2021 between 9:00
a.m. and 11:59 p.m. CEST.
Abstracts of the above presentations are currently available
online on EHA2021 Virtual Congress Platform.
About REBLOZYL (luspatercept-aamt)
REBLOZYL (luspatercept-aamt), a first-in-class erythroid
maturation agent, promotes late-stage red blood cell maturation in
animal models. Bristol Myers Squibb and Acceleron are jointly
developing REBLOZYL as part of a global collaboration.
REBLOZYL is currently approved in the U.S. for the treatment
of:
- Anemia in adult patients with beta-thalassemia who require
regular red blood cell transfusions, and
- Anemia failing an erythropoiesis stimulating agent and
requiring 2 or more red blood cell units over 8 weeks in adult
patients with very low- to intermediate-risk myelodysplastic
syndromes with ring sideroblasts (MDS-RS) or with
myelodysplastic/myeloproliferative neoplasm with ring sideroblasts
and thrombocytosis (MDS/MPN-RS-T).
In Europe, REBLOZYL is approved for the treatment of:
- Adult patients with transfusion-dependent anemia due to very
low-, low- and intermediate-risk myelodysplastic syndromes (MDS)
with ring sideroblasts, who had an unsatisfactory response or are
ineligible for erythropoietin-based therapy.
- Adult patients with transfusion-dependent anemia associated
with beta-thalassemia.
In Canada, REBLOZYL is approved for the treatment of:
- Adult patients with transfusion-dependent anemia requiring at
least two RBC red blood cell (RBC) units over 8 weeks resulting
from very low-to intermediate-risk myelodysplastic syndromes (MDS)
who have ring sideroblasts and who have failed or are not suitable
for erythropoietin-based therapy.
- Adult patients with red blood cell (RBC) transfusion-dependent
anemia associated with beta-thalassemia.
REBLOZYL is not indicated for use as a substitute for red blood
cell transfusions in patients who require immediate correction of
anemia.
About Acceleron
Acceleron is a biopharmaceutical company dedicated to the
discovery, development, and commercialization of therapeutics to
treat serious and rare diseases. Acceleron’s leadership in the
understanding of TGF-beta superfamily biology and protein
engineering generates innovative compounds that engage the body's
ability to regulate cellular growth and repair.
Acceleron focuses its research, development, and
commercialization efforts in pulmonary and hematologic diseases. In
pulmonary, Acceleron is developing sotatercept for the treatment of
pulmonary arterial hypertension (PAH), having reported positive
topline results of the PULSAR Phase 2 trial. The Company is
currently planning multiple Phase 3 trials with the potential to
support its long-term vision of establishing sotatercept as a
backbone therapy for patients with PAH at all stages of the
disease. Acceleron is also investigating the potential of its
early-stage pulmonary candidate, ACE-1334, which it plans to
advance into a Phase 1b/Phase 2 trial in systemic
sclerosis-associated interstitial lung disease (SSc-ILD) this
year.
In hematology, REBLOZYL® (luspatercept-aamt) is the first and
only erythroid maturation agent approved in the United States,
Europe, and Canada for the treatment of anemia in certain blood
disorders. REBLOZYL is part of a global collaboration partnership
with Bristol Myers Squibb. The Companies co-promote REBLOZYL in the
United States and are also developing luspatercept for the
treatment of anemia in patient populations of myelodysplastic
syndromes, beta-thalassemia, and myelofibrosis.
For more information, please visit www.acceleronpharma.com.
Follow Acceleron on Social Media: @AcceleronPharma and
LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements about
Acceleron’s strategy, future plans and prospects, including
statements regarding the development and commercialization of
Acceleron’s compounds, the timeline for clinical development and
regulatory approval of Acceleron’s compounds, the expected timing
for reporting of data from ongoing clinical trials, and the
potential of Reblozyl® (luspatercept-aamt) as a therapeutic drug.
The words "anticipate," "believe," "could," "estimate," "expect,"
"goal," "intend," "may," "plan," "potential," "project," "should,"
"target," "will," "would," and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Actual results could differ materially from those included in
the forward-looking statements due to various factors, risks and
uncertainties, including, but not limited to, that the results of
any clinical trials may not be predictive of the results or success
of other clinical trials, that regulatory approval of Acceleron’s
compounds in one indication or country may not be predictive of
approval in another indication or country, that the development of
Acceleron’s compounds will take longer and/or cost more than
planned or accelerate faster than currently expected, that
Acceleron or its collaboration partner, Bristol Myers Squibb
Corporation (“BMS”), will be unable to successfully complete the
clinical development of Acceleron’s compounds, that Acceleron or
BMS may be delayed in initiating, enrolling or completing any
clinical trials, and that Acceleron’s compounds will not receive
regulatory approval or become commercially successful products.
These and other risks and uncertainties are identified under the
heading “Risk Factors” included in Acceleron’s most recent Annual
Report on Form 10-K, Quarterly Report on Form 10-Q, and other
filings that Acceleron has made and may make with the SEC in the
future.
The forward-looking statements contained in this press release
are based on management's current views, plans, estimates,
assumptions, and projections with respect to future events, and
Acceleron does not undertake and specifically disclaims any
obligation to update any forward-looking statements.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210512005696/en/
Investors: Jamie Bernard, IRC, 617-301-9650 Associate Director,
Investor Relations
Media: Matt Fearer, 617-301-9557 Senior Director, Corporate
Communications
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