Acceleron Pharma Inc. (Nasdaq:XLRN), a leading biopharmaceutical
company in the discovery, development, and commercialization of
TGF-beta superfamily therapeutics to treat serious and rare
diseases, today announced it will host a conference call and
webcast on Wednesday, May 19, 2021 at 10:30 a.m. EDT to review
updates from the PULSAR and SPECTRA Phase 2 clinical trials of
sotatercept in patients with pulmonary arterial hypertension (PAH).
Data from the PULSAR and SPECTRA trials will have been presented
during clinical presentations at the American Thoracic Society 2021
International Conference (ATS 2021) earlier that day.
Guest Presenter:
- Aaron Waxman1, M.D., Ph.D., Director of the Pulmonary Vascular
Disease Program at Brigham and Women’s Hospital; Associate
Professor of Medicine at Harvard Medical School
The webcast will be accessible under "Events &
Presentations" in the Investors & Media page of the Company’s
website at www.acceleronpharma.com. To participate in the
conference call, please dial 833-494-1483 (domestic) or
236-714-2620 (international) and reference code #6565123.
An archived version of the webcast will be available for replay
on the Company’s website for approximately one year.
1 Dr. Waxman is the principal investigator
of the SPECTRA trial and a paid consultant to Acceleron.
About Sotatercept
Sotatercept is an investigational reverse-remodeling agent
designed to be a selective ligand trap for members of the TGF-beta
superfamily to rebalance signaling in the BMP pathway, which is a
key molecular driver of PAH. In preclinical studies, sotatercept
was shown to reverse the vascular remodeling that is a hallmark of
PAH. The PULSAR Phase 2 trial evaluating sotatercept in combination
with approved PAH-specific medicines in patients with PAH achieved
its primary endpoint of improvement in pulmonary vascular
resistance and its key secondary endpoint of improvement in
6-minute walk distance. Sotatercept was generally well tolerated in
the trial. Adverse events observed in the study were generally
consistent with previously published data on sotatercept in other
diseases. Following the PULSAR results, sotatercept was granted
Breakthrough Therapy designation from the FDA and Priority
Medicines designation from the EMA in PAH. Sotatercept is also
being evaluated in the SPECTRA Phase 2 exploratory trial.
The Company recently presented details of its Phase 3
development plan, including the design for the registrational
STELLAR trial, which is currently enrolling patients with PAH.
Acceleron is planning two additional Phase 3 studies in patients
with PAH: the HYPERION trial in newly diagnosed patients and the
ZENITH trial assessing intervention in patients diagnosed with
World Health Organization (WHO) functional class IV disease.
Sotatercept is an investigational therapy that is not approved
for any use in any country. Sotatercept is part of a licensing
agreement with Bristol Myers Squibb.
About PAH
PAH is a rare and chronic, rapidly progressing disorder
characterized by the constriction of small pulmonary arteries and
elevated blood pressure in the pulmonary circulation. PAH results
in significant strain on the heart, often leading to limited
physical activity, heart failure, and reduced life expectancy. The
5-year survival rate for patients with PAH is approximately 57%.
Available therapies generally act by promoting the dilation of
pulmonary vessels without addressing the underlying cause of the
disease. As a result, PAH often progresses rapidly for many
patients despite standard of care treatment. A growing body of
research has implicated imbalances in BMP and TGF-beta signaling as
a primary driver of PAH in familial, idiopathic, and acquired forms
of the disease.
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 of sotatercept in PAH, the
timeline for clinical development and regulatory approval of
sotatercept in PAH, the expected timing for reporting of data from
ongoing clinical trials, and the potential of Acceleron’s compounds
as therapeutic drugs. The words "anticipate," "believe," "could,"
"estimate," "expect," "goal," "intend," "may," "plan," “possible,”
"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 preclinical
testing of Acceleron’s compounds and data from clinical trials may
not be predictive of the results or success of ongoing or later
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, that
Acceleron will be unable to successfully complete the clinical
development of Acceleron’s compounds, that Acceleron may be delayed
in initiating, enrolling or completing any clinical trials, that
Acceleron’s compounds will not receive regulatory approval or
become commercially successful products, and that Breakthrough
Therapy or PRIME designation may not expedite the development or
review of sotatercept. 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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210511005335/en/
Acceleron Pharma Inc. 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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