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 for investors and analysts on Friday,
October 2, 2020 at 8:00 a.m. EDT to discuss the design of its first
registrational Phase 3 STELLAR trial of sotatercept in patients
with pulmonary arterial hypertension (PAH).
The webcast will include Acceleron’s senior management team
along with the STELLAR trial’s principal investigator, Marius
Hoeper, M.D.1 Dr. Hoeper is a Professor and Senior Physician in the
Department of Respiratory Medicine, Head of the pulmonary
hypertension (PH) program, and attending physician at the intensive
care unit, Hannover Medical School, Hannover, Germany. His main
scientific interest lies in the field of pulmonary hypertension, in
which he has published more than 250 papers.
1. Dr. Hoeper is a paid consultant to Acceleron.
Webcast and Conference Call Information
The webcast will be accessible under “Events &
Presentations” in the Investors/Media page of the company's website
at www.acceleronpharma.com. Individuals can participate in the live
conference call by dialing 877-312-5848 (domestic) or 253-237-1155
(international) and referring to the “Acceleron STELLAR Phase 3
Trial Design Conference Call.”
A replay of the webcast will be available on the Acceleron
website approximately two hours after the event.
About Sotatercept
Sotatercept is an investigational agent designed to be a
selective ligand trap for members of the TGF-beta superfamily to
rebalance BMPR-II signaling, which is a key molecular driver of
PAH. In the Phase 2 PULSAR trial, sotatercept, in patients on
stable background approved PAH therapies, achieved both its primary
endpoint (improvement in pulmonary vascular resistance) and its key
secondary endpoint (improvement in 6-minute walk distance). Also in
the PULSAR trial, a higher proportion of patients achieved the
exploratory multi-component improvement endpoint at week 24. This
endpoint was based on achieving all 3 of the following distinct
measures in PAH: improvements in WHO functional class, NT-proBNP
and 6-minute walk distance. Sotatercept was generally well
tolerated in the PULSAR trial, and 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 exploratory Phase 2
SPECTRA trial. In preclinical research published in Science
Translational Medicine, sotatercept exhibited consistent effects
across multiple components of disease, including suppressed
proliferation of pulmonary arterial smooth muscle and microvascular
endothelial cells, reduced pulmonary pressures, lessened right
ventricular hypertrophy, improved right ventricular function, and
attenuated vascular remodeling.
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 commercialization, research, and
development efforts in hematologic and pulmonary diseases. In
hematology, REBLOZYL® (luspatercept-aamt) is the first and only
erythroid maturation agent approved in the United States and Europe
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 MDS, beta-thalassemia, and myelofibrosis. In
pulmonary, Acceleron is developing sotatercept for the treatment of
pulmonary arterial hypertension (PAH), having recently presented
positive topline results of the Phase 2 PULSAR 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.
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, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200917005913/en/
Investors: Jamie Bernard, IRC, 617-649-9650 Associate Director,
Investor Relations Media: Matt Fearer, 617-301-9557 Director,
Corporate Communications
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