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Acceleron Announces Presentations on REBLOZYL® (luspatercept-aamt) at the 2021 European Hematology Association Virtual Congress

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- 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/

Contacts

Investors:
Jamie Bernard, IRC, 617-301-9650
Associate Director, Investor Relations

Media:
Matt Fearer, 617-301-9557
Senior Director, Corporate Communications