Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in cellular
metabolism and PK activation pioneering therapies for rare
diseases, today announced that data from its programs will be
presented at the European Hematology Association 2024 (EHA2024)
Hybrid Congress, to be held June 13-16, 2024, in Madrid, Spain.
Data from the Phase 3 ENERGIZE study of mitapivat in
non-transfusion-dependent thalassemia will be presented in a
plenary session on June 15, 14:45-15:15 CEST (Abstract #S104) and
in a poster session on June 14, 18-19:00 CEST (Abstract #P1529).
Additional presentations will highlight data across Agios’ pipeline
in rare blood disorders, including sickle cell disease and pyruvate
kinase deficiency.
In total, seven abstracts led by Agios and external
collaborators will be presented or published. The accepted
abstracts are listed below and are available online on the EHA
congress website at www.ehaweb.org.
ThalassemiaData from the global Phase 3
ENERGIZE study of mitapivat in alpha- or beta-
non-transfusion-dependent thalassemia.
Plenary Abstracts Session:
Title: ENERGIZE: A Global Phase 3 Study of
Mitapivat Demonstrating Efficacy and Safety in Adults with Alpha-
or Beta- Non-Transfusion-Dependent
ThalassemiaAbstract: S104Session Date and
Time: Saturday, June 15, 14:45-15:15
CESTPresenter: Ali T. Taher, M.D., Ph.D.; Naef K.
Basile Cancer Institute, American University of Beirut Medical
Center in Beirut, Lebanon
Poster Presentation:
Title: Improvements in Fatigue and 6-minute
Walk Test in Adults with Alpha- and Beta-Non-Transfusion-Dependent
Thalassemia: The Phase 3 ENERGIZE Trial of
MitapivatAbstract: P1529 Session Date and
Time: Friday, June 14, 18-19:00 CESTLead
Author: Kevin H. M. Kuo, M.D., MSc, FRCPC; Division of
Hematology, University of Toronto, Toronto, ON, Canada
Sickle Cell DiseaseA look at the design of the
Phase 3 portion of the RISE UP study, as well as information about
Phase 2 open-label renal study.
e-Poster Presentations:
Title: Study Design of the Phase 3 Portion of
RISE UP: A Phase 2/3, Randomized, Double-blind, Placebo-controlled
Study of Mitapivat in Patients with Sickle Cell
DiseaseAbstract: P2193Time:
Friday, June 14, 9:00 CESTLead Author: Biree
Andemariam, M.D.; New England Sickle Cell Institute, University of
Connecticut Health, Farmington, CT
Title: The Launch of a Global, Phase 2,
Open-label, Multicenter, Single-arm Study of Mitapivat in Patients
with Sickle Cell Disease and NephropathyAbstract:
P2194Time: Friday, June 14, 9:00 CESTLead
Author: Fuad El Rassi, M.D.; Department of Hematology and
Medical Oncology, Winship Cancer Institute, Emory University School
of Medicine, Atlanta, GA, USA; Georgia Comprehensive Sickle Cell
Center at Grady Health System, Grady Memorial Hospital, Atlanta,
GA, USA
Title: Cost Analysis of Care Expenditures of
Patients with Sickle Cell Disease of Hydroxyurea Therapy in a
Specialized Blood Center in Rio de Janeiro, Brazil
Abstract: P2306Time: Friday, June
14, 9:00 CESTLead Author: La’Ron Browne, M.D.;
Pediatric Hematology Oncology Clinical Fellow, St. Jude Children's
Research Hospital, Memphis, TN
Pyruvate Kinase DeficiencyReal-world data
describing the characteristics of pediatric patients facing iron
overload as part of their disease.
Poster Presentation:
Title: The Characteristics of Pediatric
Patients with Pyruvate Kinase Deficiency and Iron
OverloadSession Date and Time: Friday, June 14,
18-19:00 CEST Abstract: P1564Lead
Author: Rachael F. Grace, M.D., MMSc; Dana-Farber/Boston
Children’s Cancer and Blood Disorder Center, Harvard Medical
School, Boston, MA
OtherAgios’ collaborators present new data
evaluating mitapivat as a potential treatment for other rare
hemolytic anemias.
Oral Presentation:
Title: Ex Vivo Pyruvate Kinase Activation in
Hereditary Spherocytosis and Xerocytosis: Improved Enzyme Function
and Red Cell PropertiesPresentation Time: Sunday,
June 16, 11:30-12:45 CEST Abstract:
S299Presenter: Jonathan R.A. de Wilde, Ph.D.
Candidate; Red Blood Cell Research Group, Central Diagnostic
Laboratory-Research, University Medical Center Utrecht, Utrecht
University, Utrecht, the Netherlands
Conference Call InformationAgios will host a
virtual investor breakout session on June 16, 2024, at 10:00 a.m.
ET (4 p.m. CEST) to review the key clinical oral and poster
presentations from this year’s EHA meeting. The event will be
webcast live and can be accessed under “Events & Presentations”
in the Investors and Media section of the company's website at
www.agios.com. The archived webcast will be available on the
company's website beginning approximately two hours after the
event.
About AgiosAgios is the pioneering leader in PK
activation and is dedicated to developing and delivering
transformative therapies for patients living with rare diseases. In
the U.S., Agios markets a first-in-class pyruvate kinase (PK)
activator for adults with PK deficiency, the first
disease-modifying therapy for this rare, lifelong, debilitating
hemolytic anemia. Building on the company's deep scientific
expertise in classical hematology and leadership in the field of
cellular metabolism and rare hematologic diseases, Agios is
advancing a robust clinical pipeline of investigational medicines
with programs in alpha- and beta-thalassemia, sickle cell disease,
pediatric PK deficiency, MDS-associated anemia and phenylketonuria
(PKU). In addition to its clinical pipeline, Agios is advancing a
preclinical TMPRSS6 siRNA as a potential treatment for polycythemia
vera. For more information, please visit the company’s website at
www.agios.com.
Cautionary Note Regarding Forward-Looking
Statements This press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Such forward-looking statements include those
regarding the potential benefits of PYRUKYND® (mitapivat); plans
regarding future data presentations;and the potential benefits of
Agios’ strategic plans and focus. The words “anticipate,” “expect,”
“goal,” “hope,” “milestone,” “plan,” “potential,” “possible,”
“strategy,” “will,” “vision,” and similar expressions are intended
to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Such
statements are subject to numerous important factors, risks and
uncertainties that may cause actual events or results to differ
materially from Agios’ current expectations and beliefs. For
example, there can be no guarantee that any product candidate Agios
is developing will successfully commence or complete necessary
preclinical and clinical development phases, or that development of
any of Agios’ product candidates will successfully continue. There
can be no guarantee that any positive developments in Agios’
business will result in stock price appreciation. Management's
expectations and, therefore, any forward-looking statements in this
press release could also be affected by risks and uncertainties
relating to a number of other important factors, including, without
limitation: risks and uncertainties related to the impact of
pandemics or other public health emergencies to Agios’ business,
operations, strategy, goals and anticipated milestones, including
its ongoing and planned research activities, ability to conduct
ongoing and planned clinical trials, clinical supply of current or
future drug candidates, commercial supply of current or future
approved products, and launching, marketing and selling current or
future approved products; Agios’ results of clinical trials and
preclinical studies, including subsequent analysis of existing data
and new data received from ongoing and future studies; the content
and timing of decisions made by the U.S. FDA, the EMA or other
regulatory authorities, investigational review boards at clinical
trial sites and publication review bodies; Agios’ ability to obtain
and maintain requisite regulatory approvals and to enroll patients
in its planned clinical trials; unplanned cash requirements and
expenditures; competitive factors; Agios' ability to obtain,
maintain and enforce patent and other intellectual property
protection for any product candidates it is developing; Agios’
ability to establish and maintain key collaborations; uncertainty
regarding any milestone or royalty payments related to the sale of
its oncology business or its in-licensing of TMPRSS6 siRNA, and the
uncertainty of the timing of any such payments; uncertainty of the
results and effectiveness of the use of Agios’ cash and cash
equivalents; and general economic and market conditions. These and
other risks are described in greater detail under the caption "Risk
Factors" included in Agios’ public filings with the Securities and
Exchange Commission. Any forward-looking statements contained in
this press release speak only as of the date hereof, and Agios
expressly disclaims any obligation to update any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as required by law.
Contacts:
Investor ContactChris Taylor, VP, Investor
Relations and Corporate CommunicationsAgios
PharmaceuticalsIR@agios.com
Media ContactDan Budwick1AB
Mediadan@1abmedia.com
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