Pyruvate kinase

Agios to Present Clinical and Translational Data at European Hematology Association Annual Congress

Retrieved on: 
Thursday, May 11, 2023

CAMBRIDGE, Mass., May 11, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced that the company and its collaborators will present a broad range of clinical and translational data at the European Hematology Association (EHA) Hybrid Congress, hosted virtually and in person in Frankfurt, Germany, June 8-11, 2023, and continuing virtually on the Congress platform June 14-15, 2023.

Key Points: 
  • – Agios to Present New Analyses from ACTIVATE, ACTIVATE-T and Long-Term Extension Studies in Adults with PK Deficiency Reinforcing Clinical Benefit of PYRUKYND® (mitapivat) on Hemoglobin, Hemolysis, Iron Overload and Patient-Reported Outcomes –
    CAMBRIDGE, Mass., May 11, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced that the company and its collaborators will present a broad range of clinical and translational data at the European Hematology Association (EHA) Hybrid Congress, hosted virtually and in person in Frankfurt, Germany, June 8-11, 2023, and continuing virtually on the Congress platform June 14-15, 2023.
  • The accepted abstracts are listed below and are available online on the EHA meeting library website.
  • All posters will be presented during the poster session on Friday, June 9 at 16:30-17:45 CEST.
  • All presentations can be accessed on demand by registered meeting attendees on the EHA Virtual Congress platform until Aug. 15, 2023.

Agios Reports Fourth Quarter and Full Year 2022 Financial Results

Retrieved on: 
Thursday, February 23, 2023

CAMBRIDGE, Mass., Feb. 23, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today reported business highlights and financial results for the fourth quarter and year ended Dec. 31, 2022.

Key Points: 
  • Launch: Continued to execute launch, generating $4.3 million in U.S. net revenue for the fourth quarter of 2022, the third full quarter following FDA approval.
  • Revenue: Net U.S. product revenue from sales of PYRUKYND® was $4.3 million for the fourth quarter of 2022, and $11.7 million for the full year ended Dec. 31, 2022.
  • Cost of Sales: Cost of sales was $0.4 million for the fourth quarter of 2022 and $1.7 million for the full year ended Dec. 31, 2022.
  • ET to discuss fourth quarter and year end 2022 financial results and recent business activities.

Remix Therapeutics Appoints Christopher Bowden, M.D., as Chief Medical Officer

Retrieved on: 
Thursday, January 5, 2023

CAMBRIDGE, Mass., Jan. 5, 2023 /PRNewswire/ -- Remix Therapeutics (Remix), a biotechnology company developing small molecule therapies to modulate RNA processing and address the underlying drivers of disease, today announced the appointment of Christopher Bowden, M.D., as Chief Medical Officer.

Key Points: 
  • CAMBRIDGE, Mass., Jan. 5, 2023 /PRNewswire/ -- Remix Therapeutics (Remix), a biotechnology company developing small molecule therapies to modulate RNA processing and address the underlying drivers of disease, today announced the appointment of Christopher Bowden, M.D., as Chief Medical Officer.
  • "We are especially pleased to welcome Chris to the Remix team as his wealth of strategic medical and corporate experience are ideally suited for this role.
  • We look forward to leveraging his extensive clinical expertise as we advance programs from our REMaster platform toward the clinic," said Peter Smith, Ph.D., Co-Founder and Chief Executive Officer of Remix Therapeutics.
  • Dr. Bowden joins Remix from Agios, where he served as a Strategic Advisor and Chief Medical Officer (CMO) from 2014-2022.

Agios Appoints Tsveta Milanova as Chief Commercial Officer

Retrieved on: 
Tuesday, December 6, 2022

CAMBRIDGE, Mass., Dec. 06, 2022 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced the appointment of Tsveta Milanova to the role of chief commercial officer, effective Jan. 3, 2023.

Key Points: 
  • CAMBRIDGE, Mass., Dec. 06, 2022 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced the appointment of Tsveta Milanova to the role of chief commercial officer, effective Jan. 3, 2023.
  • Ms. Milanova will succeed Richa Poddar, who has been with Agios since 2016 and will continue to serve as the company’s chief commercial officer until the end of the year.
  • She has been instrumental in helping make Agios what it is today.”
    Ms. Milanova joins Agios with two decades of experience in commercial leadership and global market access in the biopharmaceutical industry.
  • She spent five years at Alexion in high-impact commercial and market access roles, including senior vice president, head of U.S. commercial; senior vice president, global commercial strategy; and senior vice president, global value, access and policy.

Agios Receives Positive CHMP Opinion for PYRUKYND® (mitapivat) for the Treatment of Pyruvate Kinase (PK) Deficiency in Adult Patients

Retrieved on: 
Friday, September 16, 2022

If approved by the European Commission (EC), PYRUKYND will be the first approved disease-modifying therapy for European patients with PK deficiency.

Key Points: 
  • If approved by the European Commission (EC), PYRUKYND will be the first approved disease-modifying therapy for European patients with PK deficiency.
  • The positive CHMP opinion was based on results from two pivotal studies, ACTIVATE and ACTIVATE-T, conducted in not regularly transfused and regularly transfused adults with PK deficiency, respectively.
  • 40 percent (n=16) of patients randomized to PYRUKYND achieved a hemoglobin response, compared to 0 patients randomized to placebo (2-sided p
  • PYRUKYND is a pyruvate kinase activator indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency in the United States.

CENTOGENE and Agios Expand Partnership for Clinical Development of PYRUKYND® (mitapivat) to Treat Children With Rare Blood Disease

Retrieved on: 
Monday, June 13, 2022

Since 2015, CENTOGENE has provided genetic testing services to Agios for the clinical development of PYRUKYND.

Key Points: 
  • Since 2015, CENTOGENE has provided genetic testing services to Agios for the clinical development of PYRUKYND.
  • CENTOGENE will continue to provide genetic testing to help identify causative mutations, including the UGT1A1 and PKLR genes, in study participants.
  • In 2015, CENTOGENE originally entered into an agreement with Agios to provide support for Agios PK deficiency clinical program.
  • CENTOGENE engages in diagnosis and research around rare diseases transforming real-world clinical, genetic, and multiomic data to diagnose, understand, and treat rare diseases.

Agios to Present Clinical and Translational Data at the European Hematology Association Annual Congress

Retrieved on: 
Thursday, May 12, 2022

CAMBRIDGE, Mass., May 12, 2022 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, today announced that clinical and translational data will be presented at the European Hematology Association (EHA) Annual Congress, hosted virtually and in person in Vienna on June 9-12, 2022.

Key Points: 
  • ET
    CAMBRIDGE, Mass., May 12, 2022 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, today announced that clinical and translational data will be presented at the European Hematology Association (EHA) Annual Congress, hosted virtually and in person in Vienna on June 9-12, 2022.
  • All presentations can be accessed on demand by registered meeting attendees on the EHA Virtual Congress platform on Friday, June 20.
  • Such forward-looking statements include those regarding the potential benefits of mitapivat; Agios plans regarding future data presentations; and the potential benefit of its strategic plans and focus.
  • These and other risks are described in greater detail under the caption "Risk Factors" included in Agios public filings with theSecurities and Exchange Commission.

Agios Reports Business Highlights and First Quarter 2022 Financial Results

Retrieved on: 
Thursday, May 5, 2022

CAMBRIDGE, Mass., May 05, 2022 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, today reported business highlights and financial results for the first quarter ended March 31, 2022.

Key Points: 
  • Executed commercial launch of PYRUKYND and generated approximately $0.8 million in net U.S. revenue for the first partial quarter following launch.
  • Research and Development (R&D) Expenses: R&D expenses were$70.1 million for the first quarter of 2022 compared to$57.7 millionfor the first quarter of 2021.
  • Selling, General and Administrative (SG&A) Expenses: SG&A expenses were$31.5 millionfor the first quarter of 2022 compared to$33.6 millionfor the first quarter of 2021.
  • Agios will host a conference call and live webcast with slides today at8:00 a.m. ETto discuss first quarter 2022 financial results and recent business activities.

DGAP-News: BB BIOTECH AG: Increased investment level balanced by established core holdings

Retrieved on: 
Friday, April 22, 2022

As a consequence of the general sector correction the investment level increased to 113.0% (previous quarter: 110.9%).

Key Points: 
  • As a consequence of the general sector correction the investment level increased to 113.0% (previous quarter: 110.9%).
  • For the first quarter 2022, BB Biotech shares' total return was -11.3% in CHF and -8.6% in EUR.
  • The team will continue to work within the established and successful investment guidelines, such as investment levels of 95% to 115%.
  • BB Biotech expects the FDA to continue its constructive, purposeful but moderating interactions with the biopharmaceutical industry under his leadership.

Agios Announces Publication of Phase 3 ACTIVATE Study in New England Journal of Medicine Demonstrating Benefits of PYRUKYND® (mitapivat) for Adults with Pyruvate Kinase Deficiency

Retrieved on: 
Thursday, April 14, 2022

CAMBRIDGE, Mass., April 14, 2022 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, today announced that data from the core period of the pivotal Phase 3 ACTIVATE study of PYRUKYND® (mitapivat) in adults with pyruvate kinase (PK) deficiency who do not receive regular transfusions were published on April 14, 2022 in the New England Journal of Medicine. Data from this study were previously presented at the European Hematology Association (EHA) Virtual Congress held in June 2021. PYRUKYND® is a first-in-class, oral PK activator and the first and only approved disease-modifying treatment for this rare, debilitating, lifelong hemolytic anemia.

Key Points: 
  • Adverse events of grade 3 or higher occurred in 10 patients (25%) who received PYRUKYND and five patients (13%) who received placebo.
  • PYRUKYND was approved in February 2022 by the U.S. Food and Drug Administration (FDA) for the treatment of hemolytic anemia in adults with PK deficiency.
  • Agios conducted an additional pivotal Phase 3 study, ACTIVATE-T, in adults with PK deficiency who receive regular transfusions.
  • PYRUKYND is a pyruvate kinase activator indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.