Agios

Agios Presents Positive Results from Phase 2 Portion of the RISE UP Pivotal Study in Sickle Cell Disease at 65th ASH Annual Meeting and Exposition

Retrieved on: 
Sunday, December 10, 2023
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CAMBRIDGE, Mass., Dec. 09, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today presented detailed results from the Phase 2 portion of the global RISE UP study of mitapivat in sickle cell disease in an oral presentation (abstract #271) at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition, which is being hosted Dec. 9-12, 2023, in San Diego.

Key Points: 
  • The safety profile for mitapivat observed in the study was generally consistent with previously reported data in other studies of sickle cell disease and other hemolytic anemias.
  • Improvements were observed in annualized rates of sickle cell pain crises, and markers of hemolysis and erythropoiesis for both mitapivat treatment arms compared to placebo.
  • “Currently there are no approved oral therapies that address both sickle cell pain crises and chronic anemia, two of the hallmark symptoms of the disease.
  • Title: A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study of Mitapivat in Patients With Sickle Cell Disease: RISE UP Phase 2 Results
    Oral Abstract Session: 114.

Agios Reports Business Highlights and Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 2, 2023
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CAMBRIDGE, Mass., Nov. 02, 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 third quarter ended September 30, 2023.

Key Points: 
  • Launch: Generated $7.4 million in U.S. net revenue for the third quarter of 2023, a 10 percent increase over the second quarter of 2023.
  • A total of 160 unique patients have completed prescription enrollment forms, representing an increase of 9 percent over the second quarter of 2023.
  • Net Loss: Net loss was $91.3 million for the third quarter of 2023 compared to $81.7 million for the third quarter of 2022.
  • ET to discuss third quarter 2023 financial results and recent business activities.

Regeneron Announces Updates to Board of Directors

Retrieved on: 
Friday, September 8, 2023
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TARRYTOWN, N.Y., Sept. 08, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that Kathryn Guarini, Ph.D., and David P. Schenkein, M.D., have joined Regeneron’s Board of Directors effective September 8, 2023.

Key Points: 
  • TARRYTOWN, N.Y., Sept. 08, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that Kathryn Guarini, Ph.D., and David P. Schenkein, M.D., have joined Regeneron’s Board of Directors effective September 8, 2023.
  • “I am thrilled to join Regeneron’s Board of Directors,” said Dr. Guarini.
  • “It has been a great privilege to be a member of Regeneron’s Board for close to 12 years,” said Dr. Tessier-Lavigne.
  • We also thank Marc for his many outstanding contributions and long-term commitment to Regeneron, and we wish him well in his next steps.”

Agios Reports Business Highlights and Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, August 3, 2023
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Launch: Generated $6.7 million in U.S. net revenue for the second quarter of 2023, a 20 percent increase over the first quarter of 2023.

Key Points: 
  • Launch: Generated $6.7 million in U.S. net revenue for the second quarter of 2023, a 20 percent increase over the first quarter of 2023.
  • Research and Development (R&D) Expenses: R&D expenses were $68.9 million for the second quarter of 2023 compared to $74.5 million for the second quarter of 2022.
  • Net Loss: Net loss was $83.8 million for the second quarter of 2023 compared to $91.8 million for the second quarter of 2022.
  • ET to discuss second quarter 2023 financial results and recent business activities.

Agios Announces Exclusive Worldwide License Agreement for Novel siRNA for the Potential Treatment of Polycythemia Vera

Retrieved on: 
Thursday, August 3, 2023
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CAMBRIDGE, Mass., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO) has entered into an exclusive worldwide license agreement with Alnylam Pharmaceuticals, Inc. under which Agios will acquire the rights to develop and commercialize Alnylam’s novel preclinical siRNA targeting TMPRSS6, as a potential disease-modifying treatment for patients with polycythemia vera (PV). This agreement combines Agios’ deep scientific expertise and capabilities in rare hematologic diseases with Alnylam’s industry-leading siRNA platform and strong track record of success.

Key Points: 
  • CAMBRIDGE, Mass., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO) has entered into an exclusive worldwide license agreement with Alnylam Pharmaceuticals, Inc. under which Agios will acquire the rights to develop and commercialize Alnylam’s novel preclinical siRNA targeting TMPRSS6, as a potential disease-modifying treatment for patients with polycythemia vera (PV).
  • This agreement combines Agios’ deep scientific expertise and capabilities in rare hematologic diseases with Alnylam’s industry-leading siRNA platform and strong track record of success.
  • Under the terms of the agreement, Agios will make an upfront payment of $17.5 million to Alnylam for an exclusive global license to the TMPRSS6 siRNA program.
  • Alnylam will provide manufacturing support for Phase 1, after which Agios will assume full responsibility for manufacturing.

EQS-News: BB BIOTECH AG: Sector rotation and fund outflows weigh on biotech stocks, but positive developments allow fund raising to strengthen industry

Retrieved on: 
Friday, July 21, 2023
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BB BIOTECH AG: Sector rotation and fund outflows weigh on biotech stocks, but positive developments allow fund raising to strengthen industry

Key Points: 
  • BB BIOTECH AG: Sector rotation and fund outflows weigh on biotech stocks, but positive developments allow fund raising to strengthen industry
    The issuer is solely responsible for the content of this announcement.
  • Media release as at July 21, 2023
    Interim report of BB Biotech AG as at June 30, 2023
    Sector rotation and fund outflows weigh on biotech stocks, but positive developments allow fund raising to strengthen industry
    The first half of 2023 has been disappointing for biotech investors.
  • This delisting will lower BB Biotech’s administrative costs and BB Biotech shareholders will still be able to buy and sell BB Biotech shares in EUR on the Frankfurt Stock Exchange.
  • The quarterly report of BB Biotech AG as at June 30, 2023, can be downloaded at report.bbbiotech.ch/Q223 or www.bbbiotech.com .

Agios Announces Positive Results from Phase 2 Portion of RISE UP Pivotal Study in Sickle Cell Disease with Both Mitapivat Dose Arms Achieving Statistically Significant Hemoglobin Response

Retrieved on: 
Monday, June 26, 2023
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CAMBRIDGE, Mass., June 26, 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 Phase 2 portion of the global RISE UP study of mitapivat in sickle cell disease met its primary endpoint of hemoglobin response for patients in both the 50 mg and 100 mg twice daily (BID) mitapivat arms. The safety profile for mitapivat observed in the study was generally consistent with previously reported data in other studies of sickle cell disease and other hemolytic anemias. Improvements were observed in markers of hemolysis and erythropoiesis and annualized rates of sickle cell pain crises at both mitapivat doses compared to placebo. These results support proceeding with the Phase 3 portion of the study.

Key Points: 
  • Improvements were observed in markers of hemolysis and erythropoiesis and annualized rates of sickle cell pain crises at both mitapivat doses compared to placebo.
  • “Sickle cell disease is a complex and debilitating disease characterized by anemia, pain crises, fatigue, cognitive effects and more.
  • Given the promising data for both mitapivat dose arms, the company will continue to analyze the study data over the coming weeks to select a dose for the Phase 3 study.
  • Agios plans to present a full analysis of the RISE UP Phase 2 data at an upcoming medical meeting.

Agios Reports Business Highlights and First Quarter 2023 Financial Results

Retrieved on: 
Thursday, May 4, 2023
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CAMBRIDGE, Mass., May 04, 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 first quarter ended March 31, 2023.

Key Points: 
  • Launch: Generated $5.6 million in U.S. net revenue for the first quarter of 2023, the fourth full quarter following FDA approval.
  • A total of 89 patients are on PYRUKYND® therapy, representing a 14 percent increase over the fourth quarter of 2022.
  • Net Loss: Net loss was $81.0 million for the first quarter of 2023 compared to $94.8 million for the first quarter of 2022.
  • ET to discuss first quarter 2023 financial results and recent business activities.

Agios Reports Fourth Quarter and Full Year 2022 Financial Results

Retrieved on: 
Thursday, February 23, 2023
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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.

PYRUKYND® (mitapivat) Approved in the EU for the Treatment of Pyruvate Kinase (PK) Deficiency in Adult Patients

Retrieved on: 
Thursday, November 10, 2022
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Agios is providing access to PYRUKYND for the treatment of PK deficiency in adults receiving care in the EU through a global managed access program.

Key Points: 
  • Agios is providing access to PYRUKYND for the treatment of PK deficiency in adults receiving care in the EU through a global managed access program.
  • PYRUKYND was previously granted orphan drug designation by the EMA, which is maintained at the time of EU marketing authorization.
  • PYRUKYND was approved by the U.S. Food and Drug Administration (FDA) in February 2022 for the treatment of hemolytic anemia in adults with PK deficiency.
  • PYRUKYND is a pyruvate kinase activator indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency in the United States, and for the treatment of PK deficiency in adult patients in the European Union.