Agios Pharma Files US Application For Mitapivat In PK Deficiency

  • Agios Pharmaceuticals Inc AGIO has submitted an FDA marketing application seeking approval for mitapivat to treat adults with pyruvate kinase (PK) deficiency.
  • The company says, if approved, mitapivat could be the first potentially disease-modifying therapy for PK deficiency.
  • The submission is based on two studies, ACTIVATE and ACTIVATE-T, conducted in not regularly transfused and regularly transfused adults with PK deficiency, respectively. 
  • A complete analysis of these data was recently presented at the European Hematology Association Virtual Congress. 
  • An extension study for adults with PK deficiency previously enrolled in ACTIVATE or ACTIVATE-T is ongoing and designed to evaluate the long-term safety, tolerability, and efficacy of treatment with mitapivat. 
  • The company remains on track to submit a marketing application in the EU in mid-2021 for mitapivat in adults with PK deficiency.
  • Price Action: AGIO shares are up 0.86% at $61 on the last check Monday.

Posted In: BriefsBiotechNewsHealth CareFDAGeneral

Ad Disclosure: The rate information is obtained by Bankrate from the listed institutions. Bankrate cannot guaranty the accuracy or availability of any rates shown above. Institutions may have different rates on their own websites than those posted on The listings that appear on this page are from companies from which this website receives compensation, which may impact how, where, and in what order products appear. This table does not include all companies or all available products.

All rates are subject to change without notice and may vary depending on location. These quotes are from banks, thrifts, and credit unions, some of whom have paid for a link to their own Web site where you can find additional information. Those with a paid link are our Advertisers. Those without a paid link are listings we obtain to improve the consumer shopping experience and are not Advertisers. To receive the rate from an Advertiser, please identify yourself as a Bankrate customer. Bank and thrift deposits are insured by the Federal Deposit Insurance Corp. Credit union deposits are insured by the National Credit Union Administration.

Consumer Satisfaction: Bankrate attempts to verify the accuracy and availability of its Advertisers' terms through its quality assurance process and requires Advertisers to agree to our Terms and Conditions and to adhere to our Quality Control Program. If you believe that you have received an inaccurate quote or are otherwise not satisfied with the services provided to you by the institution you choose, please click here.

Rate collection and criteria: Click here for more information on rate collection and criteria.