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11/3/2021
Good morning, and welcome to AGIOS's third quarter 2021 conference call. At this time, all participants are in listen-only mode. There will be a question and answer session at the end. Please be advised that this call is being recorded at AGIOS's request. I would now like to turn the call over to Holly Manning, Senior Director of Investor Relations.
Thank you, Operator. Good morning, everyone, and welcome to AGIOS's third quarter 2021 conference call. You can access slides for today's call by going to the investor section of our website, igs.com. With me on the call today with prepared remarks are Dr. Jackie Faust, our Chief Executive Officer, Dr. Sarah Guins, our Chief Medical Officer, Darren Miles, our Chief Commercial Officer, Jonathan Biller, our Chief Financial Officer and Head of Legal and Corporate Affairs, and Dr. Bruce Carr, our Chief Scientific Officer, who will join for Q&A. Before we get started, I would like to remind everyone that some of the statements we make on this call will include forward-looking statements. Actual events and results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties, and other factors, including those set forth in our most recent filing with the SEC and any other future filings that we may make with the SEC. With that, I will turn the call over to Jeff.
Thanks, Holly. Good morning, everyone, and thanks for joining our third quarter 2021 results call. Strong clinical and operational execution continue at Agios. With our NDA and MAA filings on track, our commercial team is focused on launch preparations for Minipivet, which has the potential to serve as the first disease-modifying therapy for pyruvate kinase deficiencies. Our patient support infrastructure is in place. Our field team of sales representatives and nurse clinical educators are fully engaged with healthcare providers, and our disease education efforts continue to accelerate. We are also working diligently on startup activities for three pivotal studies in thalassemia and sickle cell disease, all of which we expect to initiate by the end of 2021. These trials underscore the potential of Medipivac to serve as a pipeline within a single drug and an important new treatment option for people with these underserved, profoundly challenging, lifelong hemolytic anemias. Beyond Medipivac, we continue to advance our earlier stage clinical and R&D efforts to build sustainable future growth potential based on our leading expertise in PK activation and cellular metabolism. all within our core focus on genetically defined diseases. We look forward to this year's American Society of Hematology annual meeting, where we will be presenting new data across our clinical programs, including important updates in sickle cell disease, thalassemia, and PK deficiency. On November 17th, we plan to host an investor day to share exciting updates on our research and development pipeline, and provide further insights into our commercial launch strategy and expectations for medipivette and PK deficiency. As we look to the end of the year and 2022, AGEOS is extremely well positioned to enter our next phase of growth with our first genetically defined disease commercial launch on the horizon, three pivotal adult trials, two pivotal pediatric PK deficiency trials, and a robust pipeline filled with optionality and possibility. With that, I will now turn the call over to Sarah to walk through our clinical development programs in more detail. Sarah, welcome to your first quarterly results call as our AGIOS CMO.
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