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Agios Pharmaceuticals(AGIO) - 2024 Q3 - Earnings Call Transcript
2024-10-31 18:16
Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) Q3 2024 Earnings Conference Call October 31, 2024 8:00 AM ET Company Participants Chris Taylor - Vice President, Investor Relations and Corporate Communications Brian Goff - Chief Executive Officer Sarah Gheuens - Chief Medical Officer and Head, R&D Tsveta Milanova - Chief Commercial Officer Cecilia Jones - Chief Financial Officer Conference Call Participants Greg Harrison - Scotiabank Alex Nackenoff - Raymond James Greg Renza - RBC Capital Markets Eric Schmidt - Ca ...
Agios Pharmaceuticals(AGIO) - 2024 Q3 - Quarterly Report
2024-10-31 13:20
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-36014 AGIOS PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 26-0662915 (State or Other Jurisdiction o ...
Agios Pharmaceuticals (AGIO) Misses Q3 Earnings and Revenue Estimates
ZACKS· 2024-10-31 12:46
Agios Pharmaceuticals (AGIO) came out with quarterly earnings of $4.20 per share, missing the Zacks Consensus Estimate of $16.69 per share. This compares to loss of $1.64 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -74.84%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $1.58 per share when it actually produced a loss of $1.69, delivering a surprise of -6.96%.Over the last four quar ...
Agios Pharmaceuticals(AGIO) - 2024 Q3 - Quarterly Results
2024-10-31 10:56
Exhibit 99.1 Agios Reports Business Highlights and Third Quarter 2024 Financial Results – Completed Enrollment of the Phase 3 RISE UP Study of Mitapivat in Sickle Cell Disease; Topline Data from 52-Week Study Expected in Late 2025 – – Received $1.1 Billion in Payments from Royalty Pharma and Servier, Following FDA Approval of Vorasidenib – – Commenced Enrollment of the Phase 2b Study of Tebapivat in Lower-Risk Myelodysplastic Syndromes (LR-MDS); Granted FDA Orphan Drug Designation for Treatment of MDS – – P ...
Agios Reports Business Highlights and Third Quarter 2024 Financial Results
GlobeNewswire News Room· 2024-10-31 10:30
– Completed Enrollment of the Phase 3 RISE UP Study of Mitapivat in Sickle Cell Disease; Topline Data from 52-Week Study Expected in Late 2025 – – Received $1.1 Billion in Payments from Royalty Pharma and Servier, Following FDA Approval of Vorasidenib – – Commenced Enrollment of the Phase 2b Study of Tebapivat in Lower-Risk Myelodysplastic Syndromes (LRMDS); Granted FDA Orphan Drug Designation for Treatment of MDS – – PYRUKYND® (Mitapivat) Net Revenue of $9.0 Million in Q3; Cash, Cash Equivalents and Market ...
Agios to Webcast Conference Call of Third Quarter 2024 Financial Results on October 31, 2024
GlobeNewswire News Room· 2024-10-17 11:00
CAMBRIDGE, Mass., Oct. 17, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, today announced the company will host a conference call and live webcast on Thursday, October 31, 2024, at 8:00 a.m. ET to report its third quarter 2024 financial results and business highlights. A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company's websit ...
FDA Grants Orphan Drug Tag to AGIO's Tebapivat for Rare Cancer
ZACKS· 2024-09-12 16:35
Agios Pharmaceuticals, Inc. (AGIO) announced that the FDA has granted orphan drug designation to its novel pyruvate kinase (PK) activator, tebapivat, for the treatment of myelodysplastic syndromes (MDS), a rare type of blood cancer.The FDA generally grants orphan drug designation to investigational therapies that address rare medical diseases or conditions affecting fewer than 200,000 people in the United States. The perquisites that come from this designation include assistance in the drug development proc ...
Agios Announces FDA Orphan Drug Designation Granted to Tebapivat (AG-946) for Treatment of Myelodysplastic Syndromes (MDS)
GlobeNewswire News Room· 2024-09-11 11:00
CAMBRIDGE, Mass., Sept. 11, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company’s novel pyruvate kinase (PK) activator tebapivat (AG-946) for the treatment of myelodysplastic syndromes (MDS). “Receiving orphan drug designation for tebapivat in MDS underscores the importance of bringing ne ...
Agios to Receive $1.1 Billion in Milestone Payments Following FDA Approval of Vorasidenib
Newsfilter· 2024-08-06 21:50
– Agios Expects to Receive $905 Million Payment from Royalty Pharma and $200 Million Payment from Servier in Q3 2024; Payments Increase Agios' Pro-Forma Cash Position as of June 30, 2024, to $1.7 Billion – – Strong Cash Position to Enable Agios to Prepare for Potential PYRUKYND® (Mitapivat) Launches in Thalassemia in 2025 and Sickle Cell Disease in 2026 and Drive Pipeline Progress – CAMBRIDGE, Mass., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in cellular metabolism ...
Agios to Receive $1.1 Billion in Milestone Payments Following FDA Approval of Vorasidenib
GlobeNewswire News Room· 2024-08-06 21:50
Core Insights - Agios Pharmaceuticals is set to receive a total of $1.1 billion in milestone payments following the FDA approval of vorasidenib for Grade 2 astrocytoma or oligodendroglioma, which includes a $905 million payment from Royalty Pharma and a $200 million payment from Servier [1][2][3] Financial Position - The anticipated payments will increase Agios' pro-forma cash position to $1.7 billion as of June 30, 2024, providing strong financial resources for future initiatives [1][2] - The company expects to leverage this cash position to prepare for potential launches of PYRUKYND® (mitapivat) in thalassemia in 2025 and sickle cell disease in 2026 [1][2] Business Transactions - Agios completed the sale of its oncology business to Servier on March 31, 2021, for $1.8 billion in upfront cash, with additional milestone payments tied to the FDA approval of vorasidenib [2][3] - Under the agreement with Royalty Pharma, Agios will receive an upfront payment of $905 million and retain a 3% royalty on U.S. net sales of vorasidenib exceeding $1 billion [3] Company Overview - Agios is a leader in pyruvate kinase (PK) activation, focusing on developing therapies for rare diseases, including a first-in-class PK activator for adults with PK deficiency [4] - The company is advancing a robust clinical pipeline targeting various conditions, including alpha- and beta-thalassemia, sickle cell disease, and MDS-associated anemia [4]