Agios Pharmaceuticals(AGIO)

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Agios Pharmaceuticals(AGIO) - 2024 Q2 - Quarterly Results
2024-08-01 11:03
Exhibit 99.1 Agios Reports Business Highlights and Second Quarter 2024 Financial Results – Reported Positive Topline Data from Phase 3 ENERGIZE-T Study; Expect to File sNDA Based on ENERGIZE and ENERGIZE-T Studies Encompassing All Thalassemia Subtypes by End of 2024 – – Announced $905 Million Purchase Agreement for Vorasidenib Royalty with Royalty Pharma; Agios to Receive a Total of $1.1 Billion in Payments Upon FDA Approval of Vorasidenib – – Reported Results from Phase 3 ACTIVATE-KidsT Study of Mitapivat ...
Agios Reports Business Highlights and Second Quarter 2024 Financial Results
GlobeNewswire News Room· 2024-08-01 10:31
– Reported Positive Topline Data from Phase 3 ENERGIZE-T Study; Expect to File sNDA Based on ENERGIZE and ENERGIZE-T Studies Encompassing All Thalassemia Subtypes by End of 2024 – – Announced $905 Million Purchase Agreement for Vorasidenib Royalty with Royalty Pharma; Agios to Receive a Total of $1.1 Billion in Payments Upon FDA Approval of Vorasidenib – – Reported Results from Phase 3 ACTIVATE-KidsT Study of Mitapivat in Children with Pyruvate Kinase (PK) Deficiency Who are Regularly Transfused – – PYRUKYN ...
Agios Reports Business Highlights and Second Quarter 2024 Financial Results
Newsfilter· 2024-08-01 10:31
Core Insights - Agios Pharmaceuticals reported positive topline data from the Phase 3 ENERGIZE-T study, indicating mitapivat's efficacy across all thalassemia subtypes, with plans to file a supplemental New Drug Application (sNDA) by the end of 2024 [1][2] - The company announced a $905 million purchase agreement with Royalty Pharma for vorasidenib royalty rights, expecting to receive a total of $1.1 billion upon FDA approval of vorasidenib [1][2] - Agios reported net revenue of $8.6 million for PYRUKYND® (mitapivat) in Q2 2024, reflecting a 5% sequential increase from Q1 2024, with a total of 201 unique patients enrolled [3][5] Thalassemia Developments - The Phase 3 ENERGIZE-T study met primary and key secondary endpoints for mitapivat in adults with transfusion-dependent thalassemia [3] - Positive results from the Phase 3 ENERGIZE study were presented at the European Hematology Association 2024 Congress, demonstrating mitapivat's efficacy in non-transfusion-dependent thalassemia [3] Pediatric PK Deficiency - Topline data from the Phase 3 ACTIVATE-KidsT study of mitapivat in children with PK deficiency was announced, marking the first study to report safety and efficacy data in this demographic [3][4] - Enrollment for the Phase 3 ACTIVATE-Kids study in children not regularly transfused has been completed, with topline data expected in 2025 [3][4] Financial Performance - For Q2 2024, Agios reported a net loss of $96.1 million, compared to a net loss of $83.8 million in Q2 2023 [5][6] - Research and Development (R&D) expenses increased to $77.4 million in Q2 2024 from $68.9 million in Q2 2023, primarily due to costs associated with the siRNA TMPRSS6 program [5][6] - Cash, cash equivalents, and marketable securities totaled $645.3 million as of June 30, 2024, down from $806.4 million at the end of 2023 [6][12] Corporate Development - Agios entered a distribution agreement with NewBridge Pharmaceuticals to commercialize PYRUKYND® in the Gulf Cooperation Council (GCC) region [3] - The company anticipates filing an sNDA for mitapivat in thalassemia and completing enrollment in the Phase 3 RISE UP study for sickle cell disease by the end of 2024 [4]
Agios Announces Results from Phase 3 ACTIVATE-KidsT Study of Mitapivat in Children with PK Deficiency Who Are Regularly Transfused
GlobeNewswire News Room· 2024-08-01 10:30
– ACTIVATE-KidsT is Agios’ First Pediatric Data Readout;Safety Results Consistent with Safety Profile for Mitapivat Previously Observed in Adultswith PK Deficiency Who are Regularly Transfused – – Prespecified Statistical Criterion for the Primary Endpoint in ACTIVATE-KidsT Was Not Met; Results Were Clinically Meaningful, with Observed Response Rates Higher for Mitapivat than Placebo for the Primary Endpoint of Transfusion Reduction Response and for the Secondary Endpoints of Transfusion-Free Response and N ...
Agios Pharmaceuticals (AGIO) Expected to Beat Earnings Estimates: What to Know Ahead of Q2 Release
ZACKS· 2024-07-25 15:08
The market expects Agios Pharmaceuticals (AGIO) to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended June 2024. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The earnings report, which is expected to be released on August 1, 2024, might help the stock move higher if these key numbe ...
Agios to Webcast Conference Call of Second Quarter 2024 Financial Results on August 1, 2024
GlobeNewswire News Room· 2024-07-18 11:00
CAMBRIDGE, Mass., July 18, 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, August 1, 2024, at 8:00 a.m. ET to report its second quarter 2024 financial results and other business highlights. A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company's w ...
Agios Pharmaceuticals (AGIO) Surges 6.5%: Is This an Indication of Further Gains?
ZACKS· 2024-06-24 09:25
Agios Pharmaceuticals (AGIO) shares soared 6.5% in the last trading session to close at $45.22. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 29.9% gain over the past four weeks.The rise in share price is attributable to the company’s progress with its label expansion studies on sol-marketed Pyrukynd. Earlier this month, management reported that the phase III ENERGIZE-T study, evaluating the drug in transfusion-dependent (TD) t ...
Agios Presents Positive Results from Phase 3 ENERGIZE Study of Mitapivat in Non-Transfusion-Dependent Thalassemia in Plenary Session at the European Hematology Association 2024 Hybrid Congress
Newsfilter· 2024-06-15 12:45
– ENERGIZE is the First Study to Demonstrate Efficacy of an Oral Treatment for Non-Transfusion-Dependent Alpha- and Beta-Thalassemia – – Additional ENERGIZE Poster Presentation Highlights Improvements in Fatigue and Exercise Capacity in Patients Treated with Mitapivat Compared to Placebo – – Agios to Webcast Virtual Investor Event on June 16, 2024 at 10 a.m. Eastern Time or 4 p.m. Central European Summer Time – CAMBRIDGE, Mass., June 15, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a ...
Updated Time: Agios to Present at the Goldman Sachs 45th Annual Global Healthcare Conference on June 10, 2024 at 8:40 am ET
Newsfilter· 2024-06-06 13:00
CAMBRIDGE, Mass., June 06, 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 time of the company's presentation at the Goldman Sachs 45th Annual Global Healthcare Conference has been updated to Monday, June 10, 2024 at 8:40 a.m. ET. A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company's website at www.agios.c ...
Agios (AGIO) Up 21% on Upbeat Data From 2nd Thalassemia Study
ZACKS· 2024-06-04 17:45
Shares of Agios Pharmaceuticals (AGIO) rose more than 20% on Monday after management reported that the phase III ENERGIZE-T study, evaluating its sole marketed drug, Pyrukynd (mitapivat) in certain thalassemia patients, achieved its primary and key secondary endpoints. Image Source: Zacks Investment Research A total of 258 adult participants with transfusion-dependent (TD) alpha- or beta-thalassemia were enrolled in the ENERGIZE-T study. These patients were randomized into two treatment arms — 171 patients ...