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Agios Announces Phase 3 ENERGIZE-T Study of Mitapivat Met Primary Endpoint and All Key Secondary Endpoints in Adults with Transfusion-Dependent Alpha- or Beta-Thalassemia
GlobeNewswire News Room· 2024-06-03 10:30
– Study Achieved the Primary Endpoint; Mitapivat Demonstrated a Statistically Significant Transfusion Reduction Response Compared to Placebo – – Statistical Significance Achieved for All Key Secondary Endpoints Evaluating Additional Measures of Reduction of Transfusion Burden Compared to Placebo – – ENERGIZE-T is the First Phase 3 Study to Demonstrate Efficacy of an Oral, Disease-Modifying Treatment for Transfusion-Dependent Alpha- and Beta-Thalassemia – – As Part of Global Submission Strategy, U.S. Market ...
Agios Announces Phase 3 ENERGIZE-T Study of Mitapivat Met Primary Endpoint and All Key Secondary Endpoints in Adults with Transfusion-Dependent Alpha- or Beta-Thalassemia
Newsfilter· 2024-06-03 10:30
– Study Achieved the Primary Endpoint; Mitapivat Demonstrated a Statistically Significant Transfusion Reduction Response Compared to Placebo – – Statistical Significance Achieved for All Key Secondary Endpoints Evaluating Additional Measures of Reduction of Transfusion Burden Compared to Placebo – – ENERGIZE-T is the First Phase 3 Study to Demonstrate Efficacy of an Oral, Disease-Modifying Treatment for Transfusion-Dependent Alpha- and Beta-Thalassemia – – As Part of Global Submission Strategy, U.S. Market ...
Agios (AGIO) Up 23% on Selling Brain Cancer Drug Royalty
zacks.com· 2024-05-29 17:36
Core Viewpoint - Agios Pharmaceuticals has entered a deal with Royalty Pharma to sell royalty rights on vorasidenib, leading to a significant increase in its stock price by over 20% on May 28, 2023 [1] Financial Deal Summary - Agios will receive an upfront payment of $905 million if the FDA approves vorasidenib, which is under review for IDH-mutant diffuse glioma [2] - Royalty Pharma will receive a 15% royalty on U.S. sales up to $1 billion, and a 12% royalty on sales exceeding that threshold [2] - Agios retains a 3% royalty on U.S. sales exceeding $1 billion and a milestone payment of $200 million from Servier upon FDA approval [2] Stock Performance and Market Position - Year-to-date, Agios shares have surged 74.3%, significantly outperforming the industry average increase of 2.6% [3] - The approval of Pyrukynd for treating hemolytic anemia was crucial for Agios, providing a stable revenue stream after the divestiture of its oncology business [3] Clinical Trials and Future Prospects - Agios is conducting two phase III studies for Pyrukynd in thalassemia, with positive results from the ENERGIZE study indicating potential for the drug to be the first oral therapy for non-transfusion-dependent patients [4] - A data readout from the ENERGIZE-T study is expected soon, with plans for label expansion across all thalassemia sub-types if results are favorable [4] - Agios is also evaluating mitapivat for sickle cell disease in a phase II/III study, with the phase II portion achieving its primary endpoint [5] Industry Context - Agios currently holds a Zacks Rank 2 (Buy), indicating a favorable position in the healthcare sector [6] - Other companies in the sector, such as Arcutis Biotherapeutics and Heron Therapeutics, also show strong performance and improved earnings estimates [6][7]
Agios Announces $905 Million Purchase Agreement for Vorasidenib Royalty
Newsfilter· 2024-05-28 11:00
– Royalty Pharma to Acquire Rights to Agios' 15% Royalty on Potential Vorasidenib U.S. Net Sales for $905 Million Upfront upon FDA Approval of Vorasidenib; Agios to Share in Economics Above Certain Revenue Thresholds – – Agios Retains Rights to $200 Million Milestone Payment from Servier upon FDA Approval of Vorasidenib – – In Total, Agios to Receive $1.1 Billion in Payments upon FDA Approval of Vorasidenib; PDUFA Action Date of August 20, 2024 – CAMBRIDGE, Mass., May 28, 2024 (GLOBE NEWSWIRE) -- Agios Phar ...
How Much Upside is Left in Agios Pharmaceuticals (AGIO)? Wall Street Analysts Think 26.43%
zacks.com· 2024-05-24 14:56
Shares of Agios Pharmaceuticals (AGIO) have gained 3.2% over the past four weeks to close the last trading session at $32.69, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $41.33 indicates a potential upside of 26.4%.The mean estimate comprises six short-term price targets with a standard deviation of $8.12. While the lowest estimate of $30 indicates an 8.2% decline from the c ...
Wall Street Analysts See a 26.01% Upside in Agios Pharmaceuticals (AGIO): Can the Stock Really Move This High?
Zacks Investment Research· 2024-05-08 14:56
Group 1 - Agios Pharmaceuticals (AGIO) closed at $32.80, with a 10.4% gain over the past four weeks, and a mean price target of $41.33 indicating a 26% upside potential [1] - The mean estimate includes six short-term price targets with a standard deviation of $8.12, suggesting variability in analyst predictions; the lowest estimate is $30 (8.5% decline), while the highest is $49 (49.4% increase) [1] - Analysts show a strong agreement in revising earnings estimates higher, with the Zacks Consensus Estimate increasing by 8.8% over the last 30 days, indicating positive sentiment towards AGIO's earnings prospects [6] Group 2 - The consensus price target is often questioned for its reliability, as analysts may set overly optimistic targets influenced by business relationships [3][5] - A low standard deviation in price targets indicates a high degree of agreement among analysts regarding the stock's price movement direction [4] - AGIO holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, suggesting a solid potential upside [6]
Agios to Present at the BofA Securities 2024 Health Care Conference on May 16, 2024
Newsfilter· 2024-05-06 11:00
CAMBRIDGE, Mass., May 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 company is scheduled to present at the BofA Securities 2024 Health Care Conference on Thursday, May 16, 2024, at 11:40 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.com. A replay of the webcast w ...
Agios to Present at the RBC Capital Markets Global Healthcare Conference on May 14, 2024
Newsfilter· 2024-05-03 11:00
Company Overview - Agios Pharmaceuticals is a leader in cellular metabolism and PK activation, focusing on therapies for rare diseases [2] - The company markets a first-in-class pyruvate kinase (PK) activator for adults with PK deficiency, which is the first disease-modifying therapy for this condition [2] - Agios is advancing a clinical pipeline that includes investigational medicines for alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency, MDS-associated anemia, and phenylketonuria (PKU) [2] - Additionally, Agios is developing a preclinical TMPRSS6 siRNA as a potential treatment for polycythemia vera [2] Upcoming Events - Agios Pharmaceuticals is scheduled to present at the 2024 RBC Capital Markets Global Healthcare Conference on May 14, 2024, at 8:00 a.m. ET [1] - A live webcast of the presentation will be available on the company's website, with a replay archived for at least two weeks [1]
Agios Pharmaceuticals(AGIO) - 2024 Q1 - Earnings Call Presentation
2024-05-02 20:33
Q1 2024 Financial Results May 2, 2024 1 Agios conference call participants TOPIC PARTICIPANT Chris Taylor, VP Investor Relations and Corporate Introduction Communications Business Update Brian Goff, Chief Executive Officer Sarah Gheuens, M.D., Ph.D., ...
Agios Pharmaceuticals(AGIO) - 2024 Q1 - Earnings Call Transcript
2024-05-02 20:32
Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) Q1 2024 Earnings Conference Call May 2, 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 Gregory Renza - RBC Capital Markets Divya Rao - TD Cowen Eric Schmidt - Cantor Alec Stranahan - Bank of America T ...