Company Performance - Agios Pharmaceuticals reported a quarterly loss of $1.72 per share, which was worse than the Zacks Consensus Estimate of a loss of $1.64, and a significant decline from earnings of $0.67 per share a year ago, indicating a negative earnings surprise of -4.88% [1] - The company generated revenues of $7.1 million for the quarter ended December 2023, missing the Zacks Consensus Estimate by 9.84%, but showing an increase from $4.31 million in the same quarter last year [1] - Over the last four quarters, Agios has surpassed consensus EPS estimates three times and topped consensus revenue estimates two times [1] Stock Performance - Agios Pharmaceuticals shares have increased by approximately 16.3% since the beginning of the year, outperforming the S&P 500, which gained 4.8% [2] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$1.58 on revenues of $9.79 million, while for the current fiscal year, the estimate is -$5 on revenues of $88.47 million [4] - The estimate revisions trend for Agios Pharmaceuticals is mixed, resulting in a Zacks Rank 3 (Hold), indicating that shares are expected to perform in line with the market in the near future [4] Industry Context - The Medical - Products industry, to which Agios belongs, is currently ranked in the bottom 35% of over 250 Zacks industries, suggesting potential challenges for stock performance [5] - Medtronic, another company in the same industry, is expected to report quarterly earnings of $1.26 per share, reflecting a year-over-year decline of -3.1%, with revenues projected at $7.95 billion, up 2.9% from the previous year [6]

Q4 and Full Year 2022 Financial Results February 23, 2023 Agios conference call participants ...

– Announced Positive Results from the Phase 3 ENERGIZE Study of Mitapivat in Adults with Non-Transfusion-Dependent Alpha- or Beta-Thalassemia – – Presented Positive Results from Phase 2 Portion of the RISE UP Pivotal Study in Sickle Cell Disease at 65th ASH Annual Meeting and Exposition – – Two Additional Phase 3 Readouts of Mitapivat Expected in 2024, with a Total of Four Phase 3 Readouts by the End of 2025 – – U.S. PYRUKYND® (mitapivat) Net Revenue of $7.1 Million in Q4; Cash, Cash Equivalents and Marketa ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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 of incorpo ...

Unlike many other market segments, biotech stocks stand out for their direct relevance. For example, investors who typically wager on aerospace and defense plays usually aren’t fighter pilots. Or stakeholders of exotic car companies don’t typically engage in motor racing. However, the broader healthcare space affects every one of us.Recently, news broke that King Charles III is receiving treatment for cancer. Sure enough, well wishes from around the world poured in because Britain’s monarch and head of stat ...

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 December 2023. 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 stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to ...

Core Viewpoint - Agios Pharmaceuticals' shares rose 5.2% following positive results from the phase III ENERGIZE study, which evaluated mitapivat for treating non-transfusion-dependent thalassemia patients, achieving both primary and key secondary endpoints [1][3]. Group 1: Study Results - The ENERGIZE study enrolled 194 adult participants with non-transfusion-dependent alpha- or beta-thalassemia, randomized into two groups: 130 received 100mg of mitapivat and 64 received a placebo over 24 weeks [3]. - Patients treated with mitapivat showed a statistically significant hemoglobin response, with 42.3% achieving this compared to only 1.6% in the placebo group [3]. - Key secondary endpoints also showed significant improvements in average FACIT-Fatigue score and hemoglobin concentration, indicating lower fatigue levels in mitapivat patients [3]. Group 2: Market Potential - Agios estimates that the thalassemia patient population in the U.S. is around 8,000, with more than half being non-transfusion-dependent patients, highlighting a significant market opportunity as there are currently no approved therapies for this group [4]. - Mitapivat was previously approved by the FDA in November 2022 for adults with pyruvate kinase deficiency, marketed as Pyrukynd [4]. Group 3: Future Developments - Agios plans to seek regulatory approval for mitapivat as a treatment for all thalassemia sub-types, regardless of transfusion dependency, following the ENERGIZE-T study results expected in mid-2024 [5]. - If approved, mitapivat could have a competitive advantage over existing treatments, as it is an orally administered drug compared to gene therapy and injectable options [6]. - Agios is also conducting the phase II/III RISE UP study for sickle cell disease, with the phase II portion achieving its primary endpoint, and aims for approval by 2026 [6].

Agios Pharmaceuticals (AGIO) shares rallied 5.2% in the last trading session to close at $24.02. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 1.3% gain over the past four weeks.Share price rose after management reported encouraging results from a late-stage study, evaluating orally-administered mitapivat in non-transfusion-dependent (NTD) thalassemia patients. Patients treated with mitapivat achieved demon ...

–Mitapivat Demonstrated a Statistically Significant Increase in Hemoglobin Response Rate Compared to Placebo – – Statistical Significance Also Achieved for Key Secondary Endpoints of Change From Baseline in Both FACIT-Fatigue Score and Hemoglobin Concentration – – ENERGIZE is the First Phase 3 Study to Demonstrate Efficacy of an Oral Treatment for Non-Transfusion-Dependent Alpha- and Beta-Thalassemia – – Agios to Host Investor Webcast Event Today at 8:00 a.m. ET– CAMBRIDGE, Mass., Jan. 03, 2024 (GLOBE NEWSW ...

Agios Pharmaceuticals Inc.’s stock AGIO, +2.51% soared 19.6% early Wednesday, after the biotech announced positive results from a Phase 3 trial of a treatment for a rare blood disorder. The trial dubbed Energize sought to evaluate the company’s mitapivat therapy and met its primary endpoint of hemoglobin response in patients with non-transfusion-dependent (NTD) alpha- or beta-thalassemia. The trial also met secondary endpoints of change from baseline in FACIT-Fatigue Score and hemoglobin concentration. The ...