Agios Pharmaceuticals, Inc. - AGIO STOCK NEWS

Agios Pharmaceuticals has sold its rights to a 5% royalty on U.S. net sales of TIBSOVO® to Sagard Healthcare Partners for $131.8 million. TIBSOVO® is FDA-approved for treating patients with the IDH1 mutation in acute myeloid leukemia and cholangiocarcinoma. Agios retains potential future payments related to vorasidenib, including a $200 million milestone and 15% royalties on U.S. net sales. This transaction enhances Agios' financial flexibility, aiding in the launch of PYRUKYND® and ongoing pivotal studies.

Agios Pharmaceuticals (NASDAQ: AGIO) will host a conference call and live webcast on November 3, 2022, at 8:00 a.m. ET to discuss its third quarter 2022 financial results and business updates. The webcast will be accessible on the company’s website in the Investors section and will be archived for later replay. Agios is recognized for its pioneering work in therapies for rare and genetically defined diseases, including a first-in-class pyruvate kinase activator for PK deficiency. The company continues to advance its clinical pipeline targeting various blood disorders.

Agios Pharmaceuticals has announced inducement equity awards for its new Chief Financial Officer, Cecilia Jones, effective September 26, 2022. The Board of Directors approved grants including a nonstatutory option to purchase 118,390 shares at an exercise price of $27.88, along with restricted stock units for 22,417 shares and performance stock units for 10,760 shares. Vesting is contingent on continued service, with a structured timeline over four years for the options and annually for the restricted stocks. This move aligns with Nasdaq Listing Rule 5635(c)(4).

Agios Pharmaceuticals (NASDAQ: AGIO) announced the appointment of Cecilia Jones as its new chief financial officer, effective Sept. 26, 2022. Jones replaces Jonathan Biller, who resigned to join Vertex Pharmaceuticals. With over 20 years of financial leadership experience, including her recent role at LogicBio Therapeutics, Jones is expected to enhance Agios' financial strategy amid their ongoing commercial launch of PYRUKYND and five pivotal clinical trials. The company highlights its strong financial position, aiming to maximize its impact on rare disease therapies.

Agios Pharmaceuticals announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for PYRUKYND® (mitapivat) on September 15, 2022. This drug is aimed at treating pyruvate kinase (PK) deficiency, a rare and serious hemolytic anemia. If approved by the European Commission, it would be the first disease-modifying therapy for this condition in Europe.

The positive opinion was supported by pivotal studies demonstrating significant hemoglobin increases and reductions in transfusion burden among patients.

Agios Pharmaceuticals (NASDAQ: AGIO) announces its participation in two September investor conferences. The company will present at the Wells Fargo Healthcare Conference on September 7, 2022, at 8:35 a.m. ET, followed by the Morgan Stanley 20th Annual Global Healthcare Conference on September 12, 2022, at 4:50 p.m. ET. Live webcasts can be accessed on Agios' website, with replays available for two weeks post-event. Agios specializes in developing therapies for rare diseases, including a first-in-class treatment for pyruvate kinase deficiency and ongoing programs in various hematological conditions.

Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) announced positive results from the pivotal Phase 3 ACTIVATE-T study of PYRUKYND^® (mitapivat) for adults with pyruvate kinase (PK) deficiency, published on August 18, 2022, in The Lancet Haematology. The study demonstrated a statistically significant reduction in transfusion burden, with 37% of patients achieving a ≥33% reduction in transfusion needs. PYRUKYND is the first disease-modifying treatment approved for this condition, having received FDA approval in February 2022. The findings suggest enhanced patient quality of life and support ongoing regulatory review in Europe.

Agios Pharmaceuticals (NASDAQ: AGIO) has announced the appointments of Rahul Ballal, Ph.D., and Cynthia Smith to its board of directors. This move aims to strengthen the company's leadership as it focuses on advancing therapies for genetically defined diseases. Dr. Ballal brings over 15 years of experience in business development and hemolytic anemias, while Ms. Smith has 25 years of expertise in commercial strategy and product launches. The company continues to push forward its clinical pipeline, including treatments for conditions like sickle cell disease and thalassemia.

Agios Pharmaceuticals (NASDAQ: AGIO) announced promising results from the Phase 2 study of PYRUKYND^® (mitapivat) for treating non-transfusion-dependent α- and β-thalassemia, published in The Lancet. The study showed that 80% of patients experienced a hemoglobin increase of ≥1.0 g/dL from baseline, and significant safety results aligned with previous findings. Agios is actively enrolling subjects for the Phase 3 ENERGIZE studies to further investigate the drug's efficacy. The potential first oral therapy for thalassemia could transform treatment options for patients suffering from this debilitating condition.