Agios Pharmaceuticals Inc Stock Price, News & Analysis

Agios Pharmaceuticals has received EU marketing authorization for PYRUKYND® to treat pyruvate kinase (PK) deficiency in adults, marking it as the first disease-modifying therapy for this rare blood disorder. The approval follows positive results from pivotal studies, ACTIVATE and ACTIVATE-T, demonstrating significant clinical benefits, including increased hemoglobin levels and reduced transfusion needs. Agios aims to expand access via a global managed access program, and has plans to pursue further indications in pediatric patients and other diseases.

Agios Pharmaceuticals (NASDAQ: AGIO) presented significant clinical data at the 64th ASH Annual Meeting, highlighting the long-term benefits of PYRUKYND^® in adults with Pyruvate Kinase (PK) deficiency. Results showed improved hemoglobin levels, reduced transfusion needs, and better patient-reported outcomes. Additionally, new findings for the investigational PK activator AG-946 support its Phase 2 study in Myelodysplastic Syndromes (MDS)-associated anemia. An investor event is scheduled for Dec. 12, 2022, at 7 a.m. ET to discuss these developments.

Agios Pharmaceuticals reported strong progress in Q3 2022, with net revenue of $3.5 million from the launch of PYRUKYND®, marking the second full quarter post-FDA approval. The company received a favorable opinion from the CHMP for PYRUKYND® to treat PK deficiency in adults and is on track for key enrollment milestones in pivotal studies. Leadership changes include the appointment of Cecilia Jones as CFO and new board members. As of September 30, 2022, Agios holds $1.0 billion in cash and marketable securities.

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.