Dark pool activity was detected in AGIO stock on January 2, 2020, in after-hours trading.
We are unable to even guess if this was a buy or sell order as not enough data is present to make such a judgement call.
What we do find interesting is that Guggenheim analyst Michael Schmidt maintains a Buy rating on Agios Pharmaceuticals (AGIO) even though he downgraded quite a few other biotechnology stocks today.
Back on December 17, 2019, Piper Jaffray analyst Tyler Van Buren recommended continuing to own shares of Agios Pharmaceuticals throughout 2020. Management believes the positive beta thalassemia data increase the probability of success in sickle cell disease considering that the therapeutic target is the same between both indications, Van Buren tells investors in a research note after hosting the company. He keeps an Overweight rating on the shares with a $70 price target. Van Buren says Agios Pharmaceuticals remains a favorite name ahead of the company’s beta thalassemia and sickle cell disease updates in the first half of 2020. The disclosure at ASH that seven out of the eight initial mitapivat beta thalassemia patients responded was by far the biggest update during the conference, Van Buren told investors in a research note. During the first half of next year, Agios could see initial sickle cell data from patients treated with mitapivat, which represents an opportunity that is five-fold larger, adds the analyst. He recommends that investors continue to own Agios shares through next year and keeps an Overweight rating on the name.
Back on December 16, 2019, Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) announced that the FDA granted Breakthrough Therapy designation for TIBSOVO® (ivosidenib) for the treatment of adult patients with relapsed or refractory myelodysplastic syndrome (MDS) with a susceptible IDH1 mutation as detected by an FDA-approved test. MDS is a group of bone marrow disorders that can cause severe complications, such as infections and uncontrolled bleeding, and can lead to the development of acute myelogenous leukemia (AML).
“There is a significant need for new targeted therapeutic approaches for individuals with MDS whose disease continues to progress despite treatment with standard of care,” said Chris Bowden, M.D., chief medical officer at Agios. “The Breakthrough Therapy designation is based on results from the initial 12 patients in the MDS arm of our Phase 1 study in advanced hematologic malignancies with an IDH1 mutation and recognizes the potential for single-agent treatment with TIBSOVO® to make an impact on these patients. We recently re-opened the MDS arm of this study with the goal of generating sufficient data to pursue a regulatory filing in this indication.”
The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is under investigation to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints.
Results from the MDS arm of the ongoing TIBSOVO® Phase 1 dose-escalation and expansion study in hematologic malignancies were presented at the 7th Society of Hematologic Oncology Annual Meeting, held September 11-14, 2019, in Houston, Texas. These demonstrate that TIBSOVO® administered as a monotherapy was well tolerated and associated with durable remissions as well as the achievement and maintenance of transfusion independence in patients with relapsed or refractory MDS with an IDH1 mutation. Among the 12 patients who received 500 mg of oral TIBSOVO® daily, the median treatment duration was 11.4 months. The median age was 72.5 years, and 42% of patients were age 75 or older. As of the November 2, 2018 data cut-off, 75% (9/12) of patients had a response and 42% (5/12) had a complete response (CR). The median duration of CR had not been reached (95% CI, 2.8 months, NE). Of the patients who had a CR, 60% remained relapse-free at 12 months. In addition, 9 (75%) patients were transfusion-independent for 56 days or longer during study treatment. The most common adverse events (AEs) of any grade were back pain, diarrhea, fatigue and rash. Grade 2 IDH differentiation syndrome was observed in 1 of 12 patients. No AEs resulted in permanent discontinuation of treatment.