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AGIO

Agios Pharmaceuticals

$57.71

-1.53 (-2.58%)

07:12
02/20/19
02/20
07:12
02/20/19
07:12

Agios Pharmaceuticals announces FDA acceptance of Tibsovo sNDA

Agios Pharmaceuticals announced that the FDA has accepted the company's supplemental new drug application, or sNDA, for Tibsovo for the treatment of patients with newly diagnosed acute myeloid leukemia, or AML, with an isocitrate dehydrogenase 1, or IDH1, mutation who are not eligible for standard therapy. The sNDA was granted priority review and has been given a Prescription Drug User Fee Act action date of June 21. In addition, the FDA accepted the Tibsovo sNDA under its real-time oncology review pilot program, which aims to make the review of oncology drugs more efficient by allowing the FDA access to clinical trial data before the information is formally submitted to the agency.

AGIO Agios Pharmaceuticals
$57.71

-1.53 (-2.58%)

11/30/18
ADAM
11/30/18
NO CHANGE
Target $90
ADAM
Buy
Agios differentiation syndrome warning not a concern, says Canaccord
Canaccord analyst John Newman noted Agios Pharmaceuticals already has an FDA black box warning for differentiation syndrome for both Tibsovo and Idhifa, so he is not concerned about the recent FDA warning notice regarding the condition. He does not believe it will result in any decrease in usage, but since both are relatively new drugs, it will take time for doctors and patients to become acquainted with their safety profile. Newman reiterated his Buy rating and $90 price target on Agios Pharmaceuticals shares.
01/07/19
PIPR
01/07/19
NO CHANGE
Target $235
PIPR
Overweight
Piper Jaffray views price paid for Loxo by Eli Lilly as fair
Piper Jaffray analyst Tyler Van Buren views the price of $235 per share paid by Eli Lilly (LLY) for Loxo Oncology (LOXO) as fair. The analyst says the price is near the $250-plus he previously thought was achievable in an acquisition scenario for Loxo. Other names in the precision medicine/oncology space that could be up today as a result of the buyout are Agios Pharmaceuticals (AGIO), ArQule (ARQL), Array BioPharma (ARRY), Blueprint Medicines (BPMC), Kura Oncology (KURA), Mirati Therapeutics (MRTX) and others, Van Buren tells investors in a research note. He raised his price target for Loxo Oncology to $235 from $200 and keeps an Overweight rating on the shares.
02/14/19
PIPR
02/14/19
NO CHANGE
Target $100
PIPR
Overweight
Agios Pharmaceuticals price target lowered to $100 from $125 at Piper Jaffray
Piper Jaffray analyst Tyler Van Buren lowered his price target for Agios Pharmaceuticals to $100 following the company's Q4 results. The Idhifa and Tibsovo results were largely in-line with expectations and management emphasized the ability to capture additional IDHm franchise opportunities, Van Buren tells investors in a research note. Further, the analyst "encouraged by the degree of comfort management expressed with the ongoing AG-270 Phase I trial in MTAP-deleted cancers." He pushed backed the mitapivat launch timing given updated enrollment timelines but keeps an Overweight rating on Agios. Van Buren continues to recommend owning the stock through year-end.
02/15/19
LEER
02/15/19
UPGRADE
Target $80
LEER
Outperform
Agios Pharmaceuticals upgraded to Outperform from Market Perform at SVB Leerink
SVB Leerink analyst Andrew Berens upgraded Agios Pharmaceuticals to Outperform from Market Perform and maintained an $80 price target. Following the company's Q4 earnings, Berens says he expects a rebound in investor sentiment, driven by the realization that the stock reaction to competitive and safety concerns in AML was likely "overstated." While he continues to believe that progress in the company's solid tumor pipeline is key to unlocking value in the longer term, at current levels he thinks investors are paying very little for an option on the numerous programs.

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