Agios Pharmaceuticals, Inc. ( AGIO Quick Quote AGIO - Free Report) reported a loss of $1.48 per share from continued operations for the third quarter of 2021, narrower than the Zacks Consensus Estimate of a loss of $1.61 but wider than the year-ago quarter’s loss of $1.15.
sale of its oncology portfolio to France-based pharmaceutical company Servier, the company recorded zero revenues for the third quarter. The Zacks Consensus Estimate for the metric was $2.3 million. In the year-ago quarter, the company recorded $34.7 million in total revenues.
Shares of Agios have rallied 14.9% so far this year compared with the
industry’s 2.5% growth. Image Source: Zacks Investment Research Quarter in Detail
Research & development expenses increased 23.2% year over year to $64 million due to rise in cost related to the planned initiation of late-stage studies of mitapivat for thalassemia and sickle cell disease as well as disease education and engagement efforts for the same candidate.
Selling, general and administrative expenses were down 4.2% year over year at $27.2 million.
At the end of September 2021, cash, cash equivalents and marketable securities were $1.4 billion compared with $1.7 billion at the end of June 2021.
In June, Agios filed a new drug application (NDA) in the United States and a marketing authorization application in the EU seeking approval for its lead pipeline candidate mitapivat to treat patients with pyruvate kinase (PK) deficiency. Later in August, the company announced that the FDA
accepted the NDA for mitapivat under a priority review. Decision on the same from the FDA is expected by Feb 17, 2022.
We note that the filings in the United States and the EU are based on data from the two pivotal phase III studies of ACTIVATE and ACTIVATE-T, which evaluated mitapivat in adults with PK deficiency with one cohort not being regularly transfused while the other being transfused regularly.
Apart from PK deficiency, Agios is developing mitapivat for treating sickle cell disease (SCD), a blood disorder, and thalassemia. While a phase II/III RISE UP study on mitapivat for SCD is expected to begin this year-end, Agios initiated two phase III studies, namely ENERGIZE and ENERGIZE-T, to evaluate mitapivat in adults with one segment being not regularly transfused while the other being regularly transfused with α- or β-thalassemia.
Agios is also evaluating AG-946, its next-generation pyruvate kinase-R activator in a phase I study for the treatment of hemolytic anemia.
Zacks Rank & Stocks to Consider
Currently, Agios has a Zacks Rank #3 (Hold). Some better-ranked stocks from the biotech/drug sector are
Alkermes ( ALKS Quick Quote ALKS - Free Report) , Regeneron Pharmaceuticals ( REGN Quick Quote REGN - Free Report) and Xencor ( XNCR Quick Quote XNCR - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see . the complete list of today’s Zacks #1 Rank stocks here
Alkermes’ earnings per share estimates for 2021 have increased from 61 cents to 68 cents in the past 60 days. The same for 2022 has risen from $1.06 to $1.11 in the past 60 days. The stock has rallied 48.9% in the year so far.
Regeneron’s earnings per share estimates for 2021 have increased from $54.28 to $63.53 in the past 60 days. The same for 2022 has risen from $44.11 to $46.69 over the same period. The stock has surged 32.2% in the year so far.
Xencor’s loss per share estimates for 2021 have narrowed from 75 cents to 33 cents in the past 60 days. The same for 2022 has narrowed from $3.14 to $2.92 over the same period.