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Agios Stops Development of PKR Activator AG-519, Stock Falls
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Agios Pharmaceuticals, Inc.’s (AGIO - Free Report) shares tumbled 19.4% after the company announced that it is has decided to discontinue the development of one of its pyruvate kinase-R (PKR) activator, AG-519. The decision was taken after the verbal notification of a clinical hold by the FDA, which led the company to withdraw its investigational new drug application for the candidate.
Agios’ year-to-date share price movement shows that the stock has underperformed the Zacks categorized Medical–Products industry. In fact, the stock has crashed 30.5% so far this year, compared to a gain of 0.9% for the industry.
A phase I study assessed the safety, tolerability, pharmacokinetics, pharmacodynamics and bioavailability of AG-519 in healthy volunteers in the UK. Earlier this month, while presenting phase I data at the annual meeting of the American Society of Hematology, the company disclosed a case of drug-induced cholestatic hepatitis in the bioavailability portion of the study, for the 300 mg dose of AG-519. While the volunteer is still being monitored, no additional adverse event has been reported yet.
Additionally, AG-519 was going through a palatability (taste test) study in volunteers in the U.S. for the development of a formulation for future development.
We remind investors that shares of Agios took a hit this June when the company reported initial data from a phase I integrated single-ascending dose and multiple-ascending dose study on AG-519 in healthy volunteers. Results showed that one patient who received a 375 mg dose of AG-519 experienced a low blood platelet count (grade 2 thrombocytopenia) on day 14 of dosing.
However, in the latest press release, Agios has assured investors that the decision will not affect the company’s ongoing open-label safety and efficacy phase II study (DRIVE PK) on its lead PKR activator, AG-348, being conducted in transfusion-independent adult patients with PK deficiency.
The company is currently working on a registration path for AG-348 for the treatment of adult PK deficiency patients and plans to discuss this strategy with regulators.
Nevertheless, the decision to discontinue the development of AG-519 is disappointing. Moreover, Agios does not have any marketed product in its portfolio yet, which means that its pipeline needs to deliver. Similar pipeline-related setbacks will be detrimental for the company’s prospects.
Meanwhile, Agios and partner Celgene Corporation plan to submit a new drug application to the FDA for enasidenib for the treatment of patients with relapsed and/or refractory acute myeloid leukemia with an IDH2 mutation by the end of 2016.
Zacks Rank & Key Picks
Agios carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Sucampo Pharmaceuticals, Inc. and Vanda Pharmaceuticals, Inc. (VNDA - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Vanda’s loss estimates for 2016 narrowed from 62 cents to 52 cents, while its earnings estimates for 2017 increased from 13 cents to 22 cents over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 71% year to date.
Sucampo’s earnings estimates increased from $1.03 to $1.22 for 2016 and from $1.30 to $1.69 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.
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Agios Stops Development of PKR Activator AG-519, Stock Falls
Agios Pharmaceuticals, Inc.’s (AGIO - Free Report) shares tumbled 19.4% after the company announced that it is has decided to discontinue the development of one of its pyruvate kinase-R (PKR) activator, AG-519. The decision was taken after the verbal notification of a clinical hold by the FDA, which led the company to withdraw its investigational new drug application for the candidate.
Agios’ year-to-date share price movement shows that the stock has underperformed the Zacks categorized Medical–Products industry. In fact, the stock has crashed 30.5% so far this year, compared to a gain of 0.9% for the industry.
A phase I study assessed the safety, tolerability, pharmacokinetics, pharmacodynamics and bioavailability of AG-519 in healthy volunteers in the UK. Earlier this month, while presenting phase I data at the annual meeting of the American Society of Hematology, the company disclosed a case of drug-induced cholestatic hepatitis in the bioavailability portion of the study, for the 300 mg dose of AG-519. While the volunteer is still being monitored, no additional adverse event has been reported yet.
Additionally, AG-519 was going through a palatability (taste test) study in volunteers in the U.S. for the development of a formulation for future development.
We remind investors that shares of Agios took a hit this June when the company reported initial data from a phase I integrated single-ascending dose and multiple-ascending dose study on AG-519 in healthy volunteers. Results showed that one patient who received a 375 mg dose of AG-519 experienced a low blood platelet count (grade 2 thrombocytopenia) on day 14 of dosing.
However, in the latest press release, Agios has assured investors that the decision will not affect the company’s ongoing open-label safety and efficacy phase II study (DRIVE PK) on its lead PKR activator, AG-348, being conducted in transfusion-independent adult patients with PK deficiency.
The company is currently working on a registration path for AG-348 for the treatment of adult PK deficiency patients and plans to discuss this strategy with regulators.
Nevertheless, the decision to discontinue the development of AG-519 is disappointing. Moreover, Agios does not have any marketed product in its portfolio yet, which means that its pipeline needs to deliver. Similar pipeline-related setbacks will be detrimental for the company’s prospects.
Meanwhile, Agios and partner Celgene Corporation plan to submit a new drug application to the FDA for enasidenib for the treatment of patients with relapsed and/or refractory acute myeloid leukemia with an IDH2 mutation by the end of 2016.
Zacks Rank & Key Picks
Agios carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Sucampo Pharmaceuticals, Inc. and Vanda Pharmaceuticals, Inc. (VNDA - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Vanda’s loss estimates for 2016 narrowed from 62 cents to 52 cents, while its earnings estimates for 2017 increased from 13 cents to 22 cents over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 71% year to date.
Sucampo’s earnings estimates increased from $1.03 to $1.22 for 2016 and from $1.30 to $1.69 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.
The Best Place to Start Your Stock Search
Today, you are invited to download the full list of 220 Zacks Rank #1 "Strong Buy" stocks – absolutely free of charge. Since 1988, Zacks Rank #1 stocks have nearly tripled the market, with average gains of +26% per year. Plus, you can access the list of portfolio-killing Zacks Rank #5 "Strong Sells" and other private research. See these stocks free >>