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Agios' IND for PKR Activator AG-946 Gets FDA Clearance

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Agios Pharmaceuticals, Inc. (AGIO - Free Report) announced that the FDA has cleared its investigational new drug (IND) application for AG-946, a next-generation pyruvate kinase-R (PKR) activator. The company plans to initiate a phase I study on AG-946 by the middle of this year.

Per the press release, the regulatory body completed its 30-day safety review and gave a nod to proceed with the phase I study in healthy volunteers.

Shares of Agios have plunged 45.8% in the past year compared with the industry’s decline of 26.1%.

We remind investors that Agios’ lead PKR activator, mitapivat, is being developed for treating patients with (PK) deficiency. The company completed enrollment in two pivotal studies on mitapivat.

The studies are single-arm ACTIVATE-T analyses for addressing PK deficiency in up to 40 patients, who are on regular blood transfusions, and the ACTIVATE study for treating PK deficiency in up to 80 patients with no regular blood transfusions. Agios also closed recruitment in the phase II DRIVE PK study on mitapivat in transfusion-independent adult patients with PK deficiency.

Notably, by advancing AG-946 into clinical studies, Agios is looking to strengthen and expand its PKR activation program.

However, Agios is closely monitoring the potential impact of the COVID-19 pandemic as it might limit the timeline for initiation of its clinical studies.

The coronavirus pandemic, which claimed more than 16,000 lives globally, has compelled healthcare systems to prioritize caring for the COVID-19 patients while restricting other activities. Along the same lines, on Monday, pharma giant Eli Lilly LLY announced that it is halting enrollment in most ongoing studies and will delay new study starts in order to allow doctors and healthcare facilities to focus on efforts to combat the coronavirus disease (COVID-19).

There is also a rising concern about the impact of the coronavirus outbreak on first-quarter 2020 earnings due to supply-chain disruptions caused by the same. In mid-February, AstraZeneca AZN raised alarm bells about the outbreak weighing on its earnings in 2020. Many others are expected to follow suit.

Zacks Rank & Key Pick

Agios currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is Nephros Inc. NEPH, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Nephros’ loss per share estimates have narrowed 15.2% for 2020 over the past 60 days. The stock has rallied 54.3% in the past year.

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