Agios Pharmaceuticals, Inc (AGIO - Free Report) has entered into an exclusive collaboration and license agreement with China’s CStone Pharmaceuticals to develop and commercialize its pipeline candidate, Tibsovo (ivosidenib; AG-120), in Mainland China, Hong Kong, Macau and the Taiwan territory for leukemia indications.
Per the terms of the agreement, Agios will receive an upfront payment of $12 million and be eligible to receive up to $412 million as regulatory/sales-based milestone payments. Agios will retain all the rights to Tibsovo (ivosidenib) in the rest of the world.
CStone Pharmaceuticals will lead development in hematologic and solid tumor indications across the territory with an initial focus on acute myeloid leukemia (AML) and cholangiocarcinoma. Tibsovo will be studied both as a monotherapy and in combination with other cancer drugs. Notably, last December, Agios submitted a new drug application (NDA) to the FDA for Tibsovo (ivosidenib), which has been developed for treating patients with relapsed/refractory acute myeloid leukemia (AML) and an IDH1 mutation.
Subsequently, in February the FDA accepted the NDA under priority review for the given indication. The FDA has set a Prescription Drug User Fee Act or PDUFA action date of Aug 21, 2018. A regulatory filing for the candidate in the EU is expected during the fourth quarter of 2018 for the same indication.
Ivosidenib is currently being evaluated in a phase III study for front-line AML patients with an IDH1 mutant-positive advanced cholangiocarcinoma. We remind investors that Agios is also conducting a phase I/II trial in combination with Celgene's (CELG - Free Report) Vidaza for the treatment of newly diagnosed AML patients, not eligible for intensive chemotherapy. The FDA granted an orphan drug designation to ivosidenib for treating AML patients.
Shares of Agios have surged 53.3% year to date, outperforming the industry’s increase of 8%.
Agios currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include CRISPR Therapeutics AG (CRSP - Free Report) and Genomic Health Inc (GHDX - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here
CRISPR Therapeutics’ loss per share estimates has been narrowed by 7.8% for 2018 and 9% for 2019 in the last 60 days. The stock has skyrocketed 173% year to date.
Genomic Health’s earnings estimates have been revised 46.9% upward for 2018 and 5.6% for 2019 in the past 60 days. The stock has soared 52.6% so far this year
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