Agios Advances Mitapivat Toward Potential U.S. Accelerated Approval in Sickle Cell Disease Following Pre-sNDA Meeting with FDA [Yahoo! Finance]
Agios Pharmaceuticals, Inc. (AGIO)
Last agios pharmaceuticals, inc. earnings: 4/30 07:00 am
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Source: Yahoo! Finance
Company has already submitted proposed confirmatory trial for FDA review, as required under accelerated approval pathway Company plans to submit mitapivat sNDA in sickle cell disease in the coming months, and is actively working with FDA to achieve alignment on confirmatory trial required for submission CAMBRIDGE, Mass., March 31, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that it will pursue U.S. accelerated approval for mitapivat, an oral pyruvate kinase (PK) activator, in sickle cell disease, following completion of its pre-supplemental New Drug Application (sNDA) meeting with the U.S. Food and Drug Administration (FDA). The purpose of the pre-sNDA meeting was to present the data from the mitapivat RISE UP clinical program in sickle cell disease, including both the Phase 2 and Phase 3 trials. Based on the discussio
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AGIO
News
- Agios Pharmaceuticals (AGIO) had its price target raised by The Goldman Sachs Group, Inc. from $28.00 to $32.00. They now have a "neutral" rating on the stock.MarketBeat
- Lost Money on Agios Pharmaceuticals, Inc.(AGIO)? You May Have Been Affected by Fraud- Contact Levi & KorsinskyPR Newswire
- Insider Sells AGIO Shares Worth $82,000 -- But Context Is Everything [Yahoo! Finance]Yahoo! Finance
- Why Agios Pharmaceuticals Stock Is Up More Than 21% Today [Yahoo! Finance]Yahoo! Finance
- AGIO ALERT- The Gross Law Firm Has Commenced an Investigation on Behalf of Agios Pharmaceuticals, Inc. Shareholders Who Lost MoneyPR Newswire
AGIO
Earnings
- 2/12/26 - Miss
AGIO
Sec Filings
- 4/2/26 - Form 144
- 4/2/26 - Form 144
- 4/2/26 - Form 144
- AGIO's page on the SEC website