<div id="readability-page-1"><div id="ctl00_CPI_dvBody"><div><div><p>Add <img src="https://imageproxy.pbkrs.com/https://cdn.rttnews.com/images/v4/RTTNews-Logo-224x61.png?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" original-src="https://imageproxy.pbkrs.com/https://cdn.rttnews.com/images/v4/RTTNews-Logo-224x61.png"/> as your preferred news source on Google</p><div><p><img src="https://imageproxy.pbkrs.com/https://cdn.rttnews.com/images/v4/google.png?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" original-src="https://imageproxy.pbkrs.com/https://cdn.rttnews.com/images/v4/google.png"/> Add Now</p></div></div></div><p> Agios Pharmaceuticals (AGIO) announced that the FDA has not yet issued a regulatory decision on the supplemental New Drug Application for mitapivat for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia. The company noted that the sNDA remains under active review. The PDUFA goal date issued by the FDA was December 7, 2025.</p><p>Agios said the FDA has not provided a timeline for its regulatory decision. The company<br/>continues to work with the FDA to conclude the review of the sNDA.</p><p>Shares of Agios Pharmaceuticals are down 2.6% to $27.00 in pre-market trade on Monday.</p><p>For More Such Health News, visit rttnews.com. </p><p>For comments and feedback contact: editorial@rttnews.com</p><p>Business News</p></div></div>

AGIO

<p>Agios Pharmaceuticals' stock is falling in pre-market due to the FDA's pending decision on the supplemental New Drug Application for mitapivat. The sNDA remains under active review, with no timeline provided for the regulatory decision. Shares are down 2.6% to $27.00.</p>

Why Is Agios Pharma Stock Falling In Pre-market?