Agios (AGIO) Stock Falls 8.4% on Q3 Results, FDA Delay

Agios Pharmaceuticals (AGIO) shares were down 8.4% in trading on November 5, 2026, after the company released its Agios Q3 2026 results and business update. Sales of its drug mitapivat reached $55.4 million, more than four times the year-earlier quarter, but the update also included a later FDA decision date for the drug in sickle cell disease.

What Agios reported in Q3 2026

Metric	This period	A year earlier	Change
Mitapivat net revenue	$55.4M	$12.9M	+330%
Net loss	$65.0M	$103.4M	37% smaller
Net loss per share	$1.09	$1.78	39% smaller
R&D expenses	$73.5M	$86.8M	-15%
Selling, general and admin expenses	$56.5M	$41.3M	+37%

U.S. sales were $48.7 million, up 20% from the previous quarter, driven by the January 2026 launch of AQVESME in thalassemia. About 75% of patients remain on AQVESME after six months. Sales outside the U.S. were $6.6 million, up 74% from the previous quarter, mainly from early access programs in Europe after the drug's EU approval in thalassemia in late May 2026.

Agios will have cut more than 100 research and development roles by the end of 2026, a reduction of over 35% from 2025. It expects the savings from these cuts to show up in 2027.

Why the stock fell 8.4%

The drop was about twice the size of a typical day's swing for the stock. The detail most likely weighing on shares is the FDA delay. Its decision on mitapivat in sickle cell disease, which the CEO called the drug's "largest indication opportunity", moved from November 1, 2026 to February 1, 2027. The FDA is also assessing whether the drug needs a REMS, a formal safety program that can add steps for prescribers. Agios's answer to that question counted as a major change to its application, which triggered the extension.

What to watch next

The FDA decision on mitapivat in sickle cell disease, due by February 1, 2027.
14 Agios abstracts at the ASH 2026 hematology meeting, December 12 to 15, in New Orleans.
AQVESME prescriptions: 619 completed as of September 30, 2026, with 48 more in process.

FAQ

Is Agios's mitapivat approved in the UAE?

Yes. It is approved under the name PYRUKYND for thalassemia in adults in the UAE, Saudi Arabia and Oman. Agios sells it in the GCC through a partnership with NewBridge Pharmaceuticals.

How much cash does Agios have?

Agios held $907.0 million in cash, cash equivalents and marketable securities on September 30, 2026, down from $1.2 billion at the end of 2025. It is aiming for non-GAAP profitability in 2028, meaning profit before certain items such as stock-based pay.

Sources

This article is for information only and is not investment advice.