AGIOAGIO
This company has a year to prove it can turn the corner — and the next catalyst is the Q4 2026 earnings report, which will test whether the recent rebound is sustainable or just a fleeting rally. If the results beat expectations and the guidance is optimistic, the stock could push toward $1.50, reflecting renewed confidence in its pipeline and regulatory progress. If the report is lackluster or misses, the shares could retreat toward $0.80, signaling continued uncertainty around its clinical trials and legal exposure.
The Read
Agios surged on strong Q4 2025 earnings and pipeline updates but fell sharply after regulatory setbacks, legal investigations, and clinical trial failures overshadowed subsequent milestones and earnings beats.
The schedule
No upcoming catalysts on the current packet.
Past
- Thu30Jul
Actual outcome: Bear · $30.54 at outcome
Agios reported a Q2 earnings beat, with mitapivat net revenues surging to $44.7 million driven by the strong U.S. commercial launch of AQVESME. Despite the positive financial results, the stock fell 8.3% and breached the bear floor, as market sentiment was overshadowed by the recent discontinuation of its tebapivat sickle cell disease program and the announcement of a securities fraud investigation.
- Fri29May
Actual outcome: Bear · $26.51 at outcome
The stock fell 9.8% after Agios announced it would halt the development of tebapivat in lower-risk myelodysplastic syndromes (LR-MDS) following a Phase 2b trial that missed its efficacy goals. Although the company quickly announced a global licensing agreement for a new late-stage rare hematology asset (cevidoplenib) to diversify its portfolio, the clinical setback for tebapivat overshadowed this news and drove the sell-off.
- Fri22May
Actual outcome: Mixed · $28.33 at outcome
Agios submitted its supplemental New Drug Application (sNDA) to the FDA for accelerated approval of mitapivat in sickle cell disease on May 12, meaning the actual PDUFA decision is still pending. While the company did receive EU approval for mitapivat in thalassemia on May 22, the stock saw a muted 0.7% reaction as the market continues to await the FDA's regulatory decision for the sickle cell indication.
- Wed29Apr
Actual outcome: Mixed · $28.16 at outcome
Agios reported a Q1 loss of $1.69 per share, beating consensus estimates, alongside a 138% surge in worldwide net revenues to $20.7 million driven by the strong U.S. commercial launch of Aqvesme and Pyrukynd growth. The stock surged 13% on the day of the earnings release as the robust sales momentum and plans to submit a supplemental NDA for sickle cell disease helped alleviate recent competitive concerns from Novo Nordisk.
- Sun15Mar
Actual outcome: Bear · $28.13 at outcome
The stock traded significantly below the bear floor as the procedural EC approval was overshadowed by multiple law firm investigations into potential securities fraud and violations related to the Mitapivat Phase 3 trial results. These legal overhangs and concerns regarding the integrity of the underlying clinical data outweighed the regulatory milestone, preventing any positive price reaction to the approval.
- Thu5Mar
Actual outcome: Mixed · $27.47 at outcome
The stock remained stagnant as the FDA pre-sNDA meeting failed to provide a definitive 'green light' for the Mitapivat submission in Sickle Cell Disease, leaving the price well below the $35.00 bull target. While the drug received approval for Thalassemia in the UAE, this was overshadowed by a wave of legal investigations into potential securities fraud related to the underlying RISE UP trial data, creating a neutral-to-bearish overhang that prevented a breakout.
- Thu12Feb
Actual outcome: Mixed · $27.82 at outcome
Agios delivered a strong fundamental beat, exceeding Q4 estimates for both the top and bottom lines as Pyrukynd sales jumped 49% year over year. The company also confirmed the launch of AQVESME for thalassemia and provided a positive regulatory update, scheduling a pre-sNDA meeting with the FDA for the sickle cell disease program in Q1 2026. These results confirmed the bull case expectations for commercial trajectory and pipeline progress, allowing the stock to maintain its value well above the bear floor despite a flat immediate price reaction.
