NEW YORK, July 7, 2026, 15:07 EDT
- Agios Pharmaceuticals jumped 14.9% to $42.95 as of 2:52 p.m. EDT, putting on around $327 million in implied market cap.
- The U.S. FDA has accepted the mitapivat application for sickle cell, giving it Priority Review with a PDUFA target date of Nov. 1.
- The stock was 9.2% over Google Finance’s 12-month average target of $39.33.
- Agios will post its second-quarter earnings on July 30 at 8:00 a.m. ET.
Agios Pharmaceuticals NASDAQ:AGIO soared Tuesday after the FDA granted its sickle-cell disease application priority review. Shares pushed through the average Wall Street price target before any official FDA decision.
Agios traded at $42.95, 9.2% higher than Google Finance’s $39.33 average 12-month target. Shares were also 34.2% over RBC Capital’s $32 target, which TradingView, via The Fly, said RBC just raised from $28. BofA has a $46 target, leaving about 7.1% upside.
| Target marker | Figure | Gap from AGIO at $42.95 |
|---|---|---|
| Google Finance 12-month average | $39.33 | AGIO trades 9.2% higher |
| Google Finance highest target | $54.00 | Implied upside of 25.7% |
| Google Finance lowest target | $31.00 | AGIO is 38.5% higher |
| RBC Capital’s target | $32.00 | AGIO sits 34.2% above |
| BofA target price | $46.00 | Upside of 7.1% implied |
The FDA has accepted Agios’ supplemental New Drug Application for mitapivat and gave it Priority Review under the accelerated approval path. Agios said the agency set a Nov. 1 PDUFA date. If the drug gets approved, mitapivat would become the first oral pyruvate kinase activator available for sickle cell disease.
Sarah Gheuens, chief medical officer and R&D head at Agios, said sickle cell disease is a “large, underserved population.” She said the company’s filing is supported by over 1,300 patient-years of clinical data in hemolytic anemias. Agios Pharmaceuticals, Inc.
Agios stock outpaced the biotech sector by a wide margin. The shares topped the iShares Nasdaq Biotechnology ETF (NASDAQ:IBB) by 13.5 percentage points and the SPDR S&P Biotech ETF (NYSEARCA:XBI) by 13.3 percentage points, according to market data.
| Instrument | Snapshot price | Day move | Read-through |
|---|---|---|---|
| Agios Pharmaceuticals NASDAQ:AGIO | $42.95 | +14.9% | Stock jumped after FDA news broke |
| iShares Nasdaq Biotechnology ETF (NASDAQ:IBB) | $197.90 | +1.3% | Sector was higher, but not by much |
| SPDR S&P Biotech ETF (NYSEARCA:XBI) | $163.36 | +1.6% | Biotech names gained but trailed AGIO |
| SPDR S&P 500 ETF Trust NYSEARCA:SPY | $747.77 | -0.5% | Main index slipped |
Volume was a factor, too. Agios moved around 2.03 million shares at the time of the snapshot, about 1.8x its 1.11 million average according to Google Finance. The stock stood 6.6% under the 52-week high of $45.99.
The clinical story is still mixed. In the RISE UP study, 40.6% of patients on mitapivat met the hemoglobin-response endpoint, compared to 2.9% for placebo. But annualized sickle-cell pain crises didn’t reach significance, and there was no overall improvement in fatigue. Biree Andemariam of University of Connecticut Health said in June that patients need new options.
| RISE UP signal | Mitapivat | Placebo/comparator | Stock read |
|---|---|---|---|
| Hemoglobin response | 40.6% | 2.9% placebo | Main support for the filing |
| Patients needing blood transfusions | 23.9% | 40.6% placebo | Cuts supportive care |
| Red-cell units transfused per patient | 0.70 | 1.59 placebo | Shows anemia use for drug |
| Pain-crisis primary endpoint | Lower, but not significant | Placebo | Label and uptake risk stay |
| Fatigue key secondary endpoint | No real difference | Placebo | Keeps commercial argument going |
Agios booked first-quarter mitapivat net revenue at $20.7 million, up from $8.7 million a year ago. Cash, cash equivalents and marketable securities totaled $1.0 billion as of March 31. Net loss for the quarter was $99.1 million.
BofA thinks Agios can probably hit the $26.9 million consensus for Q2 revenue, TradingView’s Stocktwits feed reported, pointing to BofA’s focus on shifting scripts into paid sales and watching reimbursement trends. Agios has its Q2 call coming up on July 30.
