Retail investors defended Agios on Stocktwits, saying reported deaths involved critically ill patients and didn’t reflect typical use.
Retail chatter around Agios Pharmaceuticals spiked Tuesday after the company said that Saudi Arabia’s Food and Drug Authority (SFDA) approved Pyrukynd (mitapivat) for the treatment of adult patients with alpha- or beta-thalassemia, regardless of transfusion status.
The approval was granted under the SFDA’s Breakthrough Medicines Program and is based on results from the global Energize and Energize-T Phase 3 trials.
Shares of Agios Pharmaceuticals closed 3.3% higher at $36.16 on Monday, with the stock rising another 2% in after-hours trading to $36.88.
Agios had partnered with NewBridge Pharmaceuticals in 2024 to support regional commercialization efforts across the Gulf Cooperation Council (GCC), including the UAE, Kuwait, Qatar, Oman, and Bahrain.
However, the milestone approval came alongside new safety scrutiny in the U.S. market.
Leerink analyst Andrew Berens noted that three newly listed deaths involving Pyrukynd appeared in the FDA’s Adverse Event Reporting System (FAERS) in July, bringing the total to four since launch.
Two of the July cases were in young patients. Berens called the developments “potentially concerning” but cautioned that FAERS entries often lack key details and context.
In a regulatory filing, Agios said it was aware of the report and confirmed that three of the four cases had already been submitted to the FDA through standard pharmacovigilance processes.
Two patients involved were treated with Pyrukynd for pyruvate kinase deficiency under its approved U.S. indication, while one patient with sickle cell disease was treated through expanded access.
The fourth case had been reported directly to the FDA, and Agios said it is currently evaluating it.
The company added that, to date, the available information does not change Pyrukynd’s benefit-risk profile as represented in its U.S. prescribing information.
A regulatory decision on Pyrukynd for thalassemia is due from the U.S. FDA by Sept. 7. Additional filings are under review in the UAE and European Union.
On Stocktwits, retail sentiment for Agios was ‘bullish’ amid ‘extremely high’ message volume.
One user acknowledged not being bullish on the stock but noted that each reported death involved patients with severe underlying conditions.
“Two were dealing with sickle cell complications, one was 93 and already critically ill — none were stable patients simply adding Pyrukynd to an existing regimen,” the user wrote, suggesting the outcomes may not reflect typical treatment scenarios.
Another user focused on the day’s sharp intraday recovery, and said the stock had an “absolutely incredible recovery.”
Agios’ stock has risen 13.6% so far in 2025.
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