Agios Pharmaceuticals announced the FDA has extended the PDUFA goal date for its supplemental New Drug Application (sNDA) for mitapivat in sickle cell disease to February 1, 2027. The extension follows the FDA's request for additional safety data to assess the need for a Risk Evaluation and Mitigation Strategy (REMS). Agios responded with updated safety data showing no new liver injury concerns, and the FDA classified this as a major amendment, adding three months to the review. Mitapivat, already approved for other blood disorders, could become a key treatment for sickle cell disease, affecting around 100,000 U.S. patients, with Agios ready to launch pending approval.
Agios Pharmaceuticals' new PDUFA goal date for mitapivat in sickle cell disease is February 1, 2027. For readers following the health sector, here is Pluang's market snapshot as of Oct 30, 2026 18:11 WIB: out of 150 priced US health stocks, 75 rose and 70 fell. Regeneron Pharmaceuticals Inc (REGN) gained 6.87% to USD 875.00, while BrightSpring Health Services Inc. (BTSG) rose 6.53% to USD 64.15 with 90% buy orders on Pluang.
As Halloween approaches, MADD Canada warns against impaired driving caused by alcohol, cannabis, or drugs, which leads to hundreds of deaths and thousands of injuries annually in Canada. The organization urges people to plan safe transportation if co...
MADD Canada warns Canadians to avoid impaired driving during Halloween, emphasizing the risks of alcohol, cannabis, and drug-related crashes that cause deaths and injuries annually. The organization urges people to plan safe rides, watch for children...
Investec Bank Plc, acting as joint broker for SThree Plc, disclosed share transactions on October 29, 2026. The bank purchased and sold 49,799 ordinary shares of SThree Plc at prices ranging between 297.5 and 306.5 per share. No derivative or option ...
Investec Bank plc, acting as joint broker for Gamma Communications Plc, disclosed its share dealings on October 29, 2026. The bank purchased 218,193 ordinary shares at prices between 1091 and 1094 pence per share and sold 160,410 shares at prices bet...
Investec Bank Plc, acting as advisor and joint broker to Advanced Medical Solutions Group Plc, disclosed its share dealings on October 29, 2026. The bank purchased 10,640 ordinary shares at a price of 282.75 per share and sold 98 shares at 283 each. ...
