09:08 AM EDT, 08/28/2025 (MT Newswires) -- Health care stocks were edging higher premarket Thursday, with the Health Care Select Sector SPDR Fund ( XLV ) advancing by 0.2% and the iShares Biotechnology ETF (IBB) up 0.4%.
Celcuity ( CELC ) stock was more than 10% higher after the company said the US Food and Drug Administration has agreed to review its new drug application for gedatolisib under the Real-Time Oncology Review program for treating HR+/HER2- advanced breast cancer.
Novavax ( NVAX ) shares were up more than 2% after the company said the US Food and Drug Administration approved its Nuvaxovid 2025-2026 COVID-19 vaccine for adults 65 and older, as well as individuals aged 12 to 64 with underlying conditions that increase the risk of severe disease.
Telix Pharmaceutical (TLX) shares were down more than 17% after the company said the US Food and Drug Administration has requested additional data on its biologics license application for Zircaix (TLX250-CDx), an investigational PET agent for diagnosing clear cell renal cell carcinoma.