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Gedatolisib regimens double progression-free survival in advanced HR+/HER2- breast cancer vs. alpelisib plus fulvestrant

Company Fundamentals
02 Jun 2026
GlobeNewsWire
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Bullish
pluang ai news

Celcuity's Phase 3 VIKTORIA-1 trial showed gedatolisib combined with fulvestrant, with or without palbociclib, doubled progression-free survival (PFS) to about 11 months in patients with HR+/HER2- advanced breast cancer harboring PIK3CA mutations, compared to alpelisib plus fulvestrant which had a PFS of 5.6 months. The gedatolisib triplet also achieved a higher objective response rate (48.9%) and longer duration of response than the comparator. Safety profiles were favorable with fewer treatment discontinuations. These results position gedatolisib as a potential new standard of care pending FDA approval, with commercial launch anticipated in Q3 2026.

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Global automotive microcontrollers market to reach $34.31B by 2035, driven by ADAS, electrification, and software-defined vehicles.

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