tiprankstipranks
Advertisement
Advertisement

Celcuity (Giredestrant): Anticipated PIK3CA Data and Global Regulatory Momentum Support Buy Rating

Celcuity (Giredestrant): Anticipated PIK3CA Data and Global Regulatory Momentum Support Buy Rating

TD Cowen analyst Tara Bancroft has maintained their bullish stance on CELC stock, giving a Buy rating yesterday.

Meet Samuel – Your Personal Investing Prophet

Tara Bancroft has given his Buy rating due to a combination of factors tied to Celcuity’s lead asset giredestrant (Geda) and its pivotal VIKTORIA-1 program. He views the upcoming PIK3CA‑mutant breast cancer Phase III readout as a key value driver, noting that median progression‑free survival of roughly 10 months versus control would be sufficient for statistical success, with even greater upside if efficacy approaches the 15‑19 month range previously observed in Phase Ib.

Management’s confidence ahead of the July 17 PDUFA for the PIK3CA wild‑type setting, combined with Real‑Time Oncology Review, supports Bancroft’s view that a U.S. approval is likely and could enable a quicker label expansion into the mutant population. In parallel, advancing ex‑U.S. regulatory work in Europe and Japan, including plans for an EU MAA using combined datasets and established alignment with Japanese regulators, underpins his expectation of a broad, timely global launch opportunity that justifies a Buy recommendation.

Disclaimer & DisclosureReport an Issue

1