Celcuity (CELC) shares fell nearly 19% in morning trading on Wednesday as the delayed commercial launch of its newly approved breast cancer drug, gedatolisib (branded as Revtorpyk), and label concerns overshadowed the company's first U.S. FDA approval.
The FDA approved gedatolisib for certain patients with advanced breast cancer whose tumors do not carry a PIK3CA mutation, marking Celcuity’s first product to gain market entry.
Celcuity expects to begin marketing the drug in the third quarter, which surprised investors who had anticipated a more immediate launch given prior commentary on launch readiness.
The company said the delay is intended to ensure sufficient drug supply at launch; however, higher-than-expected discontinuation rates in clinical trials were highlighted in the label, weighing on investor sentiment.
Shares had briefly risen after the initial approval news but fell overall, reflecting market disappointment over the delayed launch and commercial execution risks despite the milestone approval.
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