BUZZ-Celcuity falls as delayed launch of breast cancer drug overshadows first FDA approval
CELC•Year-to-date performance
As of last close, CELC was up 11.3% year to date.
Analyst view on launch timing and volatility
"Approval was largely expected, but the company delayed the launch until late 3Q26, which we did not anticipate given prior commentary on launch readiness," Leerink Partners said.
"We expect shares to be volatile, especially following the announcement that a large shareholder sold positions" - Leerink.
Shares fall after FDA approval and delayed launch outlook
Shares of drug developer Celcuity (CELC.O) fell 7.5% to $102.7 in premarket trading.
The U.S. FDA late on Tuesday approved CELC's drug for an advanced form of breast cancer, making it the company's first product to gain market entry.
The drug, branded as Revtorpyk, intends to treat patients with advanced breast cancer whose tumors have low levels of a protein called HER2 and no mutation in a gene called PIK3CA.
CELC expects to begin marketing the drug in the third quarter.
