Shares of Celcuity rose more than 9% after the company shared big news. The U.S. Food and Drug Administration has agreed to review its new drug application for a breast cancer treatment called gedatolisib. This drug is being developed for women with a certain type of advanced breast cancer known as HR positive and HER2 negative.
The FDA is taking the application under a program called Real-Time Oncology Review. In simple words, this program helps speed things up. It allows companies to give the FDA important data early, instead of waiting until everything is fully completed. This way, the review process can move faster.
Celcuity said it will start submitting the application in September and plans to finish it by the end of 2025. The decision comes after the company reported very encouraging results from its latest trial. In that study, the combination of gedatolisib with other treatments significantly slowed down the disease.
For example, when used with fulvestrant and palbociclib, the drug reduced the risk of cancer getting worse or causing death by about 76%. Patients lived around 9.3 months without the cancer spreading, compared to just 2 months with fulvestrant alone. Even when used with just fulvestrant, the drug still cut the risk by 67% and gave patients 7.4 months of benefit compared to 2 months.
The FDA had already labeled gedatolisib as both a Breakthrough Therapy and a Fast Track drug, which shows how important it could be for patients who need better treatment options after trying other therapies.
Celcuity’s CEO Brian Sullivan said the team is very pleased with the FDA’s decision, especially coming right after the company shared strong trial results last month.
With this progress, the stock has attracted new attention. Investors are now wondering if Celcuity’s shares are still a good value or if the excitement has already been priced in.