Celcuity Stock Moves Higher After Licensing Pact With Pfizer For Gedatolisib In Breast Cancer

Celcuity Inc CELC has entered into a global licensing agreement with Pfizer Inc PFE, granting Celcuity exclusive rights to Pfizer's gedatolisib.
The pan-PI3K/mTOR inhibitor is currently in Phase 1b trial to treat patients with ER+/HER2-negative advanced or metastatic breast cancer.
Celcuity paid an upfront license fee of $5 million cash and $5 million of Celcuity's common stock.
Pfizer is eligible to receive up to $330 million of development and sales-based milestone payments and tiered royalties on potential sales.
Additional financial terms of the agreement were not disclosed.
Gedatolisib is currently being evaluated in combination with palbociclib, an oral CDK 4/6 inhibitor, and either letrozole or fulvestrant in the expansion portion of a Phase 1b trial in patients with ER+/HER2-negative advanced or metastatic breast cancer.
103 patients were enrolled in one of four different arms according to their prior treatment history for metastatic breast cancer.
Separately, preliminary data from the gedatolisib Phase 1b trial's expansion portion demonstrated the drug was well tolerated, and anti-tumor activity was noted.
53 of the 88 evaluable patients (60%) had an objective response. 75% of the patients had a clinical benefit, defined as either a confirmed objective response or stable disease for at least 24 weeks.
On the safety front, gedatolisib was also generally well tolerated, with most treatment-related adverse events being mild or moderate.
The most common serious/severe related to gedatolisib were stomatitis and rash.
Price Action: CELC shares are up 27.2% at $18.2, while PFE shares are up 0.1% at $36 in the premarket session on the last check Friday.