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

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Celcuity Stock Moves Higher After Licensing Pact With Pfizer For Gedatolisib In Breast Cancer
  • Celcuity Inc (NASDAQ: CELC) has entered into a global licensing agreement with Pfizer Inc (NYSE: 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.
 

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Posted-In: breast cancerBiotech M&A News Health Care Offerings FDA General

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