Celcuity presents data at AACR annual meeting assessing gedatolisib » 16:1204/1204/12/21
Celcuity presented results of studies evaluating gedatolisib, a pan-PI3K/mTOR inhibitor, inavolisib, a PI3K-alpha inhibitor), and navitoclax, a BCL inhibitor, in breast and ovarian patient tumors. Results were presented in two e-posters at the American Association for Cancer Research, AACR, Annual Meeting. The CELsignia RAS Network Activity test for breast and ovarian cancer identifies patients whose tumors have hyperactive RAS network signaling. The posters presented at AACR describe studies using this CELsignia test to characterize the role RAS network nodes, PI3K, mTOR, and
Celcuity price target raised to $30 from $19 at H.C. Wainwright » 06:2404/1204/12/21
H.C. Wainwright analyst…
H.C. Wainwright analyst Yi Chen raised the firm's price target on Celcuity to $30 from $19 and reiterates a Buy rating on the shares after the company entered into a global licensing agreement with Pfizer (PFE) that grants it exclusive rights to develop and commercialize gedatolisib.
|Over a week ago|
Fly Intel: Pre-market Movers » 08:5104/0904/09/21
GLSI, AFMD, CELC, FUBO, SUNW, JKS, TSM, IMOS, GSL, PRVB
Check out this morning's…
Fly Intel: After-Hours Movers » 18:3604/0804/08/21
LEVI, CELC, GTIM, FUBO, CCK, WDFC, LEDS, PSMT, PRVB
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Celcuity Inc trading resumes 16:3504/0804/08/21
Celcuity reports preliminary data from Phase 1b gedatolisib plus Ibrance trial » 16:0604/0804/08/21
Celcuity reported preliminary data for the 103 patients enrolled in the expansion portion of an ongoing Phase 1b clinical trial evaluating gedatolisib, a first-in-class PI3K/mTOR inhibitor, plus Ibrance and endocrine therapy, in ER+/HER2- advanced or metastatic breast cancer patients. As of the January 11, 2021 data cut-off date, 53 of the 88 evaluable patients had an objective response. Gedatolisib was also generally well tolerated, with the majority of treatment-related adverse events being Grade 1 or 2. The most common Grade 3 or 4 TRAEs related to gedatolisib were stomatitis and rash. "We are very encouraged by this preliminary data for gedatolisib from our ongoing Phase 1b trial in patients with breast cancer," said Brian Sullivan, CEO and Co-Founder of Celcuity. "The robust response rate and the observed tolerability profile are particularly compelling given the need for a therapeutic regimen that can address endocrine therapy resistance. We look forward to sharing additional data from the study at a future medical conference in 2021. Developing a therapeutic such as gedatolisib allows us to more fully leverage our CELsignia cellular analysis platform."
Celcuity announces gedatolisib licensing agreement with Pfizer » 16:0304/0804/08/21
Celcuity (CELC) announced…
Celcuity (CELC) announced it has entered into a global licensing agreement with Pfizer Inc. (PFE) granting Celcuity exclusive rights to Pfizer's gedatolisib, a Phase 1b pan-PI3K/mTOR inhibitor. Gedatolisib is in clinical development for the treatment of patients with ER+/HER2-negative advanced or metastatic breast cancer. Under the terms of the licensing agreement, Pfizer provided Celcuity with a worldwide license to develop and commercialize gedatolisib. Celcuity paid an upfront license fee of $5M of cash and $5M of Celcuity's common stock as upfront payment. Pfizer is eligible to receive up to $330M of development and sales-based milestone payments and tiered royalties on potential sales. Additional financial terms of the agreement were not disclosed. "We are excited about the opportunity to utilize our CELsignia platform to support the development of a potential first-in-class targeted therapy like gedatolisib," said Brian Sullivan, CEO and co-founder of Celcuity. "In light of the important role the PI3K/mTOR pathway plays in driving tumor growth when patients become resistant to endocrine therapies, we believe gedatolisib is a highly promising drug candidate to improve outcomes for patients with breast cancer. Supporting development of a potential first-in-class therapy for breast cancer, such as gedatolisib, with our CELsignia platform is a natural extension of our strategy to develop CELsignia CDx for other breast cancer therapies. We believe developing targeted therapies that benefit from the CELsignia platform while also offering companion diagnostics that enable new drug indications, creates a synergistic advantage for each program."
Celcuity Inc trading halted, news pending 16:0004/0804/08/21
Celcuity files $100M mixed securities shelf 16:4703/2303/23/21
|Over a month ago|
Celcuity 1.714M share Spot Secondary priced at $14.00 » 08:4502/2402/24/21
The deal size was…
The deal size was increased to $24M in common stock from $20M in common stock. Craig-Hallum acted as sole book running manager for the offering.