Celcuity Inc. ( CELC Quick Quote CELC - Free Report) soared almost 51% on Apr 9 following announcement of a licensing agreement with pharmagiant, Pfizer ( PFE Quick Quote PFE - Free Report) and promising preliminary data from an early-stage study on gedatolisib.
The company announced that it has signed a global licensing agreement with Pfizer, gaining exclusive rights to pan-PI3K/mTOR inhibitor, gedatolisib. Please note that the candidate is currently being developed in an early-stage study for breast cancer.
Per the terms of the agreement, Celcuity paid Pfizer $10 million in upfront payments — $5 million in cash and another $5 million in its common stock. The company will also pay Pfizer up to $330 million in development and sales-based milestone payments as well as tiered royalties on potential sales.
In a separate press release, the company announced promising preliminary data from an ongoing phase Ib study evaluating gedatolisib in combination with Pfizer’s Ibrance and an endocrine therapy in ER+/HER2- advanced or metastatic breast cancer patients. Data showed that the gedatolisib combo achieved an objective response rate of 60% asof the Jan 11, 2021 data cut-off date. A phase II/III study on gedatolisib combo is expected to start in mid-2022.
The receipt of exclusive rights to the promising candidate is likely to have boosted investors’ sentiment.
Celcuity’s shares have gained 135.8% so far this year against the
industry’s decrease of 6.7%.
We note that the company is primarily focused on developing efficient companion diagnostic tests for targeted therapies by discovering new cancer sub-types that are not detected by molecular approach-based tests.Gaining exclusive rights to gedatolisib is likely to have added its first cancer therapy to its pipeline.
The company has signed multiple collaboration agreements with different companies — including
Novartis ( NVS Quick Quote NVS - Free Report) and Puma Biotechnology ( PBYI Quick Quote PBYI - Free Report) —and universities to establish accuracy of its CELsignia platform-based diagnostic tests under development. Celcuity evaluates its collaborators’ drugs in patients selected with its diagnostic tests. The company already has three companion diagnostic tests available for different sub-types of breast cancer under development. The company is planning to combine these three tests into a single multi-pathway activity test. Zacks Rank
Celcuity currently carries a Zacks Rank #4 (Sell).
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